To learn about nutrition and health claims generally, see Introduction to Food Product Claims

What is an Authorized Health Claim?

An Authorized Health Claim describes a health claim that has been reviewed by the FDA and approved for use.

This means you can make an authorized health claim on your product or label without having for the FDA to approve it.

There must be a "significant scientific agreement" in order for the FDA to issue an Authorized Health Claim. This means that the science supporting that health claim is unlikely to change.

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What are the Approved Health Claims?

You can get a full list of authorized health claims in our article Approved Health Claims You Can Use on Your Label

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How Do I Submit a Health Claim for Approval?

Anyone may submit a petition to the FDA to issue a qualified health claim or an authorized health claim (note that only 12 authorized health claims were issued between 1990-2018). 

The petition may include clinical laboratory studies, non-clinical laboratory studies and findings released by the FDA.

You can learn more about where to submit a health claim for approval on the FDA website and you can learn more about the requirements in the Code of Federal Regulations

Health claims will be reviewed based on the criteria defined in this FDA Guidance Document

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References

Requirements for petitioning a Authorized Health Claim

Health claims will be reviewed based on the criteria defined in this FDA Guidance Document

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Contents

Cancer-Related Claims

• Dietary Lipids and Cancer
• Fiber Containing Grain Products, Fruits, Vegetables, and Cancer
• Fruits, Vegetables, and Cancer

Risk of Health Disease Claims

• Dietary Saturated Fat, Cholesterol and Heart Disease
• Fruits, Vegetables and Grain Products and Heart Disease
• Soluble Fiber and Heart Disease
• Soy Protein and Heart Disease
• Plant Sterol / Stanol Esters and Heart Disease

Other Health Claims

• Sodium and Hypertension
• Calcium, Vitamin D, and Osteoporosis
• Folate and Neural Tube Defects
• Dietary Sweeteners and Dental Tooth Decay

Below is a list of the twelve Authorized Health Claims that can be used on your product label. 

You may author your own health claim as it relates to the food-disease relationships listed. However, any health claim you write is subject to the regulations in §101.70 Subpart E Requirements for Health Claims, so it may be easier to pick one of the pre-approved ones below.

Cancer Related Claims

Dietary Lipids and Cancer

Pre-Approved Health Claims

The following authorized health claims are pre-approved for use, subject to the requirements below.

"Development of cancer depends on many factors. A diet low in total fat may reduce the risk of some cancers."

"Eating a healthful diet low in fat may help reduce the risk of some types of cancers. Development of cancer is associated with many factors, including a family history of the disease, cigarette smoking, and what you eat."

Requirements for Using These Claims:

• The food must meet the requirement for a "low fat food" (see Nutrition Content Claims).

If you wish to write your own claim on Dietary Lipids and Cancer, see Subpart E -- 101.73

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Fiber-Containing Grain products, Fruits, Vegetables and Cancer

Pre-Approved Health Claims

The following authorized health claims are pre-approved for use, subject to the requirements below.

"Low fat diets rich in fiber-containing grain products, fruits, and vegetables may reduce the risk of some types of cancer, a disease associated with many factors."

"Development of cancer depends on many factors. Eating a diet low in fat and high in grain products, fruits, and vegetables that contain dietary fiber may reduce your risk of some cancers."

Requirements for Using These Claims:

• The food must be OR contain a fruit, grain, or vegetable

• The food must meet the requirements for a "low fat food"

• The food must meet the requirements for a "good source of fiber" without fortification

If you wish to write your own claim on Fiber-Containing Grain products, Fruits, Vegetables and Cancer, see Subpart E -- 101.7

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Fruits, Vegetables, and Cancer

Pre-Approved Health Claims

The following authorized health claims are pre-approved for use, subject to the requirements below.

"Low fat diets rich in fruits and vegetables (foods that are low in fat and may contain dietary fiber, vitamin A, and vitamin C) may reduce the risk of some types of cancer, a disease associated with many factors. Broccoli is high in vitamins A and C, and it is a good source of dietary fiber."

"Development of cancer depends on many factors. Eating a diet low in fat and high in fruits and vegetables, foods that are low in fat and may contain vitamin A, vitamin C, and dietary fiber, may reduce your risk of some cancers. Oranges, a food low in fat, are a good source of fiber and vitamin C."

Requirements for Using These Claims:

• The food must be OR contain a fruit or a vegetable.

• The food must meet the requirements for a "low fat" food.

If you wish to write your own claim on Fruits, Vegetables and Cancer, see Subpart E -- 101.78

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Risk of Heart Disease Claims

Dietary Saturated Fat, Cholesterol and the Risk of Coronary Heart Disease

Pre-Approved Health Claims

The following authorized health claims are pre-approved for use, subject to the requirements below.

"While many factors affect heart disease, diets low in saturated fat and cholesterol may reduce the risk of this disease"

"Development of heart disease depends upon many factors, but its risk may be reduced by diets low in saturated fat and cholesterol and healthy lifestyles"

"Development of heart disease depends upon many factors, including a family history of the disease, high blood LDL-cholesterol, diabetes, high blood pressure, being overweight, cigarette smoking, lack of exercise, and the type of dietary pattern. A healthful diet low in saturated fat, total fat, and cholesterol, as part of a healthy lifestyle, may lower blood cholesterol levels and may reduce the risk of heart disease"

"Many factors, such as a family history of the disease, increased blood- and LDL-cholesterol levels, high blood pressure, cigarette smoking, diabetes, and being overweight, contribute to developing heart disease. A diet low in saturated fat, cholesterol, and total fat may help reduce the risk of heart disease"

"Diets low in saturated fat, cholesterol, and total fat may reduce the risk of heart disease. Heart disease is dependent upon many factors, including diet, a family history of the disease, elevated blood LDL-cholesterol levels, and physical inactivity."

Requirements for Using These Claims:

• The food must meet the requirements for a "low saturated fat food"

• The food must meet the requirements for a "low cholesterol food"

If you wish to write your own claim on Saturated Fat, Cholesterol and Coronary Heart Disease Subpart E -- 101.75

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Fruits, Vegetables, and Grain Products that Contain Fiber, and the Risk of Coronary Heart Disease

Pre-Approved Health Claims

The following authorized health claims are pre-approved for use, subject to the requirements below.

 "Diets low in saturated fat and cholesterol and rich in fruits, vegetables, and grain products that contain some types of dietary fiber, particularly soluble fiber, may reduce the risk of heart disease, a disease associated with many factors."

"Development of heart disease depends on many factors. Eating a diet low in saturated fat and cholesterol and high in fruits, vegetables, and grain products that contain fiber may lower blood cholesterol levels and reduce your risk of heart disease."

Requirements for Using These Claims:

• The food must be OR contain a fruit, grain, or vegetable

• The food must meet the requirements for a "low saturated fat" food, "low cholesterol" food, or a "low fat" food

• The food must contain 0.6g of soluble fiber per serving (without fortification).

• The soluble fiber content must de displayed in the nutrition panel.

If you wish to write your own claim on Fruits, Vegetables, and Grain Products that Contain Fiber, and the Risk of Coronary Heart Disease, see Subpart E -- 101.77

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Soluble Fiber and the Risk of Coronary Heart Disease 

Pre-Approved Health Claims

The following authorized health claims are pre-approved for use, subject to the requirements below.

"Soluble fiber from foods such as [*Insert name of applicable soluble fiber]) of this section and, if desired, the name of food product], as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies ____ grams of the [grams of soluble fiber applicable soluble fiber specified] soluble fiber from [*Insert name of applicable soluble fiber] necessary per day to have this effect."

"Diets low in saturated fat and cholesterol that include ____ grams of soluble fiber per day from [*Insert name of applicable soluble fiber] may reduce the risk of heart disease. One serving of [name of food] provides ____ grams of this soluble fiber."

*Applicable Soluble Fibers: oat bran, rolled oats, whole wheat flour, oatrim, whole grain barley, dry milled barley, barley betafiber, psyllium husk,

Requirements for Using These Claims:

• The food product must include at least 0.75g (per amount of the food typically consumed) of one of the following:

  • Oat Bran

  • Rolled oats

  • Whole wheat flour

  • Whole grain barley and dry milled barley

• The food containing oatrim must contain ≥0.75g of beta-glucan soluble fiber per amount of the food typically consumed.

• The food containing psyllium husk must contain ≥01.7g of soluble fiber per amount of the food typically consumed.

• The amount of soluble fiber must be claimed in the nutrition information label.

• The food must meet the requirement for a "low saturated fat" The only acceptable exception is if the food exceeds the requirement for "low fat" food due to fat derived from the whole oat sources.

• The food must meet the requirement for a "low cholesterol food".

If you wish to write your own claim on Soluble Fiber and the Risk of Coronary Heart Disease, see Subpart E -- 101.81

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Soy Protein and the Risk of Coronary Heart Disease

Pre-Approved Health Claims

The following authorized health claims are pre-approved for use, subject to the requirements below.

"25 grams of soy protein a day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies __ grams of soy protein."

"Diets low in saturated fat and cholesterol that include 25 grams of soy protein a day may reduce the risk of heart disease. One serving of [name of food] provides __ grams of soy protein."

Requirements for Using These Claims:

• The food must meet the nutrient requirements for a "low fat" food unless it comes from soybeans and contains no additional fat than the fat inherent in those soybeans.

• The food must meet the requirements for a "low saturated fat" food and a "low cholesterol" food.

If you wish to write your own claim on Soy Protein and the Risk of Coronary Heart Disease, see Subpart E -- 101.82

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Plant Sterol/Stanol Esters and the Risk of Coronary Heart Disease

Pre-Approved Health Claims

The following authorized health claims are pre-approved for use, subject to the requirements below.

For Plant Sterol Esters:

"Foods containing at least 0.65 g per serving of plant sterol esters, eaten twice a day with meals for a daily total intake of at least 1.3 g, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of the food] supplies ___grams of vegetable oil sterol esters."

"Diets low in saturated fat and cholesterol that include two servings of foods that provide a daily total of at least 1.3 g of vegetable oil sterol esters in two meals may reduce the risk of heart disease. A serving of [name of the food] supplies ___grams of vegetable oil sterol esters."


For Plant Stanol Esters:

"Foods containing at least 1.7 g per serving of plant stanol esters, eaten twice a day with meals for a total daily intake of at least 3.4 g, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of the food] supplies ___grams of plant stanol esters."

"Diets low in saturated fat and cholesterol that include two servings of foods that provide a daily total of at least 3.4 g of vegetable oil stanol esters in two meals may reduce the risk of heart disease. A serving of [name of the food] supplies ___grams of vegetable oil stanol esters."

Requirements for Using These Claims:

• The food must contain ≥ 0.65g of applicable plant sterol* esters per amount typically consumed.

• The food must contain ≥ 1.7g of plant stanol esters per amount typically consumed. Note that only certain food products are eligible to make this claim, including spreads, salad dressings, snack bars, and dietary supplements.

• The food must meet the nutrient requirements for a "low saturated fat" food and a "low cholesterol" food.

• The food must meet the limit for total fat per 50g -- except for spreads and salad dressings, which can exceed this limit if they have a disclosure statement such as, "see nutrition information for fat content"

• Except for salad dressing, the food must meet the minimum nutrient requirement (see §101.14(e)(6)).

*Applicable Plant Sterols: prepared by esterifying a mixture of plant sterols from edible oils with food-grade fatty acids. The plant sterol mixture shall contain at least 80%  beta-sitosterol, campesterol, and stigmasterol (combined weight).

*Applicable Plant Stanol Esters: Plant stanol esters prepared by esterifying a mixture of plant stanols derived from edible oils or byproducts of the kraft paper pulping process with food-grade fatty acids. The plant stanol mixture shall contain at least 80 percent sitostanol and campestanol (combined weight).

If you wish to write your own claim on Plant Sterol/Stanol Esters and the Risk of Coronary Heart Disease, see Subpart E -- 101.83

Other Health Claims

Sodium and Hypertension

Pre-Approved Health Claims

The following authorized health claims are pre-approved for use, subject to the requirements below.

"Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors."

"Development of hypertension or high blood pressure depends on many factors. [This product] can be part of a low sodium, low salt diet that might reduce the risk of hypertension or high blood pressure."

Requirements for Using These Claims:

• The sodium must me the requirements for a "low sodium" food (see "low sodium requirements")

If you wish to write your own claim on Sodium and Hypertension, see Subpart E -- 101.74

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Calcium, Vitamin D and Osteoporosis

Pre-Approved Health Claims

The following authorized health claims are pre-approved for use, subject to the requirements below.

"Adequate calcium throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis."

"Adequate calcium as part of a healthful diet, along with physical activity, may reduce the risk of osteoporosis in later life."

"Adequate calcium and vitamin D throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis."

"Adequate calcium and vitamin D as part of a healthful diet, along with physical activity, may reduce the risk of osteoporosis in later life."

Requirements for Using These Claims:

• If the claim references Vitamin D, then the food must exceed the requirements for a "high" level of vitamin D (see here)

• The calcium in the food must be absorbable as a nutrient.

• There may not be more phosphorus than calcium in the food (by weight.)

If you wish to write your own claim on Calcium, Vitamin D, and Osteoperosis, see Subpart E -- 101.72

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Folate and Neural Tube Defects

Pre-Approved Health Claims

Neural tube defects are a birth defect of the brain or spinal cord that can lead to disability or infant mortality.

The following authorized health claims are pre-approved for use, subject to the requirements below.

"Model health claim appropriate for foods containing 100 percent or less of the DV for folate per serving or per unit. The example contains all required elements plus optional information: Women who consume healthful diets with adequate folate throughout their childbearing years may reduce their risk of having a child with a birth defect of the brain or spinal cord. Sources of folate include fruits, vegetables, whole grain products, fortified cereals, and dietary supplements."

"Model health claim appropriate for foods intended for use by the general population and containing more than 100 percent of the DV of folate per serving or per unit: Women who consume healthful diets with adequate folate may reduce their risk of having a child with birth defects of the brain or spinal cord. Folate intake should not exceed 250% of the DV (1,000 mcg)."

The following health claims may be used if the food contains 100% or less of the daily value for the serving per-unit.

" Healthful diets with adequate folate may reduce a woman's risk of having a child with a brain or spinal cord birth defect."

"Adequate folate in healthful diets may reduce a woman's risk of having a child with a brain or spinal cord birth defect."

Requirements for Using These Claims:

• The food must meet the minimum requirements for a "good source of folate"

• The foods must not contain more than 100% of the daily recommended intake for vitamin A as retinol per serving.

• The foods must not contain more than 100% of the daily recommended intake of preformed vitamin A or D per serving.

• The nutrition information label must include information about folate.

*Note there are additional requirements for dietary supplements

If you wish to write your own claim on Folate and Neural Tube Defects, see Subpart E -- 101.72

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Dietary Sweeteners and Dental Tooth Decay

The title of this section in the legislation is "Dietary Noncariogenic Carbohydrate Sweeteners and Dental Caries"

Pre-Approved Health Claims

The following authorized health claims are pre-approved for use, subject to the requirements below.

"Frequent eating of foods high in sugars and starches as between-meal snacks can promote tooth decay. The sugar alcohol [name, optional] used to sweeten this food may reduce the risk of dental caries."

"Frequent between-meal consumption of foods high in sugars and starches promotes tooth decay. The sugar alcohols in [name of food] do not promote tooth decay."

"Frequent eating of foods high in sugars and starches as between-meal snacks can promote tooth decay. [*insert the applicable sweetener from the list below], the sugar used to sweeten this food, unlike other sugars, may reduce the risk of dental caries."

"Frequent between-meal consumption of foods high in sugars and starches promotes tooth decay. [*insert the applicable sweetener from the list below], the sugar in [name of food], unlike other sugars, does not promote tooth decay."

"Frequent eating of foods high in sugars and starches as between-meal snacks can promote tooth decay. Sucralose, the sweetening ingredient used to sweeten this food, unlike sugars, does not promote tooth decay."

Shortened Claims for Use on Small Packages:

"Does not promote tooth decay."

"May reduce the risk of tooth decay."

"[*insert the applicable sweetener from the list below] sugar does not promote tooth decay."

"[*insert the applicable sweetener from the list below] sugar may reduce the risk of tooth decay."

*Applicable Sweeteners:  xylitol, sorbitol, mannitol, maltitol, isomalt, lactitol, hydrogenated starch hydrolysates, hydrogenated glucose syrups, erythritol, D-tagatose, isomaltulose, sucralose."

Requirements for Using These Claims:

• The product must meet the requirement for sugar content claims

If you wish to write your own claim on Dietary Sweeteners and Dental Tooth Decay, see Subpart E -- 101.80 Dietary Non-Cariogenic Carbohydrate Sweeteners and Dental Caries

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References

FDA Regulation on Health Claims is Available in Subpart E 101

What You Need to Know

There are 4 major types of product claims. Each one has specific requirements.

Health Claim: Describes a relationship between a food and a reduced risk of a disease or a health-related condition.

Authorized Health Claims:A health claim that the FDA has authorized for use based on "significant scientific agreement" on the subject. 

Qualified Health Claims: A health claim is one that is supported by scientific evidence but does not achieve the "significant scientific agreement" standard. The FDA authorizes Qualified Health Claims for use only when specific wording is applied.

Nutrient Content Claims describe the level of a nutrient in a food.

Structure/Function Claims: describe the role of a nutrient or ingredient on the structure or function of the human body.

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Health Claims

A health claim describes a relationship between a food and a reduced risk of a disease or a health-related condition. This can be made in words, images (i.e. a heart), or a reference to a 3rd party certification.

Example of a Health Claim: "Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors."

Not a Health Claim: "fruits and vegetables contribute to good dietary health" This is not a health claim because no assertion is made about the reduced risk of a disease or health condition. Instead, this statement would simply be called 'dietary guidance'.)

Types of Health Claims

There are two types of health claims that appear on food labels and marketing. They are:

• Authorized Health Claims

• Qualified Health Claims

Requirements for a Health Claim

• Health claims cannot be made about the diagnosis, cure, mitigation or treatment of diseases (this is a drug claim)

• They must be complete, truthful and not misleading.

• Certain foods may be disqualified from health claims based on nutrient levels that are deemed unhealthy. See §101.14 (4)

• Health claims must be associated with a risk or health related condition for which the US population or a subgroup (i.e. the elderly) is at risk.

• The substance that is the subject of the health claim must have a taste, aroma or nutrient value when consumed at the levels used to justify the claim.

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Authorized Health Claims

See main article Authorized Health Claims

What is an Authorized Health Claim?

An Authorized Health Claim describes a health claim that has been reviewed by the FDA and approved for use.

There must be a strong scientific case in order for the FDA to issue an Authorized Health Claim. 

When there is emerging evidence between a food and a reduced risk of disease or health condition the FDA will allow the use of a "Qualified Health Claim" in food labeling.

What Health Claims Can I Use On My Product Label?

See full article Authorized Health Claims You Can Use On Your Label 

Example of a Qualified Health Claim

You may use an Authorized Health Claim or Qualified Health Claim that has already been approved by the FDA. For examples, see the 2013 FDA Labeling Guide. The wording requirements for Authorized Health Claims offer some flexibility in how that claim is stated.

Additionally, anyone may submit a notification to the FDA of a health claim based on scientific studies conducted by certain branches of the US government. This is called a Health Claim Based on an Authoritative Statement by a Scientific Body. 

The FDA may approve the health claim, reject it, or issue a Qualified Health Claim with specific guidelines about how the claim can be used.

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Qualified Health Claims

What is a Qualified Health Claim?

A Qualified Health Claim is a statement approved by the FDA for use on food labels that has strict wording requirements. 

When there is emerging evidence between a food and the reduced risk of a disease or health condition, but not enough for the FDA to issue an Authorized Health Claim, the FDA may approve a "Qualified Health Claim". 

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Nutrient Content Claims

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Nutrient Content Claims

Main Article: Nutrient Content Claims

Examples of Nutrient Content Claims

What is a Nutrient Content Claim?

A Nutrient Content Claim is a claim that characterizes the level of a nutrient in the food. 

This is different than information listed in the Nutrition Information Panel. Any claims made about nutrition outside of the Nutrition Information Panel would be considered Nutrient Content Claims.

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Structure/Function Claims

What is a Structure/Function Claim?

A Structure/Function Claim describe the role of a nutrient or ingredient on the structure or function of the human body. These may appear on the labels of foods, dietary supplements or drugs.

Examples of a Structure/Function Claim:

• "Calcium builds strong bones"

• "Fiber maintains bowel regularity"

• "Antioxidants maintain cell integrity"

Conventional food producers do not need to notify the FDA about structure/function claims or make disclaimers associated with these claims on their product labels. Producers of Dietary Supplements may face additional requirements.

Categories of Structure/Function Claims:

These claims are only associated with producers of Dietary Supplements.

Claims of General Well-Being: These describe general well-being from consumption of a nutrient or ingredient. 

Nutrient-Deficiency Disease Claims: These describe a benefit related to a nutrient deficiency disease (such as vitamin C and scurvey).

• These claims are only allowed if the claim also states how prevalent the disease is in the US.

• A business making a nutrient-deficiency disease claim must submit a notification that includes the text of the claim to the FDA no later than 30 days after marketing the dietary supplement that contains the claim.

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FDA Guidance on Authorized Health Claims

What You Need to Know:

A Nutrient Content Claim is a claim that characterizes the level of a nutrient in the food. 

This is different than information listed in the Nutrition Information Panel. Any claims made about nutrition outside of the Nutrition Information Panel would be considered Nutrient Content Claims. Some basic requirements:

• You can't make claims that could be misleading in any way.

• Terms like "low-fat" or "sugar-free" have specific nutritional thresholds.

• Most terms related to nutrition content claims are regulated (and the guidelines are below). If a nutrient content claim is not regulated then it does not mean you are allowed to make that claim.

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What You Need to Do:

• Comply with the guidelines below.

• Make sure your label is aligned with formatting guidelines in §101.13. (I have not listed these in detail)

• Keep records to verify any nutrient content claims that you make (including test results)

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Types of Nutrient Content Claims:

Implied Nutrient Claim

Describes the food or ingredient in a manner that suggests that a nutrient is present or absent in a certain amount. An implied nutrient claim may also suggest that the food may be useful in maintaining a healthy diet.

• "high in oat bran"

Expressed Nutrient Claim

An expressed nutrient claim is a direct statement about the level of nutrients in a food.

• "low sodium"

• "high protein"

• "contains 100 calories"

High Content Disclosures

Foods that contain an extremely high amount of one or more nutrients per serving must disclose this on the product label if they wish to also make a nutrient content claim.

The rationale is that, if you want to advertise the nutritional benefits of your product, then you must also disclose other nutritional characteristics that may be less desirable.

For example, if a product which is high in calories advertises itself as “low sugar” then it must also disclose that it is not a low calorie food.

The threshold required for making this type of disclosure is:

• >13g fat per serving

• 4.0g of saturated fat

• 60mg of cholesterol

• 480mg of sodium

If the reference size for a product is 30g, then you should consider the thresholds above per 50g of that product. This prevents companies from avoiding high-content disclosures by simply using a small reference amount.

These products must have the following statement: "See nutrition information for ___ content" (insert the applicable ingredient). This must be displayed clearly in bold type and no smaller than the "Net Quantity of Contents claim" on the packaging.

• This requirement does not apply to the following types of foods:

  • infant foods or foods for children under 2 yrs

  • meal products (defined in §101.13 (l))

  • main dish products (defined in §101.13 (m))

See Subpart A 101.13 (h)

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Nutrient Level Statements

You may make a statement about the amount or percentage of a nutrient in a serving. For example "less than 3g of fat per serving". Some conditions apply:

• If the statement characterizes the level of the nutrient as low, but the amount is not actually low, then this must be clarified. For example, if you wanted to say "only 10g of fat per serving" then you would have to additionally state "not a low fat food". This is because 10g of fat is not a low amount of fat for a single serving.

• Similar to above, if a statement characterizes the level of an ingredient as high but the amount is not actually high, then this must be clarified. For example, You wanted to say, "Contains at least 25mg of protein per serving", then you would have to additionally state "not a significant source of protein" because 25mg is not a significant amount of protein.

• If the quantity is not characterized in any way (by using a word like "only", then you may simply state the quantity of the nutrient in the food without any disclaimer. For example, "150 calories" or "4g of fat"

Source Subpart A 101.13 (i)

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Relative Claims

Relative claims are claims that compare the nutrient level to another reference food. These claims are allowed to use terms such as "light" "reduced" "fewer" "less" and "more". Some considerations when making relative claims:

• For claims making "less" "fewer" or "more" claims, you may compare the product to the same product (i.e. potato chips to potato chips) or to different product that is part of the same category (i.e. orange juice as a reference for vitamin C tablets).

• You can also compare to a similar product produced by another brand. If you are comparing to another brand, that brand must be widely available.

• For claims using the words "light" "added" "reduced" "extra" "plus" "fortified" or "enriched", you must compare similar food products (i.e. your orange juice to another orange juice product)

• For claims using the word "light" or any other claims, the referenced food must represent the general category of products in that claim. In other words, if you are comparing to a specific brand of lemonade, the brand you are comparing to should be nutritionally representative of lemonades overall.

• The claim include a comparison of the nutrient amounts in both products in quantitative, clear and concise language.

• You cannot make a relative claim for lower levels of a nutrient in your product if the referenced product itself meets the requirement for a "low" claim (i.e. 3g of fat or less per serving).

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Vitamin and Mineral Claims

You may make claims about vitamin or mineral contents that reference the reference daily intake (RDI) without any special disclaimers. For example "Contains 100% Vitamin C " is allowed.

If you wish to make a claim for a vitamin or mineral content for which there is no reference daily intake (i.e. recommended daily value), you may do so. 

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Formatting:

• Nutrient content claims must be less than 2x the size of the statement of identity (common name of the product) and must be in a prominent and clear type.

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Specific Nutrient Content Claim Requirements

Calorie Content Claims (i.e. "Calorie-free" "low calorie")

You may make nutrient content claims about the calorie contents of food.

"Calorie Free" Claims

 For terms such as "calorie free", no calories" "zero calories",

• The foods must contain less than 5 calories per typical serving amount.

• If the food naturally meets this condition without any special processing, then this must be described. For example "cider vinegar, a calorie-free-food"

"Low Calorie" Claims

For the terms "low calorie" "few calories" or "low source of calories",

• The food must have a serving size of >30grams and has fewer than 40 calories per serving. The reasoning here is that you can't make the portion size very small and then claim the product has "low calories per serving".

• If the food naturally meets this condition without any special processing, then this must be described. For example "celery, a low-calorie-food"

"Reduced Calorie" Claims

For the terms "reduced calorie" or "fewer calories" or "lower calories",

• The food must contains at least 25% fewer calories than the reference food (this is a relative claim)

• This claim cannot be made if the referenced product meets the definition for "low calorie"

Sugar Content Claims

Use of the terms "sugar free" "no sugar" "zero sugar" is allowed if:

• The product contains less than 0.5g of sugar per serving

• The product contains no ingredient that is a sugar or contains sugars, unless this is explained in the ingredients section

• It either is labeled as "low calorie"/"reduced calorie" or "not a reduced calorie food"/"not for weight control". The rationale here is that consumers expect sugar-free foods to be low calorie, so this must be specified.

"No Added Sugar" Claims

"No Added Sugar" claims are allowed if:

• No sugars have been added in processing or production.

• No ingredients contains added sugars (such as jam or fruit juice)

• The food it resembles and which it is substituting as a "no added sugar alternative" typically contains added sugars.

• The product bears a statement that the food is not "low calorie" or calorie reduced" unless the product meets that requirements. Again, the rationale here is that consumers expect added-sugar-free foods to be low calorie, so this must be clarified if it is not true.

"Reduced Sugar" "Lower Sugar" Claims

• The food must contains at least 25% less sugar than the reference food (this is a relative claim)

Fiber Content Claims

If you make a fiber claim, then you must also disclose the level of fat in a serving, unless the product meets the definition of a low fat food (see below)

See Subpart A -- 101.54 (d) for more details

Specific Wording Requirements

"Low" or "Free" Claims:

• You may only use the terms "low" or "free" (i.e. "fat free" or "low sodium") when you have specifically processed the food to lower the amount of that nutrient or you not included that nutrient in the formulation of the food

  • A claim of "low sodium potato chips" may be achieved by not adding salt to the chips, since potato chips typically contain salt

  • A claim of "Fat-free peanut butter" may be achieved by a process that removes fat from the peanut butter.

  • If the product inherently lacks a nutrient and it has not been specifically processed to remove that nutrient, then you must clarify that the claim refers to all foods of that type and not simply to your particular product.

See Subpart A 101.13 (e)

"High" or "Rich in" Claims:

You may use these terms if the food contains 20% or more of the Daily-Recommended-Value (DRV) in the amount that is typically consumed.

If the product is a "meal product" containing multiple foods, then you must identify which food is the subject of this claim (i.e. the serving of cauliflower in this product is high in vitamin C)

See Subpart A -- 101.54 (b) for more details

"Good Source" or "Contains"or "Provides" Claims

You may use the terms "good source" "contains" or "provides" if the food contains 10-19% of the Daily-Recommended-Value (DRV) in the amount that is typically consumed.

If the product is a "meal product" containing multiple foods, then you must identify which food is the subject of this claim (i.e. the serving of yams in this product is a 'good source' of fiber)

See Subpart A -- 101.54 (c) for more details

"More" or "Added" or "Extra" Claims

Relative Claims that contain the words "more", "fortified", "enriched", "added", "extra", and "plus" may be used to describe the following:

• protein content

• vitamins or mineral content

• dietary fiber content

• potassium

The product of the claim must have >10% more of the recommended intake than the referenced product in the claim. All other requirements for relative claims apply (see above).

See Subpart A -- 101.54 (e)

"High Potency" Claims

When Used to Describe Vitamins & Minerals:This claim may be used to describe vitamins and minerals where the product contains 100% or more of the recommended daily intake for that vitamin or mineral.

 For example "Contains botanical X with high-potency vitamin C")

When Used to Describe a Product: "High Potency" claims may be used to describe a product if it contains 100% or more of the daily intake for 2/3 of the vitamins and minerals listed in the RDI which are present at 2% or more in the product.

See Subpart A -- 101.54 (f)

"Light" or "Lite" Claims

These claims may be made if one of the following criteria are met:

The food gets 50% or more of its calories from fat and its fat content is reduced by 50% or more as compared to a similarly reference food (see relative claims).

OR

The food derives less than 50% of its calories from fat and the number of calories is reduced by 1/3 when compared to a reference food (see relative claims).

OR 

The food's fat content is reduced by 50% or more when compared to a referenced food (see relative claims).

See Subpart A -- 101.56

"Antioxidant" Claims

You may make a claim about the antioxidant nutrients present in a food insofar as:

• A recommended daily intake (RDI) has been established for each of the nutrients that are the basis for the claim.

• The nutrients subject to the claim have recognized, scientific antioxidant activity.

• The level of each nutrient in the claim must be high enough to qualify for either a "more" "good source of" or "high" claim.

• The specific nutrients which are the basis for the antioxidant claim must be referenced where the claim is made and again where that specific nutrient is listed.

See Subpart A -- 101.54 (g)

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Exceptions:

Your product may be subject to additional regulations if you produce one of the following foods.

• dietary supplements

• infant foods

• imitation foods

• Medical foods

• "meal products"

• "main dish products"

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More About Food Labeling

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References

Jan 2013 FDA Food Labeling Guide * Note that this does not include updates related to the 2016 New Rule on Nutrition Info. An updated guidance document has not been released as of Feb. 2019

For FDA Regulations on Nutrient Content Claims , See Subpart A -- Part 101 Food Labeling

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What You Need to Know:

Examples of PDP of different packaging forms

The Principal Display Panel (PDP) is the part of a food label that is most likely to be displayed to the customer when for sale. This is the front label on a product.

Size Requirement: 

The size requirement for a principal display panel is determined by the shape of the product:

Rectangular Package: The PDP must encompass the entire customer facing side of the package

Cylindrical Package: The PDP must encompass 40% of the total side-area of the package (circumference multiplied by height)

Other Packaging Shape: The PDP must encompass 40% of the surface area of the product.

Elements Required on the PDP

The following elements are absolutely required on the PDP. Labeling elements which may appear on other sections of the packaging are not listed below.

• Identity of the food (common name)

• Net Quantity of Contents

Next

Nutrition Facts Labeling

Food Product Claims

Basics of FDA Food Labeling

Understanding Date Labels

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Sources:

Part 101 -- Subpart A -- 101.1: Principal Display Panel of Package Food Form

More about Food Labeling

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References

Read the FDA Regulation of Principal Display Panels Part 101 — Subpart A — 101.1

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Most food product labels have specific requirements about what information you must state on the label, where it appears, and the format.

What Do I Need to Know?

• Some products are exempt from labeling requirements.

• Your food product must be labeled with the following labeling elements. The required location of these elements is in parentheses, when applicable.

  • Common name of the food (Principal Display Panel)

  • Net quantity of contents (PDP)

  • Ingredient list (PDP or information panel)

  • Name & location of the manufacturer, packer, or distributor (PDP or information panel)

  • Nutrition Information

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Types of Panels

Front Panel (Principal Display Panel)

The Principal Display Panel (PDP) is the front panel of the packaging

The Principal Display Panel (PDP) is the part of a food label that is most likely to be displayed to the customer when for sale. This is the front panel on a product.

Check out our article about the Principal Display Panel to learn more about the requirements for this label.

Information Panel

The Information Panel is the part of the label next to the Primary Display Panel (PDP). It generally appears to the right side of the PDP (viewer's perspective) but may appear elsewhere if this is unfeasible.

Information Panel Requirements: All of the following items must appear on either the information panel or the principal display panels

Rear Panel (Nutrition Information)

Nutrition information contains information about the nutritional composition of the product, including nutrients, vitamins, minerals, and macronutrients.

Some products may be exempt from the requirements for a nutritional label Click here to learn about Nutrition Information Label Exemptions

Check out a detailed review of the requirements for Nutrition Information labeling

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Required Elements on a Food Label

Identity (Common Name) of the Food

The identify of a product must be listed on the PDP

Common Name “Tortilla Chips”

The Identity of a food refers to the common name of that food. For example, since Doritos is not a type of food (it is a product name), the company has to list the identify of the product, "Tortilla chips" on the Primary Display Panel (front label).

The FDA has specific standards for what defines many food products. These are called "Standards of Identity" and they exist to make sure that consumers know what they're getting when they buy something at the supermarket (this is why crab substitute must be labeled "imitation crab").

For example, you can't mix corn syrup and food coloring and market it as "raspberry jam" because there are specific criteria that are required in order for you to identify your product as "jam".

If you produce a food product, it is extremely important that you understand the Standards of Identity before you create a product label.

For more information about Standards of identity, consult our guide, orthe FDA regulations:

• Subpart B Sections 130-169 (Contains specific food identities)

• Requirements for Specific Non Standard Foods

Ingredients List:

Sub-ingredients can be listed in parentheses

Ingredients must be listed in descending order by weight. The ingredients list should appear directly below the nutritional panel (if not due to space constraints, then directly to the right). The list of ingredients should start after the word, "Ingredients"

Ingredients that are themselves composed of two or more ingredients:

These can be listed in two ways:

First, the sub-ingredients can be listed after the common name of the ingredient.

For example, in this cookie dough label, the sub-ingredients in "Vegetable Shortening" are listed after that item. They are: pam oil, soybean oil, beta carotene, etc.

Second, the ingredients may be folded into the entire list of ingredients so that the ingredient containing sub-ingredients is not named. To use the example above, you may simply list the sub-ingredients of vegetable shortening among other ingredients of the product without listing vegetable shortening itself.

However, note that the ingredients still must appear in order of predominance in the finished product.

Shortened Ingredient Names:

Certain ingredient names (such as "concentrated milk") may be condensed to a shorter form in their listing ("milk"). Consult Subpart A 101.4   for more information on shortened ingredient names.

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Name & Location of the Manufacturer, Packer, or Distributor

Name & Location

The label must include the name and location of the manufacturer, packer, or distributor.

The name may be a corporation name or, in the case of an individual or partnership, the name under which the business is conducted.

If product is not manufactured or distributed by the person or company whose name appears on the label, then the wordage should express this. 

For example, if your product is produced by a contractor, you could write, 

"Manufactured for [your company name]"

or

"Distributed by [your company name]"

For the Location requirement, the requirement must be the street address, city, state, and zip code. However, the address is available in the telephone book, then you are allowed to list only the ZIP code.

For More information about this section, consult Subpart A -- §101.5

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Net Quantity of Contents

Net quantity of contents posted on the PDP

Net Quantity of Contents (in red box)

The net quantity of food contents must appear on the principal display panel (PDP). This refers to the weight of the product excluding any packaging weight.

This can be expressed in terms of weight, measure, count or a combination. Liquids must be described in terms of gallons, quarts, pints, and fluid oz. The weight should follow the words "Net Weight"

Placement:

This must be placed in the bottom 30% of the PDP and be printed horizontally (i.e. parallel to the base of the label).

For more information about this section, consult Subpart A -- §101.7

 101.8, 101.9, 13, 17, 36, 101 Subpart D , part 105

More About Labels

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References

To read the FDA Regulation about Lableing consult Subpart A -- §101.7

Small Business Exemptions:

Businesses/products that fulfill the criteria below may be exempt from the requirements for Nutritional Labeling described in Subpart A 101.9

Exemption Possibility #1: 

A business who makes sales to a consumer (can be a retailer) who:

- Conducts no more than $500,000 in annual gross sales of all products OR

- Conducts no more than $50,000 in annual gross sales of food products.

The food products exempt from labeling must not make any nutrition claims in the product or advertisement of it.

Exemption Possibility #2: 

Low Volume Exemption: A business with fewer than 100 full time employees and fewer than 100,000 units sold in the US (for the preceding 12 months) may be exempt from certain labeling requirements.

The exempt food labels or product advertising may not provide any nutrition information or make a nutrient content claim or health claim.

Source 101.9 (j) Labeling Exemptions

How to Register a Small Business Labeling Exemption:

If the exempt business is not an importer and sells fewer than 10,000 units annually, there is no requirement for registering the exemption.

If the business does not meet the above criteria, then you must file for the exemption each year. You can do this online  or by submitting this form by mail/fax

Foods that are Exempt From Labeling Requirements:

The following foods are exempt from labeling requirements. There is no registration filing required associated with the food-based exemptions below.

• Raw fruits

• Vegetables

• Fish

• Dietary Supplements (they are regulated under §101.36)

• Certain egg cartons

• Infant Formula and foods for children up to 4 yrs of age (modified requirements apply)

• Foods that contain insignificant amounts of all nutrients required to be in a nutrition panel (i.e. coffee beans, tea leaves, spices, flavor extracts, food colors,)

• Packaged single-ingredient meat products that are FDA-regulated (i.e. deer, bison, rabbit, quail, wild turkey, ostrich)

• Foods in small packages that have a total surface area of <12 sq inches

• Foods served or delivered for immediate consumption

• Food that is served in bulk containers at a retail establishment. The retail establishment must include the ingredients listing on a card or sign, if not on the bulk container itself.

• Foods that are prepared inside a retail establishment and only sold in that establishment (i.e. foods processed and sold onsite by independent delis, bakeries, or salad bars)

• Ingredients that are added to a food for an effect in processing but are present in the finished product at insignificant levels.

• Some products that are being transported to another facility where they will be processed, packed, or labeled.

More about Food Labeling

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The Scoop: There are very specific requirements for expressing nutrition information on food packaging. Use an online label generator.

What You Need to Know

Contents

New Rule on Nutrition Information

When Do New Labeling Requirements Take Effect?

Components of a Nutrition Information Label

Vitamins, Minerals, and Macronutrients

• The FDA regulates nutritional information panels, their formats, and requirements.

• Nearly all packaged products require nutrition information although exemptions do exist

• You can calculate the nutrition contents of a food using an online nutrition calculator or via a lab analysis of a food sample.

• The requirements for nutrition labels may vary depending on:

  • Food package size

  • Claims made about the product, its ingredients, and health benefits

New Rule on Nutrition Information Panels

Key Changes in Nutrition Information

In 2016, the FDA updated the requirements for nutrition information panels on foods. The changes include

• Changing the "Serving Size" to reflect how much someone customarily eats, not how much someone should eat

• Calories are now in larger and bolder type

• "Added Sugars" are now required to be included on the label

• Listings of Vitamin D and Potassium are required

• Actual amounts must be present for Vitamin D, Calcium, Iron, Postassium,

• Removal of the "Calories from fat" label requirement

• Removal of the requirement for Vitamin C and Vitamin A

When Do New Labeling Requirements Take Effect?

Businesses with >$10 million in Annual Food Sales: January 1st 2020 

Businesses with <$10 million in Annual Food Sales: January 1st, 2021.

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Components of a Nutrition Information Label:

Serving Size

The serving size must closely equate to the amount that is customarily eaten. This must be expressed in common household measures (i.e. cups, oz, tsp) and include the equivalent metric quantity in parentheses.

Nutrient Components:

The nutrition information label must include some mandatory components (i.e. calories, fat) and may include other voluntary components (vitamin A). No other declarations of nutrition information is allowed on the label, other than those listed below:

Mandatory Nutrient Components

• Calories

• "Fat" or "Total Fat"

  • Saturated Fat

  • Trans Fat

  • "Cholesterol"

  • "Sodium"

  • "Total Carbohydrate"

    • "Dietary Fiber"

    • "Total Sugars"

    • "Added Sugars"

    • "Protein

Voluntary Nutrient Components

• "Calories from saturated fat"

• "Fluoride"

• "Soluble Fiber"

• "Insoluble Fiber"

• "Sugar Alcohol"

There are specific requirements for how these nutritional elements be described, particularly when there is a small amount of them. This information can be found in 101.9 (c)

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Vitamins, Minerals and Macronutrients

The following vitamins and minerals are required on the nutritional label "Supplemental Facts" section. They must be measured in terms of percentage of daily value and weight.

The minimum requirement is listed below (must be listed in this order):

• Vitamin D,

• Calcium

• Iron

• Potassium

When additional vitamins and minerals are listed, the following order should be preserved:

Vitamins (listed in order)

• Vitamin A

• Vitamin C

• Vitamin D

• Vitamin E

• Vitamin K

• Thiamin

• Riboflavin

• Niacin

• Vitamin B6

• Folate

• Vitamin B12

• Biotin

• Pantothenic Acid

• Choline

Macronutrients & Minerals (In order)

• Calcium

• Iron

• Phosphorus

• Iodine

• Magnesium

• Zinc

• Selenium

• Copper

• Manganese

• Chromium

• Molybdenum

• Chloride

• Potassium

Vitamins and minerals must appear in the label if:

• They appear in a serving of the product

• When they are added as a nutrient supplement

• When a claim is made about them

However, non-required vitamins and minerals  may be excluded if:

• Neither the nutrient nor component are referred to on the label or advertising of the product

• If they appear in the product solely for technological purposes

Note that other vitamins and minerals may be required or permitted on the label of standardized foods (i.e. foods that have a specific definition under the FDA Standards of Identity).S

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How to Make an FDA Compliant Nutrition Information Label

FDA Aligned Nutritional Label (New Rule)

1. Have a final product: It is important that you are producing your product consistently and with the same ingredients so that the nutritional label you generate is accurate.

2. Determine the nutritional contents of your product: You can do this in one of several ways:

   • Conduct your own nutritional analysis using an online nutrition calculator. Google it or try Spark Recipes (This may not be the best one, it's the first one I found)

   • Have your product tested by a laboratory (EMSL is a nationwide provider that can do nutritional analysis)

   • Note: If the FDA tests your product due to a complaint or concern, they will conduct a nutritional analysis on 12 samples from 12 different cases.

3. Build a nutritional panel and align with the formatting guidelines:

   • The lab or online calculator may generate one for you automatically. If so, confirm it is aligned with the new nutritional facts rule (the easy way to tell is that the "calories" section is in a larger font). It should align with all of the standards listed above.

   • If you'd like to design your own, consider the image below for guidance.

Update your nutritional panel every time you make a change to the recipe or the ingredients: Additionally, you may have to change the nutritional panel if you decide to make a health claim in your advertising or on the product label.

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Looking for Something Else?

Information about labeling "variety packs" and separately packaged foods sold in one box is available in section  101.9 (11) (h) 

More About Food Labeling

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More Posts

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Resources

FDA Labeling Guide *Note this doesn't include the New Rule on Nutritional Labels

Examples of FDA compliant labels with guidance

Examples of FDA compliant labels in multiple formats

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What You Need To Know

Contents

What You Need to Know
What You Need to Do
What You Need to Have on File
Summary of Subpart G

• Subpart G describes the requirements for a Supply Chain Program.

• A Supply Chain Program demonstrates that your suppliers are producing their products (typically ingredients and packaging) in a safe manner.

• You must have a Supply Chain Program if your hazard analysis revealed a hazard requiring a supply-chain control.

• You have considerable leeway in how you verify your suppliers but there are some specific requirements (see below).

• You are obligated to document and take prompt action if you learn a supplier is not controlling a hazard as required.

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Applicability & Exemptions

This section applies to any business whose hazard analysis reveals a hazard requiring a supply-chain-applied control. This means you can't complete your Supply Chain Program until you have completed your hazard analysis.

For Example - Let's say that Ned's Raw Cookies uses pasteurized eggs as an ingredient in their product. Since Ned's Raw Cookies are sold and consumed raw, the company is not controlling for the salmonella hazard that is present in eggs.

In this case, Ned's Raw Cookies would likely rely on a supply-chain-applied control to minimize the salmonella hazard in their product. Ned's Raw Cookies would request documentation from their egg supplier to prove that the supplier is controlling the risk of salmonella. This documentation may be an audit result, a copy of supplier's food safety plan, or sufficient food safety records to show that that hazard has been controlled.

Exemptions:

You are not required to apply a supply-chain-applied-control in the following scenarios:

1. No hazards requiring a supply chain applied control exist

2. Your business (the receiving facility) is able to use a process control to eliminate/minimize the hazard.

3. Your customer provides a written assurance that they must control the hazard.

4. The food produced is not consumed by the public (i.e. it's only for research purposes within the company)

5. The supplier is a "very small business"

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What You Need to Do:

1. Review your hazard analysis to determine whether there is a hazard which requires a supply-chain-applied control.

2. Determine how you will approve the suppliers of those ingredients/packaging.

3. Request documents from your suppliers (i.e. a recent inspection report or their food safety plan) to demonstrate that they are controlling for that hazard. You may also verify your supplier's product yourself by conducting tests.

4. Review your suppliers' documents and document that you have reviewed them.

5. Only use approved suppliers

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What You Need to Have on File:

Your supply chain program must be written and contain the following:

• An explanation of how you approve suppliers

• A list of approved suppliers

• A procedure for receiving products (i.e. a receiving SOP)

• Each of the following documents for each supplier (if their ingredient has a hazard which requires a supply-chain control)

  • Documentation of having reviewed the supplier's food safety records.

  • A written inspection report of the supplier by the state, FDA, city, or other agency

• Any records of supplier non-conformance and your response to that (could be a corrective action).

Summary of §117 Subpart G

Below is a summary of Subpart G so that you can get a quick sense of the requirements. If you want to read the original text, check out the source texts, linked below.

This text is aligned with the coding used in the FDA Regulations so that you can hunt down the corresponding section with ease. For example,  you have a question about my wording in §117.405 (a) (2) then just look up this same code in the CFR.

117.405 Requirement to Establish and Implement a Supply-Chain Program

a. 

1. A facility must establish a risk-based supply-chain program for the ingredients and raw materials that have a hazard requiring a supply-chain-applied control.

2. Importers who conduct foreign-supplier-verification programs don't need to conduct supply-chain-applied controls for those materials whose hazards have been mitigated.

3. Requirements in this part don't apply to food whose use is research or testing. However this food,

i. May not be sold or given to the public

ii. Must be labeled "food for research or evaluation use"

iii. Is supplied in small quantity and disposed of.

iv. Is accompanied with documents stating the food is for research and not for public consumption.

b. The supply-chain program must be written.

c. If the supply-chain-applied control is applied by a 3rd party (i.e. not the receiving facility and not the produce supplier -- let's say it's a 3rd party that washes produce on behalf of a farm who sells it to a food processor), then the receiving facility must:

1. verify the control themselves

2. obtain documentation to verify that the control was applied.

§117.410 General Requirements Applicable to a Supply-Chain Program:

a. The supply-chain program must include:

1. Using approved suppliers (i.e. an approved supplier list)

2. The determination of appropriate supplier verification activities

3. Conducting supplier verification activities

4. Documenting supplier verification activities

5. When applicable, verifying that a supply-chain-applied control was applied by a 3rd party.

b. The following are appropriate supplier verification activities for raw materials and other ingredients:

1. Onsite audits

2. Product sampling

3. Review of suppliers food safety records

c. The supply chain program must provide assurance that a hazard requiring a supply-chain-applied control is minimized or prevented.

d. 

1. In approving suppliers and determining verification activities, you must consider:

i. The nature of the hazard

ii. Who will be applying the controls on behalf of your supplier

iii. Supplier performance, including their history, audit results, test results, etc.

iv. Storage and transportation practices

2. If you are considering the suppliers history, this may be limited if they are a small business, a farm, or a facility that is exempt from some FDA provisions.

e. If you learn that a supplier is not controlling a hazard that you identified must be controlled by the supplier, then you are obligated to document this and take prompt action.

117.415 Responsibilities of the Receiving Facility

a. 

1. the receiving facility must approve suppliers

2. The receiving facility must conduct all supplier verification activities.

3. A 3rd party may do the following on behalf of the receiving party:

i. establish procedures for receiving raw ingredients

ii. Document that written procedures for receiving raw materials are being followed

iii. Determine and conduct supplier verification activities

4. The supplier may conduct product testing themselves and provide this to the facility conducting the supplier verification.

b. A receiving facility may not accept any of the following as a supplier verification activity:

1. Determination by the supplier of appropriate supplier verification activities.

2. An audit conducted by the supplier

3. A review of records by the supplier of the supplier.

c. The receiving facility may accept a 3rd party audit result provided by the supplier.

§117.420 Using Approved Suppliers

a. Approval of Suppliers The receiving facility must approve suppliers and document it before receiving ingredients from them.

b. Written procedures for receiving raw materials and other ingredients 

1. You must write and implement procedures for receiving products (i.e. a receiving SOP)

2. Your written procedures must ensure that ingredients are only received from approved suppliers

3. The use of these written procedures must be documented (i.e. you must have a receiving log to show that you are following your written receiving procedure)

§117.430 Conducting Supplier Verification Activities for Raw Materials and Other Ingredients

a. You must conduct supplier verification activities before using the supplier.

b.

1. When a hazard in a raw material will be controlled by the supplier and the outcome of exposure to the hazard results in a serious injury or death, then:

i. the appropriate supplier verification activity is an onsite audit

ii. the audit must be conducted before that raw material is supplied and at least annually thereafter.

2. The requirements above (b) (1) don't apply if other verification activities can provide assurance that this hazard is controlled.

c. If the supplier is a qualified facility, the receiving facility doesn't need to comply with parts (a) and (b) of this section.

1. The receiving facility must get an annual written assurance of the quality facility exemption for their supplier.

2. The receiving facility must get written assurance every 2 years that the supplier is compliant with FDA regulations or the equivalent. This must include

i. description of the preventive controls in place used to control hazards.

ii. Statement that the facility is in compliance with all applicable laws.

d. If the supplier is a farm that grows produce not covered under 112 (FDA produce standards), the receiving facility doesn't need to comply with parts (a) and (b) of this section.

1. The receiving facility must get an annual written assurance of the supplier's exemption from part 112 for their supplier.

2. Obtains written assurance that acknowledges that the food is subject to FDA regulations

e. If the supplier is a shell egg producer not subject to requirements of part 118 (FDA Shell Egg Standards) because they have fewer than 3,000 laying hens, the receiving facility doesn't need to comply with parts (a) and (b) of this section.

1. The receiving facility must get an annual written assurance of the exemption from part 118 for their supplier, because the supplier has fewer than 3000 laying hens.

2. Obtains written assurance that acknowledges that the food is subject to FDA regulations

f. There must not be any financial conflicts of interests related to verification (i.e. payments to a company performing supplier verification cannot be related to the results of the activity).

§117.435 Onsite Audit

a. An onsite audit must be performed by a qualified auditor

b. The auditor must consider all regulations to which a supplier is subject. The audit must include a review of food safety plan/HACCP plan.

c.

1. The following may be substituted for an onsite audit:

i. Inspection results from the FDA, State, or local agency.

ii. Inspection results from an overseas FDA equivalent.

2. If the inspection is from a foreign authority recognized as equivalent to the FDA, then the food produced by the supplier must fall within the scope of that recognized authority.

§117.475 Records Documenting the Supply Chain Program

a. Records related to supply-chain program are subject to requirements of Subpart F

b. The receiving facility must review the supplier records below in part (c) in the same manner that they would complete their own record verification (as defined in §117.465)

c. The facility must document the following records in their supply-chain program

1. Written supply chain program

2. Documentation that an importer is in compliance with the supply chain verification program requirements.

3. Documentation of the approval of that supplier

4. Written procedures for receiving raw materials and ingredients.

5. Documentation demonstrating the use of written procedures for receiving raw ingredients (This could be a receiving log)

6. Documentation of the approval of the supplier

7. Documentation of an onsite audit, including:

i. the name of the supplier being audited

ii. documentation of audit procedures

iii. dates of the audit

iv. conclusion of the audit

v. corrective actions to be taken in response to deficiencies found in the audit.

vi. documentation that the audit was conductected by a qualified auditor

8. Documentation of sampling and testing (if conducted as part of supplier verification) 

i. Identification of ingredient tested, number of samples tested.

ii. Identification of test conducted including the analytical methods.

iii. Dates of the tests

iv. Test results

v. Corrective actions taken in response to the testing

vi. Information identifying the lab conducting testing

9. Documentation of the review of the supplier's relevant food safety records.

i. The name of the supplier

ii. Dates of the record review

iii. General nature of the records review

iv. Conclusions of the review

v. Corrective actions taken in response to deficiencies found.

10. Documentation of other supplier verification activities conducted.

11. Documentation of the determination that verification activities conducted in lieu of an onsite audit are sufficient in the case that the hazard controlled by the supplier is one that could cause serious health consequences or death. You must provide adequate assurance that the supplier is controlling those hazards.

12. Documentation of an alternative verification activity if the supplier is a qualified facility.

13. Documentation of an alternative verification activity if the supplier is a farm.

14. Documentation of an alternative verification activity if the supplier is a shell egg producer.

15. The written results of an inspection of the supplier

16. Documentation of actions taken with respect to non conformance.

17. Documentation of mitigation of a hazard, if that control is applied by a 3rd party.

18. When applicable, documentation about the 3rd party and their verification activities.

This article is for you if…

∆ You are an FDA-regulated food business

∆ You purchase packaging/ingredients from one or more suppliers

∆ You are not defined as a very small business

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Resources

FDA Regulation: Part 117 Subpart G - Supply Chain

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What You Need to Know

• Records can be electronic or paper.

• They must have:

  • Plant name / address

  • The date/time

  • Product name

  • Signature/initials

  • Actual information/observations not summaries

• You must store records onsite for at least 2 years

• You must be able to retrieve records within 24 hours.

• All records must be made available upon request
  

All of our food safety plan templates are aligned with this section.

Summary of Subpart F: Record Keeping

Below is a summary of Subpart F so that you can get a deeper sense of the requirements. If you want to read the original text, check out the source texts, linked below.

This text is aligned with the coding used in the FDA Regulations so that you can hunt down the corresponding section with ease. For example,  you have a question about my wording in §117.305 (f) (2) then just look up this same code in the CFR.

§117.301 Records Subject to the Requirements of this Subpart

This section quickly states two points, neither of which are terribly important:

1. Only the food safety plan must be dated and signed when created and updated.

2. If a business is applying for a small business exemption (aka "Qualified Facility exemption") the standards for those records is less than what is described in this section.

§117.305 General Requirements Applying to Record

Records must:

a. Be kept as originals, true copies (i.e. scans, photocopies) or electronic records.

b. Contain the actual values and observations, not summaries.

c. Be accurate, unchangeable and legible

d. be created in real-time with the activity being documented.

e. Be as detailed as necessary

f. Include:

1. information about the plant identity

2. The date (and time, if necessary)

3. Signature or initials of the observer

4. Product name and lot code, if applicable

g. Electronic records required by other regulations may be subject to the requirements in Part 11 (This is the FDA section about electronic records, it unlikely applies to your business if you are following this statute)

§117.310 Additional Requirements Applying to the Food Safety Plan

The owner or operator of the plant must sign and date the food safety plan when it is first authored and whenever it is modified.

§117.315 Requirements for Record Retention:

a.

1. All records must be retained onsite for 2 years

2. A qualified facility must retain records attesting to their exempt status.

a. Small businesses operating under a Qualified Facility exemption must retain records to support that they apply for the exemption (typically 3 years of records)

b. Records that relate to equipment or processes that are no longer used must be retained for 2 years after their discontinuation.

c. You may store records offsite (not food safety plan) if you can retrieve them within 24 hours.

d. You can store a food safety plan offsite if the plant is closed

§117.320 Requirements for Official Review

All records must be made available upon request

§117.325 Public Disclosure

Your records may be disclosed by the FDA in accordance with Chapter 20 of the CFR

§117.330 Use of Existing Records

a. Existing records used for other purposes don't have to be duplicated to satisfy these requirements.

b. The records don't have to be kept in one set.

§117.335 Special Requirements Applicable to a Written Assurance

Any written assurance (which is required by other parts of the code) must contain the date and the names/signatures of the officials making the attestation.

Part 117 -- Subpart F: Requirements Applying to Records That Must Be Established and Maintained

Resources

FDA Regulations: Part 117 -- Subpart F (Record Keeping)

More About Food Safety Plans

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This is a regulation summary For a more general guide to Food Safety Plans, start here

What You Need to Know:

This section outlines the pre-requisite for a food safety plan and associated operational and documentation requirements.

Summary of Subpart C: Hazard Analysis and Risk-Based Preventive Controls

Below is a summary of Subpart C so that you can get a quick sense of the requirements. If you want to read the original text, check out the source texts, linked below.

This text is aligned with the coding used in the FDA Regulations so that you can hunt down the corresponding section with ease. For example,  you have a question about my wording in §117.126 (a) (2) then just look up this same code in the CFR.

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§117.126 Food Safety Plan

a. Requirement for a food safety plan:

1. You must have a written and implemented food safety plan

2. It must be prepared or overseen by a Preventive Controls Qualified Individual

b. Contents of a food safety plan

It must include the following, in writing:

1. A hazard analysis

2. Preventive controls (if you identified a hazard in your hazard analysis that you deem requires a preventive control)

3. Supply chain program

4. Recall plan

5. Procedures for monitoring your preventive controls

6. Corrective Action Procedures

7. Verification procedures

c. Records: The records generated are subject to regulations under Subpart F. (i.e. you must store them either in print or electronically)

§117.130 Hazard Analysis

a. Requirement for a hazard analysis:

1. You must conduct a hazard analysis for each type of food manufactured, processed, packed, or held at your facility.

2. The hazard analysis must be written.

b. Hazard Identification: This must consider

1. known or reasonable hazards, including:

i. Biological Hazards (bacteria, parasites, etc.)

ii. Chemical hazards (i.e. toxins, pesticides, food allergens)

iii. Physical hazards (i.e. stone, glass, metal fragments)

2. Hazards that could be present in the food because:

i. the hazard occurs naturally (i.e. toxins in fish)

ii. The hazard may be accidentally introduced (jewelry from employee falls into food)

iii. The hazard may be introduced intentionally for economic gain (i.e. sabotage by a competitor)

c. Hazard Evaluation: 

i. the hazard analysis must evaluate the hazards identified to assess the severity of illness or injury that would occur and the probability that it would occur if left unaddressed.

ii. The hazard evaluation must consider environmental pathogens whenever a ready-to-eat (RTE) food is exposed to the environment before packaging.

2. The hazard analysis must consider these effects on the food:

i. formulation of the food

ii. condition and design of the facility

iii. Raw materials and other ingredients

iv. Transportation practices

v. Processing procedures

vi. Packaging and labeling activities

vii. Storage and distribution

viii. intended use of the product

ix. Sanitation, including employee hygiene

x. any other relevant factors (i.e. weather, natural toxins)

§117.135 Preventive Controls

a.

1. You must identify and implement preventive controls when required by your hazard analysis.

2. Preventive controls include: Critical Control Points and other controls.

b. Preventive controls must be written

c. Preventive controls include:

1. Process Controls: These are procedures and processes that are used to control parameters of processing (i.e. acidifying, refrigerating, cooking.) They must be written in a way that is specific to your process and they must include:

i. parameters associated with controlling the hazard (i.e. if you are using cooking as a process control, then you must include the required cook temperature and cook time)

ii. The maximum or minimum values required to control the hazard.

2. Food Allergen Controls include processes to control food allergens. These are implemented to:

i. Protect food from allergen cross contact

ii. Label food properly with allergens to ensure it isn't misbranded

3. Sanitation Controls: Practices to ensure the facility is kept clean and to minimize biological hazards. These relate to:

i. Cleanliness of food-contact surfaces (equipment, utensils, tables)

ii. Prevention of contamination of food from dirty sources (i.e. dirty people, dirty food, dirty packaging, dirty raw ingredients)

4. Supply Chain Controls: This is described fully in Part G

5. Recall Plan: You are required to have a recall plan (see below)

6. Other Controls: You may have other types of controls (i.e. hygiene training and current good manufacturing practices)

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§117.136 Circumstances in which preventive controls are not required

a. Circumstances You aren't required to implement preventive controls if any of the following apply:

1. The food cannot be consumed without application of an appropriate control (i.e. coffee beans cannot be consumed without pouring boiling water on them, which would kill any bacteria on the bean)

2. You rely on your customer, who is subject to this subpart, to ensure that the hazard is mitigated. You must:

i. Disclose in writing that the food is "not processed to control [identify hazard]" and

ii. Annually obtain written assurance that the customer is following the procedures you have provided, which will eliminate the hazard.

3. You rely on the customer who is not subject to this subpart to eliminate the hazard. You must:

i. Disclose in writing that the food is "not processed to control [identify hazard]" and

ii. Annually obtain written assurance that the customer is following the procedures you have provided, which will eliminate the hazard.

4. You rely on the customer to provide assurance that the food will be processed to control the hazard by a subsequent entity in the supply chain

i. Disclose in writing that the food is "not processed to control [identify hazard]" and

ii. Annually obtain written assurance that your customer will:

A. Disclose in documents accompanying the food that it is "not processed to control [identify hazard]"

B. Will only sell to another entity that agrees in writing that it will mitigate the hazard and obtain similar written assurance from subsequent customers.

5. You have established and implemented a system that ensures control of the hazards in your product, at the distribution step.

b. Records: You must document any circumstance (related to a., above) that applies to you, including written assurances from customers.

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§117.139 Recall Plan

If your food has a hazard that requires a preventive control,

a. You  must establish a written recall plan.

b. The recall plan must include a procedure for a recall scenario and assign responsibility for taking those steps. It must address how to:

1. Directly notify recipients of the product being recalled and how to dispose of/return the food.

2. Notify the public about any hazard in the food, when this is required to protect public health.

3. Conduct effectiveness checks to verify the recall is carried out.

4. Dispose of recalled food.

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§117.140 Preventive Control Management Components

a. You must conduct the following activities for each of your preventive controls:

1. monitoring activities

2. corrective actions

3. verification activities

b. You must conduct the following activities for your supply-chain program:

1. corrective actions, especially related to supplier non-conformance.

2. Review of records

3. Re-analysis of your supply chain program over time and as it changes.

c. You do not need to conduct the following activities for your recall plan: monitoring, corrective actions, verification activities.

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§117.145 Monitoring

as appropriate to the nature of the preventive control, you must implement

a. Written Procedures: You must have written procedures for how and how often you will monitor preventive controls.

b. Monitoring: You must monitor preventive controls enough to ensure they are being peformed.

c. Records: 

1. You must document your monitoring actions and verify this (see §117.165)

2. Exception Records: You can use exception records (i.e. the record only shows when a deviation occured.) For example, a log monitoring refrigeration may only show records when the temperature is unacceptable

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§117.159 Corrective Actions and Corrections

a. Corrective Action Procedures: 

1. You must establish and implement written corrective action procedures. They must address:

i. the presence of a pathogen in a ready-to-eat product

ii. the presence of an environmental pathogen detected.

2. Corrective Action Procedures must describe the steps to be taken to ensure that:

i. appropriate action is taken to correct a problem associated with a preventive control.

ii. Appropriate action is taken to reduce the likelihood that the problem will recur.

iii. All affected food is evaluated for safety

iv. All affected food is prevented from entering commerce.

b. Corrective Action in the Event of an unanticipated food safety problem:

1. You must follow the procedure in (b)(2) if

i. a preventive control fails and a corrective action hasn't been established.

ii. a preventive control is found to be ineffective

iii. Verification records are found to be incomplete or improper decisions were made about corrective action

2. If any of the circumstances above in (b) (1) apply, you must:

i. Take corrective action, Ensure it doesn't happen again, re-evaluate all food for safety.

ii. reanalyze your food safety plan to see if changes are required.

c. Corrections: You don't need to follow sections (a) and (b) above if

1. You take action to correct a minor and isolated problem, insofar as these are not related to allergen controls or sanitation controls.

2. You take action in a timely manner to correct a minor and isolated problem insofar as it doesn't directly impact product safety

d. Records: All corrective actions taken in this section must be documented. Corrective actions must also be verified according to §117.155

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§117.155 Verification

Note: The Verification process is one that verifies various other parts of the plans have been undertaken as specified. This can take the form of a supervisor regularly reviewing records and verifying them with a signature.

a. Verification Activities: As it relates to a preventive control, you must verify

1. That the preventive control is valid

2. that monitoring is being conducted as required.

3. that appropriate decisions are being made in relation to corrective action.

4. that the preventive control is implemented and effective.

5. the reanalysis of your preventive controls (as your process changes or at minimum every 3 years)

b. Documentation: All verification activities must be documented in records.

§117.160 Validation

a. You must validate that the preventive controls implemented actually work.

b. Your validation must:

1. Be performed by a Preventive Controls Qualified Individual (PCQI)

i. Within 90 days of beginning production or there must be written justification for why if  >90 days after production begins.

ii. Whenever a change is made that could impact how a hazard is controlled.

iii. Whenever the food safety plan is reanalyzed.

2. Must include scientific and technical evidence (or conducting your own studies) to determine whether preventive controls will control the hazards.

c. You do not need to validate:

1. Food allergen controls

2. Sanitation controls

3. Recall plan

4. Supply chain program

5. Other preventive controls if the PCQI prepares the written justification that a validation is not applicable based the nature of the hazard and the preventive control.

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§117.165 Verification of Implementation and Effectiveness

a. Verification Activities: You must verify that preventive controls are consistently implemented and effective. This includes doing the following:

1. Calibrating instruments for accuracy

2. Product testing

3. Environmental monitoring

4. Review of records to ensure they are complete and activities were performed according to the plan

i. Records of monitoring and corrective action must occur within 7 days (or provide a written justification for why not)

ii. Other records (calibration, supplier, product testing) must occur in a reasonable amount of time.

b. Written Procedures: The following activities must be written:

1. The method and frequency of calibrating tools

2. Product testing. These procedures must be scientifically valid, they must identify the tests conducted, the methods used, the pathogens, the laboratory conducting the testing, and the corrective action procedures.

3. Environmental monitoring must be: scientifically valid, identify the locations and sites to be tested, the timing and frequency of these samplings, the tests conducted and methods used, the laboratory, and the corrective action procedures.

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§117.170 Reanalysis

a. You must reanalyze your food safety plan every 3 years.

b. You must reanalyze your plan whenever:

1. A change creates a new hazard or increases an existing hazard

2. Whenever you become aware of a new hazard

3. Whenever appropriate after an unanticipated food safety problem.

4. When you find a part of your plan or a preventive control is ineffective

c. You must complete the reanalysis

1. before any changes in activities OR

2. Within 90 days of the beginning of production for a new product (or >90 days if written justification is provided)

d.  You must also document the basis for the conclusion that no revisions are required.

e. A preventive controls qualified individual must oversee this reanalysis.

f. You must conduct a reanalysis when the FDA determines necessary and when there are new developments in scientific understandings.

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§117.180 Requirements Applicable to a Preventive Control Qualified Individual and a Qualified Auditor

a. One or more PQCI must do or oversee the following:

1. preparation of the food safety plan

2. validation of the preventive controls

3. written justification for >90 day time frame for validation

4. Determination that validation is not necessary.

5. Review of records

6. Written justification for exceeding 7 day time frame for reviewing records.

7. reanalysis of food safety plan

8. determination that reanalysis can be completed in a time frame that >90 days of the production of the new food being produced.

b. A qualified auditor must consult an onsite audit:

c. 

1. To be a PCQI, one must have completed training equivalent to that developed by the FDA or be qualified through job experience. This individual may or may not be an employee of the facility.

2. To be a qualified auditor requires technical expertise achieved through training, education, or experience.

d. All training in the development and applications of preventive controls must be documented in records.

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§117.190 Implementation Records Required for this Subpart

a. You must establish records regarding the implementation of a food safety plan, including:

1. Documentation for not establishing a preventive control (you can do this in the hazard analysis using our template)

2. Records documenting the monitoring of preventive controls

3. Records documenting corrective actions

4. Records that document verification, as related to

i. Validation

ii. Verification of monitoring

iii. Verification of corrective actions

iv. Calibration of process monitoring and verification instruments

v. Product testing

vi. Environmental monitoring

vii. Records review

5. Records documenting the supply chain program

6. Records documenting training for the Preventive Conrols Qualified Individual and qualified auditor.

b. These records are subject to requirements in subpart F.

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This Article Is For You If…

∆ You manage a facility that makes, holds, or packs food.

∆ You are subject to Part 117 Subpart C (very small businesses are exempt from this requirement)

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Resources

FDA Regulation Title 21 — Part 117 — Subpart C Hazard Analysis and Risk-Based Preventive Controls

Contents

Introduction
Animal Foods
Infant Formula
Bottled Water
Dietary Supplements
Fish & Fishery Products
Juice

Introduction

If you are producing human food then you are most likely governed under Title 21 -- Chapter 1 -- Subchapter B -- Part 117. 

However, some foods are subject to special requirements. If your business produces one of the food types below, click the link to learn more their special requirements:

• Animal Food (Includes pet treats)

• Infant Formula

• Bottled Water

• Dietary Supplements

• Fish / Fishery Products (Seafood)

• Juice

If you don't produce any of these specially regulated products, then you are likely regulated under Part 117

Animal Food

If you make animal food (including pet treats), then you will be governed under Title 21 -- Chapter 1 -- Subchapter E.

Unfortunately, this resource doesn't have any detailed information for you, but you can access the regulations at the link above.

Infant Formula

Infant Formula is defined in the FDA regulation as

If your business produces infant formula, you will be required to comply with:

• Part 107 -- Infant Formula

• Part 106 -- Additional Infant Formula Requirements

Bottled Water

Bottled water is defined as:

This includes water labeled as "Drinking water", "Mineral water", "Spring water", "Purified water".

To be clear, water is the only ingredient bottled water.

Water with added carbonation (i.e. soda water, tonic water, and seltzer) is generally regulated by the FDA as soft drinks.

If you are still unclear about what is bottled water, read the definition in the FDA Regulation

Bottled Water producers are subject to the following regulations:

• Part 129 - Processing and Bottling of Bottled Drinking Water

Dietary Supplements

This term is legally complicated and only a partial definition is offered below. Click through the image to access the full definition from the FD&C Act

The regulation for Dietary Supplements can be found in the FDA Regulations at:

• Part 111 - CGMPs in Manufacturing Packaging, Labeling or Holding Operations for Dietary Supplements

• Part 190 Notification Requirements for Dietary Supplements

Fish & Fishery Products (Seafood)

Fish / Fishery Products are defined in the FDA Regulation as:

The regulation for Fish & Fishery Products can be found in the FDA Regulations at:

• Part 123 -- Fish and Fishery Products

• Part 161 -- Requirements for Specific Fish and Shellfish

Note that the Food Safety and Modernization Act has impacted the regulation of Seafood -- in some ways allowing for exemptions to the above regulations. For more detail, see the following guidance document on Seafood HACCP and the FDA FSMA

Juice

Juice is defined as:

A juice processor is regulated in the FDA Regulations at:

• Part 120 -- HACCP Systems

Unlike many other food types, juice processors must comply with Part 120 even if their product is not entering interstate commerce.

If compliant with Part 120, then Juice processors are exempt from 117 Subpart C (Food Safety Plan) and Subpart G (Supply Chain Program)

For more information on juice processing regulations, check out the Section For Juice Processors on the FDA website or this guidance document, below

What's Next:

Do you produce a different type of product?  Requirements for FDA Food Producers

Not sure if the FDA Regulates your business? Learn about FDA Jurisdiction

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More About FDA Jurisdiction

Do I Need to Register as an FDA Food Facility?

You must register as a Food Facility if you own or operate a facility that manufactures, processes, packs, or holds food for consumption in the US. You must register regardless of whether or not the food enters interstate commerce

Some products will require supplemental registrations (See Supplemental Registrations and Notifications).

You do not need to register as a food facility if you are a:

• Farm

• Restaurant - Businesses that serve food for immediate consumption

• Retail Food Establishment- Grocery Stores, Convenience Stores, A business that sells food to consumers as the business's primary function. The value of food it sells from that establishment must exceed the value of sales to all other customers (i.e. businesses)

• Non-profit food establishments in which the food is served directly to the customer

• Fishing Vessels

• Facilities that are regulated exclusively by the USDA.

• Home-operator: You do not need to register if you are processing food in your private residence

Still unclear about the requirements for Food Facility Registration? Check out this FDA Guidance Document, linked below

What Does it Mean to Be a Registered Food Facility?

Don't worry, it doesn't mean that the FDA is going to inspect you immediately. The FDA is typically a reactive agency and won't bust down the door just because you have registered.

Instead, registering allows the FDA to know that you are producing food in case something goes wrong, such as a widespread health risk associated with your food category.

How to Register as an FDA Food Facility

1. Create an Account on the FDA Website

2. Login and choose "Food Facility Registration

3. Complete the registration process online. You can use this step-by-step guide if you need additional support

4. Record the following information:

   • Registration #

   • PIN

   • Registration Expiration Date (I recommend putting this date into your calendar so you will don't miss it)

Note: If someone other than the owner/operator is registering the facility, then a verification email will be sent to the owner/operator requiring them to confirm the registration. 

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References

FDA Guidance Document: Facility Registration

Retail Exemption Applicability Flowchart

21 CFR Subpart H - Registration of Food Facilities

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Glossary

Farm
Fishing Vessel
Non-Profit Food Establishment
Restaurant
Retail Food Establishment

Interstate commerce refers to products that cross state lines prior to consumption, or products composed of ingredients that have crossed state lines.

What is Interstate Commerce?

If a product crosses state lines between the start of the manufacturing process and when it is received by the individual who purchases it, then it has entered "interstate commerce".

Additionally, if the product is composed of ingredients from out-of-state, then it is considered to be a part of "interstate commerce" -- even if the product was created and consumed in state.

The technical definition of interstate commerce is:

"(1) commerce between any State or Territory and any place outside thereof,

and

(2) commerce within the District of Columbia or within any other Territory not organized with a legislative body."

FD&C Act [21 U.S.C. 321(b)] 

Examples of food that enters interstate commerce:

• A frozen pizza business that has a website and ships to buyers nationwide.

• A food processing facility that operates in New York and supplies cookies to bakeries in New Jersey.

• A distributor that holds food products created by local food producers in a warehouse and distributes them to a local retailer who, in turn, sells them in several states

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How Does Interstate Commerce  Relate to the FDA?

Whether a product enters interstate commerce is a major factor in determining whether a food business falls under FDA Jurisdiction. The other major factor is what type of food business it is. 

However, it is worth noting that all domestic facilities that engage in food processing, production, packing, or holding, must register as a Food Facility.

Additionally, the FDA may regulate any product that is adulterated or misbranded, even if that product doesn't enter interstate commerce.

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Sources

Learn more about interstate commerce in US Code Title 21 §331

More About Jurisdiction

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References

Learn more about interstate commerce in US Code Title 21 §331

Types of Exemptions:

The following types of food businesses are exempt from some requirements defined in the Code of Federal Regulations (CFR). However, they may subject to a separate set of requirements (see source texts below)

Click on the links below to learn more about the exemption type:

• Qualified Facilities (Very Small Businesses)

• Fish and Fishery Products

• HACCP Systems (Juice Producers)

• Low Acid Foods

• Dietary Supplements

• Some Produce Processors

• Some Farms

• Alcoholic Beverages

• Agricultural Commodities

What's Next?

Very Small Business Exemptions

More about Registration

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References

21 CFR §117.5 - Exemptions

21 CFR § 123 Fish and Fishery Products

21 CFR §120 HACCP Systems 

21 CFR §113 Thermally Processed Low Acid Foods Packaged in Hermetically Sealed Containers

21 CFR §113 Dietary Supplements

The Scoop:  "Very Small businesses" can apply online for an exemption to specific parts of the FDA Regulation.

If you think you’re a qualified facility, you must attest to the FDA that this is the case. You must submit this before beginning operations or by July 31st of the applicable year if you’re changing your status from “non-qualified facility” to “qualified facility”.

You can create an account and handle all of your registrations at the FURLS website

You can do this online or by mail.  You must first be registered as a food facility 

See "FDA Food Facility Registration"

Your attestation must include the following:

1. Attestation that your facility meets the provisions for a “Qualified Facility”

2. Attestation that you’ve identified the potential hazards of your foods and are both implementing controls and monitoring those controls to ensure they are effective.

3. Attestation that your facility is in compliance with State, local, and federal laws.

If you decide to pursue a qualified facility exemption, remember that you must keep all records to support your attestations. Additionally, starting in 2020, you must also re-submit your attestation every 2 years between October 1st and December 31st.

Source Texts

Looking for more clarity?  Check out the source texts below

21 CFR 117.201 - Qualified Facility Modified Requirements

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Should I apply for a FSMA Exemption?

You should consider applying for a qualified facility exemption if you sell <$1mm of product per year

Several types of businesses are able to exempt themselves from major components of FSMA. The most common way to do this is by being a small business and applying for the “Qualified Facility” exemption. These “Qualified facilities” are subject to modified requirements (found in 117.201)

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What is the Qualified Facility Exemption?

There are two paths that a business can take to apply for a qualified facility exemption. A business must satisfy the criteria of either path:

1st Path: “Very Small Business”

A “very small business” is one that produces less than $1 million (retail value) in product each year, averaged over 3 years. Included in this calculation is both product that is sold but also product that is made and not sold. For a business that exclusively holds food, the retail value of the food they hold must be less than $1 million per year.

2nd Path: Dual Criteria

1. The average annual value of all food sold in the preceding 3 year period was less than $500,000

2. Of your sales yearly value, at least half must have been sold to a “qualified end user”. A “qualified end user” must be:

• An individual (not a business) or

• A retail food establishment that is located in the same state as the manufacturer that is purchasing directly from the facility for sale directly to consumers.

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What am I Exempt From?

If your business applies for the "Qualified Facility Exemption", then you are exempt from Subparts C and G. These two sections include comprehensive requirements related to record keeping and process control.  Small businesses will be delighted to avoid these provisions!

Here's what you can drop:

• Subpart C - This section outlines the requirements for a food safety plan, a hazard analysis, and a recall plan. If you are exempt then you do not need to follow these requirements! See the FDA Reader Guide to Subpart C

• Subpart G - Supply Chain Program. If you are exempt then you do not need to follow this section (although you should work with reputable suppliers. See the FDA Reader Guide to Subpart G

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How do I Apply for an Exemption?

Check out our article on How to Apply for a Qualified Facility Exemption

More about Registration

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References

FDA Guidance Document: Determination of Status as a Qualified Facility

What You Need to Know

Part 117 Subpart B is called Current Good Manufacturing Practices (CGMPs). 

These CGMPs outline the major requirements that a food processor must adhere to, including:

• Facility requirements

• Employee requirements

• Equipment requirements

• Cleaning requirements

• Warehousing & Distribution requirements

Summary of Current Good Manufacturing Practices

This text is aligned with the coding used in the FDA Regulations so that you can hunt down the corresponding section with ease.

For example,  you have a question about my wording in §117.110 (b) (2) then just look up this same code in the CFR.

117.10 Personnel:

For a reduced summary of this section, see Personnel

a. Disease Control: Sick employees must be excluded from operations that could result in food contamination

b. Cleanliness: Employees must have clean practices:

1. Clothing that protects against contamination

2. Adequate personal cleanliness

3. Hand washing

4. Removing unsecured jewelry

5. Wearing gloves in a safe manner

6. Wearing hair restraints

7. Storing other belongings in areas where food is exposed/equipment is washed.

8. Not eating food, chewing gum, drinking beverages, or using tobacco in food areas.

9. Taking other precautions

§117.20 Plants & Grounds

For a reduced summary of this section, see Facility Requirements

a. Grounds: They must be kept in a condition that protects against contamination. Methods include:

1. Eliminate conditions for breeding/harboring pests

2. Maintain roads, yards, parking lots

3. Drain areas (i.e. puddles) that may breed pests or contribute to food contamination

4. Even if the grounds aren’t in your control, you must still mitigate contamination hazards.

b. Plant Construction & Design: The space must be suitable in size, construction and design for food production.

1. Must have adequate space for equipment and storage.

2. Must allow you to take precautions which reduce allergen contamination and food contamination (for example -- by chemicals, filth, other materials). Ways to eliminate contamination include separating operations by: location, time, partition, air flow systems, dust control system, etc.

3. Protect food that is stored outside in bulk containers:

4. Floors, Walls, Ceilings must be constructed in a way that allows them to be cleaned. The construction of the space must allow employees to do their jobs and not contaminate food, packaging, and work areas.

5. There should be adequate lighting in all food and employee areas (including food storage areas and employee locker rooms). All bulbs and glass that is suspended over areas where food is exposed should be shatter resistant.

6. There should be adequate ventilation to minimize dust, steam, odors, and vapors.

7. Provide screens or other protection against pests (door sweeps, air curtains)

§117.35 Sanitary Operations

For a reduced summary of this section see Sanitary Operations in Food Processing Facilities

a. General Maintenance: Your space and everything in it must be in good repair to prevent food from being contaminated (i.e. no leaky ceilings, which could drip in food). Your cleaning processes should protect your food, packaging, and workspace from contamination.

b. Cleaning chemicals:

1. You must only use safe cleaning chemicals. Toxic chemicals may only be allowed in food areas if they are:

i. Required for cleaning

ii. Used in lab testing

iii. Necessary for equipment maintenance

iv.  Absolutely necessary

2. You must store toxic chemicals in a way that protects food from contamination (Label it with the everyday name and keep it away from food and packaging)

c. Pest Control - Pests aren’t allowed in any area of the plant. You must exclude pests in the space and only use pesticides when it won’t result in contamination of food, packaging or work spaces.

d. Sanitation - You must clean food contact surfaces, including utensils, tables, equipment, to protect against contamination.

1. If you process low moisture (dry) food, your food contact areas must be clean and dry before use.

2. In “wet processing” food processing areas must be cleaned before use and after any contamination occurs.

3. Paper towels, paper cups and other single-use items must be protected from contamination.

e. Non-food-contact-surfaces (i.e. walls, ceilings or anything that doesn’t touch food) must be cleaned as much as necessary to prevent contamination of food, packaging, or work areas.

f. Portable equipment and utensils must be stored in a way that doesn’t contaminate work areas.

§117.37 Sanitary Facilities and Controls

For a reduced summary of this section see Facility Requirements

a. Water Supply must be from an adequate source. Running water must be of a suitable temperature and pressure and be provided in all food processing/cleaning areas.

b. Plumbing: Must

1. Carry adequate amounts of water around the plant.

2. Remove sewage from the plant.

3. Avoid contaminating food, equipment, water supply, utensils, ec.

4. Provide floor drainage in spaces where floors get very wet

5. Avoid back flow between plumbing systems

c. Sewage Disposal: Sewage must be disposed of adequately

d. Toilet Facilities: Each plant must have clean toilet facilities.

e. Hand-washing facilities: Each plant must provide hand washing facilities.

f. Rubbish: store rubbish to minimize odor, pests, and contamination

§117.40 Equipment and Utensils

For a reduced summary of this section see Equipment and Utensils

a. Equipment and Utensils

1. Equipment and utensils must be designed to be cleanable and maintained to avoid contamination.

2. Equipment and utensils must not contaminate food with lubricants, metal fragments, water, etc.

3. Equipment must be installed in a way that they can be cleaned and maintained.

4. Food-contact surfaces must be corrosion-resistant.

5. Food-contact surfaces must be non-toxic

6. Food-contact surfaces must be maintained to protect food from allergen cross-contact

b. Seams on food-contact surfaces must be seamless to minimize accumulation of particles.

c. Equipment kept in food areas must be constructed so it can be kept clean -- even if it doesn’t contact food.

d. Machinery must be designed in a way that can be kept clean

e. Each freezer and refrigerator must have a thermometer in it.

f. pH meters, thermometers, and other measuring devices must be accurate.

g. Compressed air must be treated in a way that it does not contaminate food.

§117.80 Processes and Controls

For a reduced summary of this section see Processes and Controls

a. General:

1. All operations involving food must align with sanitation principles.

2. Quality control must be used to ensure food and packaging is safe.

3. One or more competent individuals must be responsible for sanitation

4. You must protect your food from allergens and contamination.

5. Testing must be used to identify sanitation failures or possible product contamination.

6. Any contaminated food must be discarded or treated to eliminate the contamination.

b. Raw Materials & Ingredients

1. Ingredients must be inspected for cleanliness and stored safely. If necessary, raw materials should be washed using clean water.

2. Ingredients must be safe for consumption or treated to make them safe (i.e. washed or cooked).

3. Ingredients susceptible to toxins must comply with FDA regulations.

4. Ingredients that are contaminated must comply with FDA regulations if they are to be used.

5. Ingredients must be held in containers that prevent contamination and at an acceptable temperature and humidity level.

6. Frozen ingredients must be kept frozen.

7. Ingredients stored in bulk must be safe from contamination.

8. Ingredients that contain allergens must be identified and held in a way that prevents cross-contact.

c. Manufacturing Operations:

1. Equipment must be maintained in clean condition.

2. All operations should be controlled to minimize growth of bacteria, contamination and spoilage.

3. Food requiring refrigeration must be refrigerated throughout the operation.

4. Measures used to prevent bacteria growth (i.e. cooking, sterilizing, refrigerating) must be adequate.

5. Re-work must prevent contamination and bacteria growth.

6. When ingredients are unprotected they must not be handled in a way that could cause contamination. Food on conveyor belts must be protected.

7. Equipment, containers, and utensils must be constructed and used in a way that doesn’t contaminate food.

8. You must take measures to protect your product from metal or foreign objects.

9. Contaminated food must:

i. Be disposed of OR

ii. Re-worked and re-examined,

10. Food that is being processed must be protected from contamination.

11. Heat blanching --if used-- must be performed properly

12. Foods that are used repeatedly (i.e. dipping sauces, breading) must be protected from contamination and bacteria growth

13. Filling, assembling, and packaging processes must not contaminate food.

14. Dry foods that rely on low moisture for safety must be sufficiently dry.

15. Acidified foods that rely on acid for safety must be sufficiently acidic (pH≤4.6)

16. Ice that touches food must be food quality.

§117.93 Warehousing and Distribution

Storage and transportation of food must protect the food from contamination.

(That’s it!) See source code 21 CFR 117.93 to see for yourself

§117.95 Holding and distribution of Human food by-products for use as animal food

a. By-products held for use as animal food must be protected from contamination:

1. Containers must be safe

2. Food by-products must be protected from contamination

3. By-products used for animal food must be labeled

b. Labeling must use common name

c. Shipping containers must be inspected for contamination prior to use

§117.110 Defect Action Levels

a. Quality control must be used to minimize defects

b.Mixing contaminated food with uncontaminated food to dilute the contamination level is not permitted.

Exemptions

This section applies to most traditional food processors that fall under FDA jurisdiction. However, there are some notable exceptions.

• Farms

• Fishing Vessels

• Establishments who solely hold and transport agricultural products

• Establishments who only raw process (i.e. shell or dry) nuts.

• Mixed-Type farm facilities (defined in §1.227)

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This Article is For You If…

∆ You produce, pack or pack food that is consumed in the US.

∆ Your food product enters interstate commerce

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Table of Contents

§117.10 Personnel
§117.20 Plants and Grounds
§117.35 Sanitary Operations
§117.37 Sanitary Facilities and Controls
§117.40 Equipment and Utensils
§117.80 Processes and Controls
§117.93 Warehousing and Distribution
§117.95 Holding and Distribution of Human Food Byproducts for Use as Animal Food
§117.110 Defect Action Levels
Exemptions

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References

FDA Regulations on cGMPS

These requirements are a part of the Current Good Manufacturing Practices that relates to Equipment and Utensils You can see the full guide to cGMPs here

Equipment Requirements

• Equipment and utensils must be designed to be cleanable and maintained to avoid contamination.

• Equipment and utensils must not contaminate food with lubricants, metal fragments, water, etc.

• Equipment must be installed in a way that they can be cleaned and maintained.

• Equipment kept in food areas must be constructed so it can be kept clean -- even if it doesn’t contact food.

• Machinery must be designed in a way that can be kept clean

• Each freezer and refrigerator must have a thermometer in it.

• pH meters, thermometers, and other measuring devices must be accurate.

• Compressed air must be treated in a way that it does not contaminate food.
  

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Food Contact Surface Requirements

• Food-contact surfaces must be corrosion-resistant.

• Food-contact surfaces must be non-toxic

• Food-contact surfaces must be maintained to protect food from allergen cross-contact

• Seams on food-contact surfaces must be seamless to minimize accumulation of particles.

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References

Guide to Current Good Manufacturing Practices (117 Subpart B)

This Article is For You if…

∆ Your business is regulated by the FDA

∆ You manage a facility that makes, holds, or packs food.

∆ You use equipment and utensils in your operation

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What You Need to Know:

• "Intentional Adulteration" refers to the risk of someone deliberately contaminating a food product with aim of causing harm.

• The Intentional Adulteration Rule was implemented to address bio-terrorism threats committed against food companies to contaminate the US food supply.

• It applies to some, but not all food businesses (see "Applicability" below)

• You can fulfill the requirements for a Food Defense Plan using our template

Applicability:

Does the Final Rule on Intentional Adulteration Apply to you?

If you are a business under FDA regulation with >$10m/year in sales, then you most likely are required to comply with the Intentional Adulteration Rule.

Check the exemptions below and, if they do not apply to your businesses, see "What You Need to Do?"

Exemptions from the Intentional Adulteration Rule:

See if one of the following exemptions applies to your business or check out the applicability flowchart below

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Does the Intentional Adulteration Rule Apply to My Business?

• Food businesses that are not regulated by the FDA and aren't required to register as a food facility.

• Small food businesses that produce, distribute, or hold less than $10 million dollars in product retail value per year, averaged over the last 3 years.

• Food businesses that exclusively produce one of the following:

  • Licensed alcoholic beverage producers

  • Animal-food producers

  • Food which is packed, re-packed, or re-labeled food in a way that the container around the food remains intact.

  • Food businesses that only hold food, such as a distributor (unless the food is held in large liquid storage tanks).

  • Certain foods packaged on farms (See 21 CFR 121.5)

The FDA offers a flow chart to determine if the Rule on Intentional Adulteration applies to your food business.

Compliance Timeline:

View fullsize

Large Businesses (>500 Employees): July 26th, 2019

Small Businesses (< 500 employees): July 27th, 2020

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What You Need To Do:

Access our Free Food Defense Plan Template

If you are required to follow the Intentional Adulteration Rule, then you must develop a Food Defense Plan. This plan documents that you have developed and implemented the following activities:

1. Conduct a "vulnerability assessment" to identify where your business is vulnerable

2. Develop "mitigation strategies" for addressing food defense threats.

3. Monitor your mitigation activities to make sure they're working

4. Develop corrective actions for when things go wrong

5. Conduct verification checks

6. Maintain records

7. Re-analyze your food defense as necessary

1. Conduct A Vulnerability Assessment

This is a written assessment of what areas your facility and product might be at risk to a threat of intentional adulteration. You should evaluate the following:

• The potential impact if your product was contaminated

• The degree of access available to your product

• The ability of an attacker to contaminate your product

• The possibility of an inside attacker.

The easiest way to conduct a vulnerability assessment, is to use our Food Defense Plan Template and modify it to suit your business' needs.

Source 21 CFR 121.130

2. Develop Mitigation Strategies

If you identify a vulnerability in your business, then you must address it. Your mitigation strategies could include:

• Upgrading security around your facility (i.e. adding fencing, upgrading locks, reducing access)

• Developing a way to record and manage visitors in your facility.

• Minimizing access to sensitive areas to only the people who require that access.

• Changing how you store in-process product

• Upgrading your packaging to minimize opportunity for contamination.

This section must include a written explanation of how your strategy specifically minimizes the risk(s) that you identified in your vulnerability assessment.

3. Monitor Your Mitigation Strategies

You must monitor your food defense efforts to verify that they're effective.

Some of your mitigation strategies may be a simple structural fix (i.e. fencing the facility grounds) while others may require ongoing management (implementing a visitor-access policy).

The strategies that require ongoing maintenance should be monitored to ensure that they are effective. For example, if you implement a visitor-access policy for your facility, then a supervisor should occasionally monitor that guests are wearing the required badge and that the sign-in document that you developed is actually being used.

How often must I monitor my mitigation strategies?

This is your choice. You should monitor your practices which support food defense enough to ensure that they're being performed effectively.

Do I need to keep records of my monitoring?

Yes. All of your monitoring efforts should be recorded. You can do this by keeping "exception records" where the only records kept are to document when the strategy is not working.

4. Develop Corrective Actions For When Things Go Wrong

You must have written corrective action procedures that will guide you in what to do if one of your mitigation strategies fails.

For example, let's pretend your visitor-access policy requires all guests to be checked-in and wear a badge in the processing space. When you develop that food defense strategy, you should also create a corrective-action to answer the question "What do we do if there is an unauthorized person in the production space?". Your corrective action could be registering the visitor and reviewing security footage prior to releasing the product that was being processed.

If something goes wrong in your food defense procedures, you must document that a corrective action was taken and how the problem was solved. Store this in your records.

Additionally, if take a corrective action to address a failure then you must also take action to ensure that the same failure does not recur.

5. Conduct Verification Checks

You must conduct verification activities to confirm that your mitigation strategies are being carried out effectively. This is a "double check" to make sure everything is happening according to plan.

Specifically, you must verify that monitoring is effective and that your corrective actions were taken appropriately. This verification can take the form of a manager reviewing the records that were taken during a given time-period and signing off on them.

A manager may conduct verification on the facility's visitor-access policy by reviewing the visitor registration sheet each week to ensure that it is being used.

How often must I conduct verification checks?

This is up to you. Verification should occur often enough that you can make adjustments if something is found to be wrong. For example, records are typically verified before the relevant product leaves the facility. This way, the product can be inspected or reconsidered if the verification reveals something improper occurred.

Do verification activities need to be written?

Yes. However, it does not need to be a separate form. A manager can verify a document by signature and date showing that the document was reviewed and that verification occurred.

6. Keep Records

Your Food Defense Plan must be written and on file. Additionally, you should keep records of the following for at least 2 years:

• Monitoring records

• Corrective Action records

• Verification Records

• Any documents related to the food defense plan

• When your food defense plan was changed or updated

Your records should meet the requirements outlined in Part 117 Subpart F: Record keeping

7. Reanalyze Your Food Defense As Necessary

You must reanalyze your food safety plan:

• Every 3 years at minimum

• Whenever a change is made that might expose a new vulnerability or increase your risk of intentional adulteration.

• If the FDA identifies new vulnerabilities that they deem relevant to your business.

If your business makes a change that requires an adjustment to your food safety plan, you have 90 days to update your plan and implement the new strategies.

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This article applies to you if…

∆ Your business produces, packs, or holds food under FDA regulation.

∆ Your business conducts >$10mm sales per year.

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Table of Contents

What You Need to Know

Does the Intentional Adulteration Rule Apply to Me?

What You Need to Do

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Resources

FDA Regulation: Mitigation Strategies to Prevent Food Against Intentional Adulteration"

More About FSMA

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