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Allergen Labeling Requirements
Allergen Statements are required on nearly every canned food, even when it appears obvious. (Tuna: Contains Tuna)

Allergen Statements are required on nearly every canned food, even when it appears obvious. (Tuna: Contains Tuna)

What You Need to Know:

  • All packaged food products under FDA jurisdiction are subject to allergen labeling requirements.

  • The 8 major allergens are: milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans.

  • A “Contains” statement is the most straightforward way to declare allergens.


Applicable and Exempt Foods

Packaged foods for sale in the US which were labeled after January 1st, 2006 must have an allergen statement. This includes single-ingredient packaged foods (i.e. canned tuna)

Fresh fruits and vegetables do not require an allergen statement.

Highly refined oils derived from one of the eight major allergens do not need to comply with FALCPA allergen labeling requirements (e.g. soybean oil, peanut oil)

If you believe that an allergen containing ingredient should not require an allergen warning (because it will not elicit an allergic response) then you may submit a petition to exempt that ingredient from allergen labeling.

Building a Compliant Allergen Label

Know Your Ingredients: Make a comprehensive list of all ingredients, flavors additives, and colors in your product and any allergens they may contain. Inspect the product label on all ingredients in your product and write down any allergen claims that are listed.

Next, write your allergen statement based on the information you collected. Remember, your product contains all of the allergens which are in the ingredients that you use. You can show a product’s allergen content in two ways:

Option #1: Name the allergens in the ingredients list

Option #1: Name the allergens in the ingredients list

Option #2: Use a “Contains” statement

Option #1: Include the name of the allergen in the ingredients list in parentheses after the applicable ingredient.




Option #2: Use a “contains” statement. This should be located immediately adjacent to the list of ingredients.

Processed in a Facility That Also Processes…

It’s not uncommon to see an allergen statement like this on a packaged food. But what does it mean?

According to the FDA this is known as a May Contains claim. This type of claim is not required, nor is it recommended by the FDA.

So what if a food company produce their product in an facility that also processes other allergens? It shouldn’t matter that other allergens are present in the facility — proper cleaning and production should prevent any allergen cross contact.

Double Check Your Allergen Label:

Consider the following before printing new packaging:

  • Make sure the size of the allergen statement is no smaller than the ingredients list.

  • Use the same wording as the major 8 allergens. For example, an allergen statement for a product containing butter should say, Contains: Milk, not Contains: Butter. Even though the second statement is true, the name of the allergen is milk (not butter).

  • If you suspect that a consumer may not know that a particular ingredient is an allergen (e.g. casein) then it’s best to declare the allergen specifically in a “contains” claim (e.g. “Contains: Milk).

  • If the product includes either tree nuts, fish, or crustacean shellfish then you must specify the specific ingredient that falls within that category. For example,


Ultimately, what matters is that your allergen statement is truthful and not misleading.

FAQ:

Tree Nut Allergens

This category includes:

  • Almond

  • Beech nut

  • Brazil Nut

  • Butternut

  • Cashew

  • Chestnut

  • Chinquapin

  • Coconut

  • Filbert/Hazelnut

  • Ginko Nut

  • Hickory Nut

  • Lichee Nut

  • Macadamian Nut

  • Pecan

  • Pine Nut

  • Pili Nut

  • Pistachio

  • Sheanut

  • Walnut

wheat allergens

Wheat includes the following species:

  • Dommon wheat

  • Durum wheat

  • Club wheat

  • Spelt

  • Semolina

  • Einkorn

  • Emmer

  • Khorasan wheat

  • Triticale

Crustacean Shellfish Allergens

When stating a crustacean shellfish allergen, be sure to list the specific species in which the allergen occurs. For example,

Contains: Crustacean Shellfish (Lobsters)

Also, note that Molluskan shellfish (mollusks) are not one of the 8 required allergens regulated by FALCPA.


 
Understanding Date Labels
Forget everything you think you know about expiration dates.

Forget everything you think you know about expiration dates.

What You Need to Know:

  • Date labels have nothing to do with product safety — they indicate quality.

  • A date label should show the last date of expected peak quality.

  • The recommended wording for is “Best if Used By”

  • The FDA doesn’t require a date label on any food products except infant formula.


Introduction: 

The American food consumer is misreading date-labels and mistakenly throwing out $32 billion dollars worth of food because of it. The FDA is trying to minimize food waste and so they are providing specific guidance to manufacturers about how to write date labels and guidance to consumers about how to interpret them properly.


How to Read a Date Label

What does a date label mean? 

A date label on a food should indicate the last date where the food maintains peak quality and flavor. Date labels are meant to reflect quality not food safety.

A Best-if-Used-By Date “indicates to the consumer that the product may not taste or perform as expected but is safe to be used or consumed”

Wording is inconsistent and confusing to consumers

Wording is inconsistent and confusing to consumers

Can I eat a food after the “expiration date”?

Yes! This is because it’s not an expiration date. A food which doesn’t show signs of spoilage after the specified date can still be eaten. 

Remember that food manufacturers have an incentive for you to only consume products in their “peak quality” because then you will buy their products more often. 

How do I know when a product is unsafe to eat? 

Major food industry groups have endorsed the use of “Use By” to indicate when a product should be discarded for food safety reasons but, as of 2019, the FDA hasn’t taken a stance on this topic.


How to Write a Date-Label

What wording should I use For my Date Label?

The recommended terminology is “Best If Used By”. This indicates that the date is an indicator of quality, not food safety.

The FDA recommends not using words like “sell by” or “expires on” because this obscures the meaning of a date label.

How do I pick a Best-If-Used-By date for my food product? 

Food manufacturers can collect this information by either conducting tests themselves to assess quality. You can do this by storing multiple versions of your product in the recommended storage condition and then tasting them at various time intervals to assess the point when quality begins to decline.

It’s important that you don’t produce, package or store these test-products any differently than you normally would. Finally, your Best-If-Used-By date should pass before any sort of decline in product quality.

You can also enlist a reputable testing lab to conduct testing on your behalf.

Since best-if-used-by dates are an indicator of quality, it’s important that your product is safe for consumption well beyond the date you print on the label.

Do I need to change my packaging If I am not aligned with these Standards?

No. The FDA is trying to minimize confusion to consumers and food waste nationwide. These guidelines won’t be enforced by the FDA — they are simply setting a standard for the industry to adopt.

Should I remove the date label from my product?

You can, but many retailers and some local agencies have their own requirements for printing a “use-by” date of some type. Your best bet is to adopt the FDA-approved wording and print a use-by date that you can stand behind.

Do I need a date label if my product is non-perishable?

Not to satisfy FDA standards (only infant formulas require a “use by” date.) However, large retailers may require a date label on all foods they carry, so it’s worth building the capacity to print date labels, even if you don’t use them at this time.


 
Qualified Health Claims

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

What You Need to Know:

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"

Example of a Qualified Health Claim:

"Some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer. However, FDA has determined that this evidence is limited and not conclusive."

What Qualified Health Claims Can I Use?


Qualified Health Claims 2000-2013

The attached PDF contains a list of qualified health claims released by the FDA in their 2013 Food Labeling Guide. This represents Qualified Health Claims Through 2013.

Qualified Health Claims 2013-2018

A number of Qualified Health Claims have been released since the FDA Food Labeling Guidance Document. The links below are the FDA's response, known as a "Letter of Enforcement Discretion". This includes the qualified health claim that the FDA will allow (usually in the conclusion) and the specific requirements associated with using that qualified health claim.

Cardiovascular Disease

Diabetes

Peanut Allergy

 
Gluten-Free Claims

What You Need to Know:

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The label "gluten-free" is meant to protect people who have celiac disease. A "gluten-free" claim is considered neither a health claim or a nutrient content claim

A food processor may make a "gluten-free" claim on their food product without any additional registration or notification insofar as they meet the FDA requirements for making this claim.

The following common grains contain gluten:

  • Wheat (genus Triticum)

  • Rye (genus Secale)

  • Barley (Genus Hordeum)

Any food whose label says "Contains Wheat" should be understood to contain gluten unless there is a disclaimer stating that the gluten has been removed in the manufacturing process.

Requirements for Using a Gluten Free Claim:

The following are specific product requirements for a food labeled as "gluten free". Such a food must:

  • Cannot contain any gluten containing ingredients or grains (wheat, rye, barley)

  • Cannot contain any ingredients derived from gluten-containing ingredients (i.e. "wheat flour")

  • May contain an ingredient that has been processed to remove gluten (i.e. wheat starch). However, your food must ultimately contain less than 20mg gluten per 1kg of food.

  • If your product contains wheat or lists "wheat" on the ingredient label and bears a "gluten-free" claim, then you must state the following "the wheat has been processed to allow this food to meet the FDA requirements for gluten free foods."

No additional registration or notification is required to make this claim.

How to Create an FDA Compliant "Gluten-Free" Claim

Gluten-Free.png
  1. Make sure your product complies with the requirements above (i.e. it doesn't contain gluten)

  2. Check all of the labels of ingredients in your product to confirm that none of the component ingredients in your food product contain gluten.

  3. Review all of the ingredients each time you change ingredients, suppliers, or recipes to confirm that your claim is still valid.

  4. Confirm that there is no way your product could be contaminated with gluten in the production process.

  5. Confirm that your gluten free claim is aligned with the requirements described in this section.

FAQ

WHAT ARE FOODS THAT TYPICALLY CONTAIN GLUTEN?

Wheat

  • Bread

  • Baked Goods

  • Pasta

  • Cereal

  • Salad Dressing

Rye:

  • Rye Bread

  • Cereals

Keep an Eye On:

  • Soups

  • Processed Meats

  • Salad Dressing/Marinades

  • Potato Chips

Other Gluten-Containing Grains:

  • Durum

  • Farro

  • Semolina

  • Bulgur

  • Kamut

  • Spelt

  • Triticale

Barley:

  • Malt

  • Food Coloring

  • Soups

  • Malt Vinegar

  • Beer

 

WHAT FOOD PRODUCTS DOES THE FDA REGULATION COVER?

This covers all FDA-regulated packaged foods, including dietary supplements. The rules exclude products under the USDA (eggs, poultry, meat, generally) and products under the TTB (liquor, wines an malted beverages)

IS THERE AN ACCEPTABLE LEVEL OF GLUTEN IN A "GLUTEN-FREE" PRODUCT?

The FDA regulations stipulates that, when unavoidable, there is an acceptable threshold of 20ppm (parts-per-million) or 20mg of gluten per 1kg of food. 

Practically, in order to use the label "gluten-free" your product must not cause adverse reaction in someone with celiac disease (which is more serious than a gluten sensitivity). 

A product that is labeled "gluten-free" and creates an adverse reaction to someone with celiac disease may draw scrutiny, investigation and possible recall from the FDA, even if the product falls under the acceptable threshold.

ARE TERMS SUCH AS "NO GLUTEN", "FREE OF GLUTEN", AND "WITHOUT GLUTEN" REGULATED?

Terms such as "no gluten", "free of gluten", and "without gluten" are all regulated by the FDA and are subject to the same requirements as a "gluten free" label claim.

You may make the claim "made with no gluten-containing ingredients" without adhering to the specific requirements of this section (listed above or found in §Subpart F 101.91) insofar as your claim is truthful and not misleading.

CAN I MAKE A GLUTEN-FREE CLAIM IF GLUTEN IS PROCESSED IN MY FACILITY?

Yes. Ultimately what matters is that your product will not cause an adverse reaction in someone who has celiac disease. In that case, the FDA would test your product too see if it passes the standard for gluten-free products (<20ppm gluten)

If gluten is processed in a facility where you make your gluten-free product, your ability to make a truthful claim depends on how you are able to separate your product from gluten and eliminate any threat of allergen contamination between products. Generally, this can be achieved through following Current Good Manufacturing Practices and addressing any possible scenario where gluten-contamination of your product could occur.

If you are still unsure of your ability to make this claim, you may consider making the following claim on your product: "made with no gluten-containing ingredients"

This term is not regulated according to the FDA requirements for gluten-free labeling (found in §Subpart F 101.91) and can be made insofar as the claim is truthful and not misleading.

AM I REQUIRED TO CONDUCT TEST FOR GLUTEN IF I MAKE A GLUTEN-FREE CLAIM?

No, you are simply responsible for ensuring your product meets the requirements for gluten free. A food processor may wish to test their product for gluten as a quality control measure but it is not required.

WHAT IS "CERTIFIED GLUTEN-FREE"?

Note that, while certification bodies exist, certification is not required to label your product as "gluten-free"

Note that, while certification bodies exist, certification is not required to label your product as "gluten-free"

There are several private organizations that provide certification for gluten-free claims. It works like this: food businesses pay the certifying body to conduct certification activities. If the food business passes, then they can use the certifying organizations logo on their product.

These certification names and logos may provide some consumers with assurance that the product is safe to consume.


Examples of these certifying groups include:

  • Gluten Free Certification Organization

  • Celiac Support Association

  • Allergen Control Group

Each of these programs dictates their own standards for certifying a product as "gluten-free" . This may include specific ingredient requirements, sending your product to the organization for gluten testing, and a facility inspection.

 
Authorized Health Claims You Can Use On Your Label

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:

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


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


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


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:

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


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


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


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


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:

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


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


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


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:

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

 
Nutrition Facts Labeling

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

What You Need to Know

  • 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

  • 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.


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)


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


How to Make an FDA Compliant Nutrition Information Label

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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.


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)