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FDA Reader: Simplifying Food Regulation

Sanitary Operations in Food Processing Facilities

These requirements are a part of the Current Good Manufacturing Practices that relates to Sanitary Operations. You can see the full guide to cGMPs here

Requirements For Sanitary Operations

Inadequate storage of chemicals and poor sanitation indicate a breakdown in food safe systems

Inadequate storage of chemicals and poor sanitation indicate a breakdown in food safe systems

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.


Cleaning Chemicals:

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

  • Required for cleaning

  • Used in lab testing

  • Necessary for equipment maintenance

  • 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)

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.

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.

Non-food-contact-surfaces

These 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.

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


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)


 
 

This Article is For You if…

∆ Your business is regulated by the FDA

∆ You operate a space where food is handled, packed, or produced.

∆ You want to understand cleanliness standards for your space.


More About Operating Requirements

More Posts


References

Guide to Current Good Manufacturing Practices (117 Subpart B)

Guide to Current Good Manufacturing Practices (117 Subpart B)

Low Acid Foods Packaged in Hermetically Sealed Containers
06_low_acid.png

What You Need to Know:

  • They are commonly referred to as low-acid-canned-foods (or "LACF") even though they may not be packaged in a can.

  • Low Acid Foods in Hermetically Sealed Containers are by definition (1) shelf stable, (2) heat-treated (3) have a pH of >4.6 and (4) a water activity of 0.85

  • Examples of Low Acid Foods in Hermetically Sealed Containers include: shelf-stable milk in pouches, canned beans, vegetable broth in a pouch.

  • There are 2 primary methods for processing LACF: Using a Retort (pressuring cooker) and Aseptic Processing (a sterile packaging process)

  • They are regulated in 21 CFR Part 113: Thermally Processed Low Acid Foods Packaged in Hermetically Sealed Containers

Key Terms

Low Acid Foods have a pH of >4.6 and a water activity of >0.85

Hermetically Sealed Container is packaging which prevents the entry of microorganisms and maintains the commercial sterility of the contents.

Commercial Sterility means there is zero microbiological activity (including bacteria, spores or anything that could reproduce under shelf-stable conditions

LACF ("Low-Acid-Canned-Food"): This term is used interchangeably with "Low Acid Foods Packaged in Hermetically Sealed Containers". It may apply to foods packaged in containers other than cans (i.e. flexible pouches or jars) which is why the term "hermetically sealed container" is used.

Examples of Low Acid Canned Foods:

This list only includes food products that would be governed under the FDA. Foods that fit the definition of LACF and contain >2% meat content are governed under the USDA.

  • shelf-stable milk (commonly packaged in pouches)

  • Canned tuna

  • Canned black beans

  • Canned corn

  • Canned mushrooms

  • Canned Cauliflower

  • Shelf-stable vegetable broth

Does Part 113 Apply to your food product?

Is my product a Low-Acid-Canned-Food (LACF)?

Even if your product is not "canned", it may fall under the regulation of Part 113. Use the flow (above) to the right to determine whether your product is considered a LACF (aka "low acid food in a hermetically sealed container")

Requirements for Producers of LACF

Personnel

The operators of a processing system that produces LACF must have attended an FDA approved course that instructs on how to safely process these foods. An example of an approved course is "The Better Process Control School" which is offered online or in person.

Source: Part 113.40

Equipment and Procedures

The bulk of regulation under Part 113 relates to the requirements for thermal processing and aseptic processing.

Methods for Processing LACF

The two primary methods for processing low-acid-canned-foods are retort and aseptic processing.

Retort

A retort is a large pressure cooker. Sealed containers of food (typically cans, jars, or pouches) are loaded into the retort and heated using steam and pressure. This thermal treatment kills all of the microbiological activity in the containers.

In a retort process, products are treated after they are packaged and sealed.

The use of high pressure allows the retort to achieve temperatures above boiling, which allows for products to rapidly achieve sterility.

Examples of Foods Processed by Retort: Canned beans, canned vegetables, canned soup, canned tuna

Aseptic Processes

In an aseptic process, the food products are heat processed prior to packaging. Since there is a risk that the packaging or food may become contaminated in the packaging step, the entire process takes place under sterile conditions (hence the term aseptic).

Aseptic manufacturing requires tremendous control to maintain a sterile environment during processing. The machinery to perform this type of process is typically very expensive.

Examples of Foods Processed by Aseptic Process: Shelf-Stable Milk, juice boxes

Exemptions for Producers of Low Acid Canned Foods (LACF)

Processors who operate under Part 113 are exempt from the following requirements:

  • Subpart C (Hazard Analysis and Risk Based Preventive Controls)

  • Subpart G Supply Chain Controls

However, this exemption only applies in regards to microbiological hazards regulated under Part 113. Simply -- if the food processor identifies chemical or physical hazards in their production process, they must address those hazards as they are outlined in Subpart C.

Additionally, if the processor identifies a hazard that requires a supplier-applied preventive control, then the processor would have to conduct supplier verification activities as described in Subpart G.

Source: Part 117.5 (d) (1) & (2)

FAQ

Are fermented foods regulated under Part 113?

If the fermented food has a pH of >4.6 and a water activity > 0.85, then it is considered a "low-acid-canned food" (LACF) and is regulated under Part 113.

If the fermented food has a pH of <4.6 then it is not regulated as a Low-Acid-Canned-Food (Part 113) OR an acidified food (Part 114).

Are Alcoholic Beverages Regulated Under Part 113?

No. Alcoholic beverages are not regulated under Part 113 (Low Acid Foods in Hermetically Sealed Containers) or Part 114 (Acidified Foods).

Sources

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

 
What You Need to Know About FSMA

What is FSMA?

The Food Safety Modernization Act was a piece of legislation that went into effect in 2016. It shifted the focus of food safety from responding to foodborne illness outbreaks towards preventing foodborne illness outbreaks. FSMA updates the requirements for many food businesses who fall under FDA Jurisdiction. FSMA has six major sections:

  1. Preventive Controls for Human Food (Part 117) - Requires processors of human food to develop risk-based systems focused on food safety through prevention. This includes,

  2. Foreign Supplier Verification - Ensures imported food is produced to FDA standards.

  3. Sanitary Transportation Aims to protect food in transportation

  4. Intentional Adulteration (Part 121) - Aims to protect from terrorist acts of contaminating the nation's food supply by establishing "Food Defense" requirements.

  5. Preventive Controls for Animal Food (Part 507) - Requires processors of animal food to develop risk-based systems focused on food safety through prevention.

  6. Produce Safety (Part 112) - Increases the standards of processing produce.


What Businesses Does FSMA apply to?

  • Human food processors

  • Animal food processors

  • Food transporters /shippers

  • Farms

  • Food Importers

  • Food Warehouses / Food Storage facilities

When Does FSMA Take Effect?

FSMA is being rolled out over the course of several years. Smaller businesses have been given longer timeframes for compliance. See the image below for compliance dates.

Timeline of FSMA Compliance Dates

Timeline of FSMA Compliance Dates


Selected FSMA Implementation Dates

Deadline for Preventive Controls for Human Food

  • Very Small Businesses (<$1mm sales/Yr) - 9/17/2018

  • Small Business (<500 employees) - 9/18/2017

  • Large Business (>$1mm sales/yr and >500 employees) - 9/19/2016

Deadline for Intentional Adulteration (Human food):

  • Very Small Businesses - July 26, 2021

  • Small Businesses - July 27, 2020

  • Large Businesses - July 26, 2019

FAQ

What are the FSMA requirements for my business?

All content on this website is FSMA-aligned and all articles have been updated to reflect FSMA provisions. You can learn about the major provisions of FSMA by reading this summary or browse by category to understand the specific requirements for your business.

The requirements imposed by FSMA have also been integrated into the FDA regulations, so feel free to dive into the Code of Federal Regulations and find your answers.

What is the difference between FSMA and the FDA Regulation?

FSMA is a law that was passed by congress. This updated the FDA regulation, which is a set of rules put forth by the FDA. If your business practices are aligned with the latest version of the FDA regulations, then your business is also FSMA aligned

This website is FSMA-aligned so you don't have to worry about additional FDA requirements.


What are the record keeping requirements for FSMA?

The record keeping requirements for FSMA are outlined in our summary of Part 117 Subpart F



What is a PCQI?

A PCQI is a preventive-controls-qualified-individual. This is someone who has been trained in the risk-based practices required by FSMA. There are many PCQI courses available in-person and online.

All businesses except those exempt from Part 117 Subpart C - Hazard Analysis and Risk Based Preventive Controls are required to have a PCQI to do the following:

  • Prepare the food safety plan and review as necessary

  • Supervise daily production on site.

The PCQI can be a permanent employee for the food processor but is not required to be.

 
Acidified Food Regulation (Subpart 114)

What you Need to Know:

If you are unsure of whether your product is an acidified food, see Introduction to Acid Foods

  • If you produce an acidified food, you must conduct additional filings with the FDA (free)

  • Producers of acidified foods must complete the "Better Process Control School" or an equivalent training course (available online)

Required Registrations/Filings for Acidified Food Producers

If you produce an acidified food, you must register your facility and file each acidified foods you process with the FDA.


Food Canning Establishment Registration

Paper Form: Food Canning Establishment Registration

Paper Form: Food Canning Establishment Registration

If you produce an acidified food, you must register the location where you produce that food. This filing is in addition to the normal food-facility-registration.

This filing simply notifies the FDA that acidified foods (which can be higher-risk food products) are being produced at this location. Completing this registration will not trigger an inspection.

File Electronically:Food Canning Establishment Registration (Form 2541).

File in Paper: Food Canning Establishment Registration (Form 2541)

If you have addition questions about completing Form 2541 see Instructions on Registering a Food Canning Establishment


Food Process Filing for an Acidified Food

Paper Form: Food Process Filing for an Acidified Food (Form 2541e)

Producers of acidified foods must file a scheduled process for each acidified product that they produce. If a salsa company produces 5 SKUs that are all acidified foods, then they must submit 5 process filings, one for each SKU.

There is no requirement to file for products that do not fit the definition of an "acidified food".

File Electronically:Food Process Filing for an Acidified Food (Form 2541e)

File in Paper:Food Process Filing for an Acidified Food (Form 2541e)

If you have questions about the filing process, see Instructions on filing Form 2541e


Requirements for Processing Acidified Foods

Always follow your scheduled process and contact your process authority if something goes wrong.

Process and Controls

Scheduled Process

  • The manufacturer must follow a scheduled process.

  • The schedule process must be established by a person who as expert knowledge about the acidification and processing of acidified foods.

Processing Operations

  • The food must be thermally-processed (i.e. a heat-based kill step) to eliminate bacteria capable of reproducing in the finished product. Preservatives may be used in lieu of thermal processing for controlling the growth of microorganisms that are not harmful (i.e. spoilage bacteria that would ruin the food but not cause illness in humans).

  • Keep your production records onsite (digital is fine) for at least 3 years.

Source: §114.80 (a) (1)

Acidification Procedures

Some acceptable methods used to acidify foods include:

  • Blanching ingredients in acidified solutions

  • Immersing blanched ingredients in acidified solutions

  • Directly adding a measured amount of acid solution into a batch of food.

  • Directly adding a measured amount of acid into individual containers during product.

Source 114.80 (a) (3)

Measuring pH

  • The equilibrium pH of the final product must be below 4.6 and it must reach this within the timeframe set in the scheduled process.

  • The pH of the product must be measured and recorded to maintain control throughout the process. If the final pH of the product is ≥4.0, then a potentiometric pH meter must be used (these are more accurate). If the final pH is <4.0, any type of pH meter may be used.

  • pH readings should be taken at a temperature of 20ºC-30ºC (68º-86ºF). Optimal temperature for pH test accuracy is 25ºC (77ºF).

Source 114.80 (a) (1) & (2)

For a full explanation of pH and testing methodology, see §114.90

Containers and Coding:

  • You must test and examine your containers to confirm that they protect your final product from leakage or contamination

  • Each container must be labeled with a code that specifies the following:

    • Where the product was packed

    • The contents of the container

    • The date of packing

    • The code must be changed for each personnel shift, at minimum.

Deviations from Scheduled Process

If the equilibrium pH is measured at >4.6 the processor must take one of the following steps:

  • Fully reprocess the food using a process approved by a process authority (this can be simply re-processing according to your usual method)

  • Thermally process the food as a low-acid-canned food

  • Set aside the food for evaluation by a process authority

  • Destroy the food.

Make a record of this incident, regardless of the outcome.


FAQ

Do I need to register my facility and products if I operate outside the US?

If you produce a product that meets the definition of an "acidified food" for consumption inside the US, then you must register your facility (Form 2541) and each of your acidified food products (2541e).

Processors located outside the US must also complete these registrations if their food will be exported for consumption inside the US.

Wholesalers, importers, distributors and brokers are not required to register and file processes

Source

Does compliance with Subpart 114 exempt me from other requirements?

A business operating under Acidified Food Regulations ( Subpart 114 ) is still subject to the requirements in Subpart 117 B: Current Good Manufacturing Processes as it relates to determining whether a product is adulterated.

 
Introduction to Acid Foods
Foods with a pH of &lt;4.6 are called "Acid Foods" Some types of acid foods, such as  acidified foods , are subject to specific regulation.

Foods with a pH of <4.6 are called "Acid Foods" Some types of acid foods, such as acidified foods, are subject to specific regulation.

What are Acid Foods?

Acid Foods: A food with a natural pH of ≤4.6. There are many naturally acidic foods, including apples, yogurt, peaches, onions, tomatoes, strawberries and lemons.

"Acid Foods" as a general group are not regulated, although certain sub-groups of acid foods are.

Types of Acid Foods

There are two main types of acid foods

Acid-Food-Types-1-1.jpg

Acidified Food: These are low-acid foods that has been acidified by adding something acidic so that the end product is ultimately acidic has an equilibrium pH of ≤4.6) . This includes foods such as: dill pickles, hot sauce, and pickled fish.

The FDA does not include the following to be Acidified Foods:

  • Carbonated Beverages

  • Jams, jellies & preserves

  • Naturally acid foods like peaches and most fruit juices

  • Foods with a water activity of ≤0.85

  • Foods which are stored under refrigeration

  • Fermented foods (i.e. kimchi, sauerkraut, natto)

The FDA regulates acidified foods in 21 CFR Part 114.

Formulated Acid Foods: These are composed mostly of acid foods to which a small amount of low-acid ingredients are added (generally less than 10% by weight). The low proportion of low-acid ingredients means that the pH doesn't change significantly from the pH of the dominant ingredients. Examples include:

  • Barbecue Sauce

  • Salad Dressings

  • Marinades

Use this key to determine if your food is an acidified food.

FAQ

Is my product an Acidified Food?

Consider this flow chart to determine if your product is regulated by the FDA as an Acidified Food:

Click to enlarge

What's the difference between an acidified food and a formulated acid food?

The difference between these two types acid foods depends on the proportion of low acid and high-acid ingredients in each product:

Acidified foods are typically low acid foods with an added acid (which acidifies the low acid food.)

Formulated Acid foods are composed mainly of high acid foods with a small amount of low acid foods added.

Formulated Acid Foods

In order to qualify as a "formulated acid food", the low-acid ingredients must not significantly shift the pH of the product from the natural pH of the high-acid ingredients.

For a food product whose equilibrium (final) pH is <4.0, then a shift of up to 0.4 is considered insignificant.

For a food product whose equilibrium (final) pH is >4.0, then a shift of up to 0.1 is considered insignificant.:

Example #1:  Ned's BBQ Sauce.

Ingredients by weight: Tomato paste (93%), Sugar (5%), Spices (2%)

Ned's BBQ Sauce Equilibrium pH: 3.9

pH of only High-Acid Ingredients: 3.6

Change between high-acid ingredients and final product = 0.3

Since the equilibrium pH of Ned's BBQ Sauce is below 4.0, only an increase of 0.4 or more would be considered significant. Since the low-acid ingredients only increase the pH by 0.3, this change is considered insignificant.

Outcome: Ned's BBQ Sauce is a Formulated Acid Food. It is not subject to 21CFR Part 114



Example #2: Ned's Marinade

Ingredients by weight: Tomatoes (60%) Onion (10%) Vinegar (20%) Sugar (7%) Spices (3%)

Ned's Marinade Equilibrium pH: 4.2

pH of only High-Acid Ingredients: 4.0

Change between high-acid ingredients and final product = 0.2

Since the equilibrium pH of Ned's BBQ Sauce is above 4.0, an increase of above 0.1 would be considered significant. Since the low-acid ingredients increase the pH by 0.2, this change is considered significant.

Outcome: Ned's BBQ Sauce is an acidified food. As a result, it is subject to The regulations in 21 CFR Part 114.

 
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:

blur-close-up-focus-575822-1.jpg

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

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.


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


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


References

Requirements for petitioning a Authorized Health Claim

Requirements for petitioning a Authorized Health Claim

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

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

 
 
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

 
Introduction to Food Product Claims
11_claims.png

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.


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:

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.


Authorized Health Claims

See main article Authorized Health Claims

Health-Claim-Example-1.png

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

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.


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". 


Nutrient Content Claims

Nutrient Content Claims

Main Article: Nutrient Content Claims

Examples of Nutrient Content Claims

What is a Nutrient Content Claim?

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.


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.

 
Nutrient Content 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.


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)


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. The threshold is:

  • >13g fat per serving

  • 4.0g of saturated fat

  • 60mg of cholesterol

  • 480mg of sodium

  • 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)


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)


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).


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. 


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.


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)


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"


 
Principal Display Panel

What You Need to Know:

Examples of PDP of different packaging forms

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


 
Basics of FDA Food Labeling Requirements
Most food product labels have specific requirements about what information you must state on the label, where it appears, and the format.

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


Types of Panels

Front Panel (Principal Display Panel)

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

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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


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”

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:

 

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.


 

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


Net Quantity of Contents

Net quantity of contents posted on the PDP

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

 
Exemption from Nutrition Labeling Requirements
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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.

 
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) 

 

117 Subpart G: Supply Chain Program
Truck Supply Chain.png

What You Need To Know

  • 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.


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"


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


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.