Contents

  What You Need to Know
  Applicable and Exempt Foods
  Building a Compliant Allergen Label
  Processed in a Facility That Also Processes...
  Double Check Your Allergen Label...
  FAQ

What You Need to Know:

• Most but not all foods sold in the US require an allergen statement.

• In order to create an allergen label for your product you must understand the ingredients and their origins.

• Allergen statements typically follow a standard wording that you can use. Don’t overthink it!

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Applicable and Exempt Foods

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

Fresh fruits and vegetables do not require an allergen statement.

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

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

Building a Compliant Allergen Label

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

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

How I determine what allergens are in my product

1. I write a list of all of the ingredients in my product.

2. Using my ingredients list as a guide, I take a photo of the packaging for each ingredient (including the ingredients and nutrition facts) so I can have it as a reference. Sometimes, there are ingredients where I switch between 2 brands. In that case, I'll take a photo of both brands' labels.

3. I return to the ingredients list for my product. Next to each listed ingredient, I write down any allergens that I discovered on the packaging for that ingredient. This is where it helps to have photos of the packaging labels.

4. After I've reviewed every ingredient, I'll have a list of allergens that appear in my product. Now I just format my allergen declaration using one of acceptable formats below.

Option #1: Name the allergens in the ingredients list

View fullsize

Option #2: Use a “Contains” statement

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

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

Processed in a Facility That Also Processes…

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

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

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

A “may contains” claim doesn’t mean much — it is a tool to limit business liability for any allergens that show up in your product. But don’t rely on this type of claim to compensate for bad food processing practices. While it may stop someone with a food allergy from eating your product, it will not mean that a food business is exempt from liability related to allergens in your product.

Double Check Your Allergen Label:

Consider the following before printing new packaging:

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

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

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

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

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

FAQ:

Tree Nut Allergens

This category includes:

• Almond

• Beech nut

• Brazil Nut

• Butternut

• Cashew

• Chestnut

• Chinquapin

• Coconut

• Filbert/Hazelnut

• Ginko Nut

• Hickory Nut

• Lichee Nut

• Macadamian Nut

• Pecan

• Pine Nut

• Pili Nut

• Pistachio

• Sheanut

• Walnut

wheat allergens

Wheat includes the following species:

• Dommon wheat

• Durum wheat

• Club wheat

• Spelt

• Semolina

• Einkorn

• Emmer

• Khorasan wheat

• Triticale

Crustacean Shellfish Allergens

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

Contains: Crustacean Shellfish (Lobsters)

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

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What You Need to Know

• The FDA compiles a list of ingredients that are current approved for use in food. This is known as Generally Recognized As Safe (GRAS) and you can access the database here.

• Not all ingredients have been classified as either allowable or prohibited. Sometimes, this is because the FDA hasn’t gathered enough information yet to make a determination

How to Assess Whether an Ingredient is Legal to Use in Your Product

Look it up and see if it is explicitly Banned as a Food INgredient

The FDA Substances Added to Food is a comprehensive list of ingredients which are both allowed and banned from foods. Illegal ingredients will be listed as “prohibited”

Search for FDA Guidance Documents on the Substance

Many new, trendy ingredients will not appear in the official FDA regulation or their databases. However, the FDA is quick to release guidance documents explaining their stance on a given topic — even if t hasn’t been coded into the regulation yet.

For example, while there is no mention of Cannabidiol (CBD) in the FDA Regulations, the commissioner released a report outlining the agency’s stance on the substance as a food ingredient (spoiler — it’s not allowed in food or cosmetics)

Generally Recognized As Safe (GRAS)

The GRAS list outlines ingredients which may be used in food.

Some general requirements when dealing with unusual ingredients are:

• the substance must be food grade

• If the FDA outlines specific limitations or conditions for use of that substance, it must be obeyed.

• The substance must be included as an ingredient according to standard ingredient labeling requirements.

GRAS regulations are outlined in 21 CFR Part 182 and Part 184

If an Ingredient is not on the GRAS List

A company which wishes to introduce an ingredient not on the GRAS list may file a GRAS notice with the FDA. There are two ways to demonstrate a food is “generally recognized as safe”

1) By either proving that the ingredient has been in common use since 1958. If the ingredient is of biological origins and doesn’t have any known food safety issues, it will likely be accepted. or,

2) By providing scientifically valid information about that ingredient showing its safety. The FDA will respond by either stating that the GRAS notice is sufficient or insufficient. If deemed insufficient, then that food ingredient may not be used in food until a stronger case is built and the FDA approves a submitted GRAS notice.

To access more information about filing a GRAS petition, see 21 CFR 170.3 Subpart B

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Food Labeling Errors That Can Cost You Your Business*

*and how to avoid them

Designing a food label can be a daunting task for an entrepreneur bringing a new product to market. Even after you check the boxes for nutrition facts, product claims, and display requirements, you still have to make it work with your packaging design. But if you don’t have time to make sure your label is 100% compliant with every last regulation, then at least avoid the following mistakes — they could cost you your business.

1. Undisclosed Allergens

Many FDA food recalls are related to undeclared allergens. This typically is the result of two easily-avoidable mistakes: (1) the ingredients listing on the package doesn’t match the product in the packaging and (2) The allergens in the product are not displayed prominently to the consumer.

How to Avoid This Mistake: Make sure your ingredients list is complete and that you are identifying any of the Big 8 allergens using an Allergen statement, such as “contains peanuts”.

Who Cares? The FDA, the person you made sick. 

Likelihood of Discovery: High. Food allergies are common and undeclared allergens tend to get discovered when a consumer has an allergic reaction to the product, despite having checked the label first.

What it will cost you: Because of the potentially life threatening nature of an allergic reaction to food, food manufacturers typically conduct an immediate, voluntary recall of all effected products.

2. Unauthorized Health Claims

There are clearly defined rules when it comes to the types of claims you can make about a food product’s effect on the consumer’s health. The easiest way to guarantee the wrath of the FDA and a swift food recall is to make an-unauthorized health claim or drug claim. This means making a claim about how the product or one of its ingredients affects your body or provides some sort of therapeutic affect. It is unlawful to make this type of claim on the product label itself but also on marketing materials (e.g. the company website), even if you have scientific evidence to back it up.

While the FDA has approved a small number of Authorized health claims approved for use, there are only twelve of them, plus a handful of weakly phrased qualified health claims.

How to Avoid This Mistake: Do not make any unauthorized claim about your product’s effect on the body or treatment of any ailment. Make sure any claims related to nutrition or the benefits of specific ingredients align with the regulation

Who Cares? The FDA. Here’s why: let’s say you claim that the high levels of antioxidants in your popular snack bar has been shown to support immune health in cancer patients. If cancer patients forsake treatment measures in favor of your snack bar, this could have negative public health outcomes. Major retailers will also pull these products from their shelves if they don’t discover this error before they place their order.

Likelihood of Discovery: High. Claims are typically printed prominently to get the consumer’s attention. This also means getting the attention of regulators and savvy consumers.

What it will cost you: All of the products and materials containing the unauthorized claim, possibility of brand damage and the possibility of expensive lawsuits from customers who suffered damages due to this claim..

3. No Standard of Identity (or a misleading one)

FDA labeling requirements clearly require most packaged foods to declare what the product is. This is why a Tostito’s label must clarify that the product is Tortilla Chips and Nutella must describe itself as Hazelnut Spread. While there is a great deal of controversy and open questions surrounding naming conventions for milk-alternatives and meat-alternatives, this isn’t the case for most products.

How to Avoid This Mistake: Include the common name for your product on the front label.

Who Cares? Major retailers who don’t want to be held accountable for carrying a product which could be construed as misleading.

Likelihood of Discovery: Medium-High. It may not be discovered initially, but eventually someone will notice. Typically, a failure to disclose a product’s Standard of Identity doesn’t have negative health implications for the consumer, it’s just mildly confusing, an infraction which rates lower on the FDA’s list of priorities. It’s more likely that a wholesale purchaser or retailer will find issue with this labeling error than the FDA.

What it will cost you: Mainstream retailers may refuse to carry the product until this issue is remedied.

4. Undeclared Ingredients

Even when there’s no allergen implications, the discovery of an undeclared ingredient in a product can bring public outrage to a boil and even lead to a food scare. Quite simply, consumers don’t like finding out that they have been lied to, particularly about what’s in their food.

How to Avoid This Mistake: Work with trusty suppliers and conduct supplier verification activities so you can have confidence in the ingredients you purchase. Make sure that your food labels and ingredients reflect changes made to the product formula.

Who Cares? Your most loyal customers; Twitter.

Likelihood of Discovery: Low-Medium. Using the final few rolls of old food labels after a slight change in product formulation will likely go unnoticed. The deliberate, ongoing failure to accurately convey ingredient composition is more common than we know. Large-scale food fraud can go undetected for years before being uncovered and technology is sometimes altogether incapable of detecting when ingredients are replaced with a cheaper alternative.

What it will cost you: The ongoing failure to accurately declare ingredient composition could result in lawsuits, fines, and total destruction of your brand.

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Food Labeling

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Forget everything you think you know about expiration dates.

What You Need to Know:

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

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

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

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

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Contents

  Introduction
  How to Read a Date Label
  How to Write a Date Label

Introduction: 

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

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How to Read a Date Label

What does a date label mean? 

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

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

Wording is inconsistent and confusing to consumers

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

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

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

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

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

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How to Write a Date-Label

What wording should I use For my Date Label?

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

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

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

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

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

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

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

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

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

Should I remove the date label from my product?

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

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

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

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What You Need to Know

What Are Standards of Identity?

A “standard of identity” is an agreed upon legal definition for what a food actually is. Standards of identity were introduced as a means of consumer protection. Although “common name” is the most applicable facet of Standards of Identity, there are actually three components to consider:

1. Common Name (Identity): The standardization and definition of common food names ensures that consumers know what a food product actually is. Typically, the common name is required to be written on the label of a food container.

   
   Example: A food marketed as “canned tuna” must legally be tuna and not some other fish
   
   
   
   

2. Standard of Quality: The food meets certain quality standards described in the regulations for that standardized food. (This doesn’t apply to most foods).
   
   Example: A food marketed as canned tuna cannot contain ingredients or additives that the consumer would not typically associate with canned tuna
   
   
   
   

3. Standard of Fill of Container: The packaging contains a minimum fill defined for that standardized food. This doesn’t apply to most foods)

Example: If canned tuna is advertised as 8oz of canned tuna in broth, then you are getting 8oz of tuna and not 7oz of broth and 1oz tuna.

Does My Food Product Have a Standard of Identity?

The best way to find out what the regulatory requirements are for your particular food product is to understand exactly which one of the following groups it falls into:

1. Foods for which there categorically is no definition or standard of identity

According to the FD&C act, no standard of identity or definition may be established for:

• Fruits (fresh and dried)

• Vegetables (fresh and dried)

• Avocados,

• Cantaloupes

• Citrus fruits

• Melons

This means there’s no specific definition for what is an apple and it means there’s no regulation that the word “apple” must appear on an apple that is being sold. If you produce a product that falls into this category, then you don’t need to be particularly concerned about misbranding your product due to standards of identity/definitions.

2. Non-standardized foods subject to specific requirements

These foods don’t have standards of identity per se, but they are subject to some requirements. You can quickly review this small list of foods in 21 CFR Part 102.

If the food you produce falls into this category, then it’s important to understand these requirements, but otherwise your product is not a standardized food.

3. Standardized Foods (Foods which have a standard of identity)

These are foods that the FDA has decided to define because there is a public expectation of what that food is . Anyone who makes a” standardized” food must make sure it satisfies the standards outlined for that food. These requirements range from mandated ingredients to packaging standards, to banned ingredients.

The categories for all standardized foods are listed in the sidebar to the right.You can also access these categories in CFR Parts 131-170

4. Non-standardized foods

These are foods that simply are not addressed in any of the sections referenced above. Since they are non-standard then they don’t have specific requirements for calling your food that name. Non-standardized foods must be labeled using the common or usual name for that food.

Many innovative products fall into this category. However, if you wish to market your product as something for which there is a standard of identity, then you must adhere to those standards or market your product differently.

For example, if you make a fermented chia-seed snack food that you wish to market as Chia Yogurt, then you must comply with the standards of identity definition for “yogurt” —since that’s how you are marketing the product. If your product is categorically unfit to meet the definitions of yogurt, then you may consider marketing it using descriptive terms (i.e. “fermented, plant-based snack food).

Identity Labeling Requirements

Packaged foods must be labeled with the product’s identity (common name). The requirements are as follows:

• The statement of identity must be presented in bold type on the Principal Display Panel

• If the food is marketed in multiple forms (i.e. whole, sliced, diced) then the form of the product is deemed to be part of the statement of identity

Formatting:

• The text must be bolded and in a size “reasonably related to the most prominent printed matter on the panel”

• The wording must be parallel to the base of the packaging so it reads normally when displayed (not sideways or upside down).

Less Common Requirements:

• Dietary supplements must be identified in the identity statement in one of three ways:

  • Using the term “dietary supplement”

  • Using the convention “[nutrient name] supplement” (i.e. “Iron supplement)

  • Using a descriptive term indicating the ingredients in the product (i.e. herbal supplement with vitamins)

• Substitution or imitation foods must be identified as such in the identity statement (i.e. imitation crab) A substitute food resembles another food and is meant to substitute it. An imitation food is the same except that it is nutritionally inferior to the food it imitates.

Source: 21CFR 101.3

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FAQ

What if My Product Doesn’t Have A common Name Because It’s an Innovative PRoduct?

In that case, you may use a descriptive term in the identity statement

What if My Product falls under a Standard of Identity but fails to meet the regulated standard?

A food producer may apply for a Temporary Marketing Permit (TMP) which allows them to sell their product for 15 months even though it may not confirm to some art of the applicable “standard of identity”.

For example, according to the FDA, Canned Pacific Salmon can only contain pacific salmon, water, and salmon oil.

In 1988, Bumblebee applied for a TMP which would allow them to add a tasteless, odorless preservative called sodium tripolyphosphate to the product. Normally, Bumblebee would not be allowed to sell the product as Canned Pacific Salmon, since the product would not fit the standard of identity.

However, the TMP gave them the permission to temporarily circumvent the standard of identity and sell their product (it’s worth nothing that sodium tripolyphosphate was an allowable food additive at that point.)

Food Categories with Regulated Definitions:

• BAKERY PRODUCTS

• BEVERAGES

• CACAO PRODUCTS

• CANNED FRUIT JUICES

• CANNED FRUITS

• CANNED VEGETABLES

• CEREAL FLOURS AND RELATED PRODUCTS

• CHEESES AND RELATED CHEESE PRODUCTS

• EGGS AND EGG PRODUCTS

• FISH AND SHELLFISH

• FOOD ADDITIVES

• FOOD DRESSINGS AND FLAVORINGS

• FROZEN DESSERTS

• FROZEN VEGETABLES

• FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS

• FRUIT PIES

• MACARONI AND NOODLE PRODUCTS

• MARGARINE

• MILK AND CREAM

• SWEETENERS AND TABLE SIRUPS

• TREE NUT AND PEANUT PRODUCTS

• VEGETABLE JUICES

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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

• Oleic Acid and Coronary Heart Disease (2018)

• Macadamia Nuts and Reduced Risk of Coronary Heart Disease (2017)

• Soybean Oil and Reduced Risk of Coronary Heart Disease (2017)

Diabetes

• High-Amylose Maize Starch and Reduced Risk Type 2 Diabetes Mellitus (2016)

• Psyllium Husk and a Reduced Risk of Type 2 Diabetes (2014)

• Whole Grains and a Reduced Risk of Diabetes Mellitus Type 2 (2013)

Peanut Allergy

• Ground Peanuts and Reduced Risk of Developing Peanut Allergy

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References

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

What You Need to Know:

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

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.

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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?

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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"

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.

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References

To read the FDA Regulation on gluten-free regulations, see §Subpart F 101.91

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

What is an Authorized Health Claim?

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

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

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

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What are the Approved Health Claims?

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

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How Do I Submit a Health Claim for Approval?

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

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

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

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

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References

Requirements for petitioning a Authorized Health Claim

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

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Contents

Cancer-Related Claims

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

Risk of Health Disease Claims

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

Other Health Claims

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

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

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

Cancer Related Claims

Dietary Lipids and Cancer

Pre-Approved Health Claims

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

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

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

Requirements for Using These Claims:

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

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

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Fiber-Containing Grain products, Fruits, Vegetables and Cancer

Pre-Approved Health Claims

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

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

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

Requirements for Using These Claims:

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

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

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

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

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Fruits, Vegetables, and Cancer

Pre-Approved Health Claims

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

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

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

Requirements for Using These Claims:

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

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

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

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Risk of Heart Disease Claims

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

Pre-Approved Health Claims

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

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

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

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

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

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

Requirements for Using These Claims:

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

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

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

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

Pre-Approved Health Claims

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

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

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

Requirements for Using These Claims:

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

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

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

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

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

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Soluble Fiber and the Risk of Coronary Heart Disease 

Pre-Approved Health Claims

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

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

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

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

Requirements for Using These Claims:

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

  • Oat Bran

  • Rolled oats

  • Whole wheat flour

  • Whole grain barley and dry milled barley

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

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

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

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

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

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

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Soy Protein and the Risk of Coronary Heart Disease

Pre-Approved Health Claims

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

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

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

Requirements for Using These Claims:

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

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

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

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

Pre-Approved Health Claims

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

For Plant Sterol Esters:

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

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


For Plant Stanol Esters:

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

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

Requirements for Using These Claims:

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

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

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

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

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

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

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

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

Other Health Claims

Sodium and Hypertension

Pre-Approved Health Claims

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

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

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

Requirements for Using These Claims:

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

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

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Calcium, Vitamin D and Osteoporosis

Pre-Approved Health Claims

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

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

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

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

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

Requirements for Using These Claims:

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

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

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

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

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Folate and Neural Tube Defects

Pre-Approved Health Claims

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

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

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

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

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

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

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

Requirements for Using These Claims:

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

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

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

• The nutrition information label must include information about folate.

*Note there are additional requirements for dietary supplements

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

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Dietary Sweeteners and Dental Tooth Decay

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

Pre-Approved Health Claims

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

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

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

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

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

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

Shortened Claims for Use on Small Packages:

"Does not promote tooth decay."

"May reduce the risk of tooth decay."

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

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

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

Requirements for Using These Claims:

• The product must meet the requirement for sugar content claims

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

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References

FDA Regulation on Health Claims is Available in Subpart E 101

What You Need to Know

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

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

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

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

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

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

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Health Claims

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

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

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

Types of Health Claims

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

• Authorized Health Claims

• Qualified Health Claims

Requirements for a Health Claim

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

• They must be complete, truthful and not misleading.

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

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

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

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Authorized Health Claims

See main article Authorized Health Claims

What is an Authorized Health Claim?

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

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

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

What Health Claims Can I Use On My Product Label?

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

Example of a Qualified Health Claim

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

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

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

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Qualified Health Claims

What is a Qualified Health Claim?

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

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

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Nutrient Content Claims

View fullsize

Nutrient Content Claims

Main Article: Nutrient Content Claims

Examples of Nutrient Content Claims

What is a Nutrient Content Claim?

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

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

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Structure/Function Claims

What is a Structure/Function Claim?

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

Examples of a Structure/Function Claim:

• "Calcium builds strong bones"

• "Fiber maintains bowel regularity"

• "Antioxidants maintain cell integrity"

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

Categories of Structure/Function Claims:

These claims are only associated with producers of Dietary Supplements.

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

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

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

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

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FDA Guidance on Authorized Health Claims

What You Need to Know:

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

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

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

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

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

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What You Need to Do:

• Comply with the guidelines below.

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

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

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Types of Nutrient Content Claims:

Implied Nutrient Claim

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

• "high in oat bran"

Expressed Nutrient Claim

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

• "low sodium"

• "high protein"

• "contains 100 calories"

High Content Disclosures

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

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

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

The threshold required for making this type of disclosure is:

• >13g fat per serving

• 4.0g of saturated fat

• 60mg of cholesterol

• 480mg of sodium

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

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

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

  • infant foods or foods for children under 2 yrs

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

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

See Subpart A 101.13 (h)

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Nutrient Level Statements

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

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

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

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

Source Subpart A 101.13 (i)

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Relative Claims

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

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

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

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

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

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

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

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Vitamin and Mineral Claims

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

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

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Formatting:

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

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Specific Nutrient Content Claim Requirements

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

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

"Calorie Free" Claims

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

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

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

"Low Calorie" Claims

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

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

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

"Reduced Calorie" Claims

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

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

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

Sugar Content Claims

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

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

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

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

"No Added Sugar" Claims

"No Added Sugar" claims are allowed if:

• No sugars have been added in processing or production.

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

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

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

"Reduced Sugar" "Lower Sugar" Claims

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

Fiber Content Claims

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

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

Specific Wording Requirements

"Low" or "Free" Claims:

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

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

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

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

See Subpart A 101.13 (e)

"High" or "Rich in" Claims:

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

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

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

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

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

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

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

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

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

• protein content

• vitamins or mineral content

• dietary fiber content

• potassium

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

See Subpart A -- 101.54 (e)

"High Potency" Claims

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

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

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

See Subpart A -- 101.54 (f)

"Light" or "Lite" Claims

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

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

OR

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

OR 

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

See Subpart A -- 101.56

"Antioxidant" Claims

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

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

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

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

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

See Subpart A -- 101.54 (g)

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Exceptions:

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

• dietary supplements

• infant foods

• imitation foods

• Medical foods

• "meal products"

• "main dish products"

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More About Food Labeling

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References

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

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

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What You Need to Know:

Examples of PDP of different packaging forms

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

Size Requirement: 

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

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

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

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

Elements Required on the PDP

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

• Identity of the food (common name)

• Net Quantity of Contents

Next

Nutrition Facts Labeling

Food Product Claims

Basics of FDA Food Labeling

Understanding Date Labels

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Sources:

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

More about Food Labeling

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References

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

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

What Do I Need to Know?

• Some products are exempt from labeling requirements.

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

  • Common name of the food (Principal Display Panel)

  • Net quantity of contents (PDP)

  • Ingredient list (PDP or information panel)

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

  • Nutrition Information

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Types of Panels

Front Panel (Principal Display Panel)

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

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

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

Information Panel

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

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

Rear Panel (Nutrition Information)

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

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

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

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Required Elements on a Food Label

Identity (Common Name) of the Food

The identify of a product must be listed on the PDP

Common Name “Tortilla Chips”

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

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

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

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

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

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

• Requirements for Specific Non Standard Foods

Ingredients List:

Sub-ingredients can be listed in parentheses

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

Ingredients that are themselves composed of two or more ingredients:

These can be listed in two ways:

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

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

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

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

Shortened Ingredient Names:

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

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Name & Location of the Manufacturer, Packer, or Distributor

Name & Location

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

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

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

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

"Manufactured for [your company name]"

or

"Distributed by [your company name]"

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

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

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Net Quantity of Contents

Net quantity of contents posted on the PDP

Net Quantity of Contents (in red box)

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

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

Placement:

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

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

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

More About Labels

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References

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

Small Business Exemptions:

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

Exemption Possibility #1: 

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

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

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

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

Exemption Possibility #2: 

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

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

Source 101.9 (j) Labeling Exemptions

How to Register a Small Business Labeling Exemption:

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

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

Foods that are Exempt From Labeling Requirements:

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

• Raw fruits

• Vegetables

• Fish

• Dietary Supplements (they are regulated under §101.36)

• Certain egg cartons

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

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

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

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

• Foods served or delivered for immediate consumption

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

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

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

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

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

What You Need to Know

Contents

New Rule on Nutrition Information

When Do New Labeling Requirements Take Effect?

Components of a Nutrition Information Label

Vitamins, Minerals, and Macronutrients

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

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

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

• The requirements for nutrition labels may vary depending on:

  • Food package size

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

New Rule on Nutrition Information Panels

Key Changes in Nutrition Information

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

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

• Calories are now in larger and bolder type

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

• Listings of Vitamin D and Potassium are required

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

• Removal of the "Calories from fat" label requirement

• Removal of the requirement for Vitamin C and Vitamin A

When Do New Labeling Requirements Take Effect?

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

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

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Components of a Nutrition Information Label:

Serving Size

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

Nutrient Components:

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

Mandatory Nutrient Components

• Calories

• "Fat" or "Total Fat"

  • Saturated Fat

  • Trans Fat

  • "Cholesterol"

  • "Sodium"

  • "Total Carbohydrate"

    • "Dietary Fiber"

    • "Total Sugars"

    • "Added Sugars"

    • "Protein

Voluntary Nutrient Components

• "Calories from saturated fat"

• "Fluoride"

• "Soluble Fiber"

• "Insoluble Fiber"

• "Sugar Alcohol"

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

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Vitamins, Minerals and Macronutrients

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

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

• Vitamin D,

• Calcium

• Iron

• Potassium

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

Vitamins (listed in order)

• Vitamin A

• Vitamin C

• Vitamin D

• Vitamin E

• Vitamin K

• Thiamin

• Riboflavin

• Niacin

• Vitamin B6

• Folate

• Vitamin B12

• Biotin

• Pantothenic Acid

• Choline

Macronutrients & Minerals (In order)

• Calcium

• Iron

• Phosphorus

• Iodine

• Magnesium

• Zinc

• Selenium

• Copper

• Manganese

• Chromium

• Molybdenum

• Chloride

• Potassium

Vitamins and minerals must appear in the label if:

• They appear in a serving of the product

• When they are added as a nutrient supplement

• When a claim is made about them

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

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

• If they appear in the product solely for technological purposes

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

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How to Make an FDA Compliant Nutrition Information Label

FDA Aligned Nutritional Label (New Rule)

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

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

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

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

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

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

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

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

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

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Looking for Something Else?

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

More About Food Labeling

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Resources

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

Examples of FDA compliant labels with guidance

Examples of FDA compliant labels in multiple formats

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