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

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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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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