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

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:

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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Small Business Exemptions:

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

Exemption Possibility #1: 

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

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

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

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

Exemption Possibility #2: 

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

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

Source 101.9 (j) Labeling Exemptions

How to Register a Small Business Labeling Exemption:

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

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

Foods that are Exempt From Labeling Requirements:

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

• Raw fruits

• Vegetables

• Fish

• Dietary Supplements (they are regulated under §101.36)

• Certain egg cartons

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

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

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

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

• Foods served or delivered for immediate consumption

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

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

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

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

More about Food Labeling

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

What You Need to Know

Contents

New Rule on Nutrition Information

When Do New Labeling Requirements Take Effect?

Components of a Nutrition Information Label

Vitamins, Minerals, and Macronutrients

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

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

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

• The requirements for nutrition labels may vary depending on:

  • Food package size

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

New Rule on Nutrition Information Panels

Key Changes in Nutrition Information

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

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

• Calories are now in larger and bolder type

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

• Listings of Vitamin D and Potassium are required

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

• Removal of the "Calories from fat" label requirement

• Removal of the requirement for Vitamin C and Vitamin A

When Do New Labeling Requirements Take Effect?

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

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

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Components of a Nutrition Information Label:

Serving Size

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

Nutrient Components:

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

Mandatory Nutrient Components

• Calories

• "Fat" or "Total Fat"

  • Saturated Fat

  • Trans Fat

  • "Cholesterol"

  • "Sodium"

  • "Total Carbohydrate"

    • "Dietary Fiber"

    • "Total Sugars"

    • "Added Sugars"

    • "Protein

Voluntary Nutrient Components

• "Calories from saturated fat"

• "Fluoride"

• "Soluble Fiber"

• "Insoluble Fiber"

• "Sugar Alcohol"

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

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Vitamins, Minerals and Macronutrients

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

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

• Vitamin D,

• Calcium

• Iron

• Potassium

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

Vitamins (listed in order)

• Vitamin A

• Vitamin C

• Vitamin D

• Vitamin E

• Vitamin K

• Thiamin

• Riboflavin

• Niacin

• Vitamin B6

• Folate

• Vitamin B12

• Biotin

• Pantothenic Acid

• Choline

Macronutrients & Minerals (In order)

• Calcium

• Iron

• Phosphorus

• Iodine

• Magnesium

• Zinc

• Selenium

• Copper

• Manganese

• Chromium

• Molybdenum

• Chloride

• Potassium

Vitamins and minerals must appear in the label if:

• They appear in a serving of the product

• When they are added as a nutrient supplement

• When a claim is made about them

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

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

• If they appear in the product solely for technological purposes

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

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How to Make an FDA Compliant Nutrition Information Label

FDA Aligned Nutritional Label (New Rule)

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

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

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

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

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

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

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

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

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

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Looking for Something Else?

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

More About Food Labeling

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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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