Dietary Supplement Labeling Guide: Chapter VI. Claims

April 2005

Contains Nonbinding Recommendations

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Questions

Answers

Nutrient Content Claims

What is a nutrient content claim?

A nutrient content claim expressly or by implication characterizes the level of a nutrient in a dietary supplement.

21 CFR 101.13(b)
What nutrient levels must be present in my dietary supplement products that would permit me to use nutrient content claims on my product labels?

The nutrient levels needed to use nutrient content claims are shown in Appendix D of this labeling guide.
May I use a nutrient content claim not included in FDA's regulations on my product label?

No. Only those claims, or their synonyms, that are specifically defined in regulations may be used.

21 CFR 101.13(b)
Where may I find nutrient content claims specifically defined by the FDA?

You may find the regulations for specific claims in 21 CFR 101, Subpart D (Specific Requirements of Nutrient Content Claims) as follows:
- §101.54(b) "High" claims
- §101.54(c) "Good Source" claims
- §101.54(e) "More" claims
- §101.54(f) "High potency" claims
- §101.54(g) "Antioxidant" claims
- §101.56 "Light" or "Lite" claims
- §101.60 "Calorie or Sugar" claims
- §101.61 "Sodium or Salt" claims
- §101.62 "Fat, fatty acids, and cholesterol" claims
- §101.65 Implied nutrient content claims
- §101.65(d) "Healthy" claims
- §101.67 Use of nutrient content claims for butter
What are the type size requirements for nutrient content claims?

A nutrient content claim may be no larger than twice the type size of the statement of identity (the name of the food) and may not be unduly prominent in style compared to the statement of identity.

21 CFR 101.13(f)
Am I required to provide a "Supplement Facts" panel when I make a claim?

Yes. A "Supplement Facts" panel is required if you make a nutrient content claim.

21 CFR 101.13(n)
What is a disclosure statement?

It is a statement that calls the consumer's attention to one or more nutrients (other than the nutrient that is the subject of the claim) in a dietary supplement (e.g., "See nutrition information for fat content").

21 CFR 101.13(h)(1)
When am I required to use a disclosure statement?

You must use a disclosure statement when you make a nutrient content claim and your food (including dietary supplements) contains one or more of the following nutrients in excess of the levels listed below per reference amount customarily consumed, per labeled serving, or, for a product with a reference amount of 30 g or less or 2 tablespoons or less, per 50 grams:

Fat 13.0 grams

Saturated Fat 4.0 grams

Cholesterol 60 milligrams

Sodium 480 milligrams

21 CFR 101.13(h)(1)
How must I present the disclosure statement on my label?

You must present it in easily legible boldface print or type, in distinct contrast to other printed or graphic matter.

21 CFR 101.13(h)(4)(i)
What are the type size requirements for the disclosure statement?

The type requirements for the disclosure statement are the same as those for the net quantity of contents statement in 21 CFR 101.105(i), except where the size of the claim is less than two times the required size of the net quantity of contents statement, in which case the disclosure statement is no less than one-half (1/2) the size of the claim, but no smaller than one-sixteenth (1/16) of an inch. A disclaimer statement of one thirty-second (1/32) of an inch is allowed if your package has less than three square inches of available label space and is an individual serving-size package served with meals in restaurants.

21 CFR 101.105(i) and 21 CFR 101.13(h)(4)(i)
Where must I place the disclosure statement?

You must place the disclosure statement immediately adjacent to (i.e., right next to) the claim with no intervening material (such as vignettes or other art work) other than information in the statement of identity or any other information that is required to be presented with the claim.

21 CFR 101.13(h)(4)(ii)
When can a disclosure statement be omitted from the panel bearing the nutrition information?

You can omit the disclosure statement from the panel bearing the nutrition information when the nutrient content claim appears on more than one panel of a label.

21 CFR 101.13(h)(4)(ii)
Am I required to have a disclosure statement each time I make a claim when I make several claims on one panel?

No. You are only required to have one disclosure statement per panel when you make multiple claims on a panel. The statement is required to be adjacent to the claim printed in the largest type on that panel.

21 CFR 101.13(h)(4)(iii)
When may I make a "high" or "good source" claim?

You may make a "high" claim when your dietary supplement contains at least 20% of the Daily Value (DV) (i.e. the Reference Daily Intake (RDI) or Daily Reference Value (DRV)) of the nutrient that is the subject of the claim per reference amount customarily consumed. You may make a "good source" claim when your dietary supplement contains 10 to 19% of DV.

21 CFR 101.54(b)(1) and (c)(1)
Is there any way that I can let consumers know that my product contains nutrients without DVs, such as phosphatidylserine?

You may make a statement about a nutrient for which there is no established Daily Value (DV) so long as the claim specifies only the amount of the nutrient per serving and does not imply that there is a lot or a little of that nutrient in the product (e.g., "x grams of phosphatidylserine"). You must list the dietary ingredient for which there is no DV and the quantitative amount of that dietary ingredient in the "Supplement Facts" panel in the section below the nutrients with DVs. These dietary ingredients must be identified as having no DVs by the use of the footnote "Daily Value Not Established."

21 CFR 101.13(i)(3) and 21 CFR 101.36(b)(3)
May I make statements using the words "contains" and "provides" for nutrients without DVs?

Yes. You may use such statements if, and only if, you include the specific amount of the nutrient (e.g., "Contains x grams of phosphatidylserine per serving" or "Provides x g of phosphatidylserine").

21 CFR 101.13(i)(3) and 101.54(c)(1)
Is a statement outside of the "Supplement Facts" panel that describes the percentage of the RDI of a vitamin or mineral in my dietary supplement product a nutrient content claim?

Yes. These claims are considered nutrient content claims and are not exempt from bearing a disclosure statement when required.

21 CFR 101.13(b)(1), (c) and (i)
Am I permitted to make a "low" or "free" claim when my dietary supplement product is specially processed?

Yes. If a similar dietary supplement is normally expected to contain a nutrient and your dietary supplement is specially processed, altered, formulated, or reformulated as to lower the amount of the nutrient in the food, remove the nutrient in the food, or not include the nutrient, then you are permitted to make a "low" or "free" claim as applicable.

21 CFR 101.13(e)(1)
May I make a "low" or "free" claim for my dietary supplement product if it is normally low in or free of a nutrient, and I use an appropriate disclaimer?

No. However, a claim may be used if you indicate that it refers to all products of that type and not merely to that particular brand.

21 CFR 101.13(e)(2)
Are claims such as "100 percent milk free" and "contains no preservatives" subject to the nutrient content claim requirements?

No. Such statements are not nutrient content claims so long as they are not used in a nutrient context that would make them an implied claim under 21 CFR 101.13(b)(2). The statement "100 percent milk free" is generally a claim to facilitate avoidance of milk products. "Contains no preservatives" is a claim about a substance that does not have a nutritive function.

21 CFR 101.65(b)(1) and (b)(2)
Is a "no sugar" claim subject to the nutrient content claim requirements?

Yes. Sugar content claims are subject to the nutrient content claim requirements.

21 CFR 101.60(c)(1)
When can the nutrient content claim "no added sugar" be used?

To avoid misleading consumers, the term "no added sugar" should be limited to dietary supplements containing no added sugars that are normally expected to contain them.

21 CFR 101.60(c)(2)(iv)
Must a dietary supplement bearing a "sugar free" claim be labeled "low calorie"?

No. A "low calorie" claim may not be made on dietary supplements, except when an equivalent amount of a dietary supplement that the labeled dietary supplement resembles and for which it substitutes (e.g., another protein supplement), normally exceeds the definition for "low calorie."

21 CFR 101.60(c)(1)(iii)(A)

Fat	13.0 grams
Saturated Fat	4.0 grams
Cholesterol	60 milligrams
Sodium	480 milligrams

Antioxidant Claims

What is a nutrient content claim for antioxidants?

It is a nutrient content claim that characterizes the level of one or more antioxidant nutrients present in a dietary supplement.

21 CFR 101.54(g)
Must the nutrient or dietary ingredient have an RDI to qualify for an antioxidant claim?

Yes, except as noted in question #28 below.

21 CFR 101.54(g)(1)
Are there any other requirements for a dietary supplement to qualify for an antioxidant nutrient content claim?

Yes. The nutrients that are the subject of the claim must have recognized antioxidant activity. In addition, the level of each nutrient that is the subject of the claim must be sufficient to qualify for either "high" claims in 21 CFR 101.54(b), "good source" claims in 21 CFR 101.54(c), or "more" claims in 21 CFR 101.54(e). For example, for a product to qualify for a "high in antioxidant vitamin C" claim, it must contain 20 percent or more of the RDI for vitamin C. That is, it must meet the level for "high" defined in §101.54(b). For a product to qualify for a "good source of antioxidant vitamin C" claim it must contain 10 to 19 percent of the RDI for vitamin C.

21 CFR 101.54(g)(2) and (g)(3)
What do you mean by "recognized antioxidant activity"?

Recognized antioxidant activity means that there is scientific evidence that, following absorption from the gastrointestinal tract, the substance participates in physiological, biochemical, or cellular processes that inactivate free radicals or prevent free radical-initiated chemical reactions.

21 CFR 101.54(g)(2)
May beta-carotene, which does not have an RDI, be the subject of an antioxidant claim?

Yes. You may make a claim for beta-carotene when the level of vitamin A present as beta-carotene is sufficient to qualify for the claim. For example, you may make the claim "good source of antioxidant beta-carotene" when 10% or more of the RDI for vitamin A is present as beta-carotene.

21 CFR 101.54(g)(3)
Must I list all antioxidants present in my product when making an antioxidant nutrient content claim?

Yes. The names of the nutrients that are the subject of the claim must be included as part of the claim (e.g., "high in antioxidant vitamins C and E"). Alternatively, you may link the term "antioxidant" or "antioxidants" in a nutrient content claim (as in "high in antioxidants") by a symbol (e.g., an asterisk) that refers to the same symbol that appears elsewhere on the same panel followed by the name or names of the nutrients with recognized antioxidant activity. This list should be in letters at least 1/16 of an inch in height or no smaller than half the type size of the largest nutrient content claim, whichever is larger.

21 CFR 101.54(g)(4)
Can I make other claims that describe the antioxidant properties of my product?

Yes. You may craft a statement, subject to section 403(a) of the act (the false and misleading provisions), that describes how a dietary ingredient that does not have an RDI participates in antioxidant processes. Likewise, structure/function claims may be made about antioxidants as long as such claims are not false or misleading and, if appropriate, are made in accordance with section 403(r)(6) of the act (the provisions for statements of nutritional support). For example, a claim that reads "__________, involved in antioxidant processes" would be acceptable as long as it is:
1. 1) truthful and not misleading; and
2. 2) meets the requirements of section 403(r)(6) of the act (see questions #44 through #51 of this chapter).
62 FR 49868 at 49873 (September 23, 1997)

High Potency Claims

Can I use the term "high potency" to describe an individual nutrient?

Yes. You may use the term "high potency" on your dietary supplement labels to describe individual vitamins or minerals that are present at 100 percent or more of the RDI per reference amount customarily consumed.

21 CFR 101.54(f)(1)(i)
Can the term "high potency" be used for combination products, such as botanicals with vitamins?

Yes. However, when you use the term "high potency" to describe individual vitamins or minerals in your product that contains other nutrients or dietary ingredients, you must clearly identify which vitamin or mineral you are describing by the term "high potency" (e.g., "Botanical 'X' with high potency vitamin E").

21 CFR 101.54(f)(1)(ii)
How many nutrients must be present at 100% of the DV for a multinutrient product to qualify for the term "high potency?"

You may use the term "high potency" on your multinutrient product to describe the product if it contains 100 percent or more of the RDI for at least two-thirds of the vitamins and minerals that are listed in 21 CFR 101.9(c)(8)(iv), and that are present in the product at 2 percent or more of the RDI (e.g., "High potency multivitamin, multimineral dietary supplement tablets").

21 CFR 101.54(f)(2)

Percentage Claims

What is a percentage claim?

It is a statement that characterizes the percentage level of a dietary ingredient for which a reference daily intake (RDI) or daily reference value (DRV) has not been established. You may make a percentage claim on your products without a regulation that specifically defines such a statement. These statements must be accompanied by any disclosure statement required under 21 CFR 101.13(h). There are simple percentage claims and comparative percentage claims.

21 CFR 101.13(q)(3)(ii)
What is a simple percentage claim?

It is a statement that characterizes the percentage level of a dietary ingredient for which there is no RDI or DRV (e.g., omega-3 fatty acids, amino acids, phytochemicals). The statement of the actual amount of the dietary ingredient per serving must be declared next to the percentage statement (e.g., "40 percent omega-3 fatty acids, 10 mg per capsule").

21 CFR 101.13(q)(3)(ii)(A)
What is a comparative percentage claim?

It is a statement that compares the percentage level of a dietary ingredient for which there is no RDI or DRV in a product to the amount of the dietary ingredient in a reference food. The reference food must be clearly identified, the amount of that food must be identified, and the information on the actual amount of dietary ingredient in both the dietary supplement and reference food must be declared (e.g., "twice the omega-3 fatty acids per capsule (80 mg) as in 100 mg of menhaden oil (40 mg)").

21 CFR 101.13(q)(3)(ii)(B)

Health Claims

What is a health claim?

A health claim is an explicit or implied characterization of a relationship between a substance and a disease or a health-related condition. This type of claim requires significant scientific agreement and must be authorized by FDA. The claim can be a written statement, a "third party" reference, a symbol, or a vignette.

21 CFR 101.14(a)(1) and (c)
How is a health claim different from a structure/function claim?

A health claim describes the effect a substance has on reducing the risk of or preventing a disease, e.g., "calcium may reduce the risk of osteoporosis." A health claim requires FDA evaluation and authorization prior to its use. A structure/function claim describes the role of a substance intended to maintain the structure or function of the body. Structure/function claims do not require preapproval by FDA.

21 CFR 101.14(a)(1) and (c), and 21 CFR 101.93(f)
What health claims can be used on dietary supplement labels?

Appendix E of this guide contains a list of FDA authorized health claims. An updated list is also maintained on the Internet at: A Food Labeling Guide--Appendix C. In addition to these authorized health claims, there are certain "qualified" health claims permitted by FDA. Qualified health claims are listed in Appendix F of this guide and on the Internet
What is a qualified health claim?

A qualified health claim is supported by less scientific evidence than an authorized health claim. FDA requires that qualified claims be accompanied by a disclaimer that explains the level of the scientific evidence supporting the relationship.

Unlike authorized health claims, FDA does not issue regulations for qualified health claims.

U.S. Food and Drug Administration, Guidance for Industry, Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements July 2003.
How can I use a qualified health claim if the FDA did not authorize it?

FDA will permit the use of a qualified health claim provided that 1) FDA has issued a letter stating the conditions under which we will consider exercising enforcement discretion for the specific health claim, 2) the qualified claim is accompanied by an agency-approved disclaimer, and 3) the claim meets all the general requirements for health claims in 21 CFR 101.14, except for the requirement that the evidence for the claim meet the validity standard for authorizing a claim, and the requirement that the claim be made in accordance with an authorizing regulation.

U.S. Food and Drug Administration, Guidance for Industry, Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements July 2003.
What is an agency-approved disclaimer?

An agency-approved disclaimer is a statement that discloses the level of scientific evidence used to substantiate the health claim.

FDA Task Force Final Report: Consumer Health Information for Better Nutrition Initiative, Attachment E - Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements July 2003.
How can I use additional health claims?

To use additional health claims, an individual must submit a health claim petition in accordance with 21 CFR 101.70. A new health claim may be used only after FDA issues either an authorizing regulation or a letter stating enforcement discretion conditions for a qualified health claim.

21 CFR 101.14 and 21 CFR 101.70

Structure/Function Claims

What types of structure/functure claims may be made under section 403(r)(6) of the act?

You may make the following types of structure/function claims under section 403(r)(6) of the act:
1. A statement that claims a benefit related to a classical nutrient deficiency disease and that discloses the prevalence of such disease in the U.S.;
2. A statement that describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, or characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function; or
3. A statement that describes the general well-being from consumption of a nutrient or dietary ingredient.
21 U.S.C. 343(r)(6)
What must I do when making structure/function claims in my products' labeling?

You must (1) have substantiation that such statement is truthful and not misleading; (2) include the disclaimer; and (3) notify FDA no later than 30 days after the first marketing of the product that you are making the statement in accordance with 21 CFR 101.93.

21 CFR 101.93
What text must I use for the disclaimer?

You must use the following text for the disclaimer, as appropriate:
1. singular: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease;" or
2. plural: "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."
You may not modify the wording of these disclaimers.

21 CFR 101.93(c)
Where must I place the required disclaimer?

You must place the disclaimer immediately adjacent to the claim with no intervening material, or elsewhere on the same panel or page that bears the statement. In the latter case, the disclaimer must be placed in a box and linked to the statement by a symbol (e.g., an asterisk) placed at the end of each statement that refers to an identical symbol placed adjacent to the disclaimer.

21 CFR 101.93(d)
What type size must I use for the required disclaimer?

You must use boldface type in a type size no smaller than one-sixteenth (1/16) inch for the required disclaimer.

21 CFR 101.93(e)
What are the notification procedures for structure/function claims?

The notification procedures require that you as a manufacturer, packer, or distributor making such a statement must:
1. Notify FDA within 30 days of first marketing a product whose label or labeling bears a statement made under section 403(r)(6) of the act;
2. Submit an original and two copies of the notification to the Office of Nutritional Products, Labeling, and Dietary Supplements (HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740-3835;
3. The notification must be signed by a person who can certify that the information in the notification is complete and accurate, and that the notifying firm has substantiation that the section 403(r)(6) statement is truthful and not misleading.
21 CFR 101.93(a)(1) and (a)(3)
What form must be used to notify FDA?

There is no official form to use. You may make the notification by a letter containing the required information in any format that is convenient to you.
What information must be included in the notification for structure/function claims?

You must include the following information in your notification:
1. The name and address of the manufacturer, packer, or distributor of the dietary supplement that bears the statement;
2. The text of the statement that you are making;
3. The name of the dietary ingredient or supplement that is the subject of the statement, and
4. The name of the dietary supplement (including its brand name) on whose label, or in whose labeling, the statement appears.
21 CFR 101.93(a)(2)