For those seeking basic FDA regulatory guidance on dietary supplement labeling, there is a handy summary of regulation avaiable to industry.
Known as Guidance for Industry: A Dietary Supplement Labeling Guide, it provides basic information about the labeling of dietary supplements which includes information taken from the following sources of law:
* The Nutrition Labeling and Education Act of 1990 amended the Federal Food, Drug, and Cosmetic Act (the act) in a number of important ways. Notably, by requiring that most foods, including dietary supplements, bear nutrition labeling.
* The Dietary Supplement Health and Education Act of 1994 (the DSHEA) amended the act, in part, by defining “dietary supplements,” adding specific labeling requirements for dietary supplements, and providing for optional labeling statements.
* On September 23, 1997 (62 FR 49826), FDA implemented the DSHEA by publishing several key regulations on the statement of identity, nutrition labeling, ingredient labeling, and nutrient content and health claims for dietary supplements. On June 5, 1998 (63 FR 30615), FDA amended the regulations pertaining to the nutrition labeling of extracts used in dietary supplements.
* On January 15, 1997 (62 FR 2218), FDA published regulations that require a label warning statement on dietary supplements with added iron. These regulations also required the unit-dose packaging of supplements containing 30 milligrams or more, but this requirement has been eliminated as a result of a court challenge in January, 2003.
* On July 11, 2003 (68 FR 41434), FDA published a final regulation that amended the labeling requirements for dietary supplements, as well as for conventional foods, that would make the declaration of trans fat mandatory in nutrition labeling. This regulation requires that, when present at 0.5 g or more, trans fat be listed in the Supplement Facts panel of dietary supplements on a separate line under the listing of saturated fat by January 1, 2006.
Importantly, the Guide distinguishes between nutrient content claims, health claims, and disease claims. Here are some relevant excerpts:
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 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: http://www.cfsan.fda.gov/~dms/flg-6c.html#upd. 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 at: http://www.fda.gov/oc/nutritioninitiative/list.html
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:
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.;
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
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:
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
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)
Helpfully, the FDA also has published Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act.
This document explains how the FDA has drawn on the FTC (Federal Trade Commission) rules to flesh out the substantiation requirements:
Under the Act, FDA has exclusive jurisdiction over the safety, and primary jurisdiction over the labeling, of dietary supplements. The FTC has primary jurisdiction over advertisements for dietary supplements. Given these jurisdictional assignments, we and the FTC share an interest in providing guidance on what “substantiation” means. In April 2001, FTC issued a guidance document entitled, “Dietary Supplements: An Advertising Guide for Industry.”(5) Our guidance document is modeled on, and complements, the FTC guidance document.
Dietary supplement manufacturers should be familiar with the requirements under both DSHEA and the Federal Trade Commission Act that they have substantiation that labeling and advertising claims are truthful and not misleading. Our approach provides manufacturers flexibility in the precise amount and type of evidence that constitutes adequate substantiation. Providing a standard for substantiation may also help to preserve consumer confidence in these products. To ensure compliance with the Act, we recommend that dietary supplement manufacturers carefully draft their labeling claims and carefully review the support for each claim to make sure that the support relates to the specific product and claim, is scientifically sound, and is adequate in the context of the surrounding body of evidence.
The FTC has typically applied a substantiation standard of “competent and reliable scientific evidence” to claims about the benefits and safety of dietary supplements and other health-related products. FDA intends to apply a standard for the substantiation of dietary supplement claims that is consistent with the FTC approach. This guidance document, using examples of claims that might be made for a dietary supplement, describes criteria to be considered in evaluating the nature of the claim and the amount, type, and quality of evidence in support of the claim.
What is the Substantiation Standard?
The FTC standard of competent and reliable scientific evidence has been defined in FTC case law as “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.”(6)
Although there is no pre-established formula as to how many or what type of studies are needed to substantiate a claim, we, like the FTC, will consider what the accepted norms are in the relevant research fields and consult experts from various disciplines. If there is an existing standard for substantiation developed by a government agency or other authoritative body, we may accord some deference to that standard.
In determining whether the substantiation standard has been met with competent and reliable scientific evidence, we recommend that firms consider the following issues in their assessment:
The meaning of the claim(s) being made;
The relationship of the evidence to the claim;
The quality of the evidence; and
The totality of the evidence.
Each of these issues is discussed further in this draft guidance.
These beginning documents should provide a roadmap for companies looking into dietary supplements labeling.
Our law offices can also provide further legal assistance.