Regulatory Requirements for the Labeling of Beverages and Liquid Dietary Supplements

1. General prohibition on false or misleading labeling

All claims, statements, and graphics in the labeling of foods, including beverages and liquid dietary supplements, are subject to section 403(a)(1) of the FD&C Act (21 U.S.C. 343(a)(1)), which provides that a food is misbranded if its labeling is false or misleading. The FD&C Act further provides in section 201(n) (21 U.S.C. 321(n)) that affirmative representations are not the only factor relevant to whether labeling is misleading. In determining whether the labeling of an article is misleading, “there shall be taken into account (among other things) … the extent to which the labeling fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling relates under the conditions of use prescribed in the labeling thereof or under such conditions of use as are customary or usual.”  21 U.S.C. 321(n).

2. Health claims

Beverages and liquid dietary supplements may bear health claims, which characterize the relationship between a substance (food or food component) and a disease or health-related condition (see 21 CFR 101.14(a)(1)). For more information about health claims, including procedures for our review of health claims and examples of authorized health claims, we refer you to the following:

3. Nutrient content claims

Liquid dietary supplements and beverages may bear nutrient content claims, which characterize the level of a nutrient in a food (see 21 CFR 101.13(b)).  For more information about nutrient content claims, including procedures for our review of nutrient content claims and examples of authorized nutrient content claims, we refer you to the following:

  • Sections 403(r)(1)(A), (r)(2), (r)(4), and (r)(5) of the FD&C Act (21 U.S.C. 343(r)(1)(A), (r)(2), (r)(4), (r)(5));
  • 21 CFR 101.13;
  • 21 CFR 101.69;
  • 21 CFR 101.54–101.67; and
  • References from FDA’s Web site
    • “Label Claims. General Information” (Ref. 8)
    • “FDA Modernization Act (FDAMA) Claims” (Ref. 11).

4. Structure/function claims for conventional foods

Conventional foods, including beverages, may bear certain kinds of claims about effects on the structure or function of the body (structure/function claims).  The FD&C Act defines “drug” to include articles intended to affect the structure or function of the body. This provision contains an exception for foods, which affect the structure and function of the body by virtue of providing nutrition to sustain life and health. See section 201(g)(1)(C) of the FD&C Act (21 U.S.C. 321(g)(1)(C)). “Food” is defined in section 201(f) of the FD&C Act (21 U.S.C. 321(f)) as “(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.”

Consistent with case law interpreting the “other than food” exception as applying to articles consumed primarily for taste, aroma, or nutritive value, FDA does not intend to regulate conventional foods that bear structure/function claims in their labeling as drugs if the claimed structure/function effect derives from the product’s character as a food—its taste, aroma, or nutritive value. See Nutrilab v. Schweiker, 713 F.2d 335 (7th Cir. 1983). However, if a structure/function claim promotes a product for a use other than providing taste, aroma, or nutritive value, such as blocking the absorption of carbohydrates in the gut, the claim may cause the product to be a drug under section 201(g)(1)(C) of the FD&C Act by changing its primary use. In other words, because of the use promoted in the claim, the product may no longer be consumed as a food—primarily for taste, aroma, or nutritive value—but rather as a drug for some other physiological effect.  Further, if a labeling claim about the effect of a conventional food on the structure or function of the body also states or implies that the product is useful in treating, mitigating, curing, or diagnosing a disease, the claim causes the product to be a drug under section 201(g)(1)(B) of the FD&C Act (21 U.S.C. 321(g)(1)(B)). The same is true for a disease prevention claim in the labeling of a conventional food, unless the claim is an authorized health claim about reducing the risk of a disease or health-related condition.

As with all claims in food labeling, structure/function claims for conventional foods may not be false or misleading. See section 403(a)(1) of the FD&C Act (21 U.S.C. 343(a)(1)).

5. Structure/function claims and related claims for dietary supplements

Structure/function claims in the labeling of dietary supplements are subject to section 403(r)(6) of the FD&C Act (21 U.S.C. 343(r)(6)) and our regulation in 21 CFR 101.93, as are dietary supplement labeling claims about general well-being and benefits related to a classical nutrient deficiency disease.  For more information about these claims for dietary supplements, see Ref. 8.

As with conventional foods, if a labeling claim about the effect of a dietary supplement on the structure or function of the body also states or implies that the product is useful in treating, mitigating, curing, or diagnosing a disease, the claim causes the product to be a drug under section 201(g)(1)(B) of the FD&C Act (21 U.S.C. 321(g)(1)(B)); see also 21 CFR 101.93(g).  The same is true for a disease prevention claim in the labeling of a dietary supplement, unless the claim is an authorized health claim about reducing the risk of a disease or health-related condition.

6. General food labeling requirements

Mandatory labeling for beverages and other conventional foods differs in many respects from mandatory labeling for dietary supplements.  For example, beverages must show nutrition information in the Nutrition Facts format (see 21 CFR 101.9), but dietary supplements must show nutrition information in the Supplement Facts format (see 21 CFR 101.36).  Generally, all ingredients in a beverage must be declared in the ingredient statement by their common and usual names, in descending order of predominance; however, for dietary supplements, only ingredients not listed in Supplement Facts have to be listed in the ingredient statement.  In addition, a beverage or other conventional food should not be labeled with the FDA disclaimer that is required on dietary supplement labels that bear structure/function claims or other claims described in section 403(r)(6)(A) of the FD&C Act (21 U.S.C. 343(r)(6)(A)).

FDA’s general food labeling requirements, including those that apply to dietary supplements, are in 21 CFR Part 101.

To know more, attend this session “Dietary Supplements / Nutritional / Borderline Products / OTC: Regulatory Compliance, Product Claims & Labeling Requirements” with expert speaker James Russell, who the Director of Regulatory Affairs and Business Development for RJR Consulting Inc, a leading global regulatory consulting company servicing the Life Science and Consumer Products industries, will review the dietary supplement regulations in the U.S. and discuss how to verify that your products are compliant, while citing differences with food and drug regulations. James will also cover what qualifies a substance as a dietary ingredient; considerations for manufacturers and distributors; requirements for compliant labeling; acceptable marketing claims; and necessary claim substantiation. Updates on current topics related to the industry will also be discussed.

Leave a Reply

Your email address will not be published. Required fields are marked *