Upon entering a dietary supplement store, athletes—and those who aspire to the title—shuffle toward the bolded word or phrase that best describes their current health and fitness goal: weight loss, energy, performance, etc. Whatever the goal, there are countless varieties of capsules, chews, bars, and powders (collectively, "fitness nutrition products") all promising to deliver results.
Because federal statutes and regulations treat dietary supplements differently from "conventional food products" in terms of required labels, permissible labeling claims, and approved additives, fitness nutrition products must first be properly classified, and then labeled accordingly to avoid potential FDA enforcement actions or consumer litigation.
Statutory Definitions and Regulatory Guidance
The Federal Food, Drug, and Cosmetic Act (FDCA) defines food products 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." 21 U.S.C. § 321(f). A "dietary supplement" on the other hand, is defined as a product that, among other requirements is "intended to supplement the diet […and] not represented for use as a conventional food or as a sole item of a meal or the diet." 21 U.S.C. § 321(ff). "Conventional food" is not defined by statute, and the Food and Drug Administration (FDA) has offered little more explanation of the term beyond simply stating that "[c]onventional foods are foods that are not dietary supplements."
In 1994, the Dietary Supplement Health and Education Act (DSHEA) amended federal regulations to require separate labeling schemes for conventional foods and dietary supplements. Under current regulations, conventional food labeling must include a "Nutrition Facts" panel (see 21 CFR 101.9), while dietary supplements must include a "Supplement Facts" panel (see 21 CFR 101.36).
Recognizing the increasing number of products that do not fit cleanly into these defined categories, the FDA published Guidance for Industry: Distinguishing Liquid Dietary Supplements from Beverages in January 2014. In this guidance, FDA explained that although a label characterizes a product as a dietary supplement "the product may not in fact be a dietary supplement." FDA explained how a liquid product bearing a "Supplement Facts" panel may still be a conventional food in light of representations that the product rehydrates or quenches thirst, because these are characteristics or intended uses of conventional beverages. While FDA's 2014 guidance primarily concerns liquid dietary supplements, the reasoning provided therein is applicable to other forms of dietary supplements packaged and marketed as gels, chews, and bars.
Whether a product is labeled and marketed as a conventional food or a dietary supplement is significant on numerous fronts. First and foremost, ingredients in conventional foods must be generally recognized as safe (GRAS) or approved for their intended use. The same is not true for dietary supplements. Indeed, dietary ingredients used in dietary supplements are exempt from the FDCA's food additive definition and therefore do not have to be GRAS for their intended use. FDA has recognized the potential for manufactures to evade the GRAS requirement for conventional foods by adding dietary ingredients to a conventional food and labeling the resulting product as a supplement.
Furthermore, the claims the can be used on conventional food products and dietary supplements differ. While no claim or labeling statement can be false or misleading, a claim describing the effects on the structure or function of the human body (structure/function claims) cannot be made in reference to dietary supplements without (1) substantiation that the claim is truthful and not misleading and (2) written notification to FDA. See 21 U.S.C. § 343(r)(6)(A). Structure/function claims for dietary supplements must also include a disclaimer that the FDA has not evaluated the claim and the product is not intended to "diagnosis, treat, cure, or prevent any disease." Id. The same is not true for conventional food products. In light of such requirements, structure/function claims regarding dietary supplements may be subject to preemption, see, e.g., Bronson v. Johnson & Johnson, Inc., No. C 12-04184 CRB, 2013 WL 1629191, at *6–7 (N.D. Cal. Apr. 16, 2013), whereas those involving conventional food products are not.
FDA enforcement actions are another potential source of risk for manufacturers of dietary supplements misbranded as conventional foods and vice versa. Since January 2016, the FDA has issued more than a dozen Warning Letters involving products that are labeled as dietary supplements yet represented as conventional foods. In addition to informing the manufacturer that their products are misbranded, the FDA identified numerous violations of CGMPs for dietary supplements (see 21 CFR 1110) that the manufacturer must correct if they intend to distribute their products as dietary supplements.
Given the potential for plaintiffs' firms to use FDA regulatory enforcement actions as litigation leverage, whether a product is to be marketed as a dietary supplement or conventional food ought to be determined as early as possible during product development and only after consultation regarding the various pros and cons.