Q: What is a dietary ingredient?
A: The term dietary supplement is defined in Section 3 of the Dietary Supplement Health and Education Act, ?201(ff) of the Federal Food Drug and Cosmetic Act, as: ?A product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract or combination of any ingredient described in clause A, B, C, D or E.?
Q: Does subsection E mean any substance that supplements the diet can be a dietary ingredient?
A: No. E is intended to encompass dietary ingredients such as bee pollen and glucosamine that are not vitamins, minerals, herbs or amino acids. However, the Food and Drug Administration?s interpretation of E is that mere intent to supplement the diet is not sufficient; a dietary ingredient must be a substance commonly used by humans as food. For example, fetal placenta is not a dietary ingredient, nor is whale sperm.
Q: What else is required for a substance to be considered a dietary supplement?
A: To meet the full definition in DSHEA, a dietary supplement must: a) be intended for ingestion in the form of a capsule, tablet, liquid, powder, softgel or gelcap; b) not be represented for use as a conventional food or as the sole item of a meal; and c) be labeled as a dietary supplement. For example, a sublingual spray—if intended to be absorbed through the tongue and not ingested into the body—would not be a dietary supplement.
Q: If a product meets the definition of a dietary supplement, is there any way it could be considered something other than a supplement?
A: Yes, if the label or product literature contains disease or drug claims instead of, or in addition to, permissible structure/ function claims, the FDA will consider the product a drug. (See Counselor?s Corner, July 2001 NFM for information on structure/function claims.) And if that supplement were marketed or advertised in any way as having therapeutic or drug benefits, even with strong scientific support, the FDA would deem it an unapproved new drug.
Q: What is a new dietary ingredient, and are there special regulations for NDIs?
A: DSHEA, in FDDCA ?413, defined NDIs as those not marketed in the United States as either foods or supplements before DSHEA?s passage in October 1994. If a dietary ingredient is not an NDI, it is presumed to be safe.
NDIs are subject to a premarket notification requirement to demonstrate to the FDA a reasonable expectation of safety for use. Notification requirements for NDIs, pursuant to Section 8 of DSHEA, were detailed in the September 1997 FDA regulations (21 CFR ?190.6). Notifications must be filed 75 days before marketing a product that contains an NDI.
Q: Can a drug ingredient also be a dietary supplement ingredient?
A: Yes, sometimes. If a substance was marketed as a food or dietary supplement before it was approved as a drug or antibiotic, or licensed as biologic, then it may remain on the market as a dietary supplement or be used in a supplement. However, if the substance was not previously marketed as a food or dietary supplement, a manufacturer or marketer may not sell it as a dietary supplement once the substance has been approved as a new drug or antibiotic. Nor may it be sold as a dietary supplement if it is a licensed biologic, an investigational new drug or a publicly investigated potential drug. Because of their histories, some substances, such as caffeine, may be marketed simultaneously in foods, supplements and drugs.
Q: Are hormones permissible dietary supplement ingredients?
A:No. For example, although you may see some testosterone products on the market that are labeled and advertised as supplements, the presence of testosterone in the product name or formula—in either a topical or an ingested form—would render that product a drug, according to FDA over-the-counter drug regulations. The one exception to the drug categorization is progesterone, which may be included in topical creams, with the product labeled and marketed as a cosmetic, provided that certain requirements are met. Generally the presence of a hormone in a supplement, or even a supplement product name suggesting the presence of a hormone, will render that product a drug. Human growth hormone presents an even stronger example: A section of the FFDC Act states that ?Whoever knowingly distributes, or possesses with intent to distribute, human growth hormone for any use in humans other than the treatment of a disease or other recognized medical condition ? is guilty of an offense punishable by? up to 5 years in prison or a fine or both. A precursor to HGH that otherwise meets the definition and requirements of a dietary ingredient described above may perhaps be sold as or in a dietary supplement, provided that no marketing claims imply that it is intended as, or is to be used as, a drug, but rather is for anti-aging benefits only.
Q: Do supplements and ingredients added to functional foods have to follow the same rules as dietary supplements?
A: No. Functional food is a marketing term, not an FDA category determined by statute or regulation. The term usually applies to conventional foods to which dietary ingredients have been added; these food products include labels with structure/function-type claims. (See Counselor?s Corner, March 2003 NFM for an article on functional water.) Because of the growing market for functional foods, on Jan. 30, 2001, the FDA issued a letter to numerous manufacturers in the food industry expressing its concerns about food products that contain ?novel? ingredients, such as botanicals and their extracts, that have not been previously or traditionally used as food ingredients. The FDA expressed two major concerns: First, many of these novel ingredients are not generally recognized as safe for their intended use; and second, many products that contain novel ingredients bear claims to health benefits that may not comply with federal labeling regulations.
Q: Are any dietary ingredients affected by the concern over bovine spongiform encephalopathy, or mad cow disease?
A:Potentially, yes, especially bovine glandular materials. For this reason, the FDA has recently prohibited the following cattle and cattle substances from all foods and dietary supplements: parts from ?downer? (sick) cattle; parts from ?dead? cattle (deceased before slaughter); specified risk materials known to contain high concentrations of the infectious agent for BSE, such as the brain, skull and spinal cord of cattle 30 months or older; and mechanically separated beef, a product which may contain SRMs. This new rule means that neither the gel cap for the supplement (made of ?other ingredients,? meaning fillers, excipients, etc., which are listed below the Supplement Facts box) nor the contents of a capsule or dietary supplement (the actual dietary ingredient) may contain any of the parts or substances above.
Q: Do you envision any changes in the definition of dietary supplement or in what may be used as a dietary ingredient in the future?
A: A few bills have been introduced in Congress in the past year that would eliminate whole classes of dietary ingredients, namely stimulants and steroid constituents—both very broadly defined. Other pending bills would require all dietary supplements other than those containing only vitamins to submit to the FDA—premarket?full safety and possibly efficacy evidence. Contrary to the framework of DSHEA, these pending bills would regulate supplements more like drugs than foods.
Susan Brienza is an attorney in the Denver office of the Washington, D.C., law firm Patton Boggs LLP. She practices in the areas of regulatory compliance, FDA law (including DSHEA) and FTC law. Her e-mail address is [email protected].
Natural Foods Merchandiser volume XXV/number 3/p. 110, 112