APRIL 27, 2021
—Proposed changes will combat adulterated products and
clarify FDA’s role as the regulator of products represented as dietary supplements—
WASHINGTON—Today, the Council for Responsible Nutrition (CRN), the leading trade association representing the dietary supplement and functional food industry, announced its support for revisions to the federal Food, Drug & Cosmetic Act (FD&C Act) that address a clarification to the definition of a “dietary supplement”. The proposed modifications will clarify FDA’s authority over products masquerading as dietary supplements regardless of their contents and will combat adulterated products in the market.
Often referred to as an unintended “loophole,” this Dietary Ingredient clarification addresses a class of adulterated products for which FDA has expressed uncertainty about its legal authority to regulate because they do not meet the definition of dietary supplement in the statute. Even if a product contains a Supplement Facts label, a dietary supplement Statement of Identity or is marketed as being a supplement, FDA contends that it may be beyond the regulatory reach of FDA’s dietary supplement authority if the adulterated product does not actually contain one or more dietary ingredients.1 CRN supports this clarification as it makes clear FDA’s authority to prosecute products marketed as supplements but containing only illegal ingredients.
“If a product is branded or marketed as a dietary supplement, then it should be held to account as if it was a dietary supplement,” said Julia Gustafson, vice president, government relations, CRN. “CRN and our members want to get rogue and illegal products out of the supplement market as they jeopardize public health and hurt consumer confidence in the responsible industry.”
FDA has discussed this issue publicly for two years and offered proposed amendments to address these concerns in its Technical Assistance Comments on HR 8179 in 2020. The agency’s proposed provisions will clarify its authority to take action against illegitimate products that market themselves as dietary supplements, but do not meet the statutory definition of a supplement. The proposed legislative language creates a new prohibited act, the ability to exclude imports, and the ability to seize any product labeled as a dietary supplement that fails to meet the definition of a dietary supplement.
“If enacted, these amendments will provide concrete steps towards building a safer supplement market and a more effective FDA,” said Ms. Gustafson. “Products marketed as supplements should be held to the requirements and restrictions the FD&C Act imposes on this class of regulated products, and should be subject to the enforcement tools that law provides, like seizures, mandatory recalls and criminal prosecution. CRN agrees that FDA needs these enforcement clarifications, and calls on Congress to enact these amendments to the statute to protect consumer safety for the three quarters of Americans who rely on these products to support their health and wellness.”
Along with these provisions, CRN also supports additional ways to enhance FDA’s oversight and prioritize public safety through amendments to the FD&C Act. CRN is working to establish a mandatory product listing to give FDA the ability to see into the market; taking action to revise the drug preclusion language in the definition of dietary supplements that is currently blocking the sale of CBD supplements; and revisiting New Dietary Ingredient (NDI) provisions to clarify uncertainties.
The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing 150+ dietary supplement and functional food manufacturers, ingredient suppliers, and companies providing services to those manufacturers and suppliers. In addition to complying with a host of federal and state regulations governing dietary supplements and food in the areas of manufacturing, marketing, quality control and safety, our manufacturer and supplier members also agree to adhere to additional voluntary guidelines as well as to CRN’s Code of Ethics. Visit www.crnusa.org. Follow us on Twitter @CRN_Supplements and LinkedIn.
1According to the federal Food, Drug & Cosmetic Act, a “dietary supplement—
(1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:
(A) a vitamin;
(B) a mineral;
(C) an herb or other botanical;
(D) an amino acid;
(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described [above]…
21 USC §321(ff).