On March 7, the US Food and Drug Administration (FDA) announced the availability of revised guidance for industry titled “A Dietary Supplement Labeling Guide: Chapter II. Identity Statement” (Revised Guidance).1 The Revised Guidance provides clarification on whether the term “dietary supplement” may be used as the entire statement of identity for a product without other identifying or descriptive terms. Comments can be submitted to Docket 2004D-0487 on the draft Revised Guidance at any time.
The Revised Guidance comes as a result of an inaccurate statement in the 2005 guidance for the industry titled “A Dietary Supplement Guide.”2 The inaccurate statement pertained to the negative response to a question as to whether or not the term “dietary supplement,” by itself, could be considered a statement of identity. The negative response ran directly contrary to sections 201(ff)(2)(C) and 403(s)(2)(B) of the Food, Drug, and Cosmetic Act (FD&C Act) as well as 21 C.F.R. 101.3(g), which explicitly requires dietary supplements to be identified by the term “dietary supplement” as a part of the statement of identity, with only some flexibility.
Mislabeling an FDA-regulated product, among other potential issues, is not without consequences. A dietary supplement that fails to comply with requirements under section 403 of the FD&C Act may be considered misbranded. As a prohibited act under section 301(a), violations are subject to penalties, including monetary fines and imprisonment. In an era of criminal prosecutions of prohibited acts under the FD&C Act, revisions and clarifications of guidance documents provides the regulated community with greater assurance that their products are in compliance.
For more information concerning criminal liability under the FD&C Act and best practices to avoid prosecution, please join Morgan Lewis and the North American Meat Institute on March 22 for a webinar on Crime and the Food Industry. Register for the webinar.
181 Fed. Reg. 11813 (Mar. 7, 2016) https://www.gpo.gov/fdsys/pkg/FR-2016-03-07/pdf/2016-04948.pdf; Food & Drug Admin., Dietary Supplement Labeling Guide: Chapter II. Identity Statement (Jan. 2016) http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm070594.htm.
2Food & Drug Admin., A Dietary Supplement Labeling Guide (Apr. 2005) http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm2006823.htm.
321 C.F.R. 101.3(g) (The word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product (e.g., calcium supplement) or an appropriately descriptive term indicating the type of dietary ingredients that are in the product (e.g., herbal supplement with vitamins)).