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.