While many would argue that the term “dietary supplement” has a legal standing as a statement of identity, the situation is not clear cut. In fact, in April 2005, FDA published guidance for industry on dietary supplement labeling, “A Dietary Supplement Labeling Guide.” Chapter II of this guidance contains FDA’s views on how to fulfill the statement of identity requirement for dietary supplements contained in 21 CFR § 101.3(g).
This portion of the guidance contains the following information:
Q. Can the term “dietary supplement” by itself be considered the statement of identity?
A. No. This term by itself is not appropriately descriptive to be a statement of identity. 21 CFR 101.3(g)
The regulation cited is at best ambiguous as to the correct answer to the question posed. Prior to the issuance of the guidance in 2005, the vast majority of dietary supplement products were labeled with “Dietary Supplement” as the only statement of identity. Label space is always at a premium, and this situation has not changed since FDA issued the guidance, although a few companies appear to have changed their labels to comply with the guidance. FDA has not attempted to enforce the view expressed in the guidance, which likely explains the lack of any real interest in the question of whether the guidance is correct.
However, this question became a sticking point in recent efforts to settle a multi-state investigation of a dietary supplement manufacturer, and state regulatory authorities involved were confused by FDA’s guidance. As a result, our firm, Hyman, Phelps & McNamara, submitted an analysis of the relevant statutory and regulatory requirements to FDA’s Center for Food Safety and Applied Nutrition (CFSAN).
After reviewing the analysis, a senior official within CFSAN confirmed the agency had reached the same conclusions and FDA agrees the guidance is incorrect and the correct answer to the question “[c]an the term ‘dietary supplement’ by itself be considered the statement of identity” is “Yes” rather than “No.” However, FDA has also indicated the agency is not likely to correct this guidance any time in the near future.
Given the increased number of multi-state investigations of the dietary supplement industry, manufacturers responsible for labeling dietary supplements should be aware that Texas authorities, even after learning that FDA agrees the guidance is both non-binding and incorrect, stated their intent to enforce Texas’ view of the statement of identity requirement as expressed in the FDA guidance. Other states involved in the multi-state investigation appeared to understand that, given the lack of ambiguity in the FDC Act, FDA’s acknowledgement of the error and the lack of any state requirement for a different statement of identity, there is no legal basis for state enforcement that is inconsistent with the FDC Act. Should Texas or any other state attempt to enforce the erroneous view expressed in the FDA guidance, the manufacturer targeted would have a strong basis for refusing to comply and litigating this issue.
A. Wes Siegner is a director at the firm of Hyman, Phelps & McNamara P.C., with primary practice focused on FDA and FTC regulatory and enforcement matters. This INSIDER contribution is based on a blogpost from the FDA Law Blog.