FDA Confirms that the Term “Dietary Supplement” Is a Legal Statement of Identity for Dietary Supplement Products and that FDA Guidance to the Contrary is in Error; State Regulators may Remain Confused and Have Taken Enforcement ActionMarch 4, 2009
By Wes Siegner –
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 C.F.R. § 101.3(g).
This portion of the guidance contains the following question and answer:
Can the term "dietary supplement" by itself be considered the statement of identity?
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. Nonetheless, 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, and this situation has not changed since FDA issued the guidance, although some companies have changed their labels to comply with the guidance. FDA has, to our knowledge, not taken enforcement action to force industry to change, which likely explains the lack of any real interest in the question of whether the guidance is correct as to whether the term “dietary supplement” alone meets the applicable statutory and regulatory requirements.
This question became a sticking point in recent efforts to settle a multistate investigation of a dietary supplement manufacturer, and the state regulatory authorities involved were understandably confused by FDA’s guidance. As a result, this firm submitted our analysis of the relevant statutory and regulatory requirements to FDA’s Center for Food Safety and Applied Nutrition ("CFSAN") by e-mail, the relevant substance of which follows.
Section 403(s)(2)(B) of the Federal Food, Drug and Cosmetic Act ("FDC Act"), 21 U.S.C. § 343(s)(2)(B), provides that a dietary supplement is misbranded if “the label or labeling of the dietary supplement fails to identify the product by using the term ‘dietary supplement,’ which term may be modified with the name of such an ingredient.” Therefore, the statute, which is controlling, specifies that the use of "dietary supplement" alone as the statement of identity is acceptable, but that other words may be added.
FDA’s regulation, if read alone without reference to the preamble, is less clear and is likely the source of the confusion in the guidance document. The applicable regulation states that “[d]ietary supplements shall be identified by the term 'dietary supplement' as a part of the statement of identity … .” 21 C.F.R. § 101.3(g). It is possible to read this regulation as meaning that the statement of identity must include more than just the words "dietary supplement." However, this reading would conflict with the statutory wording. FDA’s preamble to the final rule establishes that there is no inconsistency, and that the correct reading of § 101.3(g) is that the use of the term "dietary supplement" alone as the statement of identity is acceptable.
FDA’s preamble states that:
Section 201(ff)(2)(C) of the act, in defining the term “dietary supplement,'' mandates that such a product must be labeled as a dietary supplement. Section 403(s)(2)(B) of the act states that a food shall be deemed to be misbranded if it is a dietary supplement, and the label or labeling of the dietary supplement fails to identify the product by using the term “dietary supplement, which term may be modified with the name of such an ingredient.'' Section 403(i)(1) of the act requires that a food label must bear the common or usual name of the food, that is, a statement that identifies the food. Dietary supplements are labeled subject to the provisions of section 403(i)(1) of the act (see the last sentence of section 201(ff) of the act). Thus, when the act is read in its entirety, it is clear that sections 201(ff)(2)(C), 403(s)(2)(B), and 403(i)(1) of the act require that the statement of identity of a product that is marketed as a dietary supplement identify the product as such.
FDA's longstanding regulations lead directly to this result. Section 102.5 (21 CFR 102.5) sets out how the common or usual name of a nonstandardized food is to be derived. Under this provision, the common or usual name must accurately identify or describe, in as simple and direct terms as possible, the basic nature of the food. The basic nature of a dietary supplement is that it is a dietary supplement. This is the point made in both sections 201(ff)(2)(C) and 403(s)(2)(B) of the act. Thus, under 102.5(a), the common or usual name of these products must, at least in part, identify them as a dietary supplement.
62 Fed. Reg. 49,826, 49,827 (Sept. 23, 1997). The preamble clarifies that the words "as part of" in § 101.3(g) mean that the statement of identity should include the term "dietary supplement" "at least in part." Stated differently, the preamble establishes that the correct reading of § 101.3(g), consistent with the statute, is that "dietary supplement" satisfies the statement of identity requirement under § 101.3(g), but that additional words may be included.
Consistent with our reading of the statute and regulation, in its press release concerning this rule, the Department of Health and Human Services stated that “[a] statement of identity will appear on the front panel of the product label. The statement must use the terms "dietary supplement" or a term identifying the contents of the product, such as "Vitamin C supplement" or "Herbal supplement."
A senior official within CFSAN, has confirmed that CFSAN has considered this issue and agrees that FDA’s guidance is incorrect as to the answer to the question posed in the guidance, “[c]an the term ‘dietary supplement’ by itself be considered the statement of identity,” and that the correct answer should be “Yes” rather than “No.” However, FDA has also indicated that the agency is not likely to correct this guidance anytime in the near future.
Given the increased number of multistate investigations of the supplement industry, manufacturers responsible for labeling dietary supplements should be aware that Texas authorities, even after learning that FDA agrees that the guidance is incorrect and being reminded that such guidance is not binding on FDA or industry, have stated their intent to enforce Texas’ view of the statement of identity requirement as expressed in the guidance. Other states involved in the multistate 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 of 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.