FDA Notifies Industry of Enforcement Discretion Regarding DSHEA Disclaimer on Dietary Supplement Labels

Recent lawsuits have alleged dietary supplements fail to bear the dietary supplement disclaimer in a manner that complies with 101.93(d)'s proximity requirements.  FDA's letter and enforcement discretion should prove useful to dietary supplement companies defending lawsuits or demand letters on this issue.

Relevant Dietary Supplement Labeling Requirements

The Dietary Supplement Health and Education Act of 1994 (DSHEA) amended the Federal Food Drug and Cosmetic Act (FFDCA) to create a regulatory paradigm for dietary supplements.  The Act defined the term dietary supplement; established requirements for new dietary ingredients, labeling, and certain claims for dietary supplements; and authorized FDA to promulgate regulations for dietary supplement-specific current good manufacturing practices (CGMPs). 

Among other things, DSHEA added § 403(r)(6)³which addresses structure-function claims for dietary supplements. Such claims describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body in humans, and may lawfully be made where (a) the manufacturer has substantiation that the statement is truthful and not misleading; and (b) the statement contains, “prominently displayed and in boldface type,” the following disclaimer: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

Following the enactment of DSHEA, FDA promulgated regulations at 21 CFR 101.93 specifying where and how the disclaimer must be displayed when a structure-function claims is made.  Section 101.93(d) requires the disclaimer to appear on each panel of the label, and on each page of labeling, where a structure-function claim is made:

Placement. The disclaimer shall be placed adjacent to the statement with no intervening material or linked to the statement with a symbol (e.g., an asterisk) at the end of each such statement that refers to the same symbol placed adjacent to the disclaimer specified in paragraphs (c)(1) or (c)(2) of this section. On product labels and in labeling (e.g., pamphlets, catalogs), the disclaimer shall appear on each panel or page where there such is a statement. The disclaimer shall be set off in a box where it is not adjacent to the statement in question.

Letter to Industry

FDA's letter to the dietary supplement industry explains that the agency has received multiple requests to amend 21 CFR 101.93(d), is currently considering these requests, and may revise the regulation to remove the requirement that the disclaimer appear “on each panel or page where there is such a statement.”  The letter states that FDA “expect[s] that revising this regulation to remove the requirement for the DSHEA disclaimer to appear on each panel of a product label where there is a 403(r)(6) claim would be consistent with section 403(r)(6)(C) of the FD&C Act while reducing label clutter and unnecessary costs.”  FDA also notes that the agency has “rarely, if ever, enforced this requirement.”  FDA will continue to evaluate the potential impact of removing the “each panel” requirement and is “likely to propose a rule to amend this requirement”, unless significant concerns are identified.  The letter does not address disclaimer placement on websites.

FDA acknowledges that the rulemaking process can be time consuming.  Therefore, the agency intends to “exercise enforcement discretion regarding the requirement for the DSHEA disclaimer to appear on each panel of a product where a 403(r)(6) claim appears.” 

FDA does not intend to exercise enforcement discretion with respect to other 403(r)(6) and 21 CFR 101.93 requirements.

Why It Matters

Recent lawsuits have alleged dietary supplements fail to bear the dietary supplement disclaimer in a manner that complies with 101.93(d)'s proximity requirements.  FDA's letter and enforcement discretion should prove useful to dietary supplement companies defending lawsuits or demand letters on this issue. For active litigation, the FDA actions present a significant hurdle for Plaintiff's counsel and could result in cases being stayed or delayed, if not dismissed.  For manufacturers that are dealing with demand letters on this issue, the enforcement discretion offers another defense against claims for injunctive relief.  

Next Steps

We will continue to monitor for 21 CFR 101.93(d) regulatory and litigation updates.  Please contact us if you have any questions.

Authored by: Veronica Colas and Mary Grywatch.