Fixing Erroneous FDA Guidance Can Take a Decade – and Persistence

By Wes Siegner –

In April 2005, FDA published guidance for industry on dietary supplement labeling, “A Dietary Supplement Labeling Guide.”  As we wrote in 2009, an error in this guidance, stating that the term “dietary supplement” was not an acceptable statement of identity on its own for a dietary supplement product, had caused significant regulatory problems for at least one company.  When we contacted FDA on this issue in 2009, a senior FDA official acknowledged the error but also expressed his opinion that FDA was not likely to fix the guidance in the near future.  This official proved to be prophetic.

The erroneous guidance stayed on FDA’s website through last year, creating additional headaches for industry as class action lawyers used the guidance to support their lawsuits, leading us to write another blogpost urging FDA to fix the guidance.  This time, the American Herbal Products Association waded in, sending FDA a letter requesting that the guidance be fixed.

At long last FDA has addressed this problem. The following appeared in a notice in the March 7, 2016 Federal Register:

In April 2005, we issued a guidance for industry entitled "A Dietary Supplement Labeling Guide." The guidance covers the most frequently raised questions about the labeling of dietary supplements using a question and answer format and is intended to help ensure that the dietary supplements sold in the United States are properly labeled. We recently were made aware that the guidance was inaccurate in one detail. Specifically, in Chapter II, entitled "Identity Statement," question 3 asked "Can the term 'dietary supplement' by itself be considered the statement of identity?" The response to the question said that it could not, but this response was not consistent with section 403(s)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(s)(2)(B)) and our regulations at 21 CFR 101.3(g). Thus, we are revising the guidance to state that the term "dietary supplement" may be used as the entire statement of identity for a dietary supplement and to explain the basis for that conclusion.

The difficulty fixing this small but very significant, from a regulatory perspective, problem in FDA’s guidance bolsters complaints about the broader problems with FDA guidance generally. The lower standards applied to the development and issuance of guidance compared with regulations makes errors both large and small more likely.  The overreliance of FDA on guidance, which is theoretically “nonbinding” but is often treated as establishing legal requirements by FDA, the states, and the courts, combined with the low priority that FDA appears to place on fixing errors, argues for continued resistance and inquiry into FDA’s use of guidance to regulate industry.

Reminder: Register now for the May 3, 2016 Virginia Tech and HP&M Conference on Effective Documentation.  Information on the conference is available here.