Erroneous FDA Guidance Continues to Plague Industry

By Wes Siegner –

In 2005, FDA published a Dietary Supplement Labeling Guide that, among other things, provided guidance on whether the words “Dietary Supplement” by themselves satisfied the requirement that the front panel of all dietary supplement products include a statement of identity.  FDA’s answer?  “No. This term by itself is not appropriately descriptive to be a statement of identity.”  FDA cited 21 CFR § 101.3(g) as authority for its position. 

As we have pointed out in a 2009 blogpost on this issue, FDA’s guidance position is in obvious conflict with the Federal Food, Drug, and Cosmetic Act (FDC Act), as well as with FDA’s preamble to the cited regulation, where FDA explained that the words “Dietary Supplement” are sufficient as the statement of identity for a dietary supplement.  That blogpost, titled “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 Action,”  followed a struggle to resolve a multi-state investigation of a client over a variety of labeling issues, including accusations from the states that the company was violating FDA’s erroneous guidance.

We had hoped that our discussions with FDA leading to the prior blogpost might encourage FDA to fix the guidance and put an end to the matter.  We were wrong.  Recently we learned that plaintiffs’ lawyers are citing FDA’s erroneous guidance in class actions against dietary supplement manufacturers.  We learned of this problem when we were notified that the links in our 2009 blogpost to FDA’s erroneous guidance and an FDA press release cited in the blogpost were no longer functional. 

For those who continue to be plagued by FDA’s error, here we update those links:

• Dietary Supplement Labeling Guide: Chapter II. Identity Statement
• FDA 3/23/99 Press Announcement — Dietary Supplements Now Labeled With More Information Summary of Nutrition Labeling Rules for Dietary Supplements and Sample Labels 

FDA has developed “good guidance practices” and in 2011 issued a self-promotional report on FDA’s guidance practices titled “Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency.”  Pursuant to these “good guidance practices,” FDA frequently updates and revises its guidance documents.  Here however, after 10 years and even though senior FDA officials in FDA’s Food Center are (or were in 2009) aware of this significant error, FDA appears to have no desire to fix this mistake. 

All of which begs the question:  can incorrect guidance be “good guidance”?