FDA updates dietary supplement labeling guidance to confirm “dietary supplement” as appropriate SOI.

• In April 2005, FDA issued a guidance document entitled, “A Dietary Supplement Labeling Guide.”  The guidance covers the most frequently raised questions related to dietary supplement labeling in a Q&A format, and for years, it has served as a resource for the supplement industry.  Unfortunately, the guidance contained a confusing and erroneous response to a key question, namely:  “Can the term ‘dietary supplement’ by itself be considered the statement of identity?”  The response to this question said that it could not, which was inconsistent with the Federal Food, Drug, and Cosmetic Act and FDA regulations.  Although FDA and the industry have known about this error for over a decade, it went uncorrected.

• On March 7, 2016, FDA issued a Federal Register notice finally correcting this fundamental error in the guidance document.  In response to the same question, the revised guidance now reads:

  • Yes. This term describes the basic nature of a dietary supplement and therefore is an “appropriately descriptive term” that can be used as the product’s statement of identity. The statement of identity for a dietary supplement may therefore consist simply of the term “dietary supplement,” or “dietary supplement” may be part of a longer statement of identity (e.g., “cod liver oil liquid dietary supplement”). In either case, the word ‘‘dietary’’ may be deleted and replaced by another appropriately descriptive term identifying the contents of the product, such as “calcium supplement,” “herbal supplement”, or “herbal supplement with vitamins.”

• Although the error in the initial guidance document may have seemed relatively basic — and was widely disregarded as erroneous by the dietary supplement industry — mistakes of this nature can have consequences.  Particularly in today’s litigation environment, plaintiffs’ lawyers and courts look to FDA guidance as an authoritative resource in determining the appropriateness of industry conduct.  Examples such as this highlight the danger inherent in over-reliance on FDA guidance and also how difficult it can be for FDA to revise guidance even to correct even a clear and widely-acknowledged error.