Supplement Industry May Be Adopting NDI Guidance 'Where It Seems to Make Sense'
While the supplement industry is closely examining the guidance, supplement manufacturers may not be acting on all the principles contained within the document—especially while the guidance is in draft form.
FDA’s 2016 draft guidance governing a safety-related notification requirement in the 1994 Dietary Supplement Health and Education Act (DSHEA) laid out positions that were met with criticism by the industry.
Are distributors and manufacturers of dietary supplements taking decisive actions in response to the 102-page document? For instance, are they removing from retail shelves and ecommerce stores the sale of synthetic botanicals, and filing a new dietary ingredient (NDI) notice with FDA based on a change to production? Or are they taking more of a wait-and-see approach until FDA finalizes the NDI guidance?
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), said it was important for the industry to understand FDA’s interpretations in the draft document because they could foreshadow how the agency would interpret the law in an enforcement action. However, he reiterated the guidance does not carry the force of law, as FDA itself has acknowledged.
CRN is advising its member companies to “implement those parts of the guidance where it seems to make sense to the companies," Mister said in a phone interview. If a company disagrees with specific FDA positions in the document, the trade association recommended conferring with counsel and making a business decision as to whether to follow the guidance.
“You should know why you disagree with that, and be prepared to defend your actions if you are doing something that’s inconsistent with what’s in the guidance," Mister added.
Synthetic Botanicals
The topic of synthetic botanicals may afford the industry such an opportunity. Since at least 2011, and again in the 2016 draft NDI guidance, FDA asserted a synthetic copy of a constituent of a botanical does not qualify as a botanical dietary ingredient under section 201(ff)(1)(C) of the Federal Food, Drug & Cosmetic Act (FD&C), as amended by DSHEA.