The U.S. Food & Drug Administration finally delivered new guidance on New Dietary Ingredients (NDIs), just in time for the July 4 holiday. After several weeks of reporting and worrying, we've digested the news flow and spoken with leading minds throughout the industry. Here's our bottom-line analysis.
- FDA will take an unexpectedly broad view of NDI notification requirments, and an extremely narrow view of grandfathered dietary ingredients
- This guidance could have adverse impact on up to 70% of supplement products now in the marketplace
- This is only a guidance document with a 90-day comment window
- Next steps for FDA beyond the comment window remain unclear
- FDA's reduced budget further hampers the agency's ability to enforce stricter regulation
- The political machine is now churning, and industry's best advocate in this arena remains Senator Orrin Hatch (R-UT)
After a series of articles questioning FDA's ability to effectively monitor food safety in this country, the agency decided to bare its teeth and fight back. The NDI guidance now in the public arena continues a larger trend of FDA upping its scrutiny of supplements, and it also follows in the footsteps of aggressive regulatory posturing from EFSA, its European peer, around supplement health claims.
This guidance also reintroduces industry to Daniel Fabricant, formerly of the Natural Products Association and now chief supplements regulator at FDA. While Mr. Fabricant surely inherited most, if not all, of this guidance document, his positioning of it in the press suggests a very heavy hand.
Mr. Fabricant, perhaps to his credit, seems to be working right out of the gate to distance himself from critics who immediately surfaced after his appointment to question his impartiality and true ability to regulate the industry from whence he comes. According to quotes attributed to Fabricant, there is nothing about this guidance document that should come as a surprise to industry. When public health is at stake, supplement manufacturers and ingredient suppliers should have readily at hand the research necessary to prove a high level of clinical safety.
What will happen to innovation?
Innovation in the supplements industry, already hampered by a soft and uncertain economy, faces a major obstacle if this guidance bears enforceable fruit. Markets fear uncertainty, but they fear oppressive regulation even more. With industry scrambling to keep grandfathered ingredients on store shelves, who's going to fund true innovation under such a dark cloud?
Is this an industry death knell? It's way too soon to make that call, but here are a few statistics to suggest otherwise. FDA has about 10 people on NDIs. A simple document search to shore up an ODI can run as little as $15K. Maybe there's a viable middle ground in all of this uproar.
For guidance, read Patrick Rea's recent take on NDIs on the NewHope360 blog.
A list of recent NDI articles from all of the New Hope media properties appears below.