Some Speculation on Forthcoming Dietary Supplement Guidelines
If you liked the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues of July, 2011, you will love the next draft guidance, if the April 2016 meeting convened by the National Toxicology Program (NTP) provides any clues.
As you may recall, the July, 2011 draft guidance for an NDIN was particularly onerous in its mandate for extensive animal testing, the scope of which was at least on the level of a food additive petition, if not an IND. Because such demanding guidance was not in the spirit of the law and particularly burdensome for the majority of dietary supplement manufacturers (most of whom are small or micro-market capitalized companies), the guidance was met with a firestorm of criticism from industry and Congress. Although (former) Commissioner Hamburg withdrew the draft guidance, it still remains on the FDA website and has been referenced in NDIN objection letters. Still, NDINs suffer a rejection rate of 66% from a net of 610 applications (from a gross of ~900). Consumers and Industry must learn to deal with the fact that FDA has never looked favorably on dietary supplements or claims for any substance that does not come with an IND.
It is the author’s belief that the April meeting, Addressing Challenges in the Assessment of Botanical Dietary Supplement Safety pre-sages the next attempt by FDA to curtail what it sees as an industry populated with a small, but reckless industry segment willing to pack most anything into a capsule or container and play off the willingness of a public to buy into splashy internet headline stories on “important new discoveries!” that report extrapolations of half-baked and unverified research as characterizing life-enhancing new products. Also, there is a large constituency within Congress and the public that feel the dietary supplement industry is unregulated and/or out of control. On the other side of this argument are responsible manufacturers and the public that have shown a certain tenacity and push back against unreasonable FDA-ODS over-reach. Because of the strong feelings on both sides, FDA will have to launch its offensive from solid and familiar ground – this will be a two-pronged offensive, based on safety and truth- in-labeling demands. Naturally, this new offensive begs the question of why this tactic was not employed before, as it would be embarrassing to work on a pretext that has existed for the last 22 years? The answer is that the new emphasis is based on the findings of the National Toxicology Program, which forms the nexus of the now shared interests of these two agencies.