Over two and a half years now have passed since FDA issued its controversial New Dietary Ingredient (NDI) Draft Guidance, on July 5, 2011, and the agency has yet to provide facts and answers to support its recommended radical policy changes.
Following publication of the Guidance, in September 2011, Jarrow Formulas Inc. (JFI) filed a detailed 128-item Freedom of Information Act (FOIA) Request, seeking documents and information to support what most in the industry viewed as specious assumptions and unfounded conclusions by the agency.
Remarkably, in the ensuing months and years, FDA’s incomplete answers showed that the agency had no responsive documents for over 70 percent of the requests, including nothing on economic impact, nothing on its decision to redefine NDIs in contravention of DSHEA, and nothing on safety, the purported reason for many new aspects of the Guidance in the first place. For the remainder of the Requests, FDA either referred JFI to websites and publicly available information, or withheld documents claiming privilege—without providing, as required by law, the rationale for such claims or even a list of the withheld documents, known as a Vaughn Index.
As to safety, FDA had no substantive response to JFI’s basic Request 101: “All FDA documents reflecting communications, discussions, and considerations as to the safety problem(s) of concern with dietary supplements and the precise endpoint(s) —reported deaths, serious adverse events, birth defects, etc.—intended to be remedied or corrected by the Draft Guidance; and all documents reflecting estimates and mechanisms as to precisely how and to what extent the Draft Guidance would correct those safety problems of concern above.”
FDA’s answer to this request, significantly, was: “We searched our files and found no responsive information.” Similarly, there were no actual responsive documents as to FDA’s dramatic new policy on Probiotics or on “chemical alteration.” With these non-responses, key novel recommendations in the NDI Draft Guidance remain completely baseless and unfounded.
If the NDI Guidance were to be finalized as originally conceived:
- The burden would improperly shift to industry to prove that a substance is an old dietary ingredient (ODI).
- Probiotics are arguably more important for public health now than at any other time in human evolution. Yet according to the Probiotic segment, not a single new strain (subspecies) of species already on the market could be introduced; for instance, no new strain of L. acidophilus or Bifidobacteria longum would be allowed as dietary ingredients at all.
- Any synthetic vitamin or mineral (legal for decades in the U.S.) could be viewed as falling outside the “dietary ingredient” definition and thus be removed from the market, a policy that would have prohibited the introduction of coenzyme Q-10 and even B vomplex ingredients and other vitamins and amino acids.
- Inexplicably and absent any legal authority, the definition of “chemical alteration” would be vastly expanded so that far more “new” ingredients would be then subject to FDA “notification”—in essence pre-approval.
- Supplements could be regulated as unapproved food additives; and NDI Notification requirements illogically would be more burdensome than those of GRAS notifications.
JFI appealed FDA’s “Denial” of the FOIA Request in February 2012, but despite repeated requests by JFI, and vows by FDA that it is still searching for documents, no new information has been forthcoming to date. Inexplicably and enigmatically, in March 2013, FDA’s Office of Chief Counsel notified JFI attorneys of the Agency’s “discovery” of additional responsive documents, but FDA has remained silent and produced none since then. With FDA’s original meager responses to the FOIA, and now continued stonewalling over two years after the Appeal, we still have no sufficient factual, historic, scientific, nutritional, toxicological, or legal support for the misguided NDI policy.
Jarrow Rogovin, president of Jarrow Formulas, explained why he believes his company’s FOIA Request—and the FDA’s non-responses—are important: “The FDA must be held accountable for its own admitted inability to justify the radical policy changes and, in essence, new regulations of the proposed NDI Guidance. A solution in the form of a true Revision of this dangerous document must start with a thorough understanding of the scope and scale of the problem. The Guidelines as projected will help only the pharmaceutical industry and a handful of very large supplement companies, and will injure the Public by greatly reducing innovation and discouraging research. The trade associations are missing an important counter-strategy in not joining JFI in pressing the FDA to fully respond to the critical questions posed in our FOIA Request on NDIs. Only with collective and concerted action can industry achieve major modifications to the Agency’s latest attempt to cripple the supplement market. Frankly, I wonder what the trade associations are actually doing other than requesting the FDA to issue a revised NDI Guidance–whether or not there is any legal or scientific foundation for its provisions. The NPA seems to have become a training institute for FDA executives who then go on to enforce a draconian view of dietary supplements-first Daniel Fabricant, Ph. D. and now Cara Welch, Ph.D. What's next?”
There has been a considerable passage of time since the overwhelming negative Comments were received by December 2, 2011. While the Agency has promised that revisions to the NDI Guidance are in progress, and has conceded that NDIs are ingredient specific and not (in its attempted redefinition of two years ago) product specific, meaning each new formulation, JFI has no high hopes that the many other key problems in the Guidance will be addressed and rectified. The formulation approach would constitute pre-market approval.
JFI shall, of course, continue to press the Agency and the FOIA Office for the documentation and answers that FDA is required by law to provide, and hopes that all in the industry will join with us in future actions to prevent implementation of the numerous unsupported aspects of the NDI Guidance, the Final version of which the Agency has stated is a top priority for 2014.