FDA’s NDI Guidance and the 18-Year Cycle of Correcting Regulatory OverreachJuly 14, 2011
Since at least the early 1960s, FDA has attempted to exercise control over the dietary supplement market, sometimes in ways that the public, industry and Congress have found unacceptable. In the 60s, FDA proposed a regulation that would have required FDA review and approval of vitamin products that exceeded 150% of the U.S. RDA and to require the following disclaimer on vitamin supplements: "Vitamins and minerals are supplied in abundant amounts by commonly available foods. Except for persons with special medical needs, there is no scientific basis for recommending routine use of dietary supplements." The proposed disclaimer was withdrawn after hearings, but the regulation setting limits on potency was finalized in 1973. That regulation was invalidated as arbitrary and capricious by a federal appellate court, and the regulation prompted Congress to add section 411 to the Federal Food, Drug, and Cosmetic Act ("FDC Act") through the Proxmire Amendments in 1976. Among other things, section 411 restricts FDA’s authority to set maximum limits on the potency of synthetic or natural vitamins or minerals in dietary supplements.
In the 1980s, FDA pursued the theory that novel dietary supplements were in fact unapproved and therefore illegal “food additives,” bringing multiple seizure actions against a variety of products including evening primrose and black currant oil. FDA’s arguments that even pure black currant oil in a gelcap or a glass bottle was a “food additive” led to unusually strong rebukes in two appellate courts, one of which found that FDA’s argument “perverts the statutory text, undermines legislative intent, and defenestrates common sense,” while the other described FDA’s theory as an “Alice-in-Wonderland approach,” and “an end-run around the statutory scheme.” Then Congress stepped in again, 18 years after the Proxmire Amendments, and passed the Dietary Supplement Health and Education Act ("DSHEA"), clarifying that FDA has no authority to regulate dietary supplements as “food additives.”
Now, 17 years after DSHEA, FDA has published the long-awaited draft guidance on new dietary ingredients ("NDIs"), providing regulated industry with a comprehensive view of FDA’s thinking on all things NDI. If FDA translates that thinking into regulatory action, there will be multiple negative effects on the dietary supplement industry, including:
- The “grandfather” status of many dietary ingredients marketed prior to October 15, 1994 would be eliminated through (1) unachievable documentation requirements to prove prior marketing, and/or (2) the requirement that there be no change in the manufacturing method. Most ingredients that have been accepted as having “grandfather” status would instead be regulated as NDIs.
- DSHEA’s exemption from the notification requirement for NDIs “present in the food supply as an article used for food in a form in which the food has not been chemically altered” would be gutted by FDA’s view that (1) the “food supply” includes only conventional foods, not dietary supplements, and (2) “chemically altered” means virtually any process applied to any dietary ingredient other than treatment with water or ethanol, even if no change in chemical structure or properties occurs. The result is that the vast majority of NDIs would have to be the subject of a notification, unnecessarily burdening industry and swamping the agency with pointless work.
- Innovation in the supplement market, an important purpose of DSHEA, would be strangled by FDA’s view that (1) new dietary ingredient notifications ("NDINs") are applicable only to the specific manufacturer that submitted the NDIN, and (2) even minor changes in use or the manufacturing process for an NDI would require submission of a new NDIN.
- Many NDINs would be rejected as a result of FDA’s view that synthetic equivalents of certain naturally occurring NDIs do not qualify as dietary ingredients, a position that is lacking in scientific and legal merit.
In sum, if the guidance were to be finalized and implemented in anything resembling its current form, it would drastically restrict the marketing of grandfathered dietary ingredients, and stifle the development of new dietary ingredients and more efficient manufacturing methods.
The draft guidance strikes us as a missed opportunity for FDA. Rather than craft a viable path forward for the implementation of the new dietary ingredient provisions of the FDC Act, the draft guidance both ignores the purpose of DSHEA and exceeds the statutory authority granted by that legislation. The draft guidance shows that the agency has again declined to heed the corrective message delivered by Congress through the Proxmire Amendments and DSHEA. Perhaps, 18 years after DSHEA, it will be time for Congress to deliver that message again.