As the Dietary Supplement Health and Education Act moves into its second decade, it seems likely that the U.S. Food and Drug Administration will address several provisions of the bill that have yet to be clarified. These include the notification process for new dietary ingredients and the establishment of good manufacturing practices for the dietary supplements industry.
At this time, many in the industry are heartened by the appointment of Mike Leavitt as secretary of the U. S. Department of Health and Human Services, which oversees FDA. Leavitt, a former governor of Utah, has long had close ties with the dietary supplements industry. ?Based on comments he made during congressional hearings, we have no reason to think that he wants anything we don?t want,? said Michael McGuffin, president of the American Herbal Products Association, based in Bethesda, Md. ?He made it quite clear he thinks DSHEA is an enforceable law, and the fact that he?s a former governor of Utah is viewed as a positive, in terms of industry access.?
Spurred by the publication of several articles critical of the lack of guidance for introducing NDIs, FDA invited industry comment on how to improve the NDI approval process. On Nov. 15, 2004, the agency held an open meeting on the subject, and it also allowed the public to file written comments on NDIs through Feb. 1, 2005.
A study published last year in the American Botanical Council?s Herbalgram found that FDA rejected 70 percent of NDI filings for botanicals; however, the primary reason was not the safety of the ingredients, but insufficient information provided to FDA. ?The FDA has never published any complete guidance regarding what needs to go into an NDI notification, including the level of evidence needed to document an NDI?s safety,? said Mark Blumenthal, executive director of the Austin, Texas-based ABC.
The NDI provision of DSHEA was created as a trade-off with industry at the time of the bill?s passage. The industry was allowed to ?grandfather? all supplements ingredients on the market prior to Oct. 15, 2004, (often referred to as ?old dietary ingredients,? although that language is not found in DSHEA); in return, FDA was given premarket approval over all new ingredients, with companies required to file their supporting documentation 75 days before introducing the ingredient to market.
A variety of industry trade associations responded to the request for public comment on what should be included in the supporting information for NDI approval. ?There is industry confusion about the process, as well as a lack of clarity in the regulations,? said McGuffin. ?Both parties want that resolved. The law has a good, sound safety provision, but the process needs to be clarified.?
To that end, AHPA has suggested that NDI notifications require additional information, including—for botanicals—the part of the plant used, the plant?s Latin name and a list of its chemical compounds or active ingredients. ?One area of contention between the industry and some consumer groups is how much evidence is necessary to prove an ingredient?s safety,? said Blumenthal. ?Another issue is whether a particular ingredient is an NDI or not. There needs to be a formal list of what the ODIs are.?
Both AHPA and ABC advocate that FDA accept one of several industry-created lists of ingredients that were on the market before the passage of DSHEA, including lists compiled by AHPA, the National Nutritional Foods Association, the Council for Responsible Nutrition and the Utah Natural Products Alliance.
Some in the industry voice concern that FDA will ask for hard proof on an herb?s ODI status. ?That?s not fair, not rational, not appropriate, not reasonable,? said Blumenthal. ?Companies don?t keep bills of lading and invoices for 11 years. It was FDA?s responsibility to come to the table earlier in the process, if that?s the kind of documentation they wanted.?
GMPs may soon see changes as well. DSHEA enables FDA to issue good manufacturing guidelines for the dietary supplements industry; with Leavitt as Health and Human Services secretary, this long-delayed process may become a reality. ?I think we?ll actually see GMPs this year,? said McGuffin. ?We?ve been complaining for years about the tone of FDA?s message. When the draft proposing GMPs was first published, FDA called a press conference and disparaged the industry in really outrageous ways. Under Leavitt, we?ll be able to make sure the secretary knows we?re in communication with FDA with regard to the need to treat this regulated industry with the same respect they accord to other regulated industries.?
McGuffin also sees the possibility of moving forward in conjunction with FDA on a system for adverse-events reporting.
?I don?t see FDA repeating that old mantra of ?We don?t have the power, our hands are tied,? ? said Blumenthal. ?What we need is not new legislation, but fuller and more robust enforcement of existing regulation. The good news is, FDA is more adequately and completely enforcing the law.?
Mitchell Clute is a freelance writer in Crestone, Colo.
Natural Foods Merchandiser volume XXVI/number 3/p. 15, 24