A voluntary advisory committee combining academia, consumer groups, industry, Congress and FDA would help the agency through some of the "issues" where it needs "assistance" in developing a strategic plan for dietary supplement regulation under the Dietary Supplement Health & Education Act, National Nutritional Foods Association President Michael Ford said at an FDA stakeholder meeting in Washington, D.C. June 8.

"We suggest that you consider the appointment of an expert advisory panel, not necessarily through the Advisory Committee Act, but more of an ad hoc standing group that can combine the best from" all interested parties in dietary supplement regulation, Ford told the agency.

NNFA's position, according to Ford, questions "if the bureaucracy and expenditures that would be associated with appointing a committee through the Advisory Committee Act is necessary in terms of getting the expertise that you need." Instead, the trade association is "looking at the idea of a voluntary group that would have some substance from a variety of sectors that could help [FDA] through a lot of the bumpy roads ahead."

Council for Responsible Nutrition Scientific and Regulatory Affairs VP Annette Dickinson, PhD, asserted FDA needs a formal committee to address the regulatory needs of dietary supplements, echoing suggestions made by the organization at a recent House Government Reform Committee hearing (The Tan Sheet" May 31, pp. 3-5).

"CRN continues to urge FDA to establish a Dietary Supplement Advisory Committee composed of experts who are familiar with the dietary supplement industry and its issues," Dickinson's written comments state. "In the absence of a Dietary Supplement Advisory Committee, the agency has been relying on the Food Advisory Committee, which does not currently have the appropriate expertise in our product category."

FDA has implemented working groups to help familiarize the Food Advisory Committee with dietary supplement issues, but according to Dickinson, "they are not a substitute for a properly constituted full committee of appropriate experts."

However, while FDA is in the process of developing such a committee, or if it chooses not to form an advisory panel, "the immediate priority is to get that kind of expertise available to you through the Food Advisory Committee" by "incorporating into that committee representatives of the affected industry and other interests who are involved in the dietary supplement business." FAC has used outside working groups to deal with supplement topics.

Offering another opinion, Consumer Healthcare Products Association Senior VP and Science & Technology Director William Soller, PhD, suggested "something other than a formal advisory committee" should be organized to address regulation issues.

More important, Soller said, are the development of consistent adverse event reporting and Good Manufacturing Practice regs within the industry. CHPA written comments conclude "the appointment of another special advisory committee would detract at this time" from the resources necessary to address "priorities of safety, an overall strategic plan and claims policy."

"As we have looked at this landscape, we see GMPs and AERs as being the top priority issues" for FDA now, Soller said. FDA needs to use the available reporting sources for adverse events in a more efficient manner. "The sources that we have, in terms of spontaneous reporting, [are] in the medical literature, the medication error system of USP, tests of toxic exposure, the surveillance system of the American Association of Poison Control Centers" and the Consumer Products Safety Commission.

CHPA "is working on a much more detailed type of plan on AER reporting in terms of the specifics as to when you share things, who do you share them with, how are they reported on the Web site," Soller continued. The current method "is simply not something that is very helpful and is, in fact, potentially misleading. There may be another way of thinking out of the box on that one to meet the need," he suggested.

National Food Processors Association Food Labeling & Standards Director Regina Hildwine suggested a food model of adverse event reporting should be followed that would "put the burden of surveillance, the first line of reporting, on the industry."

"There is a long history on the food side of FDA-industry cooperation relative to adverse events, a long history of voluntary compliance with the industry and a long history of voluntary recalls," Hildwine said. "We would encourage FDA to keep in mind that dietary supplements are legally classified as food and to look to the food models for adverse event reporting and safety surveillance issues."

A model of food industry standard operating procedures also might be appropriate for dietary supplements, Hildwine said. "A lot of food companies have consumer response centers where they receive all kinds of responses from consumers, including, in some instances, complaints and adverse event reports, at which point science kicks in."

"NFPA has done this for decades to determine the effect, if an adverse event is associated with the suspect product, at which point the companies then kick into their process to withdraw the product from the market or engage in a recall. Then, if the agency is not already involved, involve the agency. It is very clearly drawn out at NFPA; we have a publication that helps companies set this up. We would be happy to make that available to the agency," Hildwine told FDA.

NNFA's Ford said there is an informal system of adverse event reporting by individual supplement companies, but there is "inconsistency...across the industry." Some companies will hear complaints by health food store retailers and distributors when there has been a complaint, he said, and the companies "do respond when they see a problem with the product out there. They will pull the product, but it is very inconsistent and it is quite informal."

Ford also noted a program NNFA had begun with regard to GMP compliance. "Yesterday," he said, NNFA "completed its first inspection of a member company" for its new mandatory GMP compliance requirement "put together for continuing membership in the association." The plan was devised in 1995. Ford offered "to sit down with" FDA and allow the agency to "see the process that we are using."

CRN's Dickinson said FDA's "overarching principle for GMPs" should be "to assure that products have the identity and quality that they are represented to have, so that consumers have confidence that what they see on the label is what they actually get in the product."

Soller suggested FDA "build in the kind of flexibility in GMPs that allow technology advancements and basically specify...expectations for what identity, quality, impurity" levels should be. GMPs "are best when they specify the goal and do not overengineer how to get there," he added. "That is probably the most important" approach "for any product GMP that would fall within FDA's daily work."

Formal Supplement Advisory Committee Not Necessary, NNFA's Ford Tells FDA

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