NNFA, UNPA, AHPA recommend separate herbal monographs.

SEPARATE HERBAL MONOGRAPHS URGED BY NNFA, UNPA, AHPA in comments to the President's Commission on Dietary Supplement Labels at a March 4 meeting in Baltimore, Md. Addressing how botanical products could be evaluated under FDA's existing OTC drug review process, National Nutritional Foods Association Executive Director Michael Ford noted: "We had envisioned that monographs, instead of being by condition, would be by herb."

Utah Natural Products Alliance Executive Director Loren Israelsen explained: "That's really fundamental to our notion of how an OTC process ought to operate, and that is that the botanicals ought not to be separated out -- try to stick them into an existing monograph and try to make them fit -- but that they would require their own separate monograph."

The suggestion of publishing a monograph for each herb is similar to Germany's method for handling the review of herbal medicines. Kommission E, an independent division of the German Federal Health Agency, collects information on herbal medicines and evaluates their safety and effectiveness. Kommission E has published about 400 monographs covering more than 300 herbs and herbal combinations to date.

NNFA, UNPA and the American Herbal Products Association restated their opposition to the creation under the Dietary Supplement Health & Education Act of a separate regulatory category for herbal remedies making therapeutic claims, proposing that such products be reviewed under FDA's OTC drug product review as a recognized drug category with the assistance of a separate expert advisory panel.

Such an advisory panel, the groups noted in oral and written comments to the commission, could evaluate safety and effectiveness data for therapeutic, or drug, claims for traditional medicines and herbal remedies. "All botanicals could be looked at under one advisory group," Israelsen remarked. "That's different than the current OTC process where they choose products in the therapeutic categories and find ingredients which meet that therapeutic endpoint," he said. "We're suggesting that botanicals should all be grouped together and will all have different therapeutic endpoints in many respects."

"That's where outside expertise is essential," Israelsen continued, "because that type of knowledge base is so broad that it would be difficult for the agency to find individual staffers that could manage a therapeutic category for handling botanicals within the current OTC monograph." He noted that the panel members should be botanical product experts to remedy the "lack of expertise" at FDA.

Nutritional Health Alliance Legislative Counsel Tony Martinez agreed that FDA lacks knowledge about botanicals. "The fact that there are...few if any FDA, [Federal Trade Commission] or other government employees familiar with subjects like traditional Chinese medicine, Ayurvedic health care and other cultural or ethnic health care modalities complicates the overall situation," he stated.

For traditional medicines and herbal remedies to be successfully included in the OTC review process, Israelsen said, FDA "would have to be flexible and willing to work with an advisory committee that is expert in these matters and take its advice." He noted that the agency would have to "accept that traditional medicines or herbal remedies would require a different review or mindset....Most of the evidence will be bibliographic -- it's not really based on clinical studies -- and the labeling has to be appropriate to traditional medicines, meaning that you can try to describe to the consumer that this is not a conventional OTC...it's something a bit different."

The Council for Responsible Nutrition is planning to initiate its own effort to look into botanicals "safety and quality issues" and produce a "CRN herbal agenda," CRN President and CEO John Cordaro told the commission meeting.

"We are accepting the opportunity where DSHEA has defined herbs and other botanical products as dietary supplements, i.e., foods," Cordaro said, noting that the group is planning to hire a "senior level" scientist trained as a pharmacognosist to "lead our efforts." Simultaneously, he said, the group will contract an external group of scientists to work with CRN staff and a working group of company representatives. "Our initial focus will be on the safety and quality issues that surround herbal and botanical products."

The council "will continue to explore the feasibility of designing an industry-wide system for evaluating the safety, efficacy and claims for herbal products and other dietary supplements," Cordaro stated. He remarked that CRN previously has "worked with FDA and others to establish dosage limits for vitamin and mineral supplements," declaring: "We will apply the successful CRN methods to herbal and botanical supplements and we will produce a CRN herbal agenda."

CRN concurred with UNPA, NNFA and AHPA in arguing against the creation of a new statutory or regulatory category for herbal categories. The group believes that the existing laws provide for structure/function claims and "well-substantiated" therapeutic claims.

"DSHEA, enacted only a little more than two years ago and just now beginning to be fully implemented, should be given a chance to work for all dietary supplements as foods, including herbs and other botanicals, before any changes are considered," Cordaro said. "Specifically, we believe it is premature to conclude that the existing statutory scheme...cannot accommodate legitimate claims and the provision of useful information to consumers."

CRN "believes that DSHEA provides an important and useful basis for making structure/function claims...[and] that FDA should be pressed to provide a more meaningful opportunity to make truthful health claims," Cordaro said. The group also maintains that "the drug provisions of the FD&C Act, appropriately applied, can provide for approval of well-substantiated therapeutic claims for herbal products for which medical uses have been established and accepted by experts for many years."

The Nonprescription Drug Manufacturers Association, in written comments to the commission, argues that "DSHEA does not make allowances for dietary supplements, including herbals, to bear therapeutic claims." The association asserts that "if such products bear structure/function claims, they should be considered dietary supplements. If these products bear therapeutic claims, they should be considered drugs."

The "major hurdle" for complying with DSHEA, NDMA said, is the definition of the difference between a statement of nutritional support and a therapeutic claim, the interpretation of which "is not clear-cut." NDMA recommends that the commission clarify the definition, noting that "the composition and the administration of the commission are such that this process and review could be accomplished in a timely manner and clarify the regulatory boundaries for both manufacturers and FDA to speed the full implementation of DSHEA."