Ephedra suits put DSHEA at risk

If separate legal actions being mounted by two small supplements manufacturers to overturn the Food and Drug Administration ban on ephedra succeed, it could increase pressure to amend the Dietary Supplement Health and Education Act, according to industry observers.

Major industry groups including the National Nutritional Foods Association (NNFA), the Council for Responsible Nutrition (CRN) and the Utah Natural Products Alliance supported the ephedra ban, as well as the action to prohibit the latest ingredient to incur FDA?s wrath—androstenedione.

?The ephedra issue is the first demonstration in 10 years that the agency can use DSHEA to protect consumers,? said Annette Dickinson, PhD, president of CRN.

These groups have long urged FDA to utilise its DSHEA-granted powers to ensure the dietary supplements industry is vigilantly policed. They are concerned that if the ephedra ban is overturned, DSHEA will once again face scrutiny from legislators, lobbyists and mainstream media outlets who claim it is unmanageable in its current form and are campaigning for its demise.

?If the ban is rescinded, we would be concerned that it would give ammunition to those people who would like to place the maximum constraints upon our industry and restrict consumer choice,? said Harvey Kamil, president of New York-based supplements and retail giant NBTY. ?It would feed those who seek to amend DSHEA, and once they start doing that, who knows where the buck will stop.?

NBTY voluntarily ceased trading in ephedra more than a year ago and Kamil said even if the case is successful, NBTY would not recommence trading in ephedra because of the negative stigma now attached to the herb.

?Ephedra is dead as a freely available product, whatever happens in the case,? agreed Richard Merriam, president and founder of California-based GCI Nutrients, which has also terminated ephedra trade. ?But if the veto is revoked, it could spell danger for DSHEA, and that is what we are all concerned about.?

The ban had every chance of being overturned, according to Washington DC-based legal firm Hyman, Phelps & McNamara, which, after studying the ephedra ruling, concluded FDA?s risk-benefit analysis was a misinterpretation of the Food, Drug and Cosmetics Act and therefore illegal ?regardless of whether ephedrine alkaloids do or do not present a danger to the public.?

Gerald Kessler, CEO of Washington-based Natural Organics, which trades as Nature?s Plus, was similarly apprehensive. ?The legal advice I?m getting is that the ban will be overturned because FDA didn?t do their homework and their case is technically flawed,? he said. ?If the ephedra suit wins and ephedra goes back on shelves, Congress will get scared and pass some of these bills that have been lurking to alter DSHEA—all of which are designed to put us out of business.?

The last country in Europe to permit over-the-counter ephedra sales, the Netherlands, has now banned it, as has Saudi Arabia.

NVE Pharmaceuticals, the bulk of whose $80 million revenue is derived from ephedra sales, filed its suit in a New Jersey district court on March 9. The other action is being mounted by Georgia-based mail-order firm The National Institute for Clinical Weight Loss.

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