March 31, 2004
Industry has reacted positively to the Food and Drug Administration ban on ephedra in the US, viewing it as a necessary and timely demonstration of FDA?s up until now near-latent power to enforce the Dietary Supplement and Health Education Act (DSHEA).
In its ruling, FDA acknowledged as much stating: ?DSHEA grants FDA the authority to take action against a dietary supplement when the product presents a significant risk, an unreasonable risk or an imminent hazard; does not comply with good manufacturing practices; or makes an unsubstantiated structure-function claim.?
The National Nutritional Foods Association (NNFA) agreed. ?Although critics of DSHEA have claimed it eviscerated the FDA?s enforcement powers, the agency?s actions today prove otherwise,? said David Seckman, NNFA executive director and CEO. ?Those lawmakers looking for additional legislative solutions to regulate supplements should acknowledge that DSHEA is an effective law if it is implemented and enforced.?
Perhaps most significantly, FDA indicated all food supplements will be subject to a risk/benefit safety analysis for the first time, whereas in the past, risk of injury was the only relevant criteria. The ban applies to all food supplements that contain a source of ephedrine alkaloids, such as ephedra, Ma huang, Sida cordifolia and pinellia but does not include teas, traditional Chinese medicines or over-the-counter drugs.
While individual companies trading in ephedra may yet challenge the prohibition, effective April 12, major supplement industry groups have thrown their support behind the ban. The Council for Responsible Nutrition, NNFA and the Utah Natural Products Alliance responded to the ban by issuing a joint statement.
?While the associations do not agree with every point in FDA?s justification for the final rule, we believe the agency has presented a balanced rationale,? they said. ?FDA?s discussion of the rule indicates that the agency supports access to dietary supplements ?that are safe, properly labeled and in compliance with federal law.? We are committed to working with our member companies and with FDA to ensure (these standards).?
Industry positivity was not matched in the mainstream press, which generally viewed the decision as a forerunner to the dismantling of DSHEA. ?It is clear resolution of the ephedra issue is not a resolution of the broader issues surrounding dietary supplements and their regulation under DSHEA,? said Loren Israelson, president of Utah-based consultancy LDI group, and founder of the Utah Natural Products Alliance. ?The regulation raises questions about how other supplements will be treated.? Although not named in the decision, bitter orange, usnic acid and aristolochic acid are just a few ingredients that have come under scrutiny post-ephedra.
Further muddying the waters is the imminent departure of proactive FDA commissioner Mark McLellan, who is to head the Centers for Medicare and Medicaid Services. Under his stewardship, FDA signalled its intention to enforce DSHEA more rigorously, culminating in the ephedra ban.
?Let?s hope his successor continues to exert FDA?s powers to regulate and ensure the safety of food supplements,? said Sabinsa senior executive vice president Todd Norton.
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