FDA's regulatory framework for removing dangerous dietary supplements from the market under the Dietary Supplement Health & Education Act's "unreasonable risk" standard will be issued shortly by the agency.

Commissioner Mark McClellan, MD/PhD, said the agency has developed the framework "to publish a final rule in the coming weeks that will prohibit the sale of dietary supplements containing ephedra."

"The rule states that dietary supplements containing ephedra present an unreasonable risk of illness or injury and are, therefore, adulterated" under section 402(f)(1)(A) of the FD&C Act, he noted.

"We are interpreting our standard...not to require the kind of scientific proof that is required for a drug to be brought to market - a proof of safety and effectiveness - because those large studies just are not done" for supplements, McClellan explained.

"We have to consider evidence that is not quite at that level of proof, but that is still relevant for consideration of the risks and benefits of a product."

By having this framework in place, "we do think it is going to be more straightforward to take action on other dietary supplements where appropriate," the commissioner pointed out.

McClellan's comments came Dec. 30 during a press conference announcing FDA's intent to ban the sale of all ephedrine alkaloid-containing dietary supplements.

Although the rule is still undergoing final approval within the department, the agency said it wanted to announce its decision prior to the first of the year, when diet resolutions may lead consumers to ephedra-containing products.

The ban would be effective 60 days following publication of the rule. "Everyone involved in marketing ephedra should be on notice that as soon as the rule becomes effective, we will shut you down," McClellan asserted.

McClellan also stated that "any responsible manufacturer and retailer should stop selling [ephedra-containing] products as soon as possible." He further noted that "FDA will be watching firms that replace ephedra with similarly harmful ingredients/stimulants in their products."

All currently marketed dietary supplements, with the exception of traditional Chinese herbal remedies, will be affected by the rule, FDA reports.

FDA arrived at its decision that ephedra poses an "unreasonable risk" to consumers following both extensive review of the science and of "tens of thousands" of public comments on the supplement's actual and supposed risks and benefits, according to the agency.

FDA invited public comments on ephedra and on possible approaches to regulating the supplement in March (¹ Also see "Ephedra “Black Box” Warning Considered By FDA" - Pink Sheet, 3 March, 2003., p. 6). Options included a "black box" label warning citing "heart attack, stroke, seizure and death" in connection with the supplement.

The announcement caps a six-year odyssey for the agency, during which its attempts to restrict sale of the supplement have been hampered by a lack of data. FDA first proposed requiring warnings and limiting serving sizes for ephedra-containing supplements in 1997.

However, bans in California, New York and Illinois, as well as market forces including skyrocketing product liability insurance costs, product injury lawsuits and general public concern with the safety of the ingredient, have accomplished in part what the agency has not been able to.

At this point, the mainstream sale of ephedra-containing supplements has been suspended by most major marketers and retailers.

Nevertheless, there appears to be a substantial amount of marketing that has persisted via the Internet and through smaller retail venues. FDA sent warning letters to 62 ephedra-supplement marketers it identified through website searches.

The ² list includes the more than two dozen companies that received warning letters from FDA in March objecting to athletic performance claims for their ephedra-containing supplements.

Dated Dec. 30, the recent letter alerts companies to the agency's plans to "publish a rule in the coming weeks that finds that dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury under conditions of use recommended or suggested in the labeling of the product, or...under ordinary conditions of use."

The agency also issued a consumer alert urging the public to "stop buying and using these products immediately."

Many industry groups, including the Council for Responsible Nutrition and the National Nutritional Foods Association are withholding their response to the decision until the specifics of the regulatory framework can be reviewed (see ³ Also see "Ephedra Ban Reaction Cautious From Most In Industry; Overdue, Hatch Says" - Pink Sheet, 5 January, 2004.).

However, FDA expects and is prepared for court challenges to the final rule, according to HHS Secretary Tommy Thompson.

"I would presume that more than likely, in our litigious society, you have to anticipate a lawsuit when you are taking anything off the market like we are," Thompson said.

"It is more than likely that it is going to be reviewed by the courts and we want to make sure that...we followed the law religiously and that they will be able to uphold our position."

Thompson continued, "the regulation that FDA will be publishing will set a new significant legal precedent. For the first time, we will be articulating the legal standard for protecting the public health under the standards of" DSHEA.

If industry groups choose to challenge the "unreasonable risk" standard in court, Thompson predicted FDA will defend its position and added "the court will probably give us further discretion and further supervision as it relates to this particular process."

Further, "Congress more likely now will watch this and say, '[DSHEA] works, but it should be changed in some ways' and possibly give us the power to have the [adverse] incident reports submitted" for dietary supplements, Thompson said. "That would be a giant step forward."

FDA Regulatory Framework For Ephedra Ban Expected To Get Court Review

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