U.S. Ephedra Ban Imminent

WASHINGTON--After years of wavering, the Food and Drug Administration (FDA) finally came to an unambiguous decision about ephedra dietary supplements--they will be banned from sale in the United States. Although FDA, which announced its decision along with Health and Human Services (HHS), did not have a date when the ban would take effect, FDAs Mark McClellan, M.D., Ph.D., and HHS Secretary Tommy Thompson reported all products containing ephedrine alkaloids would need to be removed from retail within 60 days of a final rule being published in the Federal Register. The rule does not apply to practitioners of Traditional Chinese Medicine (TCM) or products regulated as conventional foods, such as herbal tea.

According to McClellan, the rule will read: Dietary supplements containing ephedra present an unreasonable risk of illness or injury and are therefore adulterated under the Food, Drug and Cosmetic Act.

Until the ban takes place, FDA issued a consumer alert stating ephedra presents an unreasonable risk for illness or injury. The agency reported it explored all avenues regarding ephedra. It gathered and reviewed a prodigious amount of evidence about the herbs pharmacology; clinical studies regarding its safety and efficacy; newly available adverse event reports (AERs); published literature; and the data gathered by the RAND Corp. The regulation that FDA will be publishing will set a new significant legal precedent, Thompson said at the Dec. 30 press conference, when the ban was announced. For the first time, we will be articulating the legal standard for protecting the public health under the standards of the dietary supplement law which Congress passed approximately 10 years ago.

FDA and HHS have felt that their hands were tied when working under the Dietary Supplement Health and Education Act (DSHEA). For example, part of the decision to ban ephedra was based on newly acquired AERs that were not readily available because, under DSHEA, such AERs are not required to be submitted to FDA. In addition, McClellan reported DSHEA was challenging because it does not compel studies to be done to help FDA meet its burden of proving a supplement is dangerous.

During the press conference, McClellan reported that within the final rule, FDA also developed and publicly presented a careful new legal evaluation of our authorities. He added, We have done all we can to fulfill the requirements of the dietary supplement law. We've gone the whole nine yards to collect and evaluate all the possible evidence to reach a conclusion about an unreasonable risk to the public health. And, we will be doing our best to defend this in court. And if that's not sufficient, it may be time to reexamine the act.

When asked at the press conference why FDA is not requesting an immediate recall if ephedra is so dangerous, McClellan explained, We're working as quickly as we can under the law that Congress has given us, and that law requires us to do this very complete evaluation. Were laying the strongest possible foundations to not only take the products off the market but keep them off.

Thompson was quick to quell concerns that HHS is trying to overthrow DSHEA. We've made the law work, now it's up to Congress to make a decision whether or not they would like to short-circuit it, change the burden of responsibility. That's up to Congress--that is not our prerogative.

FDA reported it plans to enforce the ban through product seizures, injunctions against manufacturers and distributors and criminal prosecution.

Some were very happy with the decision, including the American Medical Association and California legislators. This is a huge win for consumer health and safety, said Jackie Speier (D-San Francisco), the state senator who pushed for Californias ephedra ban, which goes into effect Jan. 1. Ive been battling the ephedra industry for four long years. We did FDAs job for them, and now theyre taking notice.

Industry spokesmen said they were also pleased FDA made a decision on the issue. David Seckman, president and chief executive officer of the National Nutritional Foods Association (NNFA) and Michael McGuffin, president of American Herbal Products Association (AHPA), agreed the agencies regulated the situation appropriately. What the ephedra ban proves is that DSHEA works, Seckman said. McGuffin added, We have said all along that the FDA has authority to remove any supplement it deems to be unsafe. Today, they acknowledged that authority. He added that it remains to be seen if he and other industry members will agree with how FDA arrived at its decision.

The rationale they used when taking this action is extremely important, said John Hathcock, Ph.D., vice president of scientific and regulatory affairs for the Council for Responsible Nutrition (CRN). Hopefully, they did a proper interpretation of science and the law, or else a negative precedent is being set.

How will the supplement industry be immediately affected? Industry attorney Marc Ullman said the fate of DSHEA still hangs in the balance, based on Thompson's repeated comments that DSHEA does not allow supplements to be regulated as drugs. In the meantime, ephedra manufacturers, suppliers and retailers will have to do damage control. Namely, does it make sense to do a recall?" Ullman asked. "Or, would it be better to attempt to sell out all product before the end of the 60 days?

According to McGuffin, Those with 15 percent to 20 percent of their business in ephedra will have to reevaluate their business strategy. Theyll make it up with new products and new ingredients.

In tandem with the announcement of the ephedra ban, HHS sent letters to 62 ephedra product manufacturers--including Cytodyne Technologies, EAS and Metabolife--about the impending final rule.

Already, companies such as Oklahoma City-based Advantage Marketing Systems (AMEX:AMM) are reporting the ephedra ban will have little to no impact on sales, and the company will continue to promote non-ephedra alternatives. Not all companies, however, appear to be ready to let go of ephedra. In a company statement, Metabolife reported it respectfully disagrees with FDAs assessment of ephedra products. Following the publication of the final rule, Metabolife will carefully consider its options, the statement read. The company added it is the leader in the non-ephedra diet industry, with approximately 20-percent market share.