Ephedra Issue Puts Industry Under Magnifying Glass

Ephedra Issue Puts Industry Under Magnifying Glass

WASHINGTONBased on murmuringsfrom industry, Congress and the media, the decision to ban ephedra is only thetip of the proverbial iceberg. While details about the Food and DrugAdministrations (FDA) upcoming ephedra ban remain a mystery, a few things arefor certain: The safety of ephedra alternatives such as citrus aurantium,green tea and guarana is already under suspicion; Congressional bills are stillmoving forward in an attempt to amend the Dietary Supplement Health andEducation Act (DSHEA); FDA is having doubts about the efficacy of DSHEA; and, as aresult of FDAs painfully slow reactions, the media is still describing theindustry as unregulated.

At the moment, ephedra is one Federal Register noticeaway from being banned. At press time, the FDAs proposed ban onephedra-containing products was imminent, although the extent and date of theban were unknown. Even so, FDAs Mark McClellan, M.D., Ph.D., and Health andHuman Services (HHS) Secretary Tommy Thompson reported all products containingephedrine alkaloids would need to be removed from retail within 60 days afterthe final rule was published in the Federal Register. According toMcClellan, the rule will read: Dietary supplements containing ephedra present anunreasonable risk of illness or injury and are therefore adulterated under theFood, Drug and Cosmetic Act. FDA reported it plans to enforce the ban throughproduct seizures, injunctions against manufacturers and distributors, andcriminal prosecution.

Until the ban takes place, FDA issued a consumer alert statingephedra presents an unreasonable risk for illness or injury. The agencyreportedly gathered and reviewed a prodigious amount of evidence about the herbspharmacology; clinical studies regarding its safety and efficacy; newlyavailable adverse event reports (AERs); published literature; and the datagathered by the RAND Corp. The regulation FDA will be publishing will set anew significant legal precedent, Thompson said at the Dec. 30 pressconference, where the ban was announced. For the first time, we will bearticulating the legal standard for protecting the public health under thestandards of the dietary supplement law that Congress passed approximately 10years ago.

A simple question remains: What took so long? askedReps. Susan Davis (D-Calif.), Henry Waxman (D-Calif.) and John Dingell (D-Mich.)in a joint Jan. 7 letter. They are the same legislators who introduced HR 3377,the Dietary Supplement Access and Awareness Act, which would requireingredient lists and product labeling be submitted to HHS; manufacturers tosubmit AERs to HHS within 15 days; and post-market surveillance of any productlinked to potential health consequences. The bill would apply to allsupplements, except basic vitamins and minerals.

And Sen. Richard Durbin (D-Ill.) is still pressing onward withSB 722, which would also rattle DSHEAs foundation. In an article he wrote forThe Washington Times bi-weekly magazine, Insight, Durbin wrote,My bill doesnt require safety testing for vitamins, minerals or the vastmajority of dietary supplements; only stimulants must be proved safe beforebeing sold.

Those against DSHEA are counter-balanced by long-timesupporters and even original authors of DSHEA, such as Sen. Orrin Hatch(R-Utah). The action [taken Dec. 30] reassures me that it will now bea priority of HHS and FDA to police the marketplace and apply acceptablescientific safety standards provided under DSHEA as necessary, Hatch said.I have been assured by FDA that this determination is a reasonableapplication of the laws unreasonable risk authority provided to FDA. ... I intend to continue our dialogue to make certain FDA has thetools it needs to help maintain the public health.

In the weeks since the ephedra announcement, editorials havebeen discussing the banand DSHEA. In a Jan. 5 editorial that appeared in TheNew York Times (www.nytimes.com), theauthor wrote, It is no accident that ephedra will be the first supplementever banned for safety reasons under [DSHEA]. That sluggish response wasprecisely what the supplement industry and its more zealous customers wantedwhen they pressed Congress for protection against strict regulation. ... Underthe current lax system, there is no guarantee that the substitutes for ephedrawill be any safer. While the Times called DSHEA ill-conceived,an editorial in the Washington Post (www.washingtonpost.com)called it a truly terrible law and the Los Angeles Times (www.latimes.com)opined, Given the political clout of the supplement industry, its unlikelythat Congress will address [DSHEA entirely].

During the press conference, McClellan reported that withinthe final rule, FDA also developed and publicly presented a careful new legalevaluation of our authorities. He added, We have done all we can tofulfill the requirements of the dietary supplement law. ... If thats notsufficient, it may be time to re-examine the act. Thompson was quick to quell concerns that HHS is trying tooverthrow DSHEA. Weve made the law work, now its up to Congress to makea decision whether or not they would like to short-circuit it, change the burdenof responsibility. Thats up to Congressthat is not our prerogative.

According to industry lawyer Marc Ullman, Both men suggestthat if the regulation does not stand up to judicial scrutiny, it is incumbentupon Congress to rethink the entire legal framework governing the marketing ofdietary supplements.

FDA and HHS reported working under the guidelines of DSHEA hadbeen difficult. For example, part of the decision to ban ephedra was based onnewly acquired AERs that had not been readily available because, under DSHEA,such AERs are not required to be submitted to FDA. In addition, McClellanreported DSHEA was challenging because it does not compel studies to bedone to help FDA meet its burden of proving a supplement is dangerous.

Some were very happy with FDA and HHSs proposed ban,including the American Medical Association and California legislators. Thisis a huge win for consumer health and safety, said Jackie Speier (D-SanFrancisco), the state senator who pushed for Californias ephedra ban, whichwent into effect Jan. 1. Ive been battling the ephedra industry for fourlong years. We did FDAs job for them, and now its taking notice.

Industry spokesmen said they were also pleased FDA made adecision on the issue. David Seckman, president and chief executive officer ofthe National Nutritional Foods Association (NNFA) and Michael McGuffin,president of American Herbal Products Association (AHPA), agreed the agenciesregulated the situation appropriately. What the ephedra ban proves is DSHEAworks, Seckman said. McGuffin added, We have said all along that the FDAhas authority to remove any supplement it deems to be unsafe. Dec. 30, theagency acknowledged that authority. He added it remains to be seen if he andother industry members will agree with how FDA arrived at its decision.

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

Gerald Kessler, president of the Nutritional Health Alliance,said, The misuse of ephedra has long been a festering problem for the entiresupplement industry. My hope is that those companies that sold ephedra willimmediately comply with the ban. Any attempt to challenge the ban is not goodfor the industry or consumers.

Not everyone was as supportive of the proposed ban. A moreappropriate action under DSHEA would have been for FDA to identify the companiesabusing DSHEA label claims and seek an injunction to stop these companies fromselling ephedra-based dietary supplements, said Don Summerfield, vicepresident and co-founder of Pharmaca Integrative Pharmacy. Furthermore, FDAcould have set industry dosage standards for appropriate ephedra use in dietarysupplements. The company added it would comply with FDAs recommendationand has discontinued cold, cough and allergy products containing ephedra. InJune 2003, the company discontinued all weight-loss and sportsenhancementproducts containing ephedra.

How will the supplement industry be immediately affected?Ullman reported the fate of DSHEA still hangs in the balance, based on Thompsonsrepeated comments that DSHEA does not allow supplements to be regulated asdrugs. In the meantime, ephedra manufacturers, suppliers and retailers will haveto do damage control. Namely, does it make sense to do a recall? Ullmanasked. Or, would it be better to attempt to sell out all product before theend of the 60 days?

It looks as if the fear of losing money on remaining ephedrastock is a moot point. Even though many of the major chainssuch as Walgreens,GNC and Hi-Healthdiscontinued ephedra long ago, smaller businessesfrom California to Massachusettsexperienced anice windfall from the ban.

In Phoenix, the Jan. 16 edition of The Business Journal (http://phoenix.bizjournals.com)reported health store owners saw business more than triple the day ephedra wasgiven a kill date. Business has been going crazy, Craig Gress, owner ofScottsdale, Ariz.-based Body Concept Health & Nutrition Center, told thepaper. Approximately 40 percent of his products are ephedra-based.The phones are going crazy, our Web site is going crazy. I got one personordering 20 cases.

In Orange County, Calif., where the state ban went into effectJan. 1, customers were seen to pay as much as $59.95 for a bottle of ephedra onDec. 31. To make sure passers-by knew it was ephedras last day as a legallymarketed product, Muscle Max in Tustin brought in customers with the sign, Stockup now or forever hold your fat!