DSHEAs Defining Moment

DSHEAs Defining Moment
by Susan Colebank

As INSIDER went to press, industry members wereremembering the battle seen during the passage of the 1994 Dietary SupplementHealth and Education Act (DSHEA) and wondering if a similar fight may be on thehorizon to keep the regulation intact. The two biggest actions that haverecently shaken DSHEA followers are a Senate bill that, among other things,would make the disclosure of adverse event reports (AERs) mandatory, and atwo-day, media-saturated congressional hearing on the safety and regulation ofephedra-based products.

The Ramifications of SB 722

SB 722, introduced by Sen. Richard Durbin (D-Ill.) on March 26as the Dietary Supplement Safety Act of 2003, would not only requiremanufacturers to disclose AERs to the federal government, but also to havepremarket approval for dietary supplements that contain stimulants. As written,the bill would also categorize products promoting muscle growth as anabolicsteroids rather than dietary supplements. As of late July, SB 722 was gainingmomentum, with Sens. Hillary Clinton (D-N.Y.) and Diane Feinstein (D-Calif.) thenewest co-sponsors.

In late March, the bill was sent to the Committee on Health,Education, Labor and Pensions, which is cochaired by Sen. Edward Kennedy(D-Mass.). In an Aug. 4 industry update, the National Nutritional FoodsAssociation (NNFA) reported the bill might be added as an amendment to a fundingbill when Congress reconvenes in September. According to David Seckman, NNFAexecutive director, Durbin is looking for a way to get his bill passed in theSenate so it can have its day in the Housewhere it could be passed intofederal law.

Seckman added mandatory AER disclosure, which NNFA currentlydoes not support, would turn DSHEA on its head since it would pave the way forsupplements to receive pre-market approval, an action currently reserved fordrugs. It takes about eight years and $800 million for the process, and theindustry doesnt have the time or money to do that, he said.

Not all in the industry are opposed to disclosing AERs; infact, the American Herbal Products Association (AHPA) filed a Citizen Petitionwith the Food and Drug Administration (FDA) in March asking the agency toestablish, through rulemaking, mandatory reporting of AERs associated withdietary supplements. FDAs new AER system, CAERS, became operational in Juneand is headed by Debra Rogan, M.D., MPH, who used to work at the U.S. Departmentof Agriculture. However, it remains to be seen if CAERS will address Congressconcerns regarding the unregulated dietary supplement industry.

Durbin may yet introduce this bill on the floor this year,but we cant predict it, said Ana Micka of Citizens for Health. Itsbeen discussed as an option, though, and we take that very seriously. ...Millions of concerned citizens helped pass DSHEA in 1994 by writing and visitingcongressmen. Its going to take the same effort to keep DSHEA.

Tony Young, counsel for AHPA, added speculative legislationlike SB 722 is not a smart way to proceed when FDA already has ampleauthority to oversee everything in Durbins bill.

However, Young wasnt turning a blind eye to the billsimplications. Were closer to having DSHEA amended than we ever havebeen before, he said. Whether Durbins bill has the legs to getthrough this Senate is another issue. The real question is whether FDA is goingto work on regulating this industry and to see if DSHEA works.

Not all legislators are anti-DSHEA. Sens. Tom Harkin (D-Iowa)and Orrin Hatch (R-Utah) introduced an appropriations bill July 31SB 1538,the DSHEA Full Implementation and Enforcement Act of 2003. Not only wouldit allocate $205 million over a five-year period, beginning in fiscal 2004, foroverseeing DSHEA, but it would also mandate that the Department of Health andHuman Services submit a yearly accountability report detailing itsimplementation of DSHEA.

Congress Ephedra Hearing

The House Committee on Energy and Commerce held acongressional hearing, Issues Relating to Ephedra-Containing DietarySupplements, on July 23 and 24. Ephedra manufacturers, decision makers ofprofessional sports and FDA Commissioner Mark McClellan, M.D., Ph.D., testifiedon the safety and regulatory situation surrounding ephedra.

The hearing became heated as McClellan was incessantly grilledregarding whether FDA had the authority to ban ephedra. In his testimony,McClellan stated, [DSHEA] set up a unique regulatory framework in an attemptto strike the right balance between providing consumers access to dietarysupplements that they may choose to use to help maintain and improve theirhealth, and gave FDA the necessary regulatory authority to take action againstsupplements or supplement ingredients that present safety problems, have falseor misleading claims, or are otherwise adulterated or misbranded.

According to Seckman, the hearing brought a wide scope ofconcerns to the forefrontand for possible legislative action. Based on theconcerns raised by the committee members, any kind of legislation they coulddevelop would be mandatory disclosure of AERs, possibly premarket approval ofcertain classes of products and definitely the banning of ephedra as a dietarysupplement, he said.

Marc Ullman of New York-based Ullman, Shapiro & Ullman,which represents various companies in the natural products industry, includingNVE Pharmaceuticalsone of the ephedra manufacturers at the hearingreported one of the more likely actions to come from this hearing would be howAERs are currently handled. If the legislature is going to act, which basedon statements given to the press it appears to want to do, I suspect it wouldrelate to some sort of mandatory AER system, he said.

Like many in the industry, Ullman was hesitant to predict whatthe hearing could mean for the fate of dietary supplements. These were nottwo great days for our industry, he admitted. The hearing will definitelyhelp build momentum for more to happen. The Durbin bill has more weight behindit now. Industry needs to be concerned about these developments. Manufacturers and the like need to review their businessbehavior and their involvement in the political processand step it up anotch.

Those sentiments were echoed by others in the industry. Ifwe want DSHEA to work for us, we need to abide by its regulations, said JudyBlatman, vice president of communications for the Council for ResponsibleNutrition (www.crnusa.org). As an industry, we need to make sure to helpconsumers find companies they can trust and help businesses not cross the line.