Ephedra Targeted in Senate Hearing

Ephedra Targeted in Senate Hearing

WASHINGTON--On Oct. 8, the Subcommittee onOversight of Government Management, Restructuring and the District of Columbiaheld a hearing entitled, "Ephedra: Who is Protecting AmericanConsumers?" Panelists included San Diego-based Metabolife InternationalInc., the Federal Trade Commission (FTC) and the American Medical Association(AMA). The hearing was called by the subcommittee's chairman, Sen. RichardDurbin (D-Ill.).

The hearing began with the testimony of Kevin Riggins, a manwhose 16-year-old son died from a heart attack after allegedly taking an ephedra-containingsupplement known as Yellow Jackets. Reportedly, the teenager began taking thesesupplements during the 2001 wrestling season to give him an edge. "What Iwould like to see happen is for these products to be regulated so that a16-year-old boy or girl cannot go into a gas station or convenience store andpurchase them," Riggins said. "If these companies have a problem withrestricting access to these products so we don't have to bury another child,they are irresponsible and don't deserve to be in business."

In a cyber warning letter made public by the Food and DrugAdministration (FDA) on Oct. 7, the agency requested a Netherlands-baseddistributor of Yellow Jackets desist selling the product to U.S. citizens due toits claims that the product is the herbal equivalent of ecstasy.

According to an FDA spokesperson, Newton, N.J.-based NVEPharmaceuticals--maker of ephedra-based diet and energy enhancers--manufacturesand distributes the product. When FDA attempted to inspect the company on Oct.8, the company denied the agency access. "What the company did isn'tnecessarily illegal, it just isn't a wise decision," the spokesperson said."FDA will now do the necessary paperwork and go through the court system toget access. Several things may happen in the meantime. One, the company willrealize that FDA is going to be there eventually and open their doors, or two,the Department of Justice gets involved."

The company's president, Robert Occhifinto, had been invited toattend Durbin's hearing but declined "at the 11th hour," according toa Durbin spokesperson, reportedly due to an appearance at a court case involvingthe company.

According to Michael McGuffin, president of the American HerbalProducts Association (AHPA), the organization is pleased FDA acted to removethis product from the U.S. marketplace. "If FDA does not enforce the law,the entire class of dietary supplements suffers and our message of responsiblemarketing is lost," he said.

Another ephedra product maker did appear before thesubcommittee. Lanny Davis, legal counsel for Metabolife, reported there havebeen approximately 145 personal injury cases filed against Metbolife in statesuperior and federal district courts, representing an estimated 160 consumers.Of those cases, 100 are still active, 29 have been resolved, nine were dismissedand one was granted summary judgement. Over the years, approximately $5 millionhas been paid in personal injury cases in terms of Metabolife products, mostlyby insurance carriers.

Metabolife stated it:

But the company stands behind ephedra's safety and efficacy as aweight-loss aid when used appropriately. "To our knowledge, there is not asingle well-controlled clinical study that demonstrates that ephedra supplementsare unsafe when taken as directed," said David Brown, Metabolife'spresident and chief executive officer, in a written statement. He added thatephedra products marketed as alternatives to street drugs are unacceptable."We call on the regulatory authorities to stop this outrageous conduct andbring enforcement actions against such companies immediately."

In FTC Director J. Howard Beales' statement to the subcommittee,he reported that FTC has brought four enforcement actions challengingunqualified safety/no-side-effects claims for ephedra supplements. In responseto the subcommittee's question as to whether FDA not conducting premarketapprovals for dietary supplements has left this regulatory duty solely in thehands of FTC, Beales stated, "FTC is not the only agency to police thedietary supplement industry. ... We coordinate our enforcement efforts closestwith FDA ... the state attorneys general ... [and] with law enforcement agenciesin Canada, Mexico and other countries."

The medical community was also represented at the hearing, andit was well-acquainted with the ephedra controversy. In fact, AMA has beenencouraging FDA to ban ephedra supplements from the United States for the pastthree years. Ron Davis, M.D., a member on AMA's board of trustees, reported thatone of the problems with dietary supplement regulations is that becausesupplements are overseen as foods, "they are assumed to be safe and aresubject to limited regulatory oversight. Therefore, it is imperative thatdietary supplement products have essentially no risks, i.e., they must beextremely safe and provide some benefits for consumers," he said. "AMAbelieves that dietary supplement products containing ephedrine alkaloids fail tosatisfy this requirement for a high benefit-to-risk ratio."

Davis added that AMA has ongoing concerns that FDA has notreleased proposed regulations for Good Manufacturing Practices (GMPs)."Poor quality control may contribute to the problems associated with thesafety and efficacy of ephedra-containing dietary supplements," he said.

On behalf of the sports community, Frank Uryasz, president ofthe National Center for Drug Free Sport Inc. and a representative for theNational Collegiate Athletic Association (NCAA), expressed concern over howproduct manufacturers target young, active people with ads touting theperformance-enhancing benefits of cutting fat and increasing energy. "Suchads refer to ephedrine as a 'natural way' to achieve superior performance,"Uryasz said. "It is fair to say that those of us who educate young peopleon the dangers of supplement use feel like the proverbial lone voice in thewilderness of supplement marketing."

Sen. Durbin said at the meeting that the list of problemsinvolving ephedra is growing, and the federal government needs to act."Today, I am again asking the secretary of Health and Human Services [HHS]and FDA to take meaningful action to address the public health threat posed bythe dietary supplement industry," Durbin stated, "and to use theirauthority to suspend sales of the product in the United States until we canensure that it is safe."

HHS' Tommy Thompson responded to these concerns by issuing astatement that he has requested FDA evaluate the best scientific evidenceavailable and recommend the strongest possible warning labels for ephedraproducts. In addition, FDA announced it will implement a new program to analyzeherbal ephedra products for synthetic contaminants.

"We are pleased that, finally, two years after wepetitioned FDA to adopt the meaningful warning labels that industry uses forephedra products, Sec. Thompson has pushed FDA to adopt significant mandatorywarning labeling for these products," McGuffin stated.

For more on what was said at the hearing, visit www.senate.gov.