Ephedra Targeted in Senate Hearing

WASHINGTON--On Oct. 8, the Subcommittee on Oversight of Government Management, Restructuring and the District of Columbia held a hearing entitled, "Ephedra: Who is Protecting American Consumers?" Panelists included San Diego-based Metabolife International Inc., the Federal Trade Commission (FTC) and the American Medical Association (AMA). The hearing was called by the subcommittee's chairman, Senator Richard Durbin (D-Ill.).

The hearing began with the testimony of Kevin Riggins, a man whose 16-year-old son died from a heart attack after allegedly taking an ephedra-containing supplement known as Yellow Jackets. Reportedly, the teenager began taking these supplements during the 2001 wrestling season to give him an edge. "What I would like to see happen is for these products to be regulated so that a 16-year-old boy or girl cannot go into a gas station or convenience store and purchase them," Riggins said. "If these companies have a problem with restricting 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 Drug Administration (FDA) on Oct. 7, the agency requested a Netherlands-based distributor of Yellow Jackets must desist selling the product to U.S. citizens due to its claims that the product is the herbal equivalent of ecstasy.

According to an FDA spokesperson, Newton, N.J.-based NVE Pharmaceuticals--maker of ephedra-based diet and energy enhancers--manufactures and distributes the product. When FDA attempted to inspect the company on Oct. 8, the company denied the agency access. "What the company did isn't necessarily illegal, it just isn't a wise decision," the spokesperson said. "FDA will now do the necessary paperwork and go through the court system to get access. Several things may happen in the meantime. One, the company will realize 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 to attend Durbin's hearing but declined "at the 11th hour," according to a Durbin spokesperson, reportedly due to an appearance at a court case involving the company.

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

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

Metabolife stated it:

*Supports a ban to minors.

*Warns against taking the product if pregnant or nursing.

*Advises that those who have certain health conditions should consult with their health care professional before taking the product.

*Supports a ban on ephedra products marketed as illicit drugs.

*Does not support using synthetic ephedrine alkaloids in dietary supplements.

*Recommends ephedra products carry strict labeling statements.

But the company stands behind ephedra's safety and efficacy as a weight-loss aid when used appropriately. "To our knowledge, there is not a single well-controlled clinical study that demonstrates that ephedra supplements are unsafe when taken as directed," said David Brown, Metabolife's president and chief executive officer, in a written statement. He added that ephedra products marketed as alternatives to street drugs are unacceptable. "We call on the regulatory authorities to stop this outrageous conduct and bring 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 challenging unqualified safety/no side effects claims for ephedra supplements. In response to the subcommittee's question as to whether FDA not conducting premarket approvals for dietary supplements has left this regulatory duty solely in the hands of FTC, Beales stated, "FTC is not the only agency to police the dietary supplement industry. ... We coordinate our enforcement efforts closest with FDA ... the state attorneys general ... [and] with law enforcement agencies in Canada, Mexico and other countries."

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

Davis added that AMA has ongoing concerns that FDA has not released proposed regulations for Good Manufacturing Practices (GMPs). "Poor quality control may contribute to the problems associated with the safety and efficacy of ephedra-containing dietary supplements," he said.

On behalf of the sports community, Frank Uryasz, president of the National Center for Drug Free Sport Inc. and a representative for the National Collegiate Athletic Association (NCAA), expressed concern over how product manufacturers target young, active people with ads touting the performance-enhancing benefits of cutting fat and increasing energy. "Such ads 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 people on the dangers of supplement use feel like the proverbial lone voice in the wilderness of supplement marketing."

Sen. Durbin said at the meeting that the list of problems involving 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 by the dietary supplement industry," Durbin stated, "and to use their authority to suspend sales of the product in the United States until we can ensure that it is safe."

HHS' Tommy Thompson responded to today's concerns by requesting FDA evaluate the best scientific evidence available and recommend the strongest possible warning labels for ephedra products. In addition, FDA announced it will implement a new program to analyze herbal ephedra products for synthetic contaminants.

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

For more on what was said at the hearing, click here.

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