Ephedra

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Hi All,

This article from the Natural Products Insider magazine gives an update on ephedra's fate in congress as of five days ago.

Emmanuel Segmen

 

FDA's Handling of Ephedra Questioned Posted on: 07/24/2003

WASHINGTON--Discussion remained heated on the second and final day of Sen. Billy Tauzin's (R-La.) congressional hearing on ephedra. In the House Committee on Energy and Commerce's "Issues Relating to Ephedra-containing Dietary Supplements," testimony on July 24 had committee members meeting with overseers from the professional sports arena and representatives from regulatory bodies such as the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). Not only did ephedra continue to be attacked at the hearing, but so did the law governing it--the Dietary Supplement Health and Education Act (DSHEA)--and the entire supplement industry.

The highlight of the hearing, which included heavyweights from professional sports teams and FTC, was the testimony of FDA Commissioner Mark McClellan, M.D., Ph.D. He was honest about his view regarding ephedra, its future under FDA and the fate of DSHEA.

McClellan told the committee that ephedra, in his opinion, provides little benefit with great risks attached. However, he also reported there was not conclusive evidence linking ephedra with an increased health risk. He said the agency possessed 17,000 ephedra complaints--not all of which were for adverse event reports (AERs). "Ephedra accounts for a disproportionate share of AERs--more than half of those reported for dietary supplements," he admitted.

During the hearing, McClellan was asked about FDA's plans for warning consumers about ephedra's possible risks. He said the agency was looking at having a little black box listed on product labels. He was quick to add, "To get the label change, you don't need to change the law [DSHEA]."

The hearing became very heated as McClellan was incessantly grilled regarding whether FDA had the authority to ban ephedra. He said it did, but it also had to take into account the plethora of evidence on efficacy and safety before it could enact such a ban. In a carefully worded statement, McClellan stated, "A ban on ephedra use is in the range of options we are considering."

The banning of ephedra--and the overturning of DSHEA, for that matter--may be a ways off, not only by FDA, but also by the U.S. Congress. Rep. Cliff Stearns (R-Fla.), chairman of the Commerce, Trade & Consumer Protection Subcommittee, reported, "It's going to take a long time to legislate this--it always does."

Marc Ullman of New York-based Ullman, Shapiro & Ullman, which represents various companies in the natural products industry, including NVE Pharmaceuticals, reported DSHEA is safe from being overturned at the moment since, as Ullman stated, "Henry Waxman [a DSHEA opponent] and his views on DSHEA are in the minority."

How firm a footing does DSHEA have? The laws, as written, allow for regulators (FDA) and legislators (Congress) to disagree on a law's meaning, and that is why the court system is in place--to iron out such disagreements, said Tony Young, counsel for the American Herbal Products Association (AHPA). Although many in the industry point out that FDA has not been good at winning its court cases, those trials have generally dealt with regulating freedom of speech in regard to health claims and have not questioned FDA's actions when protecting consumer health. According to Young, in cases when FDA has targeted companies that violate the law (for example, the Cholestin case), it has won. In fact, McClellan testified, "The law has never been tested in court."

Michael McGuffin, AHPA president, watched McClellan's testimony and concluded the commissioner offered a well-informed perspective to the committee. "What McClellan tried to do was to educate them and maybe, in the best sense, that's what a hearing is supposed to do," he said.

Ullman, like many in the industry, was not quick to predict what the hearing means for the fate of dietary supplements. "These were not two great days for our industry," he admitted. "The hearing will definitely help build momentum for more to happen. Industry needs to be concerned about these developments. Manufacturers and other industry members need to review their business behaviors and their involvement in the political process--and step it up a notch."

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