Herbal industry fending off FDA

Despite a recent federal ban of two harmful dietary supplements, the herbal industry retains the clout in Washington that for years helped keep regulation of its products to a minimum, according to many consumer advocates, politicians, and doctors.

Among the signs they cite: Potentially dangerous supplements -- such as kava, an herb linked to liver failure and banned in several European nations -- remain on the market. Recently, the industry got Congress to exclude DHEA, a hormone with more than $47 million in sales, from a pending bill that would restrict steroid-like substances, according to aides to Senator Joseph R. Biden Jr., the Delaware Democrat who is one of the bill's sponsors.

Supplement makers and sellers are also mobilizing the estimated 65 percent of Americans who use these products to oppose a separate bill that would give the US Food and Drug Administration more authority over the industry. The millions of dollars the industry has contributed to members of Congress over the last decade ensures that the companies' views are heard.

Senator Orrin G. Hatch, the Utah Republican who has been the biggest Congressional advocate for dietary supplements, received $41,750 from the industry for his last reelection campaign. The industry, which Nutrition Business Journal says tallied $19.4 billion in sales last year, also has contributed $10,000 so far this election cycle to President Bush, according to the Center for Responsive Politics.

"The dietary supplement industry is very powerful politically," said Senator Richard J. Durbin, an Illinois Democrat who has introduced a bill that would impose more safety rules on supplement makers. "There's a reluctance with this administration to take on the industry."

Durbin and many consumer advocates say the FDA's recent actions to remove ephedra and androstenedione from the market were overdue and only came after evidence of the products' safety problems was so overwhelming that the industry supported a crackdown.

Durbin likens the industry's power to that of tobacco companies. "I think both industries were well aware that their product was harmful and they went to great lengths to prevent the public from realizing it," he said.

But industry spokesmen say their products are safer than most drugs and deserve to remain free of the requirements for safety testing that cover drugs. They say they support the FDA's recent actions because they are addressing serious problems that were damaging the industry as a whole.

"There are very few instances where it's necessary to take these products off the market," said Annette Dickinson, president of the Council for Responsible Nutrition. "Ephedra and andro, yes. But I would be stretched to think of any others."

For years, the FDA has had authority to regulate dietary supplements, but the balance of power shifted dramatically in 1994. Pressed by a massive grass-roots campaign orchestrated by the industry, Congress voted to allow most supplements on the market without tests for safety or efficacy and to require the FDA to prove that supplements are unsafe before halting sales.

Sales of supplements soared. As reports trickled in of deaths linked to use of ephedra as a diet pill, the FDA tried to limit the allowed dosage, but was beaten back by Congress and the industry. Short of money and burdened by other demands, the FDA put its priorities elsewhere.

Hatch, whose district includes many supplement companies and who sponsored the 1994 law, accuses the agency of deliberately dragging its feet in a vain attempt to get Congress to restore its authority over supplements.

Finally, after the industry began abandoning ephedra because of consumer lawsuits, the FDA announced a ban, effective April 12, the first prohibition of any supplement since 1994.

The companies "fight every step of the way, and when the writing is on the wall, they concede the point and stick to their guns on other issues," said Chuck Bell, programs director for Consumers Union, which has published repeated warnings about dietary supplements.

Two weeks ago, the FDA acted again, warning 23 companies to remove the steroid precursor androstenedione from the market or risk severe penalties. The FDA said the supplement, pitched as a muscle enhancer, could stunt growth in children and cause problematic sexual changes in adults. Again, the action came years after problems surfaced and only after the industry endorsed the restrictions.

Asked why the FDA had not acted sooner in both cases, a spokesman for the Bush administration's top health official, Tommy G. Thompson, said the law requires the FDA to compile a lot of evidence.

"If you don't, you can get pushed back, and you've not accomplished anything, " said Bill Pierce, spokesman for Thompson, secretary of the Department of Health and Human Services.

FDA officials this month also proclaimed a crackdown" on unsafe dietary supplements and said they are giving special scrutiny to a stimulant called bitter orange that is being used in some "ephedra-free" products. In addition, they said they are examining two other ingredients in diet supplements, aristolochic acid, a known carcinogen, and usnic acid, which has been linked to liver toxicity. In 2001, the FDA asked manufacturers to stop selling 18 products containing aristolochic acid, but two California cancer researchers reported last year that supplements with the substance were readily available on the Internet. And the Globe was able to find some still for sale.

Aristolochic acid "is the poster child for FDA's ineffectiveness" in the face of a powerful industry and the current law, said Dr. Arthur P. Grollman, a professor of pharmacology and medicine at the State University of New York at Stony Brook.

Kava is another, Grollman and others said. The FDA warned kava consumers about the potential risk of severe liver damage in March 2002. The herb, promoted for relaxation and premenstrual syndrome, is banned or restricted in Europe, Canada, and Australia. But companies here voluntarily added a warning label and kept selling, recording $30 million in US kava sales last year, according to Nutrition Business Journal.

Joseph Baca, director of compliance for the FDA office that oversees supplements, said the agency was monitoring reports of problems with kava, "as much as we do with any other dietary supplement." The FDA estimates it learns of only 1 percent of the problems with any supplement, making it hard to prove safety risks.

Some consumer advocates are pressing for Durbin's bill, which would require safety testing of all stimulants, mandate that companies report all serious side effects to the FDA, and subject steroid precursors to rules covering drugs. But Durbin acknowledges it faces stiff opposition from the industry.

To rally consumers against the bill, health consultant Beth Clay last summer started Project FANS, or Freedom of Access to Nutritional Supplements, with financial help from the industry. Another industry tactic: signs in some supplement stores proclaiming that "Senator Durbin wants to take away your vitamins," a Durbin aide said.

And one trade group, the National Nutritional Foods Association, uses a lobbying firm founded by Hatch's son to make its views known in Congress.

Hatch and industry representatives say the Durbin bill is unnecessary if the FDA does its job. They say they favor more regulation of bad actors in the industry, and Hatch has advocated small budget increases to help, but he says the current law "gives the FDA ample authority to remove unsafe, adulterated, or mislabeled products from the market."

A bill sponsored by Hatch and Biden to block sales of steroid precursors like androstenedione appears far more likely to pass than Durbin's bill, especially after the hormone DHEA was explicitly excluded from the restrictions.

"There was quite a lobby for DHEA that stalled the House version of the bill introduced in the last Congress," said an aide to Biden, who spoke on condition of anonymity. "Dropping it was an important factor in getting the support of the industry."

Five industry trade groups endorsed the bill last fall. Industry representatives say DHEA should be excluded because it is marketed to help ease aging and therefore has little potential for abuse as a performance enhancer.

But Dr. Gary Wadler, a professor at New York University School of Medicine and a member of a foundation that promotes drug-free sports, said excluding DHEA makes no sense. The body converts DHEA into andro and then into testosterone, he said. "It has the same potential for abuse as andro. It should be subject to the same restrictions."