Lawmakers seek more oversight of dietary supplement market

Hearings and legislation are launched as concerns rise about dangerous products and unsubstantiated claims.

By Joel B. Finkelstein, amednews staff. Nov. 17, 2003.

Washington -- Sales of spurious herbal remedies and dietary supplements have prompted congressional scrutiny and calls for extra regulation or enforcement.

In testimony before the Senate Commerce, Science and Transportation Committee, critics of the supplement market cited rising numbers of adverse events in arguing that government regulation has failed. These products fall under the Dietary Supplement Health and Education Act, passed in 1994.

FDA's most wanted list
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Under DSHEA, herbal remedies and botanicals are considered dietary supplements and are classified along with vitamins and minerals as foods rather than as drugs.

"There are an increasing number of reports that the quality, safety and/or efficacy of some herbal remedies is unacceptable," according to an American Medical Association statement. "Consumers cannot be sure that what is written on the product label is what is in the package. Also, there have been documented reports of impurities and adulterants in some herbal products."

Such products as ephedra-containing weight-loss pills and anabolic steroid-based performance enhancers have drawn attention to what many experts view as the law's shortcomings.

DSHEA originally was intended to make popular folk remedies more readily available to consumers, who at the time were clamoring for better access. But it may have gone too far, experts said.

Herbal remedies are considered dietary supplements and are classified as foods rather than as drugs.

"There are hundreds or thousands of dietary supplements with ridiculous claims being made for them," said Adriane Fugh-Berman, MD, associate professor in Georgetown University Medical Center's Dept. of Physiology. "There are safe and effective herbal medications that are out there, but they are in a sea of trash."

Under DSHEA, simply calling something a dietary supplement removes the Food and Drug Administration's ability to regulate the product until after it has already been placed on the market.

For example, gamma-hydroxybutyrate, a synthetic drug, was sold legally as a dietary supplement, marketed as helping to build muscle mass and as a sedative. The FDA, in the 1990s, banned the substance due to adverse events. In 2000, the government changed GHB's classification to a schedule I drug. It now has limited availability by prescription and is still sold illicitly.

"That's a synthetic drug that was put on the market as a dietary supplement, and that's a major loophole," Dr. Fugh-Berman said. "It's really different from dandelion tea."

When questions of safety arise about dietary supplements, the burden of proof that the product is dangerous falls to the FDA. With drugs, manufacturers must prove that their products are safe before they can be sold.

"In the aftermath of DSHEA, unsafe dietary supplements can remain on the market for many years," Charles Bell, programs director at the public advocacy group Consumers Union testified before the Senate panel.

"Health providers and public health authorities typically receive little premarket or postmarket information about how such products may affect human health and interact with medicines that patients are already taking," he said.

"Even where serious problems are documented, such as in the case of supplements like ephedra, ... it is difficult for the FDA to take prompt action to protect consumers," Bell added.

Giving the feds more muscle

The problem isn't with the law but with its implementation, responded proponents of legislation that would bolster FDA enforcement efforts but leave DSHEA intact.

"In the nine-plus years since DSHEA was enacted, there has been too much talk that the law handcuffs the FDA and too little effort to apply the law," testified Sen. Orrin G. Hatch (R, Utah), an author of the law. "It is impossible for this law to protect consumers if it is not enforced."

The companies that make and sell legitimate dietary supplements also do not want to see more regulation of their industry.

"The enactment of DSHEA provided the FDA, the primary agency that regulates supplements, with increased enforcement powers by establishing new labeling and potency standards," said David Seckman, the executive director and CEO of the National Nutritional Foods Assn. "For a number of reasons, this law has never been fully implemented or adequately enforced."

Many dietary supplement industry leaders have been proactive in addressing safety and efficacy concerns. For example, the main trade groups established a certification program for good manufacturing practices years before the FDA published a rule.

But such industry-based efforts are voluntary and have little or no effect on the behavior of marketers of sham dietary supplements, Dr. Fugh-Berman said.

In response to these concerns, Hatch and others have introduced legislation that would provide the FDA with more money to implement provisions of the law. But experts argued that what the FDA really needs is more power, along with more money.

Lawmakers have introduced several pieces of legislation to ban or restrict the sale of ephedra and anabolic steroids that are being sold as dietary supplements, but it should not require congressional action when the danger of such products is so clearly documented, they said.

"The FDA should ban the sale of ephedra and untested steroid equivalents," said Consumers Union's Bell. "If the FDA believes additional legal authority is needed to act on these matters, we strongly urge the Congress to provide that authority."

Other groups also called for the FDA to be given the authority to assess the safety of dietary supplements before they hit the market.

"Dietary supplements should not be held to the same standards as drugs in terms of safety and efficacy testing, at least ones that are traditionally used, but there could still be sane regulation of botanicals and other dietary supplements in a way that is separate from drugs," Dr. Fugh-Berman said.

ADDITIONAL INFORMATION:

FDA's most wanted list

The Food and Drug Administration is considering banning or restricting the sale of compounds, found in dietary supplements, that have been associated with adverse events.

Ephedra

Use: Short-term weight loss and sport performance enhancement.

Risks: Mild to moderate side effects include heart palpitations, psychiatric and upper gastrointestinal problems, tremors and insomnia. There is limited evidence that, in rare cases, ephedra may induce heart attack or stroke.

Anabolic steroids

Use: Muscle mass building or sport performance enhancement.

Risks: Side effects include musculoskeletal, cardiovascular, liver, skin, immune system and psychiatric problems. While the synthetic product is illegal to obtain without a prescription, "natural" forms are still available in some dietary supplements. Depending on their potency, these products are expected to have side effects associated with the synthetic compound.