Supplements under siege: legislation that could shelve nutritional supplements for good is working its way through Congress. FLEX, along with our sibling publications, investigates the bill that could be a bitter pill for bodybuilding

Flex, Sept, 2003 by Jeff O'Connell

It won't make newspaper headlines until the battle is already lost, but the supplement industry is under attack. If you use supplements, so are you. The DHEA pill you just swallowed? Keep taking it and soon you may see the acronym for dehydroepiandrosterone, minus the H, on the jacket of the federal agent cuffing you for using a controlled substance. The ephedra-free fat burner you're using to help shed a few pounds for a wedding or a reunion? Find a good tailor instead. As for purchasing the hottest new supplement, you might as well hit car showrooms looking for an Edsel.

The threat to the supplement industry has arrived in the form of S. 722, a bill introduced in the United States Senate at the end of March by Democratic Senator Richard Durbin of Illinois. (If passed into law, the bill would become the Dietary Supplement Safety Act of 2003.) The preceding scenarios may be alarming, but they're not alarmist. Although they may not be what the senator intends, they are likely to be the consequences of legislation that presents the stimulant ephedra and hormone precursors as a Trojan horse for changing the way all supplements are regulated, principally by treating them as drugs rather than foods.

THE PASSAGE OF DSHEA That seemingly innocuous distinction could be nothing less than the difference between the supplement industry surviving and it withering away. That supplements are a subcategory of foods, not drugs, seems self-evident, but from a regulatory standpoint it wasn't codified until 1994, when Congress modified the Federal Food, Drug and Cosmetic Act (FD&C Act) of 1938 by passing the Dietary Supplement Health and Education Act (DSHEA). It did so in response to a series of proposals made by the Food and Drug Administration (FDA) that supplement companies felt would have limited the availability of their products to consumers.

"DSHEA has been very successful because it allowed consumers to have more access to products," says David Seckman, executive director and CEO of the National Nutritional Foods Association (NNFA; Newport Beach, California), the largest natural-products trade association. (For the record, NNFA opposes S. 722.) "It also provided the framework and statutory authority for the FDA to go ahead and protect consumers from products determined to be unsafe."

What DSHEA did not do was remove the FDA from the supplement regulation process. You might think it did, though, if you listen to the antisupplement mantra of select politicians, regulators and media commentators, who conjure images of the industry as some sheriffless Wild West town, filled with rogue chemists gunslinging whatever they want into pills and bottles.

"It is widely and erroneously believed that DSHEA eviscerated the FD&C Act safety requirements for dietary supplements," says Peter Barton Hutt, partner in the Washington, DC, law firm Covington & Burling and former chief counsel for the FDA. "DSHEA actually provides greater FDA scrutiny of new dietary ingredients than exists for new conventional food ingredients and adds new safety enforcement authority for all dietary ingredients that extends beyond the FDA authority applicable to conventional food."

The root of the problem, according to some critics of the Durbin bill, is the FDA's reluctance to use the regulatory framework already in place and the statutory authority it already has to do what it's supposed to have been doing since DSHEA was passed. Echoing that view are the act's original sponsors, Democratic Iowa Senator Tom Harkin and Republican Utah Senator Orrin Hatch. "DSHEA provides a number of consumer protections while preserving consumers' freedom of choice," says Harkin. "The act needs to be enforced, not gutted."

Why hasn't DSHEA been given a fair shake? "Employees at the FDA and the Department of Health and Human Services readily discuss the agency's disdain for the law and their desire to treat dietary supplements more like drugs," says a former senior congressional aide, who has been following this issue closely for more than a decade. "Because FDA career staff are philosophically opposed to accepting the benefits of nutritional supplementation, they have as yet not fulfilled their obligations to fully and fairly implement the legislation that Congress passed and the President [Bill Clinton] signed into law."

For example, it's taken the FDA eight years to provide dietary supplement makers with guidelines for good manufacturing practices. This delay has been criticized on the Senate floor by none other than Durbin, which suggests that his frustration with the FDA's intransigence may be part of the genesis of S. 722. (Durbin's office did not return several phone calls requesting an interview for this article.) What's more, the agency has taken five years to update its system for handling reports of supplement-related adverse events.

THE EPHEDRA FACTOR Despite FDA foot-dragging on DSHEA, the act wasn't challenged seriously until the stimulant ephedra became a media buzzword. In fact, Durbin alluded to it, along with hormone-precursor supplements, in the press release announcing S. 722: "Millions of Americans take dietary supplements every day without any ill effects; in fact, some dietary supplements provide consumers with significant health benefits. However ... [a] small number of products--primarily stimulants and steroids masquerading as herbal compounds--have proven lethal to consumers."