Supplements under siege: legislation is working its way through Congress that could shelve nutritional supplements for good. Men's Fitness, along with our sibling publications, investigates the bill that would be a bitter pill for fitness buffs

Men's Fitness, August, 2003 by Jeff O'Connell

It won't make newspaper headlines until the battle is already lost, but the supplement industry is being attacked. And if you use supplements, so are you. The DHEA pill you just swallowed? Use it and soon you may see that acronym, 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 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 to the Senate of the United States at the end of March by Illinois Sen. Richard Durbin. (Should it be passed into law, the bill would become the Dietary Supplement Safety Act of 2003.) The scenarios above are alarming but not alarmist. And while they may not be the intent of the senator, they are likely to be unintended consequences of legislation that uses 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 withering away. That supplements are 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 of 1938 by passing the Dietary Supplement Health and Education Act. It did so in response to a series of proposals made by the Food and Drug Administration 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 chief executive officer of the National Nutritional Foods Association, based in Newport Beach, Calif., the largest natural-products trade association. (For the record, NNFA opposes S. 722.) "Second, it 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 is remove the FDA from supplement regulation, although you might think it did listening to the anti-supplement mantra of selected politicians, regulators and commentators, who conjure images of the industry as some sheriffless Wild West town filled with rogue chemists gunslinging whatever they want into bottles and pills.

"It is widely and erroneously believed that DSHEA eviscerated the FD&C Act safety requirements for dietary supplements," according to Peter Barton Hutt, partner in the Washington, D.C., 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, say 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.

"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 [Clinton] signed into law."

Echoing the view that DSHEA would work fine if the FDA simply implemented it correctly are the act's original sponsors, Iowa Sen. Tom Harkin and Utah Sen. Orrin Hatch. "DSHEA provides a number of consumer protections while preserving consumers' freedom of choice," says Sen. Harkin. "The act needs to be enforced, not gutted."

It's taken the FDA eight years to provide dietary supplement makers with guidelines for good manufacturing practices, the minimum requirements companies are told to meet as they test and produce supplements. This delay has been criticized on the Senate floor by none other than Durbin, suggesting that his frustration with the FDA's intransigence may be part of the genesis of S. 722.

THE EPHEDRA FACTOR

Despite the FDA's feet dragging on DSHEA, the bill wasn't seriously challenged 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."