Consumer Reports On Nutritional Supplements Articles & Resources

"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."

Ephedra is clearly problematic, if only because its pharmacological effects are greater, and its contraindications more numerous, than those of most supplements. Increasing the velocity of the discussion was the untimely death in February, from heatstroke, of Baltimore Orioles pitcher Steve Bechler. At the time, he was taking a dietary supplement that contained ephedra.

Aside from being overweight, Bechler had a history of heart and liver problems, both of which should have dissuaded him from using the product, assuming he read the label. Teammates report that he was taking more than the recommended dose, and he was working out in weather hotter and more humid than what he was used to, all while denying himself adequate food and fluids.

The complicated, potentially interdependent medical factors that likely set off a chain reaction inside Bechler's body illustrate how the stigma attached to ephedra has caused people who should know better to disregard science and reach premature conclusions. Remarkably, the county medical examiner publicly implicated ephedra as a factor in the player's death even before toxicology work had been completed.

S. 722: A TROJAN HORSE

Remember, if the FDA produces the science showing that ephedra is dangerous, it has the statutory authority to yank products containing it off the market. That threat alone has the marketplace doing the agency's work for it. Some companies, such as GNC, are voluntarily discontinuing the sale of all ephedra-based products. Other manufacturers and retailers have done likewise because they can't get insurance for them.

What scares supplement companies is that S. 722, in targeting something that is already being jettisoned, threatens to sink the whole ship that is the supplement industry. Supplement-opponents' reasoning seems to be this: Why bother impartially evaluating--and removing, if necessary--one potentially dangerous piece of cargo when you can just send a cannonball through the hull?

To understand why the negative impact of this could be seismic, consider the unique nature of the pharmaceuticals industry, whose regulatory standards supplement makers would have to meet if this bill passes. On average, researching and developing a drug and then bringing it to market costs half a billion dollars or more. A significant chunk of that sum is spent proving to the FDA that the drug is safe and effective--the two prerequisites for getting agency approval to market it. No one would venture such capital without some chance of generating a return on investment, so drug makers get a quid pro quo of sorts in the form of patent protection.

Although the windfall from a blockbuster drug fenced off from competition for several years can be enormous, companies need vast resources to engage in the process leading up to it. In 2002, for example, Pfizer and Johnson & Johnson had a combined $50 billion in prescription medicine sales and their combined market capitalization exceeded $400 billion.

Pfizer's sales alone dwarf those of the entire supplement industry, which consists largely of companies that are small and privately held. A handful of larger players are nonetheless smallish companies in the hierarchy of corporate America. Two of the largest and best-known publicly traded names in supplements, Weider Nutrition International and Twinlab, had just over $200 million in combined revenues for the most recently reported four quarters, and their combined market capitalization was just over $70 million. Under S. 722, these companies and their smaller counterparts would be subject to the same sort of regulatory codes that companies such as Pfizer and Johnson & Johnson follow--without the quid pro quo. No one is going to be issued a patent on vitamin C, garlic or creatine anytime soon.

SHIFTING BURDEN OF PROOF Here's a brief overview of the implications of S. 722 for the supplement industry.

* Reporting procedure Under DSHEA, dietary supplement manufacturers, just like food manufacturers, don't need to prove their product's safety before bringing it to market, but the FDA has the right to pull any supplement that it deems unsafe off the market. Under S. 722, this burden of proof is essentially reversed. The bill requires the establishment of an adverse-event reporting system for supplements, and once the agency receives a single such report categorized as "serious," the burden immediately shifts to the manufacturer to prove that its product is safe. This basically cuts the legs out from under DSHEA.

The event report and subsequent clinical evaluation don't necessarily have to establish cause and effect, and the event itself could have been caused by consumer misuse. Regardless, once it's on file, that manufacturer can be made to go back and earn the FDA stamp of approval that drug companies get up front. This process could take a product such as creatine or even a souped-up protein powder off the market indefinitely. Any new supplement containing a stimulant--including, for example, Chinese botanicals--would need FDA permission up front. That extremely expensive process, called premarket approval, is part of what contributes to the astronomical cost of bringing prescription medicines to market.

Says Seckman, "I'm not saying that this would actually happen, but what if one person had a serious adverse experience, as defined by this statute, with vitamin C? Does that mean that a manufacturer, or all manufacturers, of vitamin C has to prove the safety of it to the secretary of Health and Human Services, and then wait for his or her approval that it's a safe product? I think we all know that there are many, many studies out there that talk about the benefits and the safety of vitamin C."

* Postmarket surveillance

Currently, the FDA requires this when new drugs that have high risks associated with them come to market. Although certainly warranted in those cases, postmarket surveillance is another exceedingly expensive and detailed process.

Again, under S. 722, all it takes is one serious adverse experience for a given dietary supplement, and the FDA will ask its manufacturer, no matter how small, to enter this labyrinth of red tape. What's more, the supplement company would have 30 days to provide the surveillance plan. This window is so small that supplement companies would likely have to hire consultants and lawyers and draft plans preemptively, if they have any hope of producing it in time when called upon to do so.

* Controlled substances The Durbin bill seeks to amend the FD&C Act by excluding anything "chemically or pharmacologically related to testosterone," which takes products such as DHEA out of DSHEA jurisdiction and puts them in the drug realm. But not just the prescription drug realm--S. 722 would change the wording of the Controlled Substances Act so that these "drugs" would fall under it, and hence become managed by the Drug Enforcement Agency, which sets up a whole different regulatory framework. That act would also be amended to include not only hormonal substances that promote muscle growth but also those that are advertised or used to promote muscle growth, which could include a surprisingly broad range of supplements.

"These products will be gone," says the former senior congressional aide. "The fitness community will not have them unless they get them through the black market, which puts people at risk."

THE BIGGER PICTURE This isn't a debate over, say, guns or pollution, where the object of discussion has an intrinsic capacity for inflicting damage. The debate usually swirls around constitutionality and personal accountability in the former case, and costs to business versus benefits to public health in the latter. Supplements don't come without risk if you use them unwisely, particularly by not reading and following label instructions. Their basic purpose, in most cases, however, is to improve people's lives by fortifying their bodies against incomplete diets.

By and large, dietary supplements have succeeded admirably in fulfilling their promise. Consumer spending on them nearly doubled between 1994 and 2000, and sales continue to grow at above 10% annually. They've done so in large part because many of them work well, something experienced by consumers firsthand and frequently confirmed secondhand in laboratories. To suggest, as supplement critics in Congress and elsewhere sometimes do, that witless American consumers are being hoodwinked into throwing away billions of dollars on the same ineffectual products year after year not only seems condescending, but also defies common sense.

Moreover, politicians themselves constantly warn of the growing cost of health care in America, which now accounts for approximately 15% of the gross domestic product. They argue that prevention is the most cost-effective long-term solution to this looming crisis. Used appropriately and in concert with other means, dietary supplements can play a significant role here. It seems like anything but sound policymaking to preach prevention in one breath and in the next argue in favor of legislation such as S. 722, which might help put many of the manufacturers of those supplements out of business.

MAKE YOUR VOICE HEARD

Although many observers don't expect the Dietary Supplement Safety Act (S. 722) to be voted upon until early 2004, Capitol Hill insiders tell us the bill could come up for a vote in the Senate as early as this summer, as proponents look to strike while ephedra remains in the headlines. The most likely strategy for Senator Durbin would be to attach S. 722 as an amendment to the Agricultural Appropriations Bill, through which the Food and Drug Administration is funded. That will likely come to the Senate floor in the summer of 2003.

Congressional staffers interviewed for this article predict that if S. 722 were put to a vote today, it would pass. However, one reason DSHEA passed in 1994 was a huge grassroots campaign led by the industry and its consumers, thousands of whom communicated their displeasure to Congress. It will likely take a similar effort to defeat S. 722.

If you feel strongly about this issue, the best way to make your voice heard is to contact the office of one of your state's two senators. Visit .gov., and select your state from the pop-up menu. Phone numbers and e-mail addresses will be listed for each senator. Call, fax or e-mail your . senators today. Ask them not to chanqe DSHEA (the Dietary Supplement Health and Education Act of 1994). Tell them you don't want your access to dietary supplements (and that includes ephedra and prohormones such as melatonin and DHEA) to be limited. Ask them to oppose S. 722 or any similar proposed legislation.

Jeff O'Connell is senior writer for MUSCLE & FITNESS magazine. His work was recently cited in The Best American Sports Writing 2002 anthology.