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"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, ., 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."

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, from heatstroke, of Baltimore Orioles pitcher Steve Bechler in spring training, during which time he had been taking a dietary supplement which contained ephedra.

Aside from being overweight, Bechler had a history of heart and liver problems, either of which should have dissuaded him from using the product, assuming he read the label. Teammates reported that Bechler 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 foods 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 even the most rational people to disregard science and reach premature conclusions. Remarkably, the county medical examiner publicly attributed the player's death to ephedra even before toxicology work had been completed. When a medical examiner makes such a hasty, unsupported judgment, it encourages laypeople to blame ephedra for virtually any health problem that might arise internally, or to reach similar conclusions about others who use the supplement.

The results of an ephedra study commissioned by the FDA highlight the potentially self-fulfilling consequences of adverse-event reporting on a product once it's been labeled a problem child. The FDA asked the RAND Corp. to analyze 1,600 or so ephedra-related adverse events, and the Santa Monica, think tank found only two instances in which a direct cause-and-effect relationship could be established between ephedra consumption and death. If you looked hard enough, you could probably find two people allergic to peanuts who experienced similarly catastrophic reactions after eating cookies without bothering to see that nuts were labeled as ingredients.

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. And just that threat 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 insured for them.

What scares supplement companies is that S. 722, by targeting a product that is already being jettisoned, threatens to sink the whole ship that is the supplement industry. The reasoning of supplement opponents seems to be this: Why bother thoughtfully 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 S. 722 could be seismic, consider the unique nature of the pharmaceuticals industry, whose regulatory standards supplement makers would have to meet should this bill pass. 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 having 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 even engage in the process that generates it. In 2002, for example, Pfizer and Johnson & Johnson generated a combined $50 billion in prescription medicine sales, and their combined market capitalization exceeds $400 billion.

Pfizer's sales alone dwarf those of the entire supplement industry, which is fragmented among hundreds of small businesses and a few larger players that are nonetheless smallish companies in the hierarchy of corporate America. Two of the largest publicly traded names in supplementation, Weider Nutrition International and Twinlab, combined had just over $200 million in revenues for the trailing 12 months, and their combined market capitalization is a tad over $70 million. Under S. 722, these companies and their smaller counterparts would be subject to the same sort of regulatory codes that the Pfizers and J&Js of the world follow--without the quid pro quo. No one is going to be issued a patent on vitamin C, garlic or creatine anytime soon.

SHIRTING THE BURDEN OF PROOF

Here's a quick overview of S. 722's implications on the supplement industry:

* Premarket approval.

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. 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 the report is on file, the manufacturer can be made to go back after the fact and earn the FDA stamp of approval that drug companies get up front. This process could take a product like 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 what's called "premarket approval" from the FDA. That extremely expensive process is part of what contributes to the astronomical costs 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."

* Post-market surveillance.

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

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

* Controlled substances.

This is where it gets really scary. First, 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 and classifies them as prescription drugs. But rather than just impacting the prescription-drug realm, S. 722 would change the wording of the Controlled Substances Act so that these "drugs" would fall under its sway, and hence become managed by the Drug Enforcement Administration, which sets up a whole different regulatory framework. That bill would also be amended to include not only hormonal substances that promote muscle growth, but also products 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 congressional aide. "The fitness community will not have them unless they get them through the black market, which puts them at risk."

THE BIGGER PICTURE

This isn't a debate over, say, guns or pollution, where the object of discussion does have an intrinsic capacity for inflicting damage, and the argument usually swirls around constitutionality and personal accountability in the former case, and costs to business vs. 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, but their basic purpose is to improve people's lives by fortifying their bodies against incomplete diets.

And, by and large, dietary supplements have succeeded admirably in fulfilling their promise. Consumer spending on supplements nearly doubled between 1994 and 2000, and sales continue to grow at above 10% annually, in large part because many supplements work so well, something consumers know firsthand and laboratories have confirmed. 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 simply defies common sense.

Moreover, politicians constantly warn of the growing cost of health care in America. They argue that prevention is 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. To preach prevention in one breath and in the next argue in favor of legislation, such as S. 722, that might help put many of the manufacturers of those supplements out of business seems anything but sound policymaking.

MAKE TOUR VOICE HEARD

Although many observers don't expect the Dietary Supplement Safety Act (S. 722) to be voted on until early 2004, Capitol Hill insiders tell MEN'S FITNESS the bill could come up for a vote in the Senate this summer, as proponents look to strike while ephedra remains in the headlines. Expect Illinois Sen. Richard Durbin, the bill's sponsor, to attach S. 722 as an amendment to the Agricultural Appropriations Bill, through which the Food and Drug Administration is funded. That bill will likely come to the Senate floor in July '03.

Congressional staffers predict that if S. 722 were put to a vote today, it would pass overwhelmingly. However, the passage of the Dietary Supplement Health and Education Act in 1994 was due in part to a huge grassroots campaign led by the industry and 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 offices of your state's two senators. Visit .gov, choose your state from the pop-up menu, and phone numbers and e-mail addresses will be listed for each senator. Call, fax or e-mail your . senators today. Ask them not to change 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 a frequent contributor to MEN'S FITNESS. His work was cited in The Best American Sports Writing 2002 anthology.