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

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.