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THE FDA'S BURDEN
JOSH ZEMBIK
May 18, 2009
A 1994 law says that dietary supplements can be banned only if proved harmful
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May 18, 2009

The Fda's Burden

A 1994 law says that dietary supplements can be banned only if proved harmful

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In the early 1990s FDA commissioner David Kessler wanted to standardize and ensure the accuracy of food labels—including those on dietary supplements. With billions of dollars at stake, supplements manufacturers launched a p.r. blitz to oppose regulation, hiring actor Mel Gibson, who appeared in a commercial being handcuffed by FDA agents for possessing vitamins.

The industry's strategy worked. Worried that they would be deprived of their iron supplements and echinacea, Americans bombarded their congressmen with calls and letters. Rebuffing Kessler's efforts, politicians instead began drafting what would be known as the Dietary Supplement Health and Education Act (DSHEA).

Sen. Orrin Hatch (R-Utah) sponsored the legislation and found support across the aisle from Sen. Tom Harkin (D-Iowa), a proponent of natural remedies who said that bee pollen had recently cured his allergies. The tandem shepherded the bill through Congress and to the desk of President Bill Clinton, who signed it into law in October 1994.

DSHEA created a separate classification for dietary supplements: Unlike food and drugs, they would not need FDA approval before they hit the market. What's more, supplements that were subsequently shown to be ineffective could not be banned; the FDA could prohibit their sale only if they were proved to be dangerous. "We've always had a system where if you sell a product, the burden should be on you to show it works," says Kessler, who left the FDA in 1997. "DSHEA shifted the burden [to the FDA] to prove it's harmful."

As a result of DSHEA, supplements containing everything from ephedra to the date-rape drug, gamma hydroxybutyric acid (GHB), flooded the market. Some substances were prohibited after their dramatic adverse effects were proved. Others, such as supplements that either do gradual harm or produce damage only when combined with other drugs, could not be policed by the understaffed and underfunded FDA. Today even if products are discovered to have misleading labels or to be making false claims, and the manufacturer is ordered to cease production, it's not uncommon for companies to "just market the same thing as a different product," says a senior congressional staffer with extensive knowledge of DSHEA. "You'd have to be testing stuff all the time [to know if the claims were accurate], and the FDA doesn't have the people to do that."

Hatch is quick to say he believes that the FDA needs more funding to enforce DSHEA. At the same time, however, he has frequently advocated for individual supplements, fighting to keep them on the market. He initially pushed back against efforts to limit ephedra and, more recently, he succeeded in exempting one substance in the steroid family—the prohormone DHEA—from classification as a controlled drug. Although DHEA is banned by the NCAA, the NFL, the NBA and the World Anti-Doping Agency, Hatch felt it should remain legal as an antiaging remedy. Hatch's interest in the industry is parochial as well as personal. Not only is Utah the home of many supplement companies, but also the senator's son, Scott, has lobbied on behalf of the industry for almost a decade. Although Orrin says his son lobbies neither him nor his staff, Scott's firm, Walker, Martin & Hatch, has earned at least $840,000 from the Pharmaceutical Researchers and Manufacturers of America since 2002 and has represented Twinlab, a former maker of ephedra.

"It's not just about [misleading] claims—it's about quality controls," Kessler says. "We don't even know where this stuff is being manufactured. The vitamins and minerals that are added to your foods and supplements are made halfway around the world in factories that I bet are rarely if ever visited by a regulatory body." In the meantime, supplements flood store shelves, and the FDA can do little to protect consumers.

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