“The very idea that delis, grocery stores and gas stations are in the business of selling dietary supplements is a violation of common sense,” writes Dan Hurley in his new book “Natural Causes,” a lengthy polemic against the supplement industry. Hurley claims that some 1.5 million Americans have suffered adverse reactions to common vitamins and herbal supplements during the past two decades.
The book hasn't landed on any best-seller lists, but anecdotes — such as one involving a woman, an herbal paste and a burned-off nose — did help inspire recent coverage of the issue in BusinessWeek, The New York Times and on the CBS Evening News.
These reports come at a time when the supplement industry, which by all rights should be flying high on broader health and wellness trends, has begun recovering from the controversy surrounding ephedra, the herbal stimulant linked to the deaths of several pro and amateur athletes prior to its 2003 ban by the FDA.
Public outcry over that issue is over, but many of the industry's largest players have viewed future government regulation as inevitable, and as a result, last year they aggressively lobbied for Senate bill 3564, known as the “Adverse Events Reporting” bill, which requires supplement manufacturers to record and report to the FDA any deaths, birth defects, disabilities, hospitalizations or surgeries that result from the use of their products.
“It almost sounds counterintuitive that the industry would want additional regulation, but we in fact were pleased with the bill,” said Carolyn Sabatini, director of government and corporate relations for Pharmavite, manufacturer of Nature Made vitamins. “It's consistent with our responsibility as a trusted manufacturer. It's the right thing to do.”
Supporters say the AER bill is the best compromise to help enforce existing rules, found primarily in the Dietary Supplement Health and Education Act of 1994. It could also help preempt the emergence of patchwork state laws.
Yet the bill has sparked dissent from many independent retailers, smaller manufacturers and alternative-medicine trade groups, who fear the legislation, which passed in December and will go into effect in 2008, has brought the industry one step closer to being on the same regulatory footing as over-the-counter drugs. And since many older or ill consumers now take multiple prescription drugs along with supplements, AER raises the possibility that supplements could be incorrectly blamed for adverse drug interactions.
“There's a much larger agenda being pushed here [by critics of the industry], and AER is just the first step,” said Jim Fussell, campaigns director for the American Association for Health Freedom.
A public comment period this year will help refine the scope of the new regulations, offering more opportunities for debate on the issue. Meanwhile, unless they produce private-label supplements, retailers are exempt from the reporting law and need only refer concerned shoppers to the supplier's contact information, which must now be printed on product labels.
