WASHINGTON - Mary Feehan runs a health boutique near Pittsburgh, selling food and dietary supplements, but a regulatory change might put her out of business.
All dietary supplements with new ingredients must now be reviewed before they hit the shelves -- a complete reversal from how the Food and Drug Administration has regulated the industry in the past.
Navigating the new regulatory process could take hundreds of man-hours for a given product, experts say, making smaller operations like Feehan's particularly vulnerable to heightened costs.
If it takes more resources to produce a new product, the product will be more expensive to consumers and thus less desirable.
Lobbyists, members of Congress and the FDA have been waiting for a chance to make this industry safer, said Theodore Ruger, a professor at the University of Pennsylvania School of Law.
"There's a tension there because the FDA, stretching back decades, has always wanted to regulate dietary supplements more like drugs, requiring up-front approval," he said. "But citizens and congressional action have preferred a different approach."
Unlike pharmaceuticals, past dietary supplements were regulated reactively: A product goes on sale, something goes wrong, the FDA steps in and bans it.
But the Food Safety Modernization Act, passed by Congress last year, changed that. Among other reforms, it ordered the FDA to define "new dietary ingredients," a term coined by a 1994 law that requires food and drug manufacturers to get FDA approval on new ingredients before they're sold to the public.
The FDA obliged.
"Under the (1994) Dietary Supplement Health and Education Act, manufacturers have an essential responsibility to substantiate the safety of their products, with respect to new dietary supplements and ingredients," FDA spokeswoman Tamara Ward wrote in an email. "The New Dietary Ingredient process is a critical component of that responsibility."
Now, supplement vendors must go through a lengthy approval process before any products with ingredients introduced after 1994 may be sold.
Many products currently on the shelves will be grandfathered in, Ruger said, but future ingredients must go through the new approval process.
"For at least a handful of products, these new guidances will be a problem, or at least a cost, to their production," Ruger said.
Officials from GNC declined to comment. The regulations will give them a competitive advantage over smaller vendors, Ruger said, because large corporations can better handle the additional workload.
The new regulations don't take effect until early December because they're currently in a comment period, a time when the public can provide feedback before the official rules are published.
"We'll fight it," Feehan said. "... I don't know how they can regulate natural food products, as if we're out here to harm people."