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Valley businesswoman questions regulation of supplements
For 20 years, Sue Altomare has watched as customers improved their health by taking supplements and vitamins.
As owner of Health Matters, a natural-food and supplement shop in Columbiana, she worries that proposed guidelines from the U.S. Food And Drug Administration could take away customers’ rights to treat and prevent medical conditions.
She said the FDA has been trying for years to overregulate the industry and interfere with basic freedoms. She said vitamins and supplements don’t carry the same risk for side effects as pharmaceuticals.
The FDA has drafted proposed guidelines for New Dietary Ingredients that would require supplement and vitamin manufacturers to submit information on each new ingredient it uses in products. Some previously approved ingredients may need to be re-examined if changes are implemented.
The Natural Products Association, a nonprofit watchdog for regulatory and legislative issues, says it thinks the FDA has overstepped boundaries set by the 1994 Dietary Supplement Health and Education Act. It argues some companies may not be able to comply with complex requirements, which could affect future innovation and availability.
Dr. Daniel Fabricant, the FDA’s director of the Division of Dietary Supplement Programs in College Park, Md., said lots of “angry rhetoric” is going around that paints the agency as “anti-business.”
The NDI notifications are designed to clarify the agency’s expectations in the submission process, he said, and make clear what’s outlined in DSHEA.
Prior to DSHEA, there were about 4,000 dietary supplements on the market, Dr. Fabricant said, and today there are about 56,000. That type of increase warrants the enforcement of safety guidelines to protect consumers, he said.
According to the NPA, supplement sales in natural product stores increased 4.4 percent to $28 billion between 2009 and 2010.
Steve Mister, president/CEO of the Council for Responsible Nutrition in Washington, D.C., said the vitamin and supplement industry had been urging Congress to establish more clear-cut guidelines.
Instead, the FDA used it as an “opportunity to ratchet up the requirements in ways the statute never envisioned.”
He said he’s concerned because new guidelines could put a “tremendous burden” on the industry to comply, which could prevent or delay new products from coming to the market.
Filing new paperwork for each new ingredient would cause a huge workload for the industry, and the FDA would not be able to keep up with it, he said.
Dr. Fabricant called that argument “a nice hypothetical” and said a streamlined submission process should make everyone’s job easier.
Atty. Michelle C. Jackson, of the Washington, D.C.-based law firm Venable LLP, specializes in food and drug law with a focus on dietary supplements. She said she’s watching the issue “very closely,” as it may impact clients including those in the Ohio market.
New guidelines could force companies to file new ingredient paperwork every time their formula changes, she said, adding, “I don’t think it will streamline anything.”
Cindy Perkins, owner of Cindy’s Health And Vitality in Niles, said the FDA tries to enact regulations every few years that could impact the industry. “We always have to be concerned because their efforts are getting more rigorous,” she added.
She said people should become their own health advocates, do research and make decisions that are best for them.
Nancy Fox owns Health Food Center of Youngstown and said manufacturers gain nothing from putting unsafe products on the market.
She called the effort to further regulate the industry “ridiculous” and said, “There are plenty of protections in place already.”
Friday will be the deadline to comment on the FDA’s draft guidelines. Dr. Fabricant said the “fair amount” of comments received will be evaluated for legal and scientific relevance but general comments or rants don’t generally hold much bearing on the outcome. Guidelines to comment can be found at www.regulations.gov.