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FDA’s willingness to explore reform of DSHEA draws mixed reactions

dietary supplements 2019

Consumer advocates, some Democratic lawmakers and industry trade organizations reacted differently to FDA’s willingness to examine possible reform of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

The divergent reactions reflect stark differences of opinion over the reputation of the dietary supplement industry and its 25-year-old regulatory regime.

Peter Lurie, M.D., a former FDA associate commissioner who leads the nonprofit Center for Science in the Public Interest (CSPI), described DSHEA in a statement as a “deeply flawed law that has long handcuffed the FDA’s regulatory efforts and has produced the sprawling, largely unregulated and often reckless industry we have today.”

Industry trade groups weighed in with a radically different perspective. DSHEA offered consumers wide access to supplements while protecting the safety of the public, according to Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN).

“We are intrigued and enthusiastic to hear what FDA has in mind, but we will be very careful to protect that balance between access and safety,” Mister said in an interview.

FDA’s top official supported the notion that most companies in the industry are responsible. The remarks by FDA Commissioner Scott Gottlieb, M.D., also underscored the need for FDA to rigorously enforce its authority to target “bad actors” who spike products with undeclared prescription drugs or otherwise endanger the public health.

“We know that most of players in this industry act responsibly,” Gottlieb said in a statement, revealing his plans to strengthen regulation of dietary supplements. “But there are opportunities for bad actors to exploit the halo created by quality work of legitimate manufacturers to instead distribute and sell dangerous products that put consumers at risk. As the popularity of supplements has grown, so have the number of entities marketing potentially dangerous products or making unproven or misleading claims about the health benefits they may deliver.”

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