April 17, 2019

HBW Insights Quotes Claudia Lewis on Regulatory Oversight of the Vitamin, Mineral, and Supplement Product Industry

1 min

On April 11, 2019, Claudia Lewis was quoted in HBW Insights on regulatory oversight of the vitamin, mineral, and supplement (VMS) product industry, and changes the FDA may attempt to bring that would allow it to adequately evaluate product safety without restricting innovation. According to the article, attorneys noted the new dietary ingredient (NDI) notifications are problems for both industry and the FDA.

Lewis doesn't expect the FDA to ease its requirements for VMS product manufacturers and marketers, though. On NDI notifications, for instance, "I think the industry and FDA are fairly far apart on same issues," she said.

A point of contention includes whether synthetics should be considered the same as an old ingredient or as an NDI that the FDA has received notification about and filed as accepted without questions.

"When I read the Dietary Supplement Health and Education Act (DSHEA), I just don't understand why the synthetic question comes up at all," Lewis said. But the FDA contends that synthetic ingredients are not equivalents. "They take that position even if it is bioequivalent to an herbal substance," she said, adding, "This is very different from what DSHEA's intent was."