May 20, 2019

Natural Products Insider Quotes Claudia Lewis on FDA’s Authority to Protect Consumers from Dangerous Ingredients

2 min

On May 20, 2019, Claudia Lewis was quoted in Natural Products Insider regarding the strength of the Food and Drug Administration's (FDA) authority under the Dietary Supplement Health and Education Act of 1994 (DSHEA) to protect consumers when dangerous ingredients end up in products marketed as dietary supplements.

Lewis maintained FDA has the tools to properly regulate the dietary supplement industry and can "effectively" remove an unsafe ingredient from the market.

"It may take more resources on the agency's part, or the agency might have to be more forceful in certain areas, but … the law is there for them," she said.

According to the article, some experts say adverse events tied to controversial ingredients don't reflect a failure of DSHEA. Unless the legal framework governing dietary supplements is going to require pre-market approval, situations will arise in which an ingredient poses a threat to public health.

But requiring pre-market approval for dietary supplements, Lewis said, would "stifle innovation and creativity" and undermine the intent of DSHEA.

By and large, dietary supplements haven't had many safety issues. "Considering the limited number of safety issues we've had to face over the 25 years since DSHEA was implemented," Lewis said, the dietary supplement industry is "more safe than not."