FDA ‘not looking to throw out DSHEA’

FDA in recent years has supported efforts to modernize the Dietary Supplement Health and Education Act of 1994 (DSHEA). But the agency “is not looking to throw out DSHEA and start fresh,” an FDA official said Monday during an event hosted by the American Herbal Products Association (AHPA).

“Rather, we’re talking about building on the current framework,” said Cara Welch, Ph.D., acting director of FDA’s Office of Dietary Supplement Programs (ODSP).

FDA officials are among those in favor of modernizing the law to reflect changes in the marketplace over the last 27 years. The industry has ballooned “from $4 billion in sales in the ’90s to well over $40 billion today [and] from fewer than 4,000 products to estimates as high as 80,000,” Welch reflected during AHPA’s 9th Botanical Congress, a virtual event this year due to the ongoing pandemic.

FDA has proposed a requirement that dietary supplements be listed with FDA, which Welch described as one of the central components of the agency’s modernization plans first outlined in 2019.

“With mandatory product listing, we believe it’s possible to construct a narrowly tailored requirement that respects and preserves DSHEA’s original vision of consumers’ right to access safe, well manufactured and appropriately labeled dietary supplements with—just as important—upholding FDA’s ability to protect the public from unsafe and unlawful products,” Welch said.

A mandatory product listing would give FDA visibility into dietary supplement products on the market in real time, facilitating the agency’s “ability to identify products, allocate our resources and act more quickly to remove unsafe or illegal products,” Welch said.

“We are at a crossroads here,” she said. "We have an opportunity for real, common-sense reform.”

Industry stakeholders in recent years have debated the pros and cons of a mandatory product listing. Welch said FDA believes “there are ways to successfully implement the product listing requirement that [do] not impose significant burdens on responsible industry or even slow the introduction of products to the market.”

Like her predecessor, Steven Tave, Welch suggested it’s important that both FDA and industry be a part of the conversations to modernize DSHEA.

“If we are looking to move the conversation forward, stakeholder dialogue is critical,” she said. “It’s important that FDA be part of this discussion, but we shouldn’t be dictating its terms.”