FDA ‘not looking to throw out DSHEA’

An FDA official on Monday discussed the potential modernization of a 27-year-old law governing the regulation of dietary supplements.

Josh Long, Associate editorial director, Natural Products Insider

May 24, 2021

2 Min Read
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.”

About the Author(s)

Josh Long

Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition

Josh Long directs the online news, feature and op-ed coverage at Natural Products Insider, which targets the health and wellness industry. He has been reporting on developments in the dietary supplement industry for over a decade, with a focus on regulatory issues, including at the Food and Drug Administration.

He has moderated and/or presented at industry trade shows, including SupplySide East, SupplySide West, Natural Products Expo West, NBJ Summit and the annual Dietary Supplement Regulatory Summit.

Connect with Josh on LinkedIn and ping him with story ideas at [email protected]

Education and previous experience

Josh majored in journalism and graduated from Arizona State University the same year "Jake the Snake" Plummer led the Sun Devils to the Rose Bowl against the Ohio State Buckeyes. He also holds a J.D. from the University of Wyoming College of Law, was admitted in 2008 to practice law in the state of Colorado and spent a year clerking for a state district court judge.

Over more than a quarter century, he’s written on various topics for newspapers and business-to-business publications – from the Yavapai in Arizona and a controversial plan for a nuclear-waste incinerator in Idaho to nuanced issues, including FDA enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Since the late 1990s, his articles have been published in a variety of media, including but not limited to, the Cape Cod Times (in Massachusetts), Sedona Red Rock News (in Arizona), Denver Post (in Colorado), Casper Star-Tribune (in Wyoming), now-defunct Jackson Hole Guide (in Wyoming), Colorado Lawyer (published by the Colorado Bar Association) and Nutrition Business Journal.

Subscribe and receive the latest insights on the health and nutrition industry.
Join 37,000+ members. Yes, it's completely free.

You May Also Like