FDA official cites complexity of marketplace after 30 years of DSHEA

MANDALAY BAY, LAS VEGAS—Representatives of trade associations, the U.S. Food and Drug Administration and a former U.S. senator assembled Tuesday, Oct. 29, at SupplySide West to mark the 30th anniversary of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Experts in the dietary supplement industry reflected on DSHEA and also laid out their respective wish lists for the next few years.

The session — “After 30 years of DSHEA, the question is: What now?” —started with a deep dive into the story of DSHEA’s founding, through a documentary film produced by the American Herbal Products Association (AHPA), and a speech from former U.S. Sen. Tom Harkin (D-Iowa). Harkin is among a select group of lawmakers credited for getting DSHEA passed into law in 1994.

Following remarks from the former U.S. senator, FDA’s Cara Welch, Ph.D., shared insights into how the agency is dealing with the explosion of the global supplement trade, and she announced a forthcoming plan to help improve inspections and provide pre-market visibility. Welch oversees the Office of Dietary Supplement Programs (ODSP).

‘It’s a more complex marketplace’

Like others who spoke during the education and networking event, Welch was adamant that the dietary supplement market in 2024 is night and day from what it was in 1994 — both in scale and complexity.

“Regardless of what the exact numbers are, there’s massive growth in this industry,” the FDA official said. “This absolutely comes through in the growth of this marketplace, in the sales of the marketplace, the number of products, the breadth of the products. But it's also a more complex marketplace. It's a global supply chain with the internet as a retail and distribution channel. And the products look quite different. They're more diverse, they are precisely formulated, and they're often with novel ingredients or complex mixtures.”

In the face of this onslaught, Welch said one of the major goals of DSHEA — maintaining consumers’ freedom to support their personal health through natural products — has been realized.

“Absolutely, we are ensuring consumer access to products,” she said. “But do we know that FDA has what we need to adequately protect consumers?”

‘We’re not really able to connect the dots’

After walking the audience through FDA’s current regulatory capabilities under DSHEA, Welch pointed out some of the agency’s limitations and pain points. The biggest one: the onslaught of products that enter the marketplace with little FDA involvement or awareness.

“We're relying on post-market surveillance,” Welch observed. “There is virtually no barrier to entering the marketplace. I know that there's a lot of regulatory responsibilities that firms are keeping track of. There's a lot that goes into putting a product on the market. But when I say this virtually no barrier, I'm really talking about virtually no communication with FDA.”

She explained this creates a situation in which the agency simply can’t obtain an adequate, accurate picture of what is on the marketplace at any given time. For several years, FDA has advocated for legislation to require that dietary supplement products are listed with the agency.

“We have a lot of dots of information out there, but how do we make sure those dots are connected? How do we make sure we have the full picture of what a product is?” Welch asked. “Have the ingredients been properly notified [to FDA]? Are they pre-DSHEA ingredients? Are they safe? Who manufactures the product? Where are they being manufactured? Have we inspected the facility? A lot of these pieces of information are scattered about, and the way the system is set up, we're not really able to connect those dots.”

‘More agile, with more training opportunities’

So how is FDA planning to gain more pre-market visibility? Welch mentioned FDA’s proposal for mandatory product listing, which she laid out in an article she authored for SupplySide Supplement Journal (then known as Natural Products Insider) in 2023.

But she spent more time discussing the impending launch of an FDA training program that would allow for public-private partnerships between FDA, local authorities and the supplement industry itself.

“It’s an opportunity for FDA training program educational systems to be integrated with private training systems that are already out there,” Welch explained. “Our audit programs within the supplement industry could play a part in education for federal investigators, state investigators, state and local investigators. But also, FDA’s training systems could tie in with the training auditors, dietary supplement companies, really, anyone who's involved in supplements.”

Welch said she was hopeful that a recent reorganization at FDA should allow the agency to “staff up and educate and train up our inspectors.” But a public-private partnership would put more eyeballs at every stage of production, allowing the agency to do more with limited resources.

“What we really want to do is train everyone,” she said. “This will allow faster training of investigators because we'll be more agile with more training opportunities. But also all of our stakeholders will be able to get the exact same training competency that our internal investigators get. This is something that we can do to benefit the industry, and it's something that I'm really looking forward to.”

After 30 years of DSHEA, Welch said the agency remains ready and willing to face the new challenges of a 21st-century supplement market.

“There’s a lot we can do,” the FDA official said, “and a lot we will continue to do.”