FDA’s Welch on DSHEA 2.0: ‘We have an opportunity for real, common sense reform that I don’t believe we can let pass by’

25-May-2021 - Last updated on 25-May-2021 at 16:01 GMT

“FDA is not looking to throw out DSHEA and start fresh – rather we are talking about building on the current framework,” said FDA’s Dr Cara Welch. Done correctly, initiatives like a mandatory product listing would not impose significant burdens on the industry, she said.

Speaking as part of the online AHPA Botanical Congress on May 24, Dr Cara Welch, PhD, acting director of the Office of Dietary Supplement Programs (ODSP), said: “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.

“We think there are ways to successfully implement a product listing requirement that does not impose significant burdens on responsible industry or even slow the introduction of products to the market.

“But the simple fact of FDA having visibility into what the marketplace looks like at any given moment – this facilitates our ability to identify products, allocate resources, and act more quickly to remove unsafe or illegal products.”

Modernization of DSHEA

Mandatory product listing has been a central tenet of FDA’s plans to modernize the 26+ years old Dietary Supplement Health and Education Act (DSHEA), since it was mooted in 2019 by then-Commissioner of the FDA Dr Scott Gottlieb. The idea was already being discussed by some heavyweight stakeholders prior to 2019, with, for example, Scott Bass from Sidley Austin supporting a listing in 2018. Former Senator Orrin Hatch has also said it “makes sense.”

“The system that has been in place for the last 26+ years is not, at its core, a flawed system,” said Dr Welch. “I truly believe this. But it is a system that was established for a marketplace that looks quite different from today’s market. (For historical context, Amazon launched in the summer of 1994, while Google wouldn’t appear on the scene until four years later.)

“Standing where we are today, with the benefit of seeing how the current framework has been implemented over the past couple decades – including how it did not function as originally intended – we have the opportunity to make improvements.”

“We have an opportunity for real, common sense reform that I don’t believe we can let pass by,” added Dr Welch.

Working with industry

Dr Welch also noted that many of its enforcement successes last year and this have included external stakeholders.

“But from the very beginning, we’ve had partners in the responsible dietary supplement industry sending product listings, forwarding emails with marketing information, and even submitting formal complaints through FDA’s reporting system. This outreach gives FDA a step up in that we know about the existence of these products – FDA can then track it down, evaluate it, and address it,” she said.

Dr Welch also welcomed the widespread industry rejection of the idea of Nerium oleander as a dietary supplement and as a treatment for COVID-19 even as members of the Trump Administration were championing the plant.

“And shifting away from overt safety concerns, we also hear about adulterated products on the rise, possibly in response to reduced supply or, in the case of some specific botanicals, an increased demand that could not have been anticipated in advance of 2020.

“We saw how COVID created supply chain uncertainties in so many ways – shipments slowing down in transit, shipments sitting at the border, possibly for quarantine purposes, a reduced workforce across the globe, and distancing restrictions to ensure workers can stay safe.

“But we also saw industry speak really bluntly about supply chain concerns and how these concerns result in economically-motivated adulteration. I commend this discussion. I haven’t seen anyone trying to sweep this under the rug but rather airing it out publicly and disclosing it’s a problem that consumers should be aware of,” she said.

The new normal

Dr Welch finished her presentation by noting that we are all seeking a return to “normal” but how do we do that and even should we? “Normal led to this,” she said.

“Going back to the dietary supplement context, I challenge us to focus not on where we used to be or how it used to be . . . but rather, where we want to be and how we can get there. What is our new normal?”

Shared values

Commenting on Dr Welch’s comments, Michael McGuffin, AHPA President, told NutraIngredients-USA: “AHPA appreciates the clarity of Dr. Welch’s identification of FDA’s three strategic priorities for dietary supplements as consumer safety, product integrity, and informed decision-making. We share these values.

“In addition, it was good to hear Dr. Welch mention the agency’s interest in working with diverse stakeholders to evaluate how to improve current dietary supplement laws, regulations, and enforcement. AHPA looks forward to building on the excellent legal foundation that currently exists, with a focus on improving informed consumer access to a broad range of safe dietary supplements with a minimum of redundant or unnecessary new rules.”