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Aug 14, 2023

FDA makes the case for dietary supplement product listing requirement

Cara Welch | Feb 07, 2023 When the Dietary Supplement Health and Education Act

Cara Welch | Feb 07, 2023

When the Dietary Supplement Health and Education Act of 1994 (DSHEA) was signed by then-President Bill Clinton, the White House released a short statement touting the legislation as a "historic agreement" bringing "common sense to the treatment of dietary supplements under regulation and law."

Further, the press statement highlighted the diligence of the "unofficial army of nutritionally conscious people" who worked to change the law in an area deeply important to them. DSHEA amended the Federal Food, Drug and Cosmetic Act (FDCA) to establish a basic framework of dietary supplement-specific requirements for the development of a high-quality and safe dietary supplement marketplace.

DSHEA was designed to preserve consumers’ right to access dietary supplements while also providing FDA the authority to protect the public from unsafe and unlawful products. These pillars of DSHEA—the original vision of balancing consumer access to products with giving FDA the tools to protect consumers—are integral to this industry, as it moves ahead.

It's now been almost 30 years since DSHEA, and the dietary supplement industry has flourished: evolving from an approximately $4 billion market to over $50 billion in annual sales, and from an estimated 4,000 products in 1994 to more than 95,000 products today, according to the National Institutes of Health's (NIH) Dietary Supplement Label Database.

But these changes go beyond sales or the number of products. Today's dietary supplement marketplace is more complex with a global supply chain and precisely formulated products, many of which contain novel ingredients.

DSHEA was written for a marketplace that looks quite different from today's market. From FDA's perspective, we believe our regulatory framework would benefit from modernization.

Specifically, we have publicly backed the idea of a legislative change to establish a dietary supplement listing requirement.

Under our current authorities, FDA has no systematic way of knowing what dietary supplements are on the market, when new products are introduced, or what they contain. When dealing with a marketplace that has grown more than 20 times since 1994, this puts FDA at a distinct disadvantage.

A requirement for all dietary supplements to be listed with the FDA—including product-specific information such as brand name, ingredients and the amounts of each ingredient—and to be listed in a public dietary supplement database would bring transparency to the marketplace for consumers, retailers, fellow industry members and FDA.

Dietary supplement listing would facilitate a modern, risk-based regulatory approach by giving FDA visibility into the current marketplace. Also, over time, a dietary supplement listing would allow the agency to have a better understanding of how the landscape is evolving with new ingredients coming onto the market, changing formulations and new product types.

For example, understanding how an ingredient is being used (e.g., amounts, serving size and duration of use) is important to understanding a product's safety profile.

Also, having visibility into the entire dietary supplement marketplace would allow FDA to gauge the breadth of products being marketed and identify those with particular ingredients more quickly in order to take action against dangerous or illegal products.

The dietary supplement marketplace has grown significantly since DSHEA, and there is no way FDA can keep up with the changing market through the current processes we have for collecting supplement labels. We have a gap in understanding the scope of products, and we’re dependent on what we can gather from publicly available sources to cover that gap.

If FDA is aware of an issue with a specific dietary supplement or ingredient, we may be able to find a copy of the label on the internet. However, we cannot rely on such a process to be thorough or even-handed. A comprehensive database of the U.S. dietary supplement market would represent a major step in leveling the playing field across the industry.

The ability to link dietary supplement formulations to specific products being imported would provide strategic information for FDA's import activities regarding which products should be inspected at the border. FDA makes decisions on tens of millions of imported shipments each year, and screening imported products effectively for examination and potential action requires appropriate information about them.

Through a listing requirement, FDA could block unlisted products, and better prevent products containing unlawful ingredients, from entering the U.S. marketplace. And if a dietary supplement listing requirement includes information concerning where particular products are manufactured, this could be factored into a risk-based inspectional planning program. For instance, a facility that manufactures a particular product could be prioritized over a warehouse distributing it.

FDA continues to support DSHEA's foundational aspect of a consumer's right to access a wide variety of supplements. However, in today's market, access without knowledge is a deterrent for consumers looking to use dietary supplements, and a detriment to manufacturers and retailers that are accountable to their customers.

Dietary supplement listing would offer a public way to differentiate responsible industry from those looking to evade FDA regulation and empower retailers, consumers and health care professionals to make informed decisions about the products they choose to sell, purchase and recommend.

For example, retailers could choose not to stock any unlisted or incorrectly listed products, and consumers could choose not to purchase them. The conversations between a consumer and health care professional could be enhanced by searching for precise products in the database.

Despite its many advantages, we are also aware that not everyone is on board with the idea of a legislative change to implement a dietary supplement listing—or in some cases, any legislative change to the current regulatory framework. This reluctance appears to be based on a few different fronts, but many of the concerns fit the theme of either increasing the burden of responsible industry or distrust of what FDA will do with this information.

First, FDA believes a dietary supplement listing requirement can be crafted in a way that does not impose significant new burdens on responsible industry. We do not believe the burden of such a system would be great, and we have experience to help mitigate any such burdens.

Regarding what FDA would do with this information, this article has already highlighted several examples of how we envision a product listing requirement could positively impact our regulation of dietary supplements.

But maybe as importantly, let's discuss what FDA would not do with a listing requirement. We are not looking to prevent or slow the introduction of supplements to the market. In fact, a simple listing requirement does not give FDA the authority to apply premarket approval or provide new authority for premarket review.

If needed, this limitation can be made clear through legislative text. But also, it's how other registration and listing programs for FDA-regulated commodities are handled. For example, a food facility registration requirement is complete once all the required fields are filled out—a food facility faces no waiting period for FDA to confirm the information is correct.

FDA is not looking to restrict access to dietary supplements, but rather is merely hoping to keep current with the marketplace. We cannot regulate what we cannot see and, unfortunately, it's currently too easy to hide in the shadows in today's market.

A narrowly tailored dietary supplement listing requirement can provide FDA with product-specific information at the point of introduction to the market, but it shouldn't slow—or restrict—the entrance of products into commerce. Rather, a dietary supplement listing would put this information on FDA's radar with the agency then bearing the burden to follow up on products as warranted.

We are also aware that some firms would actively avoid FDA oversight. Fraudulent and deceptive behavior will persist regardless of the specific legal framework, but a dietary supplement listing requirement would make it harder for these products to blend in with responsible industry.

That said, enforcement tools would be essential to an effective dietary supplement listing program, and FDA should be empowered to utilize such tools and preserve the integrity of the listing database.

This industry has long been focused on common-sense regulation and proactively establishing requirements where there are gaps in coverage.

As I mentioned, DSHEA was supported by an unofficial army of people working to change the law in an area deeply important to them. And in the ensuing decades, additional amendments to the FDCA have established requirements for dietary supplements that were often backed by the supplement industry.

Dietary supplement listing is a common-sense reform that respects and preserves DSHEA's original goal of ensuring consumer access to a wide variety of high-quality and safe dietary supplements. Furthermore, listing would provide FDA with the information we need to help meet another pillar of DSHEA and one of our chief responsibilities: protecting the public from unsafe or otherwise unlawful products.

Cara Welch, Ph.D., is the director of the Office of Dietary Supplement Programs (ODSP) in FDA's Center for Food Safety and Applied Nutrition (CFSAN). She has been with FDA since 2014 in different roles working on regulatory, compliance and scientific matters for the agency's regulation of dietary supplements. Welch also worked in the Office of the Commissioner as the acting special assistant to the deputy commissioner for policy, legislation and international affairs, providing expertise on agency-level food policy issues. Prior to joining FDA, Welch was the SVP of scientific and regulatory affairs at the Natural Products Association (NPA). She earned her doctorate in medicinal chemistry from Rutgers University working with traditional medicinal African plants.

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