FDA budget request includes legislative proposal for a mandatory product listing

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A recent budget request submitted by the U.S. Food and Drug Administration (FDA) for Fiscal Year 2023 states that requested funds could help support the establishing of a “product listing requirement.” The idea of a mandatory product listing has been up for debate within the industry, with some seeing its benefits and others seeing it as a detriment. This isn’t the first time an FDA budget request included language asking for a legislative proposal to implement a mandatory product listing, but it has yet to come to fruition.

The language of FDA’s current request reads as follows:

“The resources requested will support the legislative proposal to amend the Dietary Supplement Health and Education Act of 1994 (DSHEA) by establishing a product listing requirement and strengthening FDA’s enforcement of products marketed as ‘dietary supplements’ that, for example, contain certain drug ingredients. New resources would support this proposal by funding necessary IT system development and new FTE to review additional product data, prioritize FDA investigations, and take compliance actions as needed to ensure that consumers who seek to augment their health with dietary supplements are protected from unsafe or otherwise unlawful products.”

Certain trade organizations see the value of a mandatory product listing or registry. The Council for Responsible Nutrition (CRN; Washington, D.C.), for example, created its own voluntary product registry that could serve as a proof of concept and template for an eventual mandatory product registry. This is called the Supplement Online Wellness Library (OWL).

The Consumer Healthcare Products Association (CHPA; Washington, D.C.) also supports the idea. In response to FDA’s budget request, CHPA president and CEO Scott Melville states: “FDA’s recent request for a 34 percent budget increase in FY2023 shows that new FDA Commissioner Robert Califf recognizes the critical importance of self-care in public health. FDA’s budget aligns with CHPA’s priorities to empower self-care by ensuring Americans continue to have access to safe, reliable, and affordable personal healthcare products including over-the-counter medicines, consumer medical devices, and dietary supplements.

“Specifically, we’re pleased to see FDA’s proposed budget also prioritizes modernization of dietary supplement regulation by supporting mandatory product listing, increasing inspection capacity, and clarifying its authority to better facilitate enforcement against unlawfully marketed products. This budget proposal makes it clear that Dr. Califf views stronger oversight of dietary supplements as a key part of FDA’s mission to advance the health and wellbeing of every American. We look forward to working with FDA and Congress as they map out the path forward for FY2023 and continue to empower consumer self-care.”

Other trade organizations are less positive about the budget request and the proposed mandatory product listing. To Daniel Fabricant, president and CEO of the Natural Products Association (NPA; Washington, D.C.), the mandatory product listing amounts to pre-market approval.

“FDA’s proposal to include mandatory product listing in their FY23 budget request is a non-starter,” says Fabricant. “Year after year, FDA receives more funding, including a $2 million increase in FY22. Yet, despite these increases, FDA consistently does less with more. Mandatory product listing is pre-market approval disguised as transparency and would only add to the bureaucratic nightmare the industry is experiencing with NAC and CBD. Instead of framing the dietary supplement industry as a regulatory crisis, FDA should recognize the importance of dietary supplements to the health and wellness of American consumers, as evident by the nearly 80% who use our products.”

The American Herbal Products Association (AHPA; Silver Spring, MD) is also skeptical about mandatory product listings, seeing them as an obstacle rather than a resource. “With the release of its FY23 budget request and summary documents, FDA has stated its desire to have Congress modernize dietary supplement regulation by amending the Federal Food, Drug, and Cosmetic Act to impose a mandatory product listing (MPL) requirement. AHPA also has interest in potential regulatory modernization, provided that it actually benefits consumers,” says Michael McGuffin, AHPA’s president. “To this end, there remain many unaddressed concerns about MPL proposals – including that any MPL requirement could destabilize the balance that the Dietary Supplement Health and Education Act struck between informed consumer access and appropriate FDA authority. With the goal of modernizing regulation while retaining this balance, AHPA advocates for the removal of obstacles to the dissemination of truthful and not misleading information to consumers. AHPA similarly advocates for amendments to the prior drug exclusion provision to establish a more-reasonable pathway to market for all natural products, even if that means that certain ingredients would eventually exist in both the pharmaceutical and dietary supplement markets.”

AHPA’s opinion on the issue also reflects that of its members, who according to a recent survey, largely believe a mandatory product listing would harm consumers and industry.