FDA proposes mandatory product listing, industry stakeholders divided
The US Food and Drug Administration released its budget proposal to Congress on Monday, which supports reform to the Dietary Supplement Health and Education Act of 1994 (DSHEA), including legislation that would require annual mandatory product listing of dietary supplement products.
The agency is requesting a total budget of $8.4 billion as part of the President’s fiscal year 2023 budget – a $2.1 billion increase over the agency’s FY 2022 appropriated funding level for investments in critical public health modernization, core food safety and medical product safety programs and other vital public health infrastructure.
“The funding outlined in this year’s FDA budget request is critical to fulfilling the agency’s mission as we continue our work on a wide range of COVID-19 and non-COVID priorities. The FDA has focused our budget request on some of today’s most urgent needs such as human and animal food safety, medical device security and e-cigarette oversight. We also continue to look ahead at our role in public health, including at ways to modernize our efforts to keep pace with evolving science, technology and potential public health emergencies,” said FDA Commissioner Robert M. Califf, MD. “Additional funding brings new ways to leverage opportunities to protect and advance the health of every American with reliable and science-based information. We look forward to continuing our work with Congress to help meet the critical public health challenges ahead.”
The FY 2023 request, which covers the period from Oct. 1, 2022, through Sept. 30, 2023, fully funds initiatives previously requested in the FY 2022 budget request and includes new efforts for high priority program areas, including legislation that would require annual mandatory product listing of dietary supplement products.
Modernizing the DSHEA
According to FDA, the US dietary supplement market has grown from about 4,000 products to somewhere between 50,000 and 80,000 products since DSHEA was enacted over 25 years ago. FDA said it is seeking to modernize DSHEA in order to strengthen the agency’s implementation and enforcement of DSHEA as well as to clarify FDA’s authorities relating to products marketed as “dietary supplements.”
Specifically, FDA is seeking to amend DSHEA to:
- Require annual listing with FDA of individual dietary supplement products, including basic information about each unique product
- Clarify FDA’s authorities over products marketed as dietary supplements to facilitate enforcement against unlawfully marketed products. These amendments would allow FDA to know when new products are introduced, quickly identify dangerous or illegal products on the market, and take appropriate action to protect consumers when necessary.
The report noted that the requested funding increase will allow FDA to increase scientific and regulatory capacity focused on dietary supplements: “Consumers are increasingly seeking out dietary supplements to augment their diet and improve their health. There has been a ten-fold increase in the dietary supplement market since the passage of DSHEA, from $4 billion to $40 billion. This trend has only increased during the COVID-19 pandemic. Yet most dietary supplements can be lawfully introduced to the market without ever notifying FDA. 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.”
Earlier this month, the Office of Dietary Supplement Program’s FY22 budget was raised from $10.7M to $12.7M.
Industry reacts
The budget request received mixed reviews from industry stakeholders, with some praising the FDA Commissioner and others accusing FDA of seeking pre-market approval under the guise of transparency.
CHPA applauds stronger oversight
“FDA’s recent request for a 34% 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,” said Scott Melville, President and CEO of the Consumer Healthcare Products Association. “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.”
AHPA: "Unaddressed concerns"
“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. 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,” Michael McGuffin, president of the American Herbal Products Association.
NPA: MPL equates to “Pre-market approval”
“FDA’s proposal to include mandatory product listing in their FY23 budget request is a nonstarter. 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,” said Daniel Fabricant, President and CEO of the Natural Products Association.
Efforts to budget's passage will face challenges in Congress where the Senate is split 50-50, with Democrats maintaining a slight majority in the House.
