FDA again pushes proposal for dietary supplement product listing

As part of the Biden administration’s FY23 budget proposal to Congress, FDA outlined a proposal to amend the Dietary Supplement Health and Education Act of 1994 (DSHEA) through a requirement that supplement products be listed annually with the agency, "including basic information about each unique product."

FDA also is seeking to clarify its “authorities over products marketed as dietary supplements to facilitate enforcement against unlawfully marketed products,” according to its report justifying its proposed budget request.

“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 stated.

FDA also proposed mandatory product listing for dietary supplements in budget requests to Congress during the Trump administration.

Lawmakers have been working on draft language to require dietary supplement products be listed with FDA, according to industry sources, although no such bill has been introduced in Congress.

Industry stakeholders are hotly divided on the advantages and disadvantages of mandatory product listing.

Advocates of FDA's proposal have said it would have many benefits, including providing consumers a centralized resource to learn about ingredients they're seeking and providing retailers confidence that all products on their shelves are known to FDA. Another argument is mandatory product listing would help FDA better focus its enforcement resources on non-compliant products.

"We share FDA’s interest in creating a more transparent industry for regulators and consumers alike," said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), in a statement. "We also appreciate FDA’s continued efforts to clarify its jurisdiction over products that are marketed as dietary supplements but fail to actually contain a legal dietary ingredient. While we differ from FDA’s current reservations on enforcement—CRN believes FDA’s Office of Dietary Supplement Programs does indeed have authority over products that call themselves out as supplements regardless of their contents—we are on record supporting legislation to provide clarity on this matter."

Scott Melville, president and CEO of the Consumer Healthcare Products Association (CHPA), said he was "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 [FDA Commissioner Dr. Robert Califf] views stronger oversight of dietary supplements as a key part of FDA’s mission to advance the health and wellbeing of every American," Melville added in a statement. 

On the other hand, Natural Products Association (NPA) President and CEO Dan Fabricant described FDA's proposal for a mandatory product listing as a "non-starter."

"Year after year, FDA receives more funding, including a $2 million increase in FY22," he said in a statement. "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."

The American Herbal Products Association (AHPA) also has questioned the benefits of mandatory product listing.

"AHPA also has interest in potential regulatory modernization, provided that it actually benefits consumers," said Michael McGuffin, president of AHPA, in a statement. "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."

Since DSHEA’s passage, the U.S. market has grown from roughly 4,000 dietary supplement products to somewhere between 50,000 and 80,000 products, according to FDA’s budget proposal.

"There has been a ten-fold increase in the dietary supplement market since the passage of DSHEA, from $4 billion to $40 billion," FDA stated. "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."

FDA said its requested resources would support its legislative proposal to amend DSHEA by creating a product listing mandate and strengthening its "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 [full-time employee] 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," the agency added in its budget request report.

FDA is seeking a FY23 budget of $8.4 billion, a nearly 34% ($2.1 billion) increase over its FY22 appropriated funding level. FDA's request includes $3.7 billion in budget authority, an increase of $356 million, and $3 billion in user fees, an increase of $153 million. Another $1.6 billion in requested funding would support FDA's capabilities to prepare for future pandemics. 

Of the proposed $356 million increase in its budget authority, FDA would earmark $76 million in new funding towards strengthening food safety and nutrition, according to the Alliance for a Stronger FDA. 

In a news release, FDA said the increased funds would be used to invest in "critical public health modernization, core food safety and medical product safety programs and other vital public health infrastructure.”

Recently, the FDA office responsible for overseeing dietary supplements got a $2 million boost in funding through the end of the current fiscal year. The Office of Dietary Supplement Program’s FY22 budget was increased to $12.7 million, up from $10.7 million.

“With additional funding, ODSP will be able to increase its compliance and enforcement efforts of unlawful products, thus helping to protect the public health,” an FDA spokesperson told Natural Products Insider.

FDA FY21 activities review

FDA’s budget proposal announced Monday also disclosed the agency’s recent activities related to dietary supplements and other FDA-regulated commodities.

While FDA acknowledged it inspected fewer dietary supplement facilities in FY21, the agency said its compliance activities resulted in 111 warning letters, 1,299 import refusals, the filing of three injunctions, one seizure and 22 criminal convictions.

“FDA continued to emphasize regulatory actions aimed at protecting consumers from dangerous or otherwise unlawful products—including fraudulent products that were, in some cases, marketed as dietary supplements,” the agency stated. “These included products making unlawful claims related to Covid-19; claims to cure, treat, mitigate, or prevent diabetes, depression and other mental health disorders, and infertility. In addition, FDA also posted 69 public notifications for products that have been found to be tainted with undeclared drugs, many of which are marketed as dietary supplements.”

FDA in FY21 also responded to 49 new dietary ingredient notifications and acknowledged 27 of them without objections. It objected to the other notices due to identity and safety concerns and for other reasons.

During this same period, FDA also received more than 2,400 adverse event reports related to dietary supplements, which are evaluated by clinical reviewers in the Center for Food Safety and Applied Nutrition, according to its budget request.