Four trade associations on Thursday requested lawmakers allocate an additional $5 million to fund an office at FDA responsible for regulating dietary supplements.
The Office of Dietary Supplement Programs (ODSP) is responsible for regulating an industry whose products are used by more than 170 million consumers, according to the industry groups.
If the request to allocate more funds to ODSP is granted, the office will have an FY22 budget of around $15 million. Lindsay Haake, an FDA spokeswoman, said ODSP has a FY21 budget of more than $10 million, similar to FY20.
Those who signed the letter included the leaders of the American Herbal Products Association (AHPA), Consumer Healthcare Products Association (CHPA), Council for Responsible Nutrition (CRN) and United Natural Products Alliance (UNPA).
The trade associations sent the letter to the top two members of the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies: Sen. Tammy Baldwin, a Democrat from Wisconsin, who chairs the subcommittee; and Sen. Hoeven, a Republican from North Dakota, and the subcommittee’s ranking member.
Industry groups are lobbying Congress to give FDA’s supplements office more resources to police a growing marketplace. Following passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), the industry has ballooned from around $6 billion in annual sales to more than $55 billion last year, the groups advised Baldwin and Hoeven.
“This robust growth of the industry reflects not only increased interest among consumers for these products, but also significant advancements in the science of nutrition and wellness,” the trade organizations wrote. “This growth also brings new regulatory responsibilities for FDA to monitor appropriately the marketplace.”
The trade associations expressed their gratitude to lawmakers for providing increased funding over the past several years to support FDA enforcement actions against firms illegally producing and selling adulterated products.
“Responsible industry sees adequate funding for the agency as an important step for increasing consumer safety and industry adherence to the law, but also as a demonstration of the government’s commitment to eliminating illegal activity and leveling the playing field for the majority of companies already following the law,” the letter stated.
COVID-19 significantly impacted FDA’s operations and oversight, including the number of inspections of dietary supplement facilities.
FDA in FY20 conducted 289 inspections of dietary supplement facilities for compliance with cGMPs (current good manufacturing practices), Natural Products Insider previously reported. The number of inspections was down 52% from 598 in the prior fiscal year.
Nonetheless, FDA reported in its recent FY22 budget request to Congress that its dietary supplement compliance activity in FY20 resulted in 49 warning letters, 15 detentions and one injunction filed.
Also in its FY22 budget request, FDA stated “new funding would provide modest increases to FDA’s programs for cosmetics and dietary supplements.”
The industry groups urged Baldwin and Hoeven to provide a $5 million increase in funding for ODSP as part of their FY22 appropriations for FDA.
“While we fully understand and appreciate the budget pressures the Committee faces,” the trade associations wrote, “we believe such an increase is warranted given the substantial growth in, and size of, the marketplace and the need to make up for the lapse in inspections and related ODSP activities caused by the pandemic.”
FDA had no comment on the letter, and representatives for Baldwin and Hoeven did not immediately respond to a request for comment.