Trade associations request additional $5 million in funding for FDA supplement office

By Hank Schultz contact

- Last updated on GMT

©Getty Images - YaYa Ernst
©Getty Images - YaYa Ernst

Related tags: Dietary supplement caucus, Dietary supplement industry, regulations

Four trade associations have banded together to ask Congress to allocate an additional $5 million in funding to help the US Food and Drug Administration regulate dietary supplements.

The four associations letter was send yesterday to Sen. Tammy Baldwin, D-WI, and Sen. John Hoeven, R-ND.  The two are the chairman and ranking member of the Senate subcommittee that governs recommendations for the FDA budget.

The letter was signed by the heads of the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition on the United Natural  Products Alliance.  UNPA led the funding request effort this year.

The additional $5 million is requested to bolster the efforts of FDA’s Office of Dietary Supplement Programs.  ODSP Acting Director Cara Welch, PhD, said the number of full time equivalents (FTEs), a headcount equivalent, stands at about 30 to 32 in the office at any one time.  Industry stakeholders have frequently observed that this is a tiny number to regulate an industry that has grown by leaps and bounds since the passage of the Dietary Supplement Health and Education Act in 1994 that created the modern marketplace.

Bigger market, more violative products

“In the United States, more than 170 million consumers use dietary supplements each year as a cost-effective way to take an active role in managing their healthcare. After the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement industry has grown from around $6 billion in annual sales to over $55 billion in 2020. 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 letter stated.

Industry stakeholders have long opined that FDA lacks enough funding and manpower to police this growing market.  The advent of online sales, something only dimly foreseen in 1994, means new violative products can enter the market with dizzying speed.

“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 read.

Inspections backlog

The associations also noted that 2021 and 2022 will be catchup years for FDA, as the Agency struggles to bring site inspections back up to speed and clear a backlog that accumulated during the global pandemic.

“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,”​ the associations wrote.

Related topics: Regulation

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