Jim Jones, the FDA’s deputy commissioner for human foods, highlighted that the market has grown more than ten times in size since Congress passed the Dietary Supplement Health and Education Act in 1994, and argued that authorities had failed to keep up with this “quickly expanding” marketplace.

“There are virtually no barriers to entry to the dietary supplement market,” he told the Health Subcommittee of the House Energy and Commerce Committee in the US House of Representatives. “Bad actors have continued to exploit the halo created by the quality work of legitimate manufacturers by continuing to distribute and sell dangerous products that put customers at risk.”

However, critics described his testimony as “disappointing”, saying that it did not accurately reflect the state of play in the US nutraceutical market.

Notion that industry size impedes agency’s work is ‘irresponsible’

Daniel Fabricant, Natural Products Association (NPA) president and CEO, described Jones’s argument as “irresponsible”.

“We held out hope for new ideas, so it’s troubling to see that new leadership holds the same antiquated views on the industry,” he wrote in a LinkedIn post. “The notion that the size of the industry is somehow an impediment to the agency doing its job is irresponsible.

“The agency can get labels now via inspection authorities, and should know everyone who is out there already, per the FSMA facility registration requirements. Getting those labels hasn’t been a priority, so why is it only a priority for Congress? If they don’t know who is out there per the registration requirements, that’s news to us, and that should be a top priority over all else.

“More concerning is that the agency seems more than happy to let the states run amok on developing new laws for the industry that are in contravention to the federal requirements, yet the agency remains silent. It appears that ideal for them would be new authorities but no responsibility.”

Listing requirement would promote safety and increase regulatory transparency, says FDA

Jones’s testimony follows a July proposal in which US Senate majority whip Dick Durbin introduced legislation requiring dietary supplement manufacturers to list their products with the FDA – a legal change that the agency has supported for years. Durbin previously pushed for such changes to be made in 2022, but the legislation failed to pass Congress.

If successful this time, the Dietary Supplement Listing Act of 2024 would require companies to provide the FDA with product names, ingredient lists, and electronic copies of product labels. It also stipulates that companies make allergen statements and share any health claims relating to the product.

In his testimony supporting the Act, Jones said: “We are committed to working with Congress on authority to require dietary supplement manufacturers to list their products, including the ingredients in their products, with FDA.

“FDA is confident that an improved framework to regulate dietary supplements would bring significant benefit to public health by promoting consumer safety, allowing FDA to quickly identify dangerous or illegal products on the market to take appropriate action, and increasing regulatory transparency.”

However, Fabricant rejected these claims.

“Mr Jones also seems unaware of the significant burdens that manufacturers and brands of supplements have to meet to enter the industry and be compliant with not just the FFDCA [the Federal Food, Drug, and Cosmetic Act] ... but with FTC [the Federal Trade Commission] and other state and federal authorities,” he added.

“The adverse event reporting requirements are the same for supplements and OTC [over-the-counter] medicines, yet I have never heard the drug programme at FDA bash the OTC industry for having ‘virtually no barriers to entry’. Unfortunate but not surprising.

“For the supplement programme to be more successful than it is currently regarded, better priorities would be to work with the industry and all stakeholders on state pre-emption, drug preclusion interpretation, and enhanced/targeted/augmented cGMP [current good manufacturing practice] inspections. No new authorities would be needed to advance these issues.”