Industry hits back over FDASLA Act aiming to increase regulation in supplements and cosmetics

30 May 2022 --- New legislation granting the US Food and Drug Administration (FDA) more control over cosmetic and dietary supplements, has been met with strong opposition across the industry. Amid accusations of increasing powers to the agency, industry organizations are demanding a rewording of the FDA Safety and Landmark Advancement (FDASLA) Act of 2022.

The act, introduced by the US Senate Committee on Health, Education, Labor and Pensions (HELP), will reauthorize the FDA’s user fee arrangements for prescription drugs, generic drugs, biosimilars and medical devices. As a result, the FDA will have control over reviewing and approving the cosmetics and dietary supplements US citizens use.

“This legislation will ensure the FDA has the resources it needs to do its work and enable the agency to finally provide serious oversight of the cosmetics and dietary supplements people in the US use every day,” Patty Murray, committee chair of HELP.

“Families want to know the products they entrust their health to are safe and effective – which is why this bipartisan legislation is so important.”

A “redundant” move?
The American Herbal Products Association (AHPA) stresses its opposition to mandatory product listing (MPL) – which is included in FDASLA Act – because it is “unnecessary and redundant” to existing FDA authority. The AHPA adds the Act is unlikely to address any clear regulatory need and will reduce access to safe and lawful dietary supplements.

If an MPL requirement is established, AHPA further proposes extensive changes that would minimize its burdens and outlines several alternate revisions to the Federal Food, Drug and Cosmetic Act that would advance the health of US citizens by providing better education for and access to safe dietary supplements.

The Act will allow the FDA to have control over reviewing and approving the cosmetics and dietary supplements US citizens use.The Council for Responsible Nutrition (CRN) responded to the Senate HELP Committee’s introduction of the FDASLA Act. “CRN is disappointed with the FDASLA Act,” says Steve Mister, president and CEO at CRN.

“A strong mandatory listing program administered by the FDA would provide consumers and regulators with a complete understanding of the marketplace and the range of products and ingredients currently marketed as dietary supplements.”

“However, mandatory product listing should not be used as a barrier for a compliant dietary supplement to enter the market. Unfortunately, the current draft of this bill does not include this essential protection, nor does it safeguard confidential business information,” Mister continues.

Fears surrounding the wording
The Consumer Healthcare Products Association (CHPA) said the FDASLA act: “takes steps needed to provide consumers with more information and greater transparency into products they rely on every day, including dietary supplements and cosmetics,” outlines Scott Melville, CEO of CHPA.

Nonetheless, both the CHPA and CRN voiced concern over the language used in the Act, amid fears this will grant the FDA sweeping powers.

“This bill includes new language that would grant FDA broad authority to potentially prevent legitimate dietary supplements from entering the market at the whim of the agency,” Mister explains.

“This new legislation must provide explicit assurance that the FDA may neither reject a submission nor create qualifications on submissions that permit the agency to reject a listing. The new legislation should also avoid creating new prohibited acts which could have unintended consequences for the industry.” 

CHPA and CRN voiced concern over the language used in the Act, amid fears this will grant the FDA sweeping powers.Melville adds the language in the bill should go further to provide consumers additional assurances regarding the safety and integrity of dietary supplements sold in the US.

A “need” to step in with regulations
In detail, the FDASLA Act will boost cosmetics and dietary supplement regulation, increase market competition to bring drug costs lower and increase the number of locations where opioids and other dangerous medicines can be safely disposed of.

Additionally, the Act will modernize the data used to promote the development of medical products, including the use of alternatives to animal testing.

The need for regulations within the cosmetics industry is further highlighted by the FDA, which previously issued a warning that procedures used by some cosmetic industry members to test for asbestos in talc-containing cosmetic products may not always identify asbestos – a known human carcinogen with well-documented health hazards.

Following new rulings regarding the European Commission’s Cosmetic Products Regulation, the UK government is amending its cosmetics legislation. The move will see the ban of chemicals used in skin lightening products and fragrances in cosmetics, such as methyl heptine carbonate, atranol and chloratranol.

By Nicole Kerr