Industry slams FDASLA Act progress, fearing financial repercussions

15 Jun 2022 --- The move by the US Senate Health, Education, Labor and Pensions Committee (HELP) to pass the Food and Drug Administration Safety and Landmark Advancement (FDASLA) Act was met with disappointment by industry organizations, which have branded the legislation as “dangerous” and “unwise.”

If the legislation is also passed by the US Congress, the provisions will be written into law and would repeal the Bioterrorism Act’s protections for dietary supplement manufacturers.

This repeal would allow the FDA to reject ingredients like cannabidiol (CBD) and N-acetyl-L-cysteine (NAC) from being marketed as dietary supplements administratively. Industry argues this gives the FDA sweeping powers and lacks checks and balances.

“The FDA has been public with our desire to maintain the balance established by the Dietary Supplement Health and Education Act (DSHEA) of consumers’ right to access safe, well-manufactured and appropriately labeled dietary supplements with, just as importantly, upholding the FDA’s ability to protect the public from unsafe and otherwise unlawful products,” an FDA spokesperson, tells NutritionInsight.

Industry sacrifice?
According to the National Products Association (NPA), these provisions are “damaging.”

“The reauthorization of the FDA user fee program is not the appropriate vehicle to include controversial dietary supplement legislation, especially since it has not undergone the appropriate committee review and debate,” says Daniel Fabricant, president and CEO at NPA.

The NPA requested measures prohibiting the FDA from removing products from the listing unless and until the product is subject to final agency action.Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN) said they could not support FDASLA as it was.

“We will continue to pursue a mandatory listing program that simultaneously increases transparency for consumers and FDA without sacrificing essential protections for industry.” 

Financial ramifications
The NPA requested the Senate HELP committee remove the whole dietary supplement part of the FDASLA or include measures prohibiting the FDA from excluding or removing products from the listing unless and until the product is subject to final agency action.

“Prohibiting the FDA from excluding or removing products from the listing unless there is final agency action is the only way the industry can preserve any due-process rights against the agency should a dispute arrive, like the current disputes over CBD and NAC,” says Daniel Fabricant, president and CEO of NPA.

“We are disappointed that the significant economic, consumer and security-related concerns that have been raised by NPA, other experts and thousands of US constituents, appear to have fallen on deaf ears.”

Crackdown on illegal products
In response to NPA’s backlash, the FDA spokesperson stated: “The FDA does not comment on pending legislation. That said, the FDA has proposed – as part of the FY 2023 president’s budget – the authority to require products marketed as dietary supplements to be listed with the FDA.”

“This would allow the FDA to know when new products are introduced, quickly identify illegal products, improve transparency and promote risk-based regulation.”

CRN states the outcome of the FDASLA – which fails to include protections necessary for responsible industry to thrive – is disappointing.The FDA previously cautioned the public over bodybuilding products misleadingly labeled as dietary supplements, which could contain illegal substances associated with potentially serious health risks.

It has also sent warning letters to companies that illegally marketed products containing unapproved delta-8 THC.

Alternative solutions?
CRN adds that the outcome of the Senate HELP Committee vote on the FDASLA is highly disappointing. The organization argues the legislation fails to include protections necessary for responsible industry to thrive. It favors a mandatory product listing (MPL) program instead.

The MPL – which is included in FDASLA Act – will require companies to have the ingredients in their dietary supplement appear on the label under federal regulations, including, for example, the amount per serving of each listed ingredient, onditions of use, warnings and precautions.

“As the industry’s leading proponent for a federal mandatory product listing program operated by FDA, CRN remains steadfast in our belief that such a program can provide consumers and the agency the transparency they want and need from the marketplace.”

The DSHEA and Bioterrorism Act
Congress passed the DSHEA in 1994, granting the FDA regulatory power over dietary supplements.

DSHEA, on the other hand, does not require dietary supplement manufacturers to register their goods with the FDA, leaving the agency without the authority or information it needs to completely comprehend and oversee the market. 

“A public database as proposed in the FDASLA is completely inconsistent with the facility registration provisions of the Bioterrorism Act,” adds Fabricant.

“Twenty years ago, Congress decided there was a compelling reason to protect specific information about dietary supplement production from falling into the hands of people with malicious intent. The current version of the FDASLA insufficiently shields critical pieces of information.”

“Over 100,000 constituents have contacted to register their strong opposition to the dietary supplement provisions in the FDASLA. Our industry has never been required to pay user fees, nor do we have pre-emption from state tort claims for other FDA-regulated products,” continues Fabricant. 

CRN adds that any legislation it supports must safeguard consumers and responsible industry with essential protections. This includes unwavering language that FDA may neither reject a submission nor create qualifications on submissions that would permit the agency to reject a listing, concludes Mister. 

By Nicole Kerr