AHPA advocates for sensible regulatory solutions to address ‘bad actors’ as FDA pushes for MPL

• By: AHPA
• On: 09/23/2024 12:29:49
• In: Regulation / Legislation

September 23, 2024

The American Herbal Products Association (AHPA) disagrees with U.S. Food & Drug Administration (FDA) Deputy Commissioner Jim Jones's recent statement that there exist “virtually no barriers to entry to the dietary supplement market” – a claim he used to support the agency's continued push for a mandatory product listing (MPL) requirement for dietary supplements.
 
Jones made these statements as part of his September 10, 2024, testimony before the U.S. House Energy and Commerce Committee's Subcommittee on Health during its hearing entitled “Evaluating FDA Human Foods and Tobacco Programs.” At the hearing, Jones posited that “FDA authorities and resources have not kept up” with the dietary supplement marketplace that has grown exponentially since the 1994 enactment of the Dietary Supplement Health and Education Act (DSHEA). Jones further asserted that “bad actors” selling dangerous and illegal products put consumers at risk.
 
AHPA has a strong history of supporting amendments to dietary supplement laws when such changes clearly benefit consumers and minimize burdens on the industry. For example, AHPA was a leading advocate for establishing serious adverse event reporting requirements under the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006. While AHPA agrees that FDA has not “kept up” with the complexities of the modern dietary supplement market in certain respects, proponents of MPL requirements have not clearly articulated the benefits of a premarket product listing requirement. Due to this lack of clear benefits, AHPA has long taken the position that it cannot support – but does not oppose – the concept of an MPL requirement for dietary supplements.
 
That said, AHPA has opposed specific MPL legislative proposals based on their terms, which commonly would overly burden industry, not provide FDA with any information to which it does not already have access under existing law, and do nothing to disrupt the flow of drug-spiked products masquerading as dietary supplements, which would fall outside the scope of MPL requirements applicable only to products meeting the law's definition of “dietary supplement.”
 
“We have yet to be convinced that the supposed benefits of MPL would justify the costs to industry and FDA as well as the potential unintended consequences that would result from the establishment of such a system,” said AHPA President Michael McGuffin. “However, AHPA supports the creation of a new, targeted ‘prohibited act' that would give FDA the authority the agency seeks to remove dangerous and illegal products, such as tianeptine tablets and liquids, from the market while protecting the existing balance struck by DSHEA.”
 
AHPA remains committed to working collaboratively with industry colleagues, regulators, and lawmakers to ensure the safety and integrity of the dietary supplement marketplace. However, AHPA urges FDA to focus on enforcing its current regulatory authorities and addressing the real threats posed by dangerous and illegal drugs. AHPA will continue to advocate for regulatory and legislative solutions that will protect consumer access to legitimate products and empower the agency to protect the public health, including by enforcing against criminals who profit from harming consumers while misappropriating the mantle of the responsible dietary supplement industry.