Mandatory product listing (MPL) has been a central tenet of FDA’s plans to modernize the 26+ years old Dietary Supplement Health and Education Act (DSHEA), since it was mooted in 2019 by then-Commissioner of the FDA Dr Scott Gottlieb. The idea was already being discussed by some heavyweight stakeholders prior to 2019, with, for example, Scott Bass from Sidley Austin supporting a listing in 2018. Former Senator Orrin Hatch has also said it “makes sense.”
Recent reports suggest that legislation proposing mandatory product listing for dietary supplements could be soon be introduced in Congress.
“Visibility into the marketplace”
Speaking at the AHPA Botanical Congress earlier this year, Dr Cara Welch, then-acting director of the Office of Dietary Supplement Programs (ODSP), said: “With mandatory product listing, we believe it’s possible to construct a narrowly-tailored requirement that respects and preserves DSHEA’s original vision of consumers’ right to access safe, well-manufactured, and appropriately labeled dietary supplements with, just as important, upholding FDA’s ability to protect the public from unsafe and unlawful products.
“We think there are ways to successfully implement a product listing requirement that does not impose significant burdens on responsible industry or even slow the introduction of products to the market.
“But the simple fact of FDA having visibility into what the marketplace looks like at any given moment – this facilitates our ability to identify products, allocate resources, and act more quickly to remove unsafe or illegal products.”
Dr Welch followed up these comments at the Dietary Supplements Regulatory Summit in July by saying that FDA is well aware that adding a premarket listing requirement to existing regulations is an idea that that does not enjoy universal appeal.
Some trade associations, notably the Council for Responsible Nutrition, have come out strongly in support of such an initiative.
AHPA has thus far taken the stance of neither supporting nor opposing the proposal, and the association recently conducted a survey to assess its members’ stance on the topic.
The survey* included neutrally presented, equally weighted arguments commonly made in support of and in opposition to MPL. AHPA members responded to the survey and answered two questions about MPL’s potential impact on the dietary supplement market (consumers and industry) and what position AHPA should take on the issue
The results indicated that approximately 52% of respondents stated that MPL would harm dietary supplement consumers and industry, and that AHPA should actively oppose MPL. Approximately 18% of respondents stated that MPL would benefit dietary supplement consumers and industry, and that AHPA should actively support MPL. The remaining respondents, about 30%, stated that MPL would not provide significant benefit or harm, and supported AHPA maintaining its current position to “refrain from supporting” MPL.
AHPA President Michael McGuffin said his organization is committed to continuing its engagement with “industry and government stakeholders to better help all involved understand the potential costs and benefits of MPL”.
* the survey focused on Active member responses other than “I don’t know” or “I need more information”, from 72 total responses from all AHPA members.