US Consumer Health Industry In 2023: Mandatory Listing Has Supplement Sector’s Attention
Executive Summary
Chief executives of OTC drug and supplement industry trade groups discussed potential market and regulatory developments affecting their members’ businesses. HBW Insight reports here on whether support will emerge in Congress for FDA to gain MPL authority for all supplements sold in US.
The US dietary supplement industry begins 2023 watching Congress for signs of support among lawmakers for granting the Food and Drug Administration an authority which has generated disagreement in the industry.
Chief executives of OTC drug and supplement industry trade groups recently discussed questions about potential market and regulatory developments affecting their members’ businesses.
HBW Insight reports here on whether support and momentum will emerge in Congress for the FDA to gain authority to impose mandatory product listing with the agency for all supplements sold in the US.
In this series, HBW Insight previously reported on the consumer health sector’s outlook for supply chains and production and on OTC drug firms’ outlook for the FDA potentially publishing a final rule which would expand switch opportunities as well as their anticipation of marketplace results from the agency’s overhaul of its OTC monograph program and on the VMS sector keeping close watch on the FDA resolving its years-long hemp-derived ingredient conundrum (see related stories).
Still ahead, HBW Insight reports on the vitamin, mineral and supplement product sector’s outlook for market-boosting change potentially coming from the FDA resolving its protracted struggle to explain and enforce the NDI notification requirement.
MPL Land In Broader
Supplement Regulation Bill?
Mandatory product listing (MPL), a requirement suggested by the FDA with industry split on support, was proposed in multiple Senate bills without support in the House during the previous session. (Also see "US VMS Industry Makes Lame Duck Session List, Checks It Twice For MPL Language" - HBW Insight, 6 Dec, 2022.)
The American Herbal Products Association isn’t entirely opposed to an MPL proposal.
Realizing that “some of the trade organizations are still very supportive of MPL and would like to put together a package” of regulatory changes, the AHPA is open to amending the Food, Drug and Cosmetic Act “in a way that improves the consumer experience with dietary supplements” or “improves safety, improves quality, improves access and provides information,” said president Michael McGuffin.
“The kind of starting point is OK, what is the package and is MTL a necessary part of the package? Will congressional colleagues … be supportive of some of these other changes that industry would like so that we can have a discussion about a broad package rather than an MPLS only? That's going to be a great interest in the 118th Congress,” McGuffin added.
The association’s support largely would depend on whether MPL authority limits the FDA producing a public-facing database of information on VMS products available in the US, or imposes a “requirement” that the agency will use to launch regulatory actions.
For instance, would a listing including labeling with ingredients that the FDA deems unlawful for use or subject to an NDI notification authorize the agency “to use that listing to remove that product?”
“If that can't be described as actually pre-market approval, it's post-market removal? But I can't find much air between those two ideas,” McGuffin said.
The FDA, meanwhile, doesn’t need submissions from manufacturers or marketers to identify products available to US consumers, including products which would prompt enforcement action.
“The other argument is, well, FDA could do that today. They got the Google too. They can go find all the products they are tolerating some of those in the marketplace, even as there's an import alert ,even as they've publicly stated it's an NPI for which there's insufficient safety information. So, I don't really see that it changes a lot,” McGuffin said.
Cosmetic MPL Shows Supplement Listing Not Needed?
Appropriators’ report related to the FDA’s fiscal year 2023 budget as part of the omnibus spending bill Congress passed in December noted support among lawmakers for granting MPL authority to the agency. (Also see "Congress Boosts FDA Food Safety Budget Nearly $700M, Orders Reports On Formula Supply" - HBW Insight, 2 Jan, 2023.)
McGuffin suggests weighing appropriators’ mention of support against the results of the previous session of Congress.
“The expectation that mandatory product listing was going to go into effect on January 1, 2024, didn't happen,” he said.
“We'll continue the conversation. At this point, we’ll see what happens in the new Congress and we’ll see what happens with the other trade groups.”
Stakeholders and other parties interested in the question of MPL for the VMS sector should consider that the requirement was included in the legislation included in the omnibus spending bill to overhaul the FDA’s regulation of cosmetics manufacturing and marketing. (Also see "Compliance Clock Starts Ticking Under Historic Modernization of Cosmetic Regulations Act" - HBW Insight, 3 Jan, 2023.)
The legislation also authorizes the FDA to establish good manufacturing practices for cosmetics and requires facility registrations and adverse event reporting from firms.
“That's all new. They've been unregulated in all of those areas, and they have mandatory product listing,” McGuffin said.
The MPL requirement for cosmetic products isn’t the same requirement that’s been proposed in the Senate for VMS products. Supporters of an MPL for VMS products should consider the differences.
“The big differences are the dietary supplement concept MPL included a requirement for FDA to make public a database created from the listings. There is no such requirement for cosmetics,” McGuffin said.
“Another difference is when a cosmetics company introduces a new product, they've got 120 days to notify, to update their listing to identify their new product; whereas the dietary supplement version would have essentially required listing prior to issuing into the marketplace.”
Another difference isn’t stated in the cosmetic MPL requirement or the VMS product proposal, but in whether mandatory listing is needed for either category.
McGuffin pointed out supplements are made by firms subject to facility registration for 20 years and to GMP inspections for 15 years. Cosmetic firms haven’t had either requirement.
“As a baseline, what's known about dietary supplements in the marketplace is 15 years of GMP data and 20 years of facility registration data versus zero and zero for cosmetics,” he said.
“I think there's at least a question that has to be raised just because there's mandatory product listing for cosmetics based on a need identified, as FDA doesn't know anything about them, versus the need for supplements, where FDA knows a lot about them. That's the conversation we're going to have.”
‘No Value’ In Supplements At FDA?
The National Products Association’s view of an MPL for VMS products isn’t as nuanced. President and CEO Daniel Fabricant says the FDA’s suggestion that an MPL is needed is another sign the agency isn’t using its existing authorities to regulate the industry but asks for more anyway.
“They think their job when it comes to dietary supplements is to develop policies that make the industry smaller, that restrict the industry's ability to grow versus to regulate the space,” he said.
“As far as their whole pursuit of this MPL, their statements where the industry has grown to grown too big, too fast; one, that's not their call to make, and two, OK, ‘Well, you have authorities, you can go into any facility you want in a reasonable time and get that information you need’.”
Fabricant bases his view of the FDA’s regard for the supplement industry from his experience heading its dietary supplements programs and from the agency’s history with the industry.
“There is somewhat of an institutional culture that just sees no value in the commodity. Until that changes, how they conduct their business isn't going to change, and ultimately, that's going to have to change,” he said.
“When you hear messaging from people pretty high up at FDA that the industry has grown so much, is that a bad thing? Is that a negative? And I didn't think that FDA’s job was to inhibit growth. I thought their job was to protect consumers. The two aren't mutually exclusive.”
‘All Chaos’ Likely In Congress, Passing MPL Unlikely?
The NPA sees little likelihood for legislation passing to impose MPL for VMS products during this session of Congress.
Fabricant expects little cooperation or collaboration among Republicans in the House as well as with Democrat members.
“It's pretty safe to say that we're not going get [MPL legislation] in the next few years. It's probably going to be all chaos all the time because as far getting people to agree on anything, it seems like those ships have left shore right now,” he said.
Fabricant noted the NPA is having difficulty determining the thinking of GOP members who held up Kevin McCarthy’s election speaker in exchange for California representative’s pledges on committee assignments and procedures, including allowing holding a vote to remove the speaker on one member’s proposal.
The NPA’s difficulty could be because those lawmakers don’t know what they want.
“It’s like there's nothing other than to make misery. … There's really no clear sign, if they had clear designs on how they wanted rules restricted or things like that. Great, but this all seems like they want to kind of really shortcut the process for seniority, the process for who gets someone's committee and well, then you've got chaos. You've got to have some sense of order here,” Fabricant said.
HBW Insight will continue US consumer health industries' 2023 outlook with reporting on changes potentially coming from the FDA solving its new dietary ingredient notification requirement conundrum.