Trade associations representing manufacturers and retailers of dietary supplement products have been lobbying to change language in a bill in the U.S. Senate as a congressional committee prepares to mark up the FDA Safety and Landmark Advancements (FDASLA) Act.
Introduction of the bill last month drew concerns from industry trade associations, including those that have generally been supportive of a legislative proposal that would require manufacturers to list their dietary supplement products with FDA.
The Council for Responsible Nutrition (CRN) has generally supported the requirement for mandatory product listing (MPL), including the Dietary Supplement Listing Act of 2022, a stand-alone bill introduced in April by Sen. Dick Durbin (D-Ill.) and co-sponsored by Sen. Mike Braun (R-Ind.). On the other hand, CRN has identified concerns with the FDASLA Act.
“We’ve said from the very beginning our mantra is [MPL is] a birth certificate, not a driver’s license,” CRN President and CEO Steve Mister said in an interview. “There cannot be any premarket approval in this legislation that would allow FDA to choose which products get put into the listing and which ones don’t.”
“We don’t see anything in the bill or in the Durbin bill that does that, but we are hearing all of the criticisms that are coming up from other parts of the industry,” he said. “We are asking that something be put expressly in the legislation that says FDA may not reject a listing that is properly given to it. This cannot be a form of premarket approval.”
Natural Products Association (NPA) President and CEO Dan Fabricant said his group has consistently opposed MPL, including in the Dietary Supplement Listing Act. One of the concerns he's expressed is FDA may delist a product containing an ingredient subject to a disagreement between FDA and industry over its legality, such as CBD. He's also raised concerns about the release of certain sensitive information to the public and feels FDA has ample authority today to crack down against unlawful products marketed as dietary supplements, as well as plentiful access to product labels.
“A public database of products is unnecessary to promote the public health and is inconsistent with the facility registration provisions of the Bioterrorism Act,” Fabricant wrote in a May 22 email to staff of the Senate Health, Education, Labor and Pensions (HELP) Committee. “Congress decided 20 years ago there was a compelling reason to protect information about food production from falling into the hands of people with malicious intent, and the discussion draft’s limited attempt to shield a couple of pieces of this information is insufficient.”
MPL has been a divisive issue within industry, highlighting philosophical differences over the best ways to protect dietary supplement businesses, foster confidence in the marketplace and even lobby Capitol Hill.
CRN, the Consumer Healthcare Products Association (CHPA) and the United Natural Products Alliance (UNPA) have been working together to communicate suggested changes to the FDASLA Act, according to Mister. Meanwhile, NPA and the American Herbal Products Association (AHPA) recently wrote a joint letter to some key lawmakers that expressed “grave concerns” with the FDASLA Act.
“It would be so much better if organizations who have concerns would come to the table and work towards a solution rather than standing on the sideline and lobbying these objections that can all be explained away,” Mister said. “There are forces larger than the industry that are at work out there: Consumer organizations who really are not happy with the fact that FDA does not know what’s on the market.”
The groups range from the American Medical Association (AMA) to the Center for Science in the Public Interest (CSPI) and Pew Charitable Trusts, “and those voices are not going away,” Mister continued.
He added, “Let’s sit down and find a solution that works for everybody rather than just standing on the side and saying, ‘We will not do anything.’ If you stand in front of a bus and you don’t get on board and try to steer it, you’re likely to get run over by the bus.”
AHPA President Michael McGuffin responded his organization has been “actively engaged” and “on the bus,” and he said to imply otherwise was “nonsense.”
“We believe that we have probably kept the bus on the straight and narrow as actively as anyone else,” McGuffin said in an interview. “It would be uninformed to imply that AHPA has not been at the table except that I know that all of the organizations that are supporters [of MPL] are fully aware of how actively AHPA has been at the table.”
He said AHPA has been engaged with congressional offices, its members and regulators, including Cara Welch, who directs FDA’s Office of Dietary Supplement Programs (ODSP).
“Any idea that we’re sitting around to see what happens is nonsense,” McGuffin added.
Fabricant also said NPA’s “been at the table all along,” and he criticized trade groups that supported the stand-alone legislation introduced by Braun and Durbin.
“Coming to the table isn’t supporting a bill hoping that the sponsors of the bill are going change it the way you like it later,” he said. “That’s lobbying 101. I’m not going to the clown table. We didn’t support a bill that didn’t protect the industry” from the outset.
In addition to generally opposing MPL, AHPA and NPA leaders also proposed certain changes to the FDASLA Act after the Senate HELP Committee released a draft version of the bill in May. For instance, Fabricant requested specifying FDA doesn’t have authority to “remove or restrict any product from listing unless that product has been the subject of final agency action.” And among its requested changes: AHPA opposed a proposed mandate that FDA create a public database under an MPL regime. Both trade associations have expressed concerns that an FDA-managed database of dietary supplement products could be used by plaintiffs’ attorneys hungry to exploit companies, including those whose labels may not appear in the database due to factors outside their control.
And in a joint letter to lawmakers with oversight of FDA issues—including Senate HELP Committee Chair Patty Murray (D-Wash.)—McGuffin and Fabricant maintained any legislation pertaining to supplements should be distinct from the FDASLA Act since supplement companies do not pay user fees and have not been a part of such legislation in the past. Several other FDA-regulated commodites, including prescription drugs, are subject to user fees.
And unlike cosmetics, MPL has not been subject to any debate in a congressional hearing, Fabricant said in an interview.
Mister doesn’t perceive as problematic the inclusion of dietary supplement language in the FDASLA Act.
“This is not a drug bill; this is an FDA bill,” he said. “If you look back at the history of the user-fee reauthorization, they often have things on them that are not specific to prescription drug user fees.”
Mister cited the challenges of passing legislation today, considering the divisive and “caustic” environment on Capitol Hill, adding “you have to find something that’s moving.”
“This is a bill that opens up the [Federal] Food, Drug & Cosmetic Act for amendment,” Mister said. “It is perfectly appropriate to put other things in the bill that have to do with the Food, Drug & Cosmetic Act. … This idea that, ‘Well, you don’t belong in the bill,’ that’s how things work in Washington today. You find something that is germane, that is moving, and then you hop on board.”
Fabricant countered industry is on the bill because “people who don’t know their way around Washington basically got captured by [Sen.] Dick Durbin and Pew Charitable Trusts [and] were willing participants in that capture.” He also pointed out the version of the user-fee reauthorization program introduced by the House of Representatives does not include language pertaining to dietary supplements.
Mister acknowledged concerns with the FDASLA Act as introduced. However, he dismissed the idea that it demonstrates CRN doesn’t understand the legislative process on Capitol Hill.
“I think it’s premature for folks to look at the bill as introduced, assume that that’s going to be the bill that gets enacted, and accuse us of not knowing what we’re doing,” he said. “It’s all part of a very sophisticated process.”
But if the Senate does not grant the changes in the FDASLA Act requested by his organization and others, CRN is prepared to oppose the bill.
“That is not a flip-flop,” he said, addressing criticisms made by the likes of NPA that CRN has changed its position on MPL, following introduction of the FDASLA Act.
CRN has “a certain list of things that we have said are important to us from the very beginning, and we’re trying to work the process,” Mister added. “But if it appears [lawmakers] are not listening to us, we will oppose that provision of the bill and try to have it stripped out.”
Fabricant claims the industry groups supporting MPL have lost credibility and “should not have a leg to stand on with anyone” unless they withdraw their support for the stand-alone Braun/Durbin bill.
MPL, he argued, is “not just a driver’s license, but it’s a registration, a certificate of insurance, it’s everything.”
Though industry trade organizations are firmly divided on MPL, McGuffin maintained the groups have been “united in almost everything” for well over a decade or two. He cited consensus on such issues as including making dietary supplements eligible for reimbursements under health savings and flexible spending accounts, elevating the FDA Division of Dietary Supplement Programs to an office, increasing funding for ODSP and advocating for strong FDA enforcement of its regulations.
The debate over MPL within industry associations presents a risk of implying such divisions are typical, according to McGuffin.
“It’s not the norm,” he concluded. “It’s out of the ordinary, which is probably why it’s so remarkable.”