Mandatory product listing provision removed from FDA user fee reauthorization in newly introduced appropriations bill

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The U.S. Senate Committee on Appropriations has released the text of the “Continuing Appropriations and Ukraine Supplemental Appropriations Act of 2023.” The bill includes the FDA user fee reauthorization without the inclusion of so-called “super riders” in order to ensure the passage of this “must-pass” legislation. Among the excluded “super riders” was the provision to establish a mandatory product listing (MPL) or registry for dietary supplements. This provision was originally attached to the “FDA Safety and Landmark Advancement Act (FDASLA)” drafted by the U.S. Senate Committee on Health, Education, Labor, and Pension (HELP).

Industry has been split on the issue since the introduction of the “Dietary Supplement Listing Act of 2022” by U.S. Senate Majority Whip Dick Durbin (D-IL). However, the inclusion of the provision in FDASLA, must pass legislation, placed a ticking clock on industry advocates to either negotiate more favorable language or convince Congress to drop the provision. Advocates like the Natural Products Association (NPA; Washington, D.C.) have been vocal opponents of mandatory products listings, and argue that the Durbin bill and FDASLA provision provide FDA with too much administrative power over dietary supplements.

“The FDASLA provides the FDA with an excessive administrative burden that exceeds the current scientific safety evaluation for FDA when companies wish to introduce a new supplement into the market. Providing the FDA with authority to decide administratively what is to be listed will only be abused, causing extreme economic harm,” wrote Daniel Fabricant, PhD, president and CEO of NPA, in a letter to the Senate HELP Committee. NPA, along with the American Herbal Products Association (AHPA; Silver Spring, MD), have also argued that a MPL is unnecessary and that the current regulatory framework gives FDA sufficient tools to enforce regulation, even if the agency does not effectively use its authority.

On the other hand, the Council for Responsible Nutrition (CRN; Washington D.C.) has shown support for Durbin’s bill, arguing that MPL will give FDA a more complete understanding of the industry, and allow for more effective oversight without becoming a barrier to entry. CRN set up its voluntary product registry, the Supplement Online Wellness Library (OWL), as a model for what a mandatory product listing database could look like, and demonstrate industry’s ability to comply with the requirements. The Consumer Healthcare Products Association (CHPA; Washington, D.C.) also expressed support for MPL as an important component for modernizing DSHEA, but emphasized the need for more comprehensive reform.

Despite ideological differences on the merits of MPL, the language of FDASLA was viewed as overly burdensome on industry, even for CRN and CHPA. Advocates such as AHPA, CRN, and CHPA, therefore, urged the Senate HELP Committee to revise the language to include industry protections, but the bill passed committee anyway, losing any support from industry advocates it did have. However, an FDA user fee reauthorization bill introduced on the House side did not include a MPL provision, and ranking member of the Senate HELP Committee, Senator Richard Burr (R-NC), introduced his own version of FDA user fee reauthorization called the “Food and Drug Administration Simple Reauthorization Act” which excluded the MPL provision. Burr cited concerns about the burdensomeness of the dietary supplement provision, its threat to innovation by not including protections for proprietary business information. It became clear that there were differences of opinion on the merits of the dietary supplement provision within Congress as well.

The exclusion of a MPL provision for this latest draft of the appropriations bill is a relief for some and a missed opportunity for others. For example, CRN in response to the new appropriations bill reiterated its commitment to the creation of a mandatory product listing. “CRN is pleased that the text of the continuing resolution, which includes the reauthorization of the drug user fee program, has been released and appears likely to be passed by Congress later this week, continuing to fund important functions at FDA,” said Julia Gustafson, CRN’s vice president of government relations. “We are, however, disappointed that, due to time constraints and the need to produce a ‘clean bill’ that can win congressional approval at this eleventh hour, leaders of both parties decided remove all of the ‘super riders’ that were included by the U.S. Senate to this ‘must-pass’ legislation. CRN expressed concerns with that text as it passed the Senate HELP Committee, but we believe our concerns can be addressed to produce a workable registry for all dietary supplements.

“CRN remains committed to the creation of a mandatory registry for dietary supplements, and the greater insight it will give to FDA as regulator and the transparency it will offer to all consumers. Already, conversations are occurring on Capitol Hill about other possible vehicles to enact MPL before the end of this Congress, and we look forward to continuing our seat at these negotiations.”

While happy with the outcome, Fabricant is not celebrating just yet, acknowledging that efforts to establish MPL will continue. “We’re not taking any victory laps,” he told Nutritional Outlook. “First and foremost, thanks to everybody who wrote emails and called their members of congress. This narrative that the industry is dangerous, the industry is un- or under-regulated is a problem, and the bigger problem is we have folks within the industry now that are spreading that, so we have to stay vigilant of that. Our message to everybody is to stay on it. We’re going to keep our grass roots up, Senator Durbin made it clear he’s going to try again and we’re going to keep pushing back. So, we’re a long way from done. While we appreciate everyone’s work on this and everyone’s emails, and we’re grateful, we need to keep going. We’re not done yet, there are no victory laps.”

While happy with the outcome, Fabricant is not celebrating just yet, acknowledging that efforts to establish MPL will continue. “We’re not taking any victory laps,” he told Nutritional Outlook. “First and foremost, thanks to everybody who wrote emails and called their members of congress. This narrative that the industry is dangerous, the industry is un- or under-regulated is a problem, and the bigger problem is we have folks within the industry now that are spreading that, so we have to stay vigilant of that. Our message to everybody is to stay on it. We’re going to keep our grass roots up, Senator Durbin made it clear he’s going to try again and we’re going to keep pushing back. So, we’re a long way from done. While we appreciate everyone’s work on this and everyone’s emails, and we’re grateful, we need to keep going.”

For a full breakdown of arguments for or against MPL, listen to Episodes 11 and 12 of The Nutritional Outlook Podcast, available on SoundCloud, Apple Podcasts, Google Podcasts, and now Spotify.

Updated on Wednesday September 28, 2022 at 2:59PM