On December 23, 2022, the House passed the Consolidated Appropriations Act of 2023 (H.R.2617), anomnibus spending billconsisting of all 12 fiscal year 2023 appropriations bills. It provides $1.7 trillion in discretionary resources across the fiscal year 2023 appropriations bills. On Thursday, December 29, 2022, President Bidensigned H.R. 2617 into law.
The government funding package includes emergency supplemental funding to help deal with recent natural disasters and extreme weather events, as well as emergency resources to support Ukraine. What it does not include: provisions establishing amandatory product listing (MPL)requirement for dietary supplements marketed in the United States.
Industry responds to exclusion of MPL provisions
Natural products industry leaders have been divided on the topic of MPL.
The American Herbal Products Association (AHPA) reported that the exclusion of MPL provisions came within weeks of AHPA’s letterto the leadership of the Senate and House of Representatives committees with oversight over the U.S. Food and Drug Administration (FDA). AHP requested that MPL language be excluded from any must-pass appropriations legislation considered during the last weeks of this Congress. AHPA also noted that the exclusion of MPL followed aDecember 7 floor speechin whichSen. Dick Durbin(D-IL) made his final appeal to his Senate colleagues to include MPL legislation in the omnibus bill.AHPA shared,"AHPA has been actively engaged with legislative discussions on MPL for years and will continue to represent the diverse perspectives of AHPA’s membership in future discussions. These efforts, among others, are part of AHPA’s continued advocacy for modern dietary supplement regulations that will provide greater consumer access to truthful information and a more equitable and transparent path to market for new dietary ingredients."
Related: AHPA: Mandatory Product Listing Could Cost Dietary Supplement Industry $20M
Daniel Fabricant, Ph.D., President and CEO of the Natural Products Association (NPA), said, “This is a big win for consumers, for innovation, and for access to the healthy products that millions of Americans rely on and turned to during the height of the pandemic. We expected that industry critics would try to use the lame duck as another backdoor opportunity to jam this through and that’s exactly what happened. But thanks to NPA’s advocacy and the tens of thousands of individuals who took part in our grassroots campaign, that effort was rejected. We are incredibly thankful to our members, our Board of Directors, and our allies in Congress who stood firm against this misguided and unnecessary approach.”
Related: NPA Alerts DHS, HHS & DOJ to Concerns with Dietary Supplement Listing Act of 2022
Commenting on behalf of the Alliance for Natural Health USA, Gretchen DuBeau, Executive and Legal Director, said,"ANH welcomes the news that mandatory product listing will not be included in the omnibus funding bill this year. U.S. consumers appreciate access to a broad range of affordable dietary supplements. They do not want unnecessary additional regulation that will increase costs and decrease access to this overwhelmingly safe option to support their health naturally."
Related: Dietary Supplement Listing Act of 2022 Introduced; Industry Divided
Regarding MPL, Consumer Healthcare Products Association (CHPA) said it is supportive of the concept, but "we do not support it as a standalone measure, as FDA requires more tools to remove bad actors and illegal products from the marketplace. CHPA supports a more comprehensive approach to regulatory reform that includes MPL, as well as additional tools FDA needs to stop criminals, such as increased cGMP inspections and Remote Regulatory Assessments. While CHPA appreciates the attention given to dietary supplement reform this year, there is undoubtedly still more work to be done to appropriately balance consumer access with FDA oversight, and CHPA looks forward to working with lawmakers in support of comprehensive dietary supplement reform in the 118th Congress.”Commenting on its stance on MPL and clarifying its view of what MPL is, the Council for Responsible Nutrition (CRN), stated: "CRN is a longtime supporter of FDA’s calls for a federal dietary supplement listing program as a critical new tool for the agency, retailers, and consumers offering more transparency of the dietary supplement marketplace in the U.S. CRN’s Board of Directors, which drives the association’s policies and legislative strategy, has repeatedly endorsed both the general policy and the specific legislative aspects of a dietary supplement product registry for several years. In 2017, CRN launched theSupplement OWL as a model of a product registry, which is now required for CRN members who market supplements in the U.S., and to which many non-member companies voluntarily submit their labels as well."
CRN also clarified: "Dietary Supplement Listing Act is not a form of premarket approval. Nothing in the original legislation conferred any ability by FDA to reject a submitted label and in an effort to counter this misinformation campaign, CRN requested and obtained the insertion of language stating, “Nothing in this section shall be construed…to grant the Secretary authority to require the approval of a dietary supplement prior to marketing.” More recently accepted revisions would also add, “A listing is deemed complete once all fields of required information have been completed by the responsible person who represents that the product will be marketed in the United States as a dietary supplement.” Claims that dietary supplement listing is akin to premarket approval of supplements are just false."
In a January 3, 2023 response to the Dietary Supplement Listing Act’s exclusion from the end-of-year Omnibus package, CRN expressed disappointed that Dietary Supplement Listing, as revised by Senator Richard Durbin (D-IL) after extensive negotiations with CRN, was not included. "Dietary supplement listing could have advanced FDA’s oversight of the marketplace and demonstrated the industry’s commitment to be held accountable among retailers and consumers. The absence of full industry support of a listing in the 117thCongress is a missed opportunity," CRN said in a statement. "CRN is nevertheless encouraged by the inclusion of language in the Agriculture/FDA Appropriations Committee report that accompanies the legislation which states: 'The agreement supports FDA's proposal to require that all products marketed as dietary supplements be listed with FDA. The agreement believes that FDA's authorities over products marketed as dietary supplements should be clarified to facilitate enforcement against unlawfully marketed products.'”
CRN reported that this bi-partisan, bicameral report language indicates there is "substantial interest in Congress to address the gap in enforcement tools which hampers FDA’s oversight of the $56 billion dietary supplement industry."
What's Next for MPL?
AHPA said Sen. Durbin reportedly has vowed to continue to push for MPL legislation in the next Congress, which will convene in January 2023.
CRN President & CEO Steve Mister further stated: “Dietary supplement listing will happen, it will just take a little more time. We encourage our fellow industry stakeholders to exhibit leadership and come to the negotiating table in the next Congress to address their concerns.
“As FDA has repeatedly stated, it cannot regulate what it can’t see, and dietary supplement listing will illuminate the dark corners of the marketplace by requiring all dietary supplement labels to be enrolled with the agency when these products come to market. Responsible companies across this industry have complained for years about lax enforcement of DSHEA—it’s disheartening that when the chance to provide a meaningful tool to FDA was presented, it didn’t receive more widespread support.
“Much disinformation has been propagated by the opponents of a dietary supplement product registry. We are confident that, with time, many of these opponents will appreciate its benefits. Reputable companies will be advantaged by that level of transparency and the ability to identify and protect themselves against the very actors that vex responsible players today.
“Retailers are looking for ways to self-regulate and curate the products they offer for sale; consumers want to know the products they purchase are visible to regulators. CRN looks forward to advancing these goals with our continued support for dietary supplement listing.”
CRN Welcomes Passage of INFORM Consumers Act
Regarding the INFORM Consumers Act, which was included in the end-of-year Omnibus package, CRN said this legislation is "critical to ensuring that consumers may purchase safe products from online marketplaces. With the enactment of this policy, online marketplaces will now be required to verify the identity of high-volume third-party vendors; this will help to combat the sale of counterfeit and illicit products."CHPA applauded the passage of the omnibus appropriations bill, noting that the inclusion of the INFORM Consumers Act "will protect millions of American consumers from bad actors peddling counterfeit and stolen goods by creating more transparent and accountable marketplaces. CHPA thanks Senators Dick Durbin and Bill Cassidy and Representatives Jan Schakowsky and Gus Bilirakis for their leadership on this critical issue."
CHPA also said the bill includes several CHPA-backed measures. “Included in this package is the Modernization of Cosmetics Regulation Act," CHPA shared. "Beauty and personal care products have an excellent safety record, but the key statutory provisions authorizing FDA regulation of these products have not been updated since the enactment of the Federal Food, Drug, and Cosmetic Act of 1938. CHPA has long pushed for the modernization of these regulations and is pleased that FDA will now have the appropriate authority and resources it needs to oversee this sector for decades to come."
