Senate Health, Education, Labor and Pensions (HELP) Committee Chair Senator Patty Murray (D-WA), and Ranking Member Senator Richard Burr (R-NC), officially introduced the FDA Safety and Landmark Advancements (FDASLA) Act, including language to mandate product listing of dietary supplements. The committee had previously released a discussion draft of the bill. 

The legislation reauthorizes FDA’s prescription drug, generic drug, biosimilar, and medical device user fee agreements and is considered must-pass legislation. However, the House of Representatives Energy and Commerce Committee version of the FDA user fee package does not include the mandatory product listing provision. 

The Council for Responsible Nutrition (CRN) has advocated for federal mandatory product listing, and supported the Dietary Supplement Listing Act of 2022 (S. 4090), introduced by Sen. Dick Durbin (D-IL) and Sen. Mike Braun (R-IN) in April.

However, CRN said the FDASLA Act fails to 1) provide explicit assurance that FDA may neither reject a product submission nor create qualifications on submissions that would permit the agency to reject a listing; 2) include assurances that confidential or proprietary business information is protected from release to the public; and 3) avoid creating new prohibited acts which could have unintended consequences for the industry.

“CRN is optimistic there are still opportunities to address concerns with the bill as introduced,” said CRN President and CEO Steve Mister, “and we look forward to working with Senate HELP Committee members and their staffs to achieve a proposal that safeguards consumers.”

Mister added that CRN was “dismayed that none of the changes we offered to the discussion draft were incorporated in the bill as introduced. There is still time for the Senate to recognize and incorporate changes to address our objections; however, if our significant concerns are not addressed, CRN is prepared to oppose the inclusion of any provisions relevant to dietary supplements in the FDASLA.”

The Consumer Healthcare Products Association (CHPA) expressed concerns with the FDASLA Act as well. “CHPA has been consistent in its support of the policy of Mandatory Product Listing (MPL) for dietary supplements, but we remain extremely concerned with the provisions contained within FDASLA as introduced in the Senate,” said CHPA President and CEO Scott Melville. “Not only does the language need to be amended to specifically target bad actors and to increase—not decrease—innovation, but the bill should go further to provide consumers with additional assurances regarding the safety and integrity of dietary supplements sold in the U.S.”

He added that CHPA remains committed to an “appropriate listing system for dietary supplements that will enhance consumer safety and confidence, and we look forward to continuing to work with Congress as the FDASLA Act moves through the legislative process.”

The American Herbal Products Association (AHPA) opposes mandatory product listing, saying it would be unnecessary, redundant, and unlikely to address FDA’s regulatory needs while limiting consumer access to safe products. AHPA reiterated that position in feedback to the Senate HELP Committee.

However, if an MPL requirement is established, AHPA proposed extensive changes that would minimize its burdens, and outlined several alternate revisions to the Federal Food, Drug and Cosmetic Act (FD&CA) that would “more meaningfully advance the health of American citizens by providing better education for and access to safe dietary supplements.”

If MPL is retained in the FDASLA, then compliance should be greatly simplified AHPA said, to require submission of: 1) identification of and contact information for the responsible person and the associated owner, operator or agent in charge (if a domestic firm) or U.S. agent (if a foreign entity); and 2) product labels.

AHPA also said quantitative information on ingredients in proprietary blends must not be required, FDA must not be permitted to reject listing submissions, and a public-facing database of dietary supplement labels should not be authorized or created.

Instead, AHPA identified other legislative priorities that if adopted as amendments to the FD&CA could “advance the health of American citizens by providing better education for and access to safe dietary supplements.”

• Supplement education for consumers. Current restrictions on dissemination of truthful and non-misleading information about dietary supplements by marketers should be removed, including in online commerce. This would require an amendment to 21 U.S.C. § 343-2.
• Revisiting supplement ingredient market restrictions. The prior drug exclusion provision at 21 U.S.C. § 321(ff)(3)(B) excludes from the federal definition of a “dietary supplement” any “article” approved or authorized for investigation as a new drug (under certain broad conditions), and this exclusion is permanent. This provision should be amended to place a time limit on this restriction when the subject article is a dietary ingredient as described at 21 U.S.C. § 321(ff)(1), including, for example, a vitamin, a mineral, or an herb or other botanical.
• Definition of “chemical alteration” as applied to dietary ingredients. The FD&CA establishes certain requirements for any ingredient defined as a “new dietary ingredient” at 21 U.S.C. § 350b(d), and differentiates these requirements if the ingredient is “an article used for food in a form in which the food has not been chemically altered” (21 U.S.C. § 350b(a)(1)). But the term “chemically altered” is not defined by statute, leading to uncertainty as to the application of this provision. Congress should therefore create a statutory definition for the term “chemically altered” to establish that subjecting ingredients present in the food supply to traditional food manufacturing or preparation processes, such as filtration and cooking, does not constitute chemical alteration.

Ultimately, AHPA recommended the Senate HELP Committee consider “a more patient and transparent approach to amending the FD&CA as it affects dietary supplements.” 

“The idea that the only mechanism that can be used by the U.S. Congress to improve dietary supplement laws is by attaching limited legislative proposals to must-pass legislation should be set aside to allow for a more thoughtful process that would provide a better opportunity to more thoroughly improve the regulation of dietary supplements.”