FDASLA Act of 2022

June 8, 2022

The U.S. Senate is considering two separate bills that would create a new requirement for mandatory product listing (MPL) for all dietary supplements marketed in the United States;  S. 4348, the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDASLA), and S. 4090, standalone legislation recently introduced by Senator Durbin (D-IL) and Senator Braun (R-IN). The HELP committee met on Tuesday, June 14th, in a hearing to discuss the bill with added amendments – one being submitted by Senator Romney for our industry, that wasn’t approved by the HELP committee. The roll count vote 13-9 allowed the bill to be sent to the Senate floor.

The House companion bill HR 7667 which did not include any reference to cosmetics or dietary supplement regulation will most likely be discussed in conference in the coming days, including both Senate and House members where it could be revised further and voted upon.

SENPA’s primary concern is contained in Section 403 (D) of Subtitle B-Dietary Supplements of S. 4348, the FDASLA bill.  We believe this provision could impose unnecessary regulatory burdens to retailers who would qualify as entities “holding or distributing” the dietary supplement.  This could apply to all products manufactured by any dietary supplement manufacturer, and product made for the retailer as a “privately labeled dietary supplement.” SENPA opposes subjecting retailers mandatory reporting requirements in the proposed new legislation.

SENPA is also concerned about “mandatory listing number” to be assigned by FDA and the potential undue burden this could place on manufacturers.  We have asked for clarification on this provision and how it might be construed as requiring pre-market approval for new products. 

Independent retailer interests are not adequately represented in this proposed legislation, which now requires an exemption from regulatory provisions that will threaten the economic welfare of our members.  As a result, it is essential that we activate our grassroots network to enable you, as a constituent, employer and small business owner to represent the interests and welfare of your customers.   

  • Description: A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes.
  • Bill Number: S.4348
  • Chamber: Senate
  • Introduced: May 26, 2022
  • Lead Sponsor:
  • Our Position: Opposed
  • Latest Action: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Cosponsors

Richard M. Burr

Bill History

July 13, 2022
Calendars
Placed on Senate Legislative Calendar under General Orders. Calendar No. 444.
July 13, 2022
Committee
Committee on Health, Education, Labor, and Pensions. Reported by Senator Murray with an amendment in the nature of a substitute. Without written report.
June 14, 2022
Committee
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
May 26, 2022
IntroReferral
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.