The stopgap funding measure, which much be passed by Sept. 30 and which will bankroll government operations through Dec. 16, 2022, includes a pared down version of a bill reauthorizing FDA user fees.
Durbin helped get current MPL ball rolling
That periodic exercise is usually confined to the fees themselves, which FDA collects from drug and medical device manufacturers. This year, however, the bill contained additional provisions for new cosmetics and dietary supplement regulations. Among the supplement provisions was a Mandatory Product Listing (MPL), that requires a manufacturer to submit a label and certain other information to FDA before putting a product on the market.
As far as Durbin’s office is concerned, that idea originated with him when, in May, his office released a statement that “applauded the inclusion of a modified version of his Dietary Supplement Listing Act of 2022 in the Senate Health, Education, Labor and Pension (HELP) Committee’s recently-released draft Food and Drug Administration (FDA) User Fee package. “
However, once the fees reauthorization was folded into the omnibus stopgap funding measure, the supplement and cosmetics riders were stripped out. This is a common practice for such omnibus bills that must meet a deadline so as to keep to a minimum possible points of disagreement that might derail the process.
Manufacturers would be responsible for keeping listings up to date
Sen. Durbin apparently is unfazed by that prospect, though. In an amendment offered today, Sen. Durbin seeks to reinstate the MPL requirement. As formulated in his amendment, supplement manufacturers would be responsible for the premarket notification as well as keeping those listings up to date with notices of new labeling, product reformulations or discontinuations.
MPL is an idea that has garnered some support with the industry. One of its chief champions has been the Council for Responsible Nutrition, which views the requirement as something that would give the impression that the industry is a responsible player. The United Natural Products Alliance has also voiced its cautious support, after certain sticking points in the original language of the requirement were ironed out.
The American Herbal Products Association argued consistently against the need for and wisdom of a MPL requirement. Another opponent has been the National Products Association, which views the requirement as both unnecessary and rife with the potential for abuse. NPA said today that it doubts the amendment will survive into the final version of the continuing resolution. Nevertheless, the group said it intends to martial grassroots support to help make sure that doesn’t happen.