The U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) formally introduced FDA Safety and Landmark Advancements Act (FDASLA) on Friday, May 27, 2022. Previously, the Senate HELP Committee released its discussion draft. FDASLA is legislation that would reauthorize user fee agreements for prescription drugs, generic drugs, biosimilars, and medical devices from the FDA, but would also include language that would create a mandatory product listing requirement for manufacturers of food supplements.
The proposal for a mandatory product registry has been the subject of much debate within the industry, particularly with the introduction of the Dietary Supplement Listing Act of 2022 by Senators Dick Durbin and Mike Braun, and more recently , the FDASLA. Proponents view mandatory product listings as a foregone conclusion given that the FDA has sought funding from Congress for such an initiative for years, but also believe it will be a useful tool for regulators to take enforcement action against bad actors. . Advocates also see this as an opportunity to be transparent as an industry and elevate its reputation.
Critics and skeptics of mandatory product listings see it as a way to give new powers to an agency that has been ineffective in enforcing regulations with the existing tools at its disposal. Not only would such a requirement increase the burden on industry, they say, but the bills as written do not contain explicit language ensuring that listing does not equate to pre-market approval. .
Upon the release of the FDASLA, in which language regarding the regulation of dietary supplements remained largely unchanged despite industry feedback, stakeholders are calling for changes.
“The CHPA has been consistent in its support of the Mandatory Product Listing (MPL) policy for dietary supplements, but we remain extremely concerned about the provisions contained in the FDASLA as presented to the Senate today. “, said Scott Melville, president and CEO of the Consumer Healthcare Products Association (CHPA; Washington, DC), in a prepared statement. “Not only should the language be changed to specifically target bad actors and to increase – not decrease – innovation, but the bill should go further to provide consumers with additional assurances regarding safety and integrity. dietary supplements sold in the United States”
For example, the bill contains a provision that would require manufacturers to list the ingredients of a proprietary blend and the amount per serving of diet ingredients in a proprietary blend.
The Council for Responsible Nutrition (CRN; Washington, DC), which supported the Dietary Supplement Listing Act of 2022, is also critical of FDASLA. “The mandatory product list should not be used as a barrier to market entry for a compliant dietary supplement. Unfortunately, the current bill does not include this essential protection, nor does it protect confidential business information. “said Steve Mister, President. and CEO of CRN, in a press release. “In addition, this bill includes new language that would grant the FDA broad authority to potentially block legitimate dietary supplements from entering the market at the agency’s discretion.”
CRN made the following suggestions to FDASLA:
- “Provide explicit assurance that FDA can neither reject a submission nor create qualifications on submissions that would allow the agency to reject a listing;
- Include assurances that confidential or proprietary business information is protected from public disclosure; and
- Avoid creating new prohibited acts that could have unintended consequences for the industry.”
These suggestions were made by CRN to the Senate HELP Committee prior to the formal introduction of the bill. “CRN is appalled that none of the changes we proposed to the discussion draft have been incorporated into the bill as presented. There is still time for the Senate to acknowledge and incorporate changes to address our objections; however, if our significant concerns are not resolved, CRN is prepared to oppose the inclusion of any dietary supplement provisions in the FDASLA.
The American Herbal Products Association has also made a number of suggestions for the revision of the bill which can be found here.
While the Senate’s reauthorization of FDA user fees contains a mandatory product listing provision, the House version did not.