The Mandatory Product List, or MPL, is an idea that has been around for a number of years as part of the “DSHEA 2.0” discussions. It’s something Cara Welch, PhD, new director of the FDA’s Office of Dietary Supplement Programs defended in the past.
The idea is that supplement manufacturers would be required to register a new product with the FDA before bringing it to market. FDA officials have mentioned in interviews and public forums that not having an accurate picture of the supplements available on the market hampers its ability to effectively regulate the industry. Some industry players, such as the Consumer Healthcare Products Association (CHPA) and the Council for Responsible Nutrition (CRN), for their part, have gradually come round to the idea that implementing an MPL would be a way to show that the industry is serious about cooperating in bringing about better regulations.
The latest MPL iteration does not include the earlier language
The devil, however, is as always in the details. The latest version of MPL is incorporated into the FDA Safety and Landmark Advancement Act of 2022 (FDASLA), a US Senate bill sponsored by Senator Patty Murray, D-WA and Senator Richard Burr, R-NC. The bill reauthorizes fees collected by the FDA in the drug and medical device sectors and, as such, is intended to be passed on in one form or another.
However, the wording of this bill once it emerged from the committee that deals with dietary supplements is seen as too broad and does not closely reflect the MPL ideas that have been hammered out over the past year between lawmakers and industry. FDASLA language as it stands could compromise trade secrets, require information from companies beyond what is on the label, and could give the FDA new powers equivalent to premarket approval.
NPA: No surprise, the MPL process has derailed
Daniel Fabricator, PhD, president and CEO of the Natural Products Association, said that from his organization’s perspective, it’s no surprise that the MPL cart went off the rails. The NPA believed from the start that the MPL was a bad idea and that it was a mistake to believe that industry could handle the process once lawmakers got their teeth into it.
“We believe that the industry generally does not support MPL”, says Manufacturer. “The bill for paid applications is a heavy train that has left the station. We don’t know what the amendment process will be on the floor. There may not be. »
“The three associations (CHPA, CRN and United Natural Products Alliance) thought they could manage the process. Now we need everyone to come together to shut this thing down,” he said.
CHPA and CRN officials countered that it’s easy to take side-shots, and quite another to actively engage with lawmakers in an attempt to modernize the industry’s regulatory structure.
CHPA: responsible stakeholders must work to modernize regulations
“Food supplement regulations need to be modernized, and every responsible stakeholder knows it,”said Duffy MacKay, ND, CHPA senior vice president for dietary supplements.
“MPL has been considered by Congress several times over the past decade, including a legislative proposal by Senator Durbin in 2011. MPL was also included in the latest FDA budget request. The FDASLA attempts to address dietary supplement regulatory issues, but it is too broad, imposes unnecessary burdens on industry, and falls short of needed comprehensive reforms,” MacKay added.
“CHPA remains committed to an appropriate listing system for dietary supplements and other critical upgrades. We look forward to continuing to work for, not against, long-term modernization,” he said.
CRN still supports the idea of MPL
The Council for Responsible Nutrition was an early advocate for MPL, and that hasn’t changed, said Steve Mister, president and CEO of CRN.
“CRN continues to support the concept of a mandatory product list for dietary supplements and believes this will bring needed transparency to our market. The CRN engaged in conversations with members of Congress on both sides of the aisle for a year, resulting in a strong bipartisan approach to the MPL. It is therefore disappointing that the FDASLA language adopted by the Senate HELP Committee does not respect the extensive negotiations that took place to achieve transparency without foregoing industry innovation,” said sir.
“The CRN is prepared to pivot to vigorously oppose the inclusion of MPL for dietary supplements in the FDASLA without the legislative assurances and protections we have requested.
“The NPA’s recent comments continue to prove its lack of understanding of the legislative process. It’s easy to be a ‘Monday Morning Quarterback’ when you don’t engage constructively with members of Congress and don’t have access to the facts because you weren’t in the room.he concluded.