Another year, another FDA attempt to impose pre-market approval for dietary supplements

Once again, the President’s budget proposal for fiscal year 2025 calls for Congress to pass the agency’s “mandatory product listing” (MPL) proposal​.

Once again, I’m confident certain industry cheerleaders will applaud this misguided idea, as they have in the past.

Once again, I am urging our industry not to be fooled into thinking that this is anything other than pre-market approval by another name—and if you don’t believe me, believe what the FDA is trying to engineer behind the scenes.

Allow me to explain what I mean by that.

NPA collaborated with our champions in the House and Senate in 2022 to knock MPL out of the original Senate legislative package to reauthorize the FDA’s various user-fee programs despite the fanatical support for MPL from certain industry organizations. During that debate, those organizations accused NPA of spreading misinformation about the true nature of MPL. They tried to suggest that neither the FDA nor Congress were seeking authority to require pre-market approval of dietary supplements.

We continue to disagree on what the language in the proposal would have accomplished. But there can be no doubt about the FDA’s true intent based on new information that has recently come to light.

A recent Freedom of Information Act request has uncovered a document authored by FDA officials to provide “technical assistance” to the legislative drafters of the MPL proposal.

In that document, the FDA asked Congress to give the agency the authority to establish a “unique dietary supplement identifier system”. The language requested by the FDA would have demanded that “the label of each dietary supplement shall contain the unique dietary supplement identifier assigned by the Secretary”. Moreover, this requirement would have applied to existing supplements already on the market, not just new products—and without any deadline for the FDA to approve a submission and assign said identifier.

In other words, if the FDA had its way, no dietary supplement could be marketed without the agency granting a “unique dietary supplement identifier” at its discretion and on its own timeline.

How is that not a form of pre-market approval?

To be fair, the Senate drafters were smart enough to know that this proposal was too brazen. They no doubt told FDA officials to bide their time and wait for a better opportunity to insert the “unique dietary supplement identifier” into law. But now that this language has seen the light of day, there can no longer be any doubt about the FDA’s ultimate aim.

Giving the FDA an administrative excuse to reject ingredients from being marketed as dietary supplements without any regard for the science or history is a non-starter. A bipartisan Congress understood that in 2022. It’s long past time for the FDA and certain industry organizations to end their shared MPL crusade once and for all.

Go to the Natural Products Association’s website (www.npanational.org​) and click to act. Tell Congress “NO” on MPL for FDA.