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FDA’s Mandatory Product Listing for Dietary Supplements Reintroduced in the U.S. Senate

FDA’s Mandatory Product Listing for Dietary Supplements Reintroduced in the U.S. Senate

Washington, D.C. Despite bipartisan opposition that led to its rejection twice in 2022, Senator Richard Durbin (D-IL) has renewed his bid to enact the FDA’s controversial Mandatory Product Listing (MPL) proposal for dietary supplements.  NPA led the effort to defeat previous attempts by Sen. Durbin and others to attach a similar proposal first to FDA user fee legislation and then to an omnibus government funding bill without any hearings or public debate.

The timing of the introduction is especially curious, as Sen. Durbin and his staff were scheduled to visit an NPA member company for a facility tour and discussion just one week ago.  On the eve of the visit, the Senator’s team cancelled the meeting without explanation.

“NPA remains deeply concerned with this misguided and unnecessary approach to dietary supplements, which are safe and heavily regulated.  This proposal has been rejected repeatedly because it’s bad for consumers and bad for American manufacturers and retailers and it should be rejected again.  We were hoping to have a productive discussion with the Senator and his team but evidently they are not interested in that and only scoring political points,” said Dr. Daniel Fabricant, president and CEO of the Natural Products Association.

“The FDA already has access to information regarding who is making dietary supplements, what products are made at which facilities, when new ingredients are introduced into commerce, and whether any products are associated with serious adverse events.  This old proposal will hurt consumers and needlessly damage the industry as it mirrors over-the-counter premarket drug regulations and is more stringent than current regulations, including, the NDI provision which is a notification rather than a pre-market approval. This bill is entirely at odds with the current regime which has delivered world-class consumer safety and broad access to important nutritional supplements for over a generation.”

As the oldest and largest trade association in the dietary supplement industry, NPA has blocked repeated attempts to enact this proposal for several years. NPA also engaged its grassroots network and urged the industry to join the thousands of health and wellness advocates to contact their members of Congress to warn them about the economic harm of this legislation.  The effort produced over 85,000 emails to Congress in opposition.

In 2022, the influential members of the House Energy and Commerce Committee expressed significant concerns with including a similar proposal to provisions from the Dietary Supplement Listing Act to FDA user fee legislation, noting that the provisions were not debated under regular order, that no hearings were held, and that no formal committee consideration of the provisions was conducted.