Bill ‘amounts to pre-market approval for supplements’, NPA warns 

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A new Bill introduced in the US Senate last week amounts to pre-market approval for dietary supplements and would lead to consumer harm, higher prices and stagnated innovation. 

That’s the claim being made by the Natural Products Association (NPA), which is mobilising industry to warn about the economic damage it says the legislation would inflict. 

The new Bill – the Dietary Supplement Listing Act of 2022 – was introduced by US Senate Majority Whip Dick Durbin (D-IL) and US Senator Mike Braun (R-IN).

The bipartisan legislation is being presented as a measure to deal with supposed gaps in the existing Dietary Supplement Health and Education Act (DSHEA). The Bill would require companies to inform the US Food and Drug Administration (FDA) of the name of every product they manufacture or distribute, provide a full list of ingredients and an electronic copy of the label, and state any health claims they have made. 

The NPA strongly objects to the intervention. “NPA is deeply concerned with the Dietary Supplement Listing Act of 2022, which would establish pre-market approval for dietary supplements. The FDA has several tools at its disposal, including mandatory facility registration, with associated penalties for failure to comply,” 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. The Durbin-Braun approach will hurt consumers and needlessly damage the industry. It mirrors over-the-counter premarket drug regulations and is more stringent than current regulations, including the NDI provision, a notification rather than a pre-market approval. The Dietary Supplement Listing Act 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.”

The NPA has been fighting the proposal for several years and is now calling on the wider industry to mobilise to warn about the economic harm it says the legislation will inflict. 

Fabricant continued: “We support transparency, but this legislation fails to recognize the deficiencies of the FDA by making them less accountable to the industry. Congress should be more focused on performing an in-depth performance review and analysis of the FDA’s current authorities to determine if they are effectively using those which they currently have before creating a pre-market approval process for dietary supplements that FDA will only misuse to create problems as we’ve seen with NAC and CBD. As proposed, there are only two groups we can see who would benefit from this approach:  1) the trial-attorney industry through additional frivolous class-action lawsuits based on alleged injuries caused by foods or supplements, and 2) disreputable individuals looking to create counterfeit products based on the ingredients and formulations in the database, hoping they can turn a quick profit.”

“Unfortunately, and surprisingly, the Council for Responsible Nutrition is foursquare in support of this misguided and dangerous legislation, so there is a great risk that Members of Congress may be led to believe that it is supported by industry when that couldn’t be further from the truth. NPA has activated its industry-leading grassroots operation to elevate our concerns. Still, we also strongly encourage our friends in the industry to join our growing movement and to convince elected officials that this is the wrong path at exactly the wrong time.”

Main image: The NPA wrote to Senator Dick Turbin last week

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