Durbin-Braun Bill Amounts to Pre-Market Approval for Dietary Supplements
NPA Warns of Consumer Harm, Higher Prices, and Stagnated Innovation
WASHINGTON – Senator Richard Durbin (IL) today accused the natural products industry of selling “gas station heroin,” and announced that he and Senator Mike Braun (IN) will soon be introducing mandatory dietary supplement product listing legislation.
“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.”
As the oldest and largest trade association in the dietary supplement industry, NPA has fought against this proposal for several years. NPA is also engaging its grassroots network and urging 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 late Senator Hatch, Congressman Waxman, President Clinton, and others unanimously passed DSHEA in 1994 because they understood the importance of an appropriately regulated industry for dietary supplements. The federal government has a wide variety of enforcement powers and a significant track record of punishing criminals who break the law. 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.”