Two US Senators this week introduced a Bill in the US Senate that calls for the mandatory registration of dietary supplements with the Food and Drug Administration (FDA), together with comprehensive product disclosure. They say that the FDA and consumers are currently “flying blind when it comes to dietary supplements”.
The US natural products industry appears to be split over the development, with some leading groups welcoming the Bill but others sharply critical.
The new Bill – the Dietary Supplement Listing Act of 2022 – was introduced on Tuesday by US Senate Majority Whip Dick Durbin (D-IL) and U.S. 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). While DSHEA, introduced in 1994, provided the FDA with the authority to regulate dietary supplements it doesn’t require dietary supplement companies to register their products with FDA. This, say the two Senators, leaves the agency without without the information to properly use that authority effectively.
The Bill would require companies to inform the 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.
Speaking on the Sentate floor, Durbin said: “70% of people in America take a dietary supplement including me. I also believe that Americans who take vitamins, minerals, and herbs for their health and well-being have a right to know what’s in those supplements. Many people assume that if a product is sold in the United States of America, somebody has inspected it and it must be safe. Unfortunately, that’s not always true.”
Durbin added that the FDA was unable to tell him how many dietary supplements. “They gave us a range, somewhere between 50,000 dietary supplements and 80,000. A gap of 30,000 products! What’s going on here? So they don’t know even how many products there are, let alone what’s in them. So when it comes to dietary supplements the US FDA and American consumers are pretty much flying blind.”
Durbin emphasised the enormous growth that had taken place in the US supplements industry since DSHEA came into force. “This industry is worth $50 billion today. Iy is big.”
They (FDA) gave us a range, of somewhere between 50,000 dietary supplements and 80,000. A gap of 30,000 products! What’s going on here? So, they don’t know even how many products there are, let alone what’s in them.”
US Senate Majority Whip Dick Durbin (D-IL)
Supplements industry trade association, the Council for Responsible Nutrition, supports the Bill. Its president and CEO, Steve Mister, said: “Transparency is the best disinfectant, and a mandatory product listing will give FDA and consumers visibility into the dietary supplement marketplace. CRN member companies produce a large portion of the dietary supplements marketed in the United States, so we know responsible industry supports mandatory product listing for supplements. We appreciate the opportunity to work with Sens. Durbin and Braun on this critical legislation.”
But the Natural Products Association (NPA) called the new legislation “unfair and unneeded”. NPA president, and CEO, Dr. Daniel Fabricant, said: “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.”