By Sean Moloughney, Editor05.03.22
Another issue of Nutraceuticals World and another late-breaking development at press time. The day before our May issue went to press, Senators Dick Durbin (D-IL) and Mike Braun (R-IN) introduced the Dietary Supplement Listing Act of 2022 (S. 4090), which would require dietary supplement manufacturers to file product information with FDA.
While introducing the proposal on the Senate floor on Apr. 26, Durbin argued that FDA and consumers are “flying blind” and need to have basic information about what products are on the market, what’s in them, where they’re manufactured, etc. FDA “has the authority to regulate dietary supplements and take dangerous products off the market, but it lacks information that it needs to use this authority effectively,” Durbin argued.
Under the Dietary Supplement Health and Education Act (DSHEA) and the Food Safety Modernization Act (FSMA), supplement manufacturers must ensure safety of their products, register food facilities with FDA, and maintain current Good Manufacturing Practices (cGMPs), but there is no pre-market approval of products. However, FDA must be notified when a company introduces a New Dietary Ingredient (NDI) into commerce.
The bill he and Braun are introducing would require dietary supplement manufacturers to provide “the names of their products, the ingredients they contain, an electronic copy of the label, a list of any health claims made, and more,” Durbin said. Companies that refuse to comply would be considered “misbranded.”
The proposed bill, responds to FDA’s recent request for more insight and regulatory authority over the dietary supplement industry, which has grown from about $4 billion in 1994 to an estimated $56 billion today.
Durbin has been down this road before. In 2013 he introduced the Dietary Supplement Labeling Act, which was met by fierce resistance that ultimately sank the bill. For his part, he acknowledged his adversarial past with dietary supplement stakeholders, and noted passage of adverse event reporting (AER) legislation with the late former Senator Orrin Hatch (R-UT), a coauthor of DSHEA who died on Apr. 23.
Dietary supplement representatives were united in their praise and appreciation of Hatch, who was regarded as a “champion” for the dietary supplement industry, “a titan” for natural products stakeholders, “a principled legislator,” “a tremendous statesman, “a champion for health freedom,” and more. Hatch was also recalled for his ability to work across political divides.
Now I imagine industry folks have a few names for Durbin as well given his history. However, based on public statements and conversations I’ve had recently, there does seem to be some momentum for modernizing DSHEA within the industry. However, there’s also significant disagreement and division.
How will things play out from here? Stay tuned to our coverage ... and let us know what you think.
While introducing the proposal on the Senate floor on Apr. 26, Durbin argued that FDA and consumers are “flying blind” and need to have basic information about what products are on the market, what’s in them, where they’re manufactured, etc. FDA “has the authority to regulate dietary supplements and take dangerous products off the market, but it lacks information that it needs to use this authority effectively,” Durbin argued.
Under the Dietary Supplement Health and Education Act (DSHEA) and the Food Safety Modernization Act (FSMA), supplement manufacturers must ensure safety of their products, register food facilities with FDA, and maintain current Good Manufacturing Practices (cGMPs), but there is no pre-market approval of products. However, FDA must be notified when a company introduces a New Dietary Ingredient (NDI) into commerce.
The bill he and Braun are introducing would require dietary supplement manufacturers to provide “the names of their products, the ingredients they contain, an electronic copy of the label, a list of any health claims made, and more,” Durbin said. Companies that refuse to comply would be considered “misbranded.”
The proposed bill, responds to FDA’s recent request for more insight and regulatory authority over the dietary supplement industry, which has grown from about $4 billion in 1994 to an estimated $56 billion today.
Durbin has been down this road before. In 2013 he introduced the Dietary Supplement Labeling Act, which was met by fierce resistance that ultimately sank the bill. For his part, he acknowledged his adversarial past with dietary supplement stakeholders, and noted passage of adverse event reporting (AER) legislation with the late former Senator Orrin Hatch (R-UT), a coauthor of DSHEA who died on Apr. 23.
Dietary supplement representatives were united in their praise and appreciation of Hatch, who was regarded as a “champion” for the dietary supplement industry, “a titan” for natural products stakeholders, “a principled legislator,” “a tremendous statesman, “a champion for health freedom,” and more. Hatch was also recalled for his ability to work across political divides.
Now I imagine industry folks have a few names for Durbin as well given his history. However, based on public statements and conversations I’ve had recently, there does seem to be some momentum for modernizing DSHEA within the industry. However, there’s also significant disagreement and division.
How will things play out from here? Stay tuned to our coverage ... and let us know what you think.
