The Durbin-Blumenthal act would give consumers of dietary supplements a clearer understanding of what they are taking by:
Allowing FDA to track how many dietary supplements are on the market and what ingredients they contain. Under The Dietary Supplement Labeling Act, manufacturers would be required to provide registration information for new products within 30 days after being marketed. They would also be required to provide a description of each product, its ingredients, and a copy of the label. If a product is removed from the market, they would be required to inform the FDA.
- Requiring more information on product labels including warnings associated with specific ingredients. The bill would require dietary supplements labels to display a warning if the product contains an ingredient that may cause serious adverse events, drug interactions, contraindications or risk for subpopulations such as children and pregnant women. If a proprietary blend contains such a dietary ingredient, the weight per serving of that ingredient must be disclosed on the label. Labels also would have to include the batch number, which would help the FDA identify and recall contaminated product.
- Giving FDA the authority to require manufacturers to provide proof for any potential health benefit claims. Manufacturers of dietary supplements are allowed to use claims about the benefits of their product for marketing purposes. Manufacturers are also required to have substantiation supporting claims on product labels to ensure they are truthful and not misleading. The Dietary Supplement Labeling Act would give FDA the authority to require manufacturers, upon request, to submit substantiation supporting structure and function claims on labels.
- Directing the FDA to clarify the distinction between dietary supplements and food and beverage products with additives. The vague distinction between a dietary supplement and a conventional food has created a murky and growing market space where industry is selling products like beverages with high levels of additives that act as stimulants and brownies with high levels of ingredients that lull the body into relaxation. The bill would direct the FDA to establish a definition for conventional foods in order to clarify for industry, for consumers and even for the agency itself what products are foods and should be regulated as foods and what products are meant to be health aids and should be regulated as dietary supplements.
Durbin and Blumenthal first introduced the Dietary Supplement Labeling Act in June 2011. The legislation follows a bipartisan effort led by Durbin in 2006 to enact legislation, theDietary Supplement and Nonprescription Drug Consumer Protection Act whichrequires manufacturers to report serious adverse events related to consuming dietary supplements, enhancing the FDA's ability to identify and respond more quickly to potential health problems. Today?s Dietary Supplement Labeling Act would build on that by requiring dietary supplement manufacturers to disclose the known risks of ingredients and display a mandatory warning if the product contains a dietary ingredient that may cause potentially serious adverse events. Labels would also have to include the batch number, which would help the FDA identify and recall contaminated product.