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Legislation Calls for Stricter Oversight of Dietary Supplements

Federal lawmakers have introduced legislation to protect consumers from potentially dangerous dietary supplements. The Dietary Supplement Labeling Act, introduced by Senators Dick Durbin (D-IL) and Richard Blumenthal (D-CT), would require supplement makers to provide more information about their products and give the U.S. Food and Drug Administration greater authority to regulate their ingredients and health claims.

“Consumers don’t know some dietary supplements are unsafe until they’re in the hospital, and by that time it’s too late,” Sen. Blumenthal said. “This legislation would make lifesaving information available to the FDA that may stop suspect products from causing injury or even death.”

As San Diego product liability attorneys, we agree that supplements are a growing concern. According to a 2013 report by the Government Accountability Office, the FDA received an average of 2,100 dietary supplement adverse event reports a year from 2008 to 2011. By comparison, the agency received less than 400 in 2007.

As outlined by Sen. Durbin’s office, the Dietary Supplement Labeling Act would specifically:

  • Allow the FDA to track how many dietary supplements are on the market and what ingredients they contain. 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.
  • Require 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. Labels also would have to include the batch number, which would help the FDA identify and recall contaminated product.
  • Give the FDA the authority to require manufacturers to provide proof for any potential health benefit claims. 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.
  • Direct the FDA to clarify the distinction between dietary supplements and food and beverage products with additives.