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.”
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.