According to Sen. Durbin's press release, the bill would require 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 to help FDA identify and recall contaminated products.
In a statement from the Michael McGuffin, president of the American Herbal Products Association, he stated, “The issues that are emphasized in Senator Durbin's announcement appear to propose legislative solutions where regulatory standards would suffice. Under current law, supplements are not allowed to be represented as conventional foods and must be labeled to include all information—including safety information—that is material in light of the consequences that may result from their use. And while no one will argue with the wisdom of using product batch numbers, it is already the standard industry practice to do so.”
In associated remarks entered on the Senate floor on July 30, 2013, Sen. Durbin said the bill also includes a provision to require all dietary supplement products to be registered with the Food and Drug Administration.
“AHPA opposed the product registration requirement in 2011 and will oppose it again in this latest version of the bill,” added Mr. McGuffin.