Senator Richard Durbin, D-Ill., has re-introduced the Dietary Supplement Labeling Act. The bill, co-sponsored by Sen. Richard Blumenthal, D-Conn., would require dietary supplement companies to register all supplements with the Food and Drug Administration (FDA) and would amend certain supplement labeling requirements.
"Like the previous version of this bill, the legislation would impose a product registration requirement for dietary supplements even though conventional foods bear no such burden," said American Herbal Products Association (AHPA) President Michael McGuffin. "There is no reason that product registration is needed specifically for dietary supplements and AHPA opposes this provision."
The bill also directs the Department of Health and Human Services to coordinate with the Institute of Medicine to compile a list of dietary supplement ingredients that could cause potentially serious adverse events, drug interactions, contraindications or potential risks to subgroups such as children and pregnant or breastfeeding women.
"There are numerous authoritative references already available to provide safety information on dietary ingredients, including AHPA's Botanical Safety Handbook for herbal ingredients," McGuffin said. "Instead of using taxpayer funds to reinvent the wheel, the existing resources should be recognized."
The bill would also require the Secretary of Health and Human Services to establish a definition for the term "conventional food" for purposes of the Federal Food, Drug, and Cosmetic Act; require FDA to establish mandatory warning label requirements for some dietary supplements; and mandate inclusion of a batch number on each supplement product label.
"The issues addressed in Senator Durbin's bill appear to propose legislative solutions where regulatory standards would suffice," McGuffin said. "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."