Legislation Introduced to Improve Dietary Supplement Safety; Bill Would Significantly Increase Burdens on Industry and FDA

By Riëtte van Laack –

Last week, Senator Richard Durbin (D-IL) introduced “the Dietary Supplement Labeling Act of 2011” (S. 1310).  The bill proposes to amend the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to “improve the safety of dietary supplements.” Durbin’s bill includes a requirement that dietary supplements manufacturers register with FDA their dietary supplements, a list of dietary ingredients contained in these supplements, and copies of the label and labeling of these dietary supplements.  Failure to register a dietary supplement or keep the information up to date causes that product to be misbranded. 

In addition, Durbin’s bill would mandate FDA and the Institute of Medicine (“IOM”) to identify (based on review of the literature) dietary ingredients that cause potentially serious adverse events, drug interactions, contraindications, or potential risks to subgroups such as children and pregnant women, and establish warning statements for dietary supplements containing these potentially unsafe ingredients.  If a potentially unsafe dietary ingredient is part of a proprietary blend, the product label must disclose the amount of that dietary ingredient per serving.  The bill further proposes to require that a dietary supplement label includes a batch number, and that FDA establish a definition of “conventional foods.”

If passed, the Dietary Supplements Labeling Act of 2011 will significantly increase the administrative burden for dietary supplement manufacturers.  Particularly the requirement to disclose the amount of certain dietary ingredients in proprietary blends is cause for concern as the quantitative composition of a proprietary blend is generally considered a valuable trade secret. 

Durbin’s bill also will impose a significant burden on FDA and IOM without an apparent benefit.  FDA currently has ample authority to address safety issues of dietary supplements and remove unsafe dietary supplements from the market.  Moreover, FDA has the authority – and has used that authority – to take enforcement action against dietary supplements that are conventional foods marketed as dietary supplements.