Congress Once Again Requests the GAO to Put Dietary Supplements Under the MicroscopeJuly 4, 2007
On May 14, 2007, Representatives John Dingell (D-MI), Henry Waxman (D-CA), and Bart Stupak (D-MI) sent a letter to the Government Accountability Office (“GAO”) requesting that the office update its July 2000 report on the safety of dietary supplements and functional foods. Congress’ increased scrutiny of dietary supplement regulation has been anticipated since the November 2006 election and the change in control of Congress.
In its July 2000 report, GAO identified three major weaknesses in the dietary supplement and functional food regulatory system: (1) a “lack of a clearly defined safety standard for new dietary ingredients;” (2) a “lack of safety-related information on [some product] labels;” and (3) FDA’s failure to investigate “reports [about] health problems potentially caused by” dietary supplements and functional foods. Several changes have occurred since the report was issued. For example, the congressional letter cites FDA’s 2004 ban on ephedra-containing supplements, the Bioterrorism Act of 2002 (requiring registration of dietary supplement manufacturers to improve traceability of products), and the enactment of the Dietary Supplement and Nonprescription Drug Protection Act of 2006 (introducing a mandatory adverse event reporting system for dietary supplements and non-prescription drugs) as significant improvements that may help FDA ensure the safety of dietary supplements. Nevertheless, Congress continues to be concerned about the safety of dietary supplements, and the May 2007 letter asks GAO to determine “what challenges remain.”
Specifically, the letter requests that GAO examine three different aspects of FDA’s activities concerning dietary supplements. First, based on the ephedra experience, the lawmakers question FDA’s ability to monitor emerging safety concerns associated with dietary ingredients. Although the Dietary Supplement and Nonprescription Drug Protection Act of 2006 does not become effective until December 22, 2007, the letter asks GAO to determine FDA’s progress in implementing this law and to evaluate whether it provides FDA with adequate authority to prevent a repeat of the ephedra experience.
Second, the letter raises a concern about the safety of the use of dietary ingredients in conventional food products (suggesting that such use is increasing), and requests that the GAO investigate FDA’s effectiveness in monitoring associated safety issues.
Finally, the letter expresses concern about consumer confusion which, according to the lawmakers, “has increased as the number of dietary supplement claims have proliferated.” Although this is not a safety issue, the letter requests information about FDA actions to “ensure that consumers understand label claims and have adequate information about the safety and efficacy of dietary supplements.”