Rep. Henry A. Waxman (D-CA), Rep. John D. Dingell (D-MI), Rep. Bart Stupak (D-MI), and Sen. Dick Durbin (D-IL) released a new Government Accountability Office (GAO) report identifying several factors that limit FDA‘s ability to protect consumers from unsafe dietary supplements. These factors are limits on FDA‘s authority to obtain information about dietary supplements on the market, few FDA resources devoted to dietary supplement oversight, and limits on FDA‘s authority to remove unsafe dietary supplements from the market.

The report calls for additional FDA regulatory authority to ensure better FDA oversight of dietary supplements, including enhanced registration of dietary supplement facilities and expanded reporting of adverse health effects of supplement products. The report recommends that FDA issue guidance to industry to clarify which supplement ingredients are new and to submit evidence of safety before they can be marketed. The report also notes the need for more consumer outreach and education.

‘I am troubled that the FDA lacks the basic information necessary to protect consumers from unsafe dietary supplements,’ said Rep. Waxman, Chairman of the Energy and Commerce Committee. ‘The FDA clearly needs to have more resources to give consumers real protection. I intend to work with my colleagues in Congress to ensure that FDA has the tools it needs to address this and other important public health missions.’

‘We know that there are problems with the FDA. Reports like this show us just how deep the problems run,’ said Rep. Dingell, Chairman Emeritus of the Energy and Commerce Committee. ‘FDA is woefully unprepared to deal with dietary supplements and in its current condition, FDA can not fix the problem. FDA needs the resources and adequate authorities so the agency can start addressing this problem. The GAO findings are quite valuable and Americans will be quite distressed as they learn just how ineffective the FDA has become in regulating dietary supplements.’

‘Based on GAO‘s analysis, we can add dietary supplements to the growing list of products that show the FDA is failing at its core mission of protecting the public‘s health,’ said Rep. Stupak, Chairman of the Oversight and Investigations Subcommittee. ‘We need new leadership in place at the FDA to finally begin the task of recommitting the agency to protecting the American people from unsafe food, drugs, medical devices and now dietary supplements. The FDA should review and quickly implement GAO‘s recommendations, particularly working to expand efforts to collect adverse event data from consumers in order to better understand the problems encountered with use of dietary supplements.’

‘There are 29,000 varieties of dietary supplements on the market today with 1,000 new products being introduced each year. Many of these products are safe; I take my vitamins every day. The problem is that some supplements contain concentrated extracts of herbs and botanicals mixed with other ingredients that can be harmful,’ said Assistant Senate Majority Leader Durbin. ‘Our experience with ephedra should convince everyone that the FDA should have the regulatory authority it needs to protect the American consumer. I will continue work with my colleagues in Congress and with the administration to make sure we do to everything we can to protect the public health.’

The GAO report, Dietary Supplements: FDA Should Take Further Actions to Improve Oversight and Consumer Understanding, states that a lack of information is one of the most significant factors that limit the FDA‘s ability to identify and properly act on safety concerns regarding dietary supplements and foods with added dietary ingredients. GAO recommends that the FDA issue guidance on new dietary ingredients and clarify the difference between dietary supplements and foods with added dietary ingredients to prevent firms from circumventing safety standards by simply reclassifying their products as dietary supplements. The report noted the need for improved education and outreach efforts to increase consumer understanding of the safety and efficacy of dietary supplements and foods with added dietary ingredients. And GAO also recommends that the FDA be given additional authority to require firms to self-identify as dietary supplement companies, to provide information about their dietary supplement and dietary additive products and ingredients, and to report adverse events.

• GAO Report: Dietary Supplements: FDA Should Take Further Actions to Improve Oversight and Consumer Understanding