February 9, 2004
Dear Secretary Thompson:
Consumers Union (CU), publisher of Consumer Reports magazine, commends the Department of Health and Human Services, and the Food and Drug Administration (FDA) for its recent action to ban the sale of dietary supplements containing ephedrine alkaloids (“ephedra” or “ma huang”). As you know, CU has long advocated for its removal from the market.
We strongly support the FDA’s action to ban ephedra. However, we believe that the dangers relating to the use of dietary supplements are not limited to ephedra. Nine years ago, Consumer Reports magazine published a list of five supplements, including ephedra, that the FDA had warned could cause serious harm to consumers. Despite the recent ban on ephedra, the other ingredients highlighted (chaparral, comfrey, lobelia, and yohimbe) continue to be sold today.
In the absence of sufficient FDA action, Consumer Reports continues to strongly urge consumers to avoid all weight-loss and energy-boosting supplements, especially those that are now touted as “ephedra-free.” As reported in the January 2004 issue of Consumer Reports (article attached), herbal supplements that are labeled ‘ephedra-free’ are not necessarily safer than ephedra. Many include similar central nervous stimulants, such as synephrine-containing bitter orange (citrus aurantium). Synephrine is not only structurally similar to ephedrine but also may affect the body in ways similar to ephedra. Because there is no required pre-market safety evaluation for those products, consumers have no assurance that the problems experienced by ephedra users will not continue with a switch to ephedra-free products. Of additional concern is the fact that these supplements may interact unfavorably with other medicines that consumers are taking. Unfortunately, not all consumers will receive our message, and may pay with their lives.
In order to prevent additional deaths and serious injuries that can be caused by herbal supplements, we believe that changes must be made to the Dietary Supplement Health and Education Act (“DSHEA”), the law that allows untested dietary supplement products to be widely marketed and sold. In addition, we believe that the FDA should not permit dietary supplements to be sold without adequate pre-market safety testing. Finally, and most important, we believe that dietary supplement manufacturers should be required to report all adverse events promptly to the FDA, as advocated by you in a December 30th press conference on the ephedra ban. It is only in this way that the FDA can be adequately informed of injuries caused to consumers from the use of a particular dietary supplement product.
We are today writing to members of the Senate and the House to urge members to provide the FDA with enhanced authority and funding to act quickly when it receives reports regarding unsafe supplements and untested steroid equivalents. We are urging members of the Senate to support Senate Bill 722, sponsored by Senator Richard Durbin, that would enhance FDA’s authority to ban dietary supplements that are stimulants and untested steroid equivalents. S. 722 also would require manufacturers to report adverse events for dietary supplements, and would increase the FDA’s authority to compel submission of additional safety information for supplements deemed to pose serious hazards to consumers. In addition, we are urging members of the House to support H.R. 3377, sponsored by Representative Susan Davis, which would increase FDA’s authority to ensure supplements are safe and require manufacturers to report adverse events to the agency.
We look forward to working with you to ensure consumers can use dietary supplement products safely and with confidence.
Janell Mayo Duncan
Legislative and Regulatory Counsel
Marvin M. Lipman, M.D., FACP
Chief Medical Adviser
Yonkers, New York
cc: Mark B. McClellan, M.D., Ph.D, FDA Commissioner