On Dec. 30, 2003 the U.S. Food and Drug Administration announced its intention to ban retail sales of dietary supplements containing the controversial herb ephedra, a.k.a. ma huang (Ephedra sinica), or any of the ephedra alkaloids, e.g., ephedrine and pseudoephedrine. (This action does not affect over-the-counter or prescription drug products.) FDA intends to issue regulations in January, with a 60-day effective date. Thus, in March, it is likely that it will be illegal to sell such supplements. FDA cited numerous adverse event reports (AERs) and its independent evaluation by the RAND Corporation as part of its basis for removing ephedra form the market. California, Illinois and New York have already banned the sale of ephedra supplements.
FDA has also issued a consumer warning that people should not use ephedra-containing dietary supplements for weight loss (or any other reason), especially at this time of the year when many people are going on diets after the Holidays. The agency has also written letters to 62 ephedra supplement manufacturers informing them of the impending ban.
News stories in many daily papers and electronic media have been discussing FDA’s action. One of the most frequent topics is the subject of the risks associated with the use of ephedra and the many AERs associated with its use.
ABC will revise this notice as new developments occur.
ABC has several articles and an extensive monograph available on this website to help the public understand the issues surrounding the ephedra controversy:
For the monograph on ephedra from ABC’s new book, The ABC Clinical Guide to Herbs, click here.
For an explanation of the FDA’s proposed label warnings for ephedra issued in March 2003, click here.
For an article on some of the deficiencies and drawbacks associated with the American Association of Poison Control Centers’ TESS (Toxic Exposure Surveillance System) database, click here.
For information on the ban, the FDA Press Release, copy of its warning letter, etc. go to http://www.fda.gov/oc/initiatives/ephedra/december2003/.