Ephedrine is a natural constituent of the herb ephedra and a synthetic compound present in certain over-the-counter drug products. The herbal form, known as Ma Huang in China, has been used as a remedy for asthma. In western cultures, ephedrine, the active drug product ingredient, has been used as a bronchodilator and decongestant for various respiratory problems. More recently, dietary supplements containing ephedra have been promoted for weight reduction and as a performance enhancer in body building and other sports.
Under the provisions of the Dietary Supplement Health and Education Act of 1994 (DSHEA), the Food and Drug Administration (FDA) must show that a supplement is unsafe and causes harm before it can be removed from the market. In 1997, following several hundred reports of adverse effects alleged to be caused by ephedra use, FDA proposed rules to restrict the dosage, require specific warnings on ephedra-containing supplements, prohibit supplements containing ephedrine combined with other known stimulants, and require warnings against excessive intakes. This proposal was criticized for the lack of scientific evidence to support FDA’s dosage limitations and the labeling requirements. In 2000, FDA withdrew part of the proposed rule, but subsequent highprofile deaths attributed to ephedra led FDA to re-propose the original regulation in 2003. On December 30, 2003, the Department of Health and Human Services (HHS) and FDA announced plans to prohibit sale of ephedra, using the safety provisions of DSHEA for the first time.