| CAOMA Testimony for 2003 FDA Ephedra Labeling Proposal |
| April 4, 2003 - CAOMA responds to the FDA's proposed new ephedra labeling standards. |
| Attachment 1 - FDAs 2003 Proposed Labeling Standards |
| April 4, 2003 - FDA's proposed new ephedra labeling standards. |
| Attachment 2 - CA Health & Safety Code 110423 |
| April 4, 2003 - California health & Safety Code Section 11023. |
| Ephedra Facts |
| March 15, 2003 - Ephedra is an herb that grows naturally worldwide in desert areas. It has been used Chinese herbal medicine for at least a thousand years, and possibly longer in America, where it was known in Utah as Indian or Mormon tea. |
| History of Ephedra Regulation |
| March 15, 2003 - Numerous proposals to regulate ephedra have been proposed, based upon the fact that ephedra contains ephedrine compounds that are commonly used in over-the-counter cold medications. Ephedrine is used in the illicit production of methamphetamines. |
| FDA Cracks Down on Mis-Branded Body-building Supplements |
| February 28, 2003 - Washington DC - The FDA issued warning letters to a number of dietary supplement manufacturers for products containing ephedra and that claimed to enhance muscle building strength and mass, in probable violation of labeling standards for products introduced into interstate commerce. |
| HHS Re-opens Ephedra Labeling Proposal |
| February 28, 2003 - Washington DC - The US Department of Health and Human Services published a press release announcing the re-opening of a request for comments about a regulatory proposal first presented by the FDA in 1997 and modified in 2000, but apparently never fully adopted. The following is a copy of the press release. |
| RAND Report on Ephedra |
| February 28, 2003 - The RAND report on ephedra concludes that ephedra or ephedrine plus caffeine products result in short-term weight loss of up to two pounds per month for up to four to six months; that nausea, vomiting, anxiety, and palpitations are the most commonly reported side effects; and that the rarity of serious adverse events such as seizure, stroke, and death requires further study and should identify the role that caffeine plays. |
| CAOMA Testimony for 1997 FDA Proposal |
| August 16, 1997 - CAOMA response to the FDA's proposal to regulate ephedra. CAOMA challenged some of the FDA's assumptions and recommends that the dosage of ephedrine-containing dietary supplements be regulated in a manner consistent with the regulation of ephedrine-containing drugs, and requested an exemption for the labeling of ephedra when prescribed by licensed acupuncturists. |
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