Texas Enforcing New Ephedrine Rule
September 8, 2001
Texas officials recently passed a regulation requiring all supplements containing the stimulant ephedrine (also known as ephedra) to carry labels providing a toll free number to the Food & Drug Administration where users can report side effects. This is the first such regulation of its kind in the United States. Texas public health officials insist that they are enforcing the new rule, despite reports that the Bush administration opposes the label.
Ephedrine side effects are linked to more than 80 U.S. deaths. Attempts to regulate the substance have failed to stop the nearly $17 billion-a-year industry. Ephedrine enjoys strong lobbyist support. In addition, the dietary supplement is not subject to the strict prescription drug protocols of the FDA.
According to phone records and other sources, a representative of U.S. Health and Human Services Secretary Tommy Thompson spoke numerous times with Texas health officials regarding the new regulation. Reports indicate that Metabolife, a major dietary supplement maker, contacted Thompson, questioning the propriety of requiring the label.
Dietary supplements are sold in supermarkets and pharmacies without a prescription. Because supplements are not regulated by the FDA, any deaths or reported side effects do not have to be reported to the agency. Texas health officials hope to improve reporting with the new label requirement.
In related ephedrine news, this week, consumer advocacy group Public Citizen filed a petition requesting that the FDA ban the sale of products containing ephedrine.
-- Article Courtesy of InjuryBoard.com
More ...
- Metabolife Complaints Do Not Yield Enough Information
- Ephedrine Negative Side Effects: American Heart Association Calls For Ephedra Ban
- Ephedra Dangers: California Senator Introduces Legislation Banning Ephedra
.