Ephedrine: FDA Appeal
What is Ephedrine, Ephedra and Ma Huang?
These terms are used to refer to the same substance derived from the plant Ephedra. (There are many common names for these evergreen plants, including squaw tea and Mormon tea.) Ephedra is a shrub-like plant that is found in desert regions in central Asia and other parts of the world. The dried greens of the plant are used medicinally. Ephedra is a stimulant containing the herbal form of ephedrine, an FDA-regulated drug found in over-the-counter asthma medications.
Ephedrine FDA Decision Overturned
Ephedra is a herb used over 5000 years ago to treat several disorders, such as asthma and bronchitis. Because ephedra has the ability to increase metabolism, and burn fat it became a popular ingredient used in diet pills.
About 12 to 17 million people consumed ephedra in 1999, reports the Americian Herbal Products Association. The Nutrition Business Journal estimated that sales of ephedra in 2002 were $1.25 billion.
Ephedra is so powerful its safety was questioned the FDA removed ephedra also known by its chinese name Ma-huang from the market in April 2004 claiming that it was responsible for dozens of deaths.
In an overturn of the FDA decision, Judge Tena Campbell stated that drug agencies had failed to prove that ephedra at low doses was dangerous, and that it lacked the authority to ban the substance without such proof. She called for the FDA to lift the ban on ephedra.
The US ban on ephedra was reversed on April 14, 2005, among other things the court clarified that the FDA must follow the 1994 Dietary Supplement Health and Education Act (DSHEA) and can not treat dietary supplements like drugs or medical devices.
According to the court, the FDA did not conclusively establish that low doses of ephedra pose significant or unreasonable risk by a preponderance of the evidence. Apparently, sompanies that sell ephedra based products are allowed to resume selling products with no more than 10 mg of naturally occurring ephedrine alkaloids.