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Ephedrology; THE BAN
WHATS THE DEAL WITH THE BAN ON EPHEDRA

In 1997, the FDA proposed a regulation on ephedra to limit the dose of alkaloids present in a supplement to 8 mg with a recommendation of no more than 24 mg per day.

In 2000, this limitation was withdrawn because of "concerns regarding the agency's basis for proposing a certain dietary ingredient level and a duration of use limit for these products." In 2004, the FDA imposed a ban on ephedrine alkaloids that are marketed for reasons other than respiratory disease.

On April 14, 2005, the” U.S. District Court for the District of Utah ruled that the FDA did not have proper evidence that low dosages of ephedrine alkaloids are actually unsafe.” On August 17, 2006, the U.S. Court of Appeals upheld the FDA's final ruling stating that all dietary supplements containing ephedrine alkaloids illegal for marketing in the United States. Ephedrine is currently legal in many forms depending on the intended use and varying from state to state.

LOCAL LAW: 2) (a) A product containing ephedrine shall not be considered a controlled substance if the product is a food product or dietary supplement that meets all of the following criteria:

(i) It contains, per dosage unit or serving, not more than the lesser of twenty-five milligrams of ephedrine alkaloids or the maximum amount of ephedrine alkaloids provided in applicable regulations adopted by the United States food and drug administration, and no other controlled substance.

(ii) It contains no hydrochloride or sulfate salts of ephedrine alkaloids. (iii) It is packaged with a prominent label securely affixed to each package that states all of the following: the amount in milligrams of ephedrine in a serving or dosage unit; the amount of the food product or dietary supplement that constitutes a serving or dosage unit; that the maximum recommended dosage of ephedrine for a healthy adult human is the lesser of one hundred milligrams in a twenty-four-hour period for not more than twelve weeks or the maximum recommended dosage or period of use provided in applicable regulations adopted by the United States food and drug administration; and that improper use of the product may be hazardous to a person’s health. The alkaloids ephedrine and pseudoephedrine are the active constituents of the plant. Pseudoephedrine is used in over-the-counter decongestant

Ephedra label: ma-huang (ephedra sinica) (stem extract)....100mg standardized to 8% l-ephedrine, equivalent to 8mg of l-ephedrine

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