What Are Ephedrine Alkaloids?
The ephedrine alkaloids that are contained in dietary supplements are not identical to pure synthetic ephedrine. While ephedrine is one of the alkaloids present in ephedra extracts, these extracts also include other alkaloids, such as pseudoephedrine, that are less potent than ephedrine, as well as alkaloids that slow the absorption of ephedrine from the digestive tract and/or counteract the stimulant effects of the ephedrine in the extracts. Therefore, from an overall safety standpoint, ephedrine alkaloids contained in ephedra are safer than pure ephedrine, which itself is very safe when consumed as directed.
The ephedrine that is used in drug products in the United States was originally extracted from the herb Ephedra, but is now chemically synthesized. Ephedrine is “generally recognized as safe and effective” by the FDA for over-the-counter (OTC) drug use as a bronchodilator at doses up to 25 mg of ephedrine taken up to 6 times per day, for a total daily dose of 150 mg per label directions. The FDA has approved pseudoephedrine for OTC use at a dose of up to 60 mg per serving up to 240 mg per day.
In 1996, FDA reported that it had received no reports of significant adverse events for OTC ephedrine products when consumed at the recommended dose despite decades of widespread use by consumers without a physician’s supervision.
The current industry and national standard for dietary supplements containing ephedrine alkaloids is a maximum of 25 mg total ephedrine alkaloids (that is, the total amount of ephedrine, pseudoephedrine and other alkaloids), not to exceed 100 mg per day. These limits were developed based on the long history of safe use of the more potent ephedrine OTC products at higher levels, as well as historical and clinical evidence supporting the safety of Ephedra itself.
Suggested Reading:
