Update on the Regulatory Status of Ephedrine

W. Steven Pray, Ph.D.

For many years, ephedrine was one of the most dangerous and least needed products available without a prescription. It was considered to be safe and effective for the treatment of asthma in the 1970s, however, it has no place in the current treatment of asthma, according to the 2002 National Institutes of Health/National Heart, Lung, and Blood Institute updated guidelines. 1, 2 In 1997, the FDA proposed new regulations to govern sales of ephedrine and ephedrine combination products when sold as dietary supplements. The proposal included 800 adverse event reports for this dangerous chemical.3 In 2000, the FDA added another 270 adverse event reports while in the same year revealing that it had received almost 15,000 comments opposing any new actions against ephedrine. The comments, mostly from ephedrine distributors, were thought to be the result of a massive letter-writing campaign orchestrated by those with a financial interest in selling ephedrine-containing products. The comments led the FDA to withdraw the most salient parts of the proposed regulations, leaving Americans unprotected and demonstrating the power of ephedrine manufacturers. Finally, on February 6, 2004, the agency determined the use of ephedrine alkaloids posed unreasonable risk to users and issued a final rule prohibiting sale of ephedrine-containing dietary supplements. Many ephedrine manufacturers are based in Utah, which has been termed the “silicon valley of herbal supplements.”4 A Utah-based nutritional supplement manufacturer brought a lawsuit against the FDA challenging the 2004 ban of ephedrine and federal judge Tena Campbell ruled against the FDA. Judge Campbell found that the agency had not proven that a 10 mg dose of ephedrine was dangerous.However, the ruling seemed not to recognize the simple fact that many ephedrine users do not respect labeled doses, and freely opt to take two, three or fifteen tablets at will. As a direct result of the ruling, kiosks in malls trumpeted, “We now have ephedra again!” Finally, on August 21, 2006, the U.S. Court of Appeals in Denver upheld the FDA’s ban of ephedrine-containing dietary supplements, ruling that no dose of ephedrine has been proven safe. That ruling left only the issue of using ephedrine for legitimate medical purposes. On July 13, 2005, the FDA issued a proposed rule to ban all combinations of ephedrine and guaifenesin (e.g., Primatene® tablets).5 However, the products will continue to be marketed until the rule is final. The other danger of the continued availability of ephedrine is that it may be used as a starter chemical in methamphetamine production. The Combat Methamphetamine Epidemic Act of 2005 largely halted sales of ephedrine (and pseudoephedrine) products except by a pharmacist or with specific restrictions by non-pharmacy “mobile retail vendors.” Purchasers must present a government-issued photo ID and sign a logbook recording their name and address, the date and time of sale, and signature. The seller must record the name of the medication and the quantity sold. Electronic logbooks are allowed. Pharmacy sales of ephedrine are limited to 3.6 grams per day to each customer or 175 25-mg tablets of ephedrine hydrochloride, according to the U.S. Department of Justice. The 30-day limit is 9 grams of ephedrine, equivalent to 439 25-mg tablets of ephedrine hydrochloride or 466 25-mg tablets of ephedrine sulfate.6 These new national restrictions allow the prudent pharmacist to educate patients about the limited usefulness of ephedrine and preferable alternatives for treatment in those with a legitimate medical need for ephedrine use. When finalized, the FDA final rule will ban all nonprescription sales of ephedrine in any form whatsoever, protecting the health of the American people when this dangerous, largely useless nonprescription ingredient is removed from pharmacy shelves. 1. Available from: http://www.fda.gov/cder/otcmonographs/bronchodilator/new_bronchodilator.htm . Accessed January 10, 2007. 2. Available from: http://www.nhlbi.nih.gov/guidelines/asthma/index.htm. Accessed January 10, 2007. 3. Pray WS. "Asthma," in Nonprescription Product Therapeutics. Lippincott Williams & Wilkins, Baltimore, 2005; pp. 281-292. 4. Available from: http://home.comcast.net/~bkrentzman/sup.vitamin.alt/supplements/3.utah.herb.bus.html. Accessed January 10, 2007. 5. Available from: http://www.fda.gov/OHRMS/DOCKETS/98fr/05-13708.pdf. Accessed January 10, 2007. 6. Available from: http://www.deadiversion.usdoj.gov/meth/trg_retail_081106.pdf. Accessed January 10, 2007. Return to Top