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On January 9, 2002, Canadian regulatory authorities announced the initiation of a voluntary recall of certain products containing the drug supplement Ephedra and one of its pure chemical constituents, ephedrine. Ephedra and ephedrine are mostly found in dietary supplements promoted for weight loss and energy enhancement. If voluntary compliance with the recall is not achieved, the option for stronger regulatory action, including the seizure of violative products, was left open.
Public...
On January 9, 2002, Canadian regulatory authorities announced the initiation of a voluntary recall of certain products containing the drug supplement Ephedra and one of its pure chemical constituents, ephedrine. Ephedra and ephedrine are mostly found in dietary supplements promoted for weight loss and energy enhancement. If voluntary compliance with the recall is not achieved, the option for stronger regulatory action, including the seizure of violative products, was left open.
Public Citizen’s Health Research Group has already filed a petition to the Food and Drug Administration to ban all ephedrine-containing dietary supplements. You can access the petition at www.citizen.org/publications/release.cfm?ID=7053 or by writing to us for a copy at Health Research Group, 1600 20th Street, NW, Washington, DC 20009.
The Canadian decision was reached after a risk assessment concluded that these products pose a serious health risk. Adverse events including stroke, heart attacks, heart rate irregularities, seizures, psychoses and deaths have been reported in association with the use of some products containing Ephedra or ephedrine.
This recall deals with the following types of Ephedra or ephedrine products:
1. Products having a dose of more than 8 milligrams of ephedrine or with a label recommending more than 8 milligrams per dose or 32 milligrams per day and/or are labeled or implied for use exceeding seven days.
2. All combination products containing Ephedra or ephedrine together with another stimulant such as caffeine and other ingredients which might increase the effect of Ephedra or ephedrine in the body.
3. Products with labeled or implied claims for appetite suppression, weight loss promotion, metabolic enhancement, increased exercise tolerance, body-building effects, increased energy or wakefulness, or other stimulant effects.
This action by the Canadian authorities is a rational regulatory policy to protect their citizens from dangerous drug supplements. In this country, the public must face alone the irrationality of an unregulated market for drug supplements because of the Dietary Supplement Health and Education Act enacted in 1994.
What You Can Do
You should not use Ephedra or ephedrine-containing drugs. They are dangerous and without a legitimate medical use.
