United States of America - The Food and Drug Administration has made a review of 140 reports of adverse drug reactions linked to the use of dietary supplements containing ephedrine alkaloids. The FDA has called for additional information before proposing limits to the dosing level and duration of use (1).
In addition to these actions, the Agency has issued a Guidance for Industry on Street Drug Alternatives in response to the proliferation of various products promoted as alternatives to illicit street drugs. These products, which are intended to affect psychological states are generally labelled as containing herbals, vitamins, minerals or amino acids. Given their intended use, the FDA does not consider street drug alternatives to be dietary supplements. Street drug alternatives are therefore considered as unapproved and misbranded drugs that are subject to regulatory action, including seizure and injunction (2).
1. US Food and Drug Administration. Dietary supplements containing ephedrine alkaloids: docket update, availability. http://www.fda.gov/OHRMS/DOCKETS/98fr 31 March 2000.
2. US Food and Drug Administration. Guidance for Industry on Street Drug Alternatives. http://www.fda.gov/OHRMS/DOCKETS/98fr.040300d.txt 31 March 2000.