FDA and "street drug alternatives"

Agency will announce the availability of an industry guidance on "street drug alternatives" in the April 3 Federal Register. The guidance outlines FDA's policy concerning products manufactured or marketed as alternatives to illicit street drugs, stating any such item is "an unapproved new drug and a misbranded drug in violation of sections 505 and 502 of the [FD&C] Act" and such violations may result in "seizure and injunction." FDA also notes many of these products are "labeled as containing botanicals...[or] vitamins, minerals or amino acids," while others "are being marketed as dietary supplements." However, because street drug alternatives are not "intended to supplement the diet," FDA maintains they do not fall under this regulatory category. Copies of the guidance will be available at www.fda.gov/cder/guidance/index.htm; comments may be submitted to the agency at any time