Resolution Year 2001
Resolution Number 2:
FDA Action on Herbal Products Containing Ephedrine.
Whereas, dietary supplements containing ephedrine alkaloids continue to be promoted for uses such as weight loss, body building, increased energy, and in some marketing programs as a safe and natural alternative to illicit street drugs, and
Whereas, the effects of these alkaloids are potentially powerful ones which can result in tremors, seizures, heart attacks and strokes, and
Whereas, the U.S. Food and Drug Administration (FDA) , on June 2, 1997, proposed a dosage limitation of 8 mg of ephedrine alkaloids per serving, and a duration of use of no more than 7 days, in an effort to reduce the risks associated with these products, and
Whereas, FDA subsequently withdrew these two proposed limitations in April 2000 and reopened the public comment period from August 10- September 30, 2000 to generate additional information regarding the safety of these products, and
Whereas, over seven months have passed since the comment period closed and nothing has issued from FDA on this matter, therefore be it
Resolved, that the Association of Food and Drug Officials (AFDO), express strong concern to FDA about the continued uncontrolled marketing of these potentially dangerous herbal products, and be it further
Resolved, that AFDO ask FDA to expedite its' policy decision on this issue and provide effective regulatory guidance in this difficult public health protection area.
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