FDA adoption of OTC ephedrine safety limits for herbals urged by supplement group.
This article was originally published in The Tan Sheet
Executive Summary
EPHEDRINE SUPPLEMENT LEVEL AKIN TO OTC AMOUNT allowed under FDA's 1986 final monograph for cough/ cold (bronchodilator) products is urged by the Ad Hoc Committee for Dietary Supplement Safety in Dec. 2 comments to the agency. Citing the monograph's establishment of the current 25 mg single-dose limit as a safe level for ephedrine-containing OTC bronchodilator products, the ad hoc committee suggests the same amount be permitted for dietary supplement products. The 25 mg level has been endorsed by a number of supplement industry groups, including the Dietary Supplement Safety and Science Coalition ("The Tan Sheet" Dec. 8, p. 20).