Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -1306

Accepted - Volume 326

Comment Record
Commentor Mr. Carmen Catizone Date/Time 2003-04-03 16:43:01
Organization National Association of Boards of Pharmacy
Category Association

Comments for FDA General
1. General Comments The National Association of Boards of Pharmacy (NABP) is the professional organization that represents state boards of pharmacy in all regions of the United States, the Virgin Islands, Puerto Rico, eight provinces of Canada, three states in Australia, New Zealand, and South Africa. NABP was established in 1904 to develop uniform standards and procedures for pharmaceutic licensure and for the transfer of licensure. Over the past 99 years, NABP has been repeatedly called upon to develop programs and services to assist the state boards in their charge to protect the public health, safety, and welfare. It is in this capacity that we respond to the Food and Drug Administration’s (FDA) proposed rule on dietary supplements containing ephedrine alkaloids. NABP and the state boards of pharmacy support the proposed rule that would require manufacturers of dietary supplements containing ephedrine alkaloids to attach the warning statements published in the proposed rule. We also support an FDA determination that such products present “a significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling, or if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use,” and any subsequent regulatory action. In fact, NABP encourages the FDA to classify all ephedrine-containing products as prescription drugs. NABP is pleased to provide these comments regarding this important issue. If we can be of any further assistance, please do not hesitate to contact me.

EC -1306