|
|
Article: ATF Fitness Products, Oakmont, PA, Nov. 19 (Philadelphia).(Human Drugs & Dietary Supplements)
- Article from:
- Warning Letter Bulletin
- Article date:
- February 1, 2005
CopyrightCOPYRIGHT 2005 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
|
In October 2004, FDA investigators Robert Davis and William Bender inspected ATF Fitness Products and found that according to the labeling, the company's dietary-supplement products--Sci-Fit Pro-cuts--contained MaHuang extract, which is a source of ephedrine alkaloids.
Dietary supplements containing ephedrine alkaloids are considered adulterated under the Federal Food, Drug and Cosmetic Act because they present "a significant or unreasonable risk of illness or injury."
Furthermore, FDA said ATF could not provide documentation to demonstrate compliance regarding the export of supplements, including ...