Israelsen GMP Tips: Watch “Wild Card” Law, Use CoA As Legal Documents
This article was originally published in The Tan Sheet
Executive Summary
Enforcement actions brought by the Federal Trade Commission against dietary ingredient companies that provide false or misleading certificates of analysis to supplement manufacturers could be an effective mechanism for assuring supply quality, according to Utah Natural Products Alliance Executive Director Loren Israelsen
You may also be interested in...
Supplement Industry Must Make United Response To NDI Guidance – AHPA
A united response from industry on the new dietary ingredient draft guidance could help prevent FDA from creating an even more burdensome policy, say representatives of the American Herbal Products Association.
AHPA opposes irradiation
The American Herbal Products Association submits a letter Dec. 14 to FDA's Center for Food Safety and Applied Nutrition requesting the agency deny a food-additive petition that would allow the use of ionizing irradiation on dietary supplements and dietary ingredients. The petition, submitted by Steris Corp in 2003, proposed that food-additive regulations be amended to provide for the safe use of ionizing radiation for the control of microbial contamination on dietary supplements and dietary ingredients, up to a maximum absorbed dose of 30 kGy (1"The Tan Sheet" Oct. 1, 2007, p. 6). AHPA proposed limiting ionizing radiation for supplements to 30 kGy, while the petition suggests the limit be from 3 to 30 times higher than currently allowed for all but two food categories. Irradiation currently is allowed in the U.S. for 11 food categories...
Supplement GMPs Stress Responsibility, Put Firms In Driver’s Seat For Testing
The dietary supplement good manufacturing practices final rule provides "a very flexible framework for required testing," said Vasilios H. Frankos, director of the dietary supplement programs division for FDA's Center for Food Safety and Applied Nutrition