Saturday, April 26, 2003
"Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements" (CGMP) is a proposed FDA rule which would impose strict standards of manufacturing on the nutritional supplement industry. "The standards put forth in this document are so severe that they exceed those imposed upon the pharmaceutical companies, which are Goliaths with virtually unlimited resources in comparison to nutritional companies...the added burden would at least triple the price. "There can be little doubt that the proposed rule would level most small businesses (which comprise most of the industry). Far fewer companies would survive, and these would tend to be the largest and most conservative, resulting in significantly less competition and far less innovation. CGMP would ensure not only a rollback of complex products, but also hinder or halt the development of new products. "The FDA would have the right to conduct unrestricted inspections of nutritional companies at their discretion and could, for subjective reasons, shut down companies that are in their political beacon...the FDA's solution to 'good manufacturing' is nothing less than the imposition of arbitrary and undefined powers enabling it to exercise repression of all with whom it disagrees.
at 4/26/2003 01:05:00 PM