From: Abbey Meyers [ameyers@rarediseases.org] Sent: Tuesday, March 11, 2003 1:25 PM To: fdadockets@oc.fda.gov Subject: DOCKET NO. 96N-0417 Re: Docket No. 96N-0417 FDA Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients & Dietary Supplements Dear Sirs or Madams: We are very pleased that FDA has finally published proposed labeling and manufacturing standards for dietary supplements. These regulations are long overdue, and we urge you to finalize the rules as quickly as possible, and then vigorously enforce them. As FDA knows, many dietary supplements have been adulterated or misbranded. CGMPs are needed to prevent sub-potent and super-potent products, and contaminated products that are a danger to public health. Every nutritional supplement product should be manufactured with rigorous quality controls, as well as standardized packaging and labeling. The industry’s attempts to regulate itself have been a miserable failure. We are concerned, however, that large manufacturers will have one year to comply, while small manufactures will have three years to comply. When consumers purchase a nutritional supplement, they do not have any idea if the manufacturer is small or large. Thus they may be purchasing mislabeled and adulterated products up to three years from now, while mistakenly believing that FDA regulates the product. We suggest that any product that does not live up to these standards one year after the regulations go into effect should be labeled to say, “This product may not conform with government standards for purity and potency.” This will give consumers a reasonable warning that the manufacturer has not met government standards. It will also prevent small fly-by-night manufacturers from making sham products and then going out of business within a year. Similarly it will reward small companies that comply with the new standards before the three-year limit. We applaud the FDA for finally moving forward to protect the public from mislabeled and contaminated nutritional supplements. We urge you to finalize the regulations quickly, and then to rigorously enforce them. Very truly yours, Abbey S. Meyers President National Organization for Rare Disorders (NORD) P.O. Box 1968 Danbury, CT 06813-1968 203-744-0100 ameyers@rarediseases.org http://www.rarediseases.org -------------------------------------------------------------------------------------------- Each contribution to NORD assures the continuity of our unique programs that serve the 25 million Americans who, because their diseases are rare, might otherwise be forgotten. Consider showing your support for NORD by making a gift at http://www.rarediseases.org/helping/donate Subscribe to NORD's e-News. You'll receive breaking news affecting the rare-disease community directly in your inbox. Simply send an e-mail to: subscribe@rarediseases.org