-Urges FDA To Incorporate Industry "Best Practices"-
WASHINGTON, D.C., August 12, 2003 - The Council for Responsible Nutrition (CRN), one of the dietary supplement industry's leading trade associations, this week reinforced its commitment in support of "strong, realistic Good Manufacturing Practices (GMPs)" for dietary supplements, but urged the Food and Drug Administration (FDA) to seriously consider industry recommendations that would incorporate current "best practices" and make the final rule more workable in order to "better meet the needs and expectations of consumers for improved health."
Following submission of an extensive set of comments to FDA, CRN President Annette Dickinson, Ph.D., noted "As FDA pointed out in the preamble to the proposed GMP rule, 'Congress enacted the Dietary Supplement Health and Education Act (DSHEA) to ensure consumers' access to safe dietary supplements.' CRN agrees that new GMPs will be beneficial to consumers and to the industry, provided the regulations are appropriately modeled after food GMPs, strike the proper balance between adequate control and necessary flexibility, reflect high quality standards currently observed by responsible manufacturers, and are adequately enforced by FDA for both U.S. and foreign product manufacturers, large and small."
CRN's comments covered a range of topics, including the purpose, scope and likely impact of the rule; the importance of process control versus over-reliance on end-product testing; ways to strengthen the proposed rule; and legal implications. In addition, CRN submitted a 53-page chart detailing specific section-by-section recommendations and an 84-page side-by-side comparison of the proposed GMPs, the 1997 advanced notice of proposed rule making, food GMPs and drug GMPs.
One of CRN's key concerns with the proposed rule is its lack of a stronger focus on process controls and its over-reliance on exhaustive end-product testing. "Quality cannot be tested into a product, but must be built into the product from beginning to end," stated Dr. Dickinson. "If a company incorporates the right process controls from the beginning and follows them every step of the way, much of the burdensome, exhaustive, expensive end-product testing suggested by FDA becomes redundant and unnecessary." CRN has provided an outline describing a strong and effective process control system, which includes written procedures for key operations and identity testing for all bulk ingredients at the time they are received.
CRN also takes issue with FDA's suggestion that the proposed rule should apply to both ingredient suppliers and finished product manufacturers. While CRN and its member companies are committed to producing the highest quality products, the association believes that it makes the most sense for the proposed rule to be applied only to the finished product manufacturer who would then be the "gatekeeper" for the product's quality. Dietary supplement ingredient suppliers, like all food ingredient suppliers, would continue to be covered by the existing food GMPs. "For many ingredient suppliers, the bulk of their business is in the conventional food industry with dietary supplements representing a small percentage of business. There is no rationale for requiring them to apply two different sets of GMPs to their manufacturing plants, employees, and processes and our concern is that if they are required to do so, it could negatively affect industry and consumers."
CRN believes there are many issues such as this that would benefit from further discussion and urges FDA to hold public hearings or workshops before finalizing the rule.
A complete set of CRN's comments, as well as a comprehensive press kit including a list of spokespeople available to accredited journalists, can be accessed at http://www.crnusa.org/shellnrGMPPressKit081103.html or by calling Judy Blatman at 202-204-7962.
The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing dietary supplement ingredient suppliers and manufacturers. CRN members adhere to a strong code of ethics, comply with dosage limits and manufacture dietary supplements to high quality standards under good manufacturing practices.