Docket Management
Docket: 96N-0417 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients a
Comment Number: EC -7

Accepted - Volume 7

Comment Record
Commentor Mr. John Young Date/Time 2003-03-26 14:28:31
Organization Robinson Pharma, Inc.
Category Dietary Supplement Industry

Comments for FDA General
1. General Comments Most of my career is in the drugs and biologics industries and its my thoughts that this is a VERY GOOD MOVE for the dietary supplement industry. I especially like the portion of the proposed regulations which define and empower the quality organizations within the business. My concern is this: The testing requirements of incoming raw materials (some exotic) for identity, purity, efficacy, etc, will shut down a good portion of the industry. The cost and the effort involved in getting analytical methods alone would be a hurtle that the company I work for could not surmount. One thing that we currently do is use the first of code of raw materials as the testing standard for the follow on materials. Identity and/or assays are run on these material to establised the base line. This is revised once per year. Of course we use any standards that are avaliable. Do the proposed regulations require validations. What is the difference between validations and verifications in the eyes of the FDA? Much of the facilities and equipment in the industry are very old and lack the historical documents that I know are retained in the drug side. Will we have to commission expensive efforts just to establish base line information on old facilities and equipment? Thanks.

EC -7