Docket Management
Docket: 96N-0417 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients a
Comment Number: EC -15

Accepted - Volume 7

Comment Record
Commentor Dr. Stefan Gafner Date/Time 2003-05-02 14:59:01
Organization Tom's of Maine
Category Dietary Supplement Industry

Comments for FDA General
1. General Comments As a follow up on the Food & Drug Law Institute audioconference April 23, we would like to submit the following comments: In general, we appreciate the effort of the government to impose cGMP to manufacturers of dietary supplement. We are convinced that this rule will indeed bring an improvement of the quality of products manufactured as dietary supplements. We think however that some points of the rule need particular attention. In 111.20 you require that the manufacturing facility has controlled temperature and humidity. As most of the equipment used in the manufacture is cleaned with large amounts of hot water (e.g. with hoses), temperature and humidity controls are not pratical. We also think that incoming raw material testing should be part of the rule (especially as growing, harvesting, storage and distribution is exempted from the rule) and not only done when the finished product testing is not possible due to the lack of a validated method. We would like clarification of the following question: if a raw material contains an unknown amount of excipients, is it necessary to quantify the excipients or can we just assess the active material and rely on the vendor's specification for the excipient content? Finally, we wondered about the financial impacts on small and very small companies. Considering the costs of an HPLC (which we consider a standard equipment for GMP quality control), including maintenance and CFR part 11 requirements (in the range of US $60,000) and somebody to operate the instrument, with an additional $30,000 as only parts of the costing, we wonder how the FDA came up with the low numbers presented at the seminar. Sincerely Stefan Gafner, Ph.D. Tom's of Maine

EC -15