From: Michael Cleary [m.cleary@nutritionnow.com] Sent: Monday, August 11, 2003 4:04 PM To: fdadockets@oc.fda.gov Cc: marty@nutritionnow.com Subject: Comments on Docket Number 1996N-0417 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients a Re: Comments on Docket Number 1996N-0417 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients Sir: I was unable to submit our comments through the interface on your web site: http://www.accessdata.fda.gov/scripts/oc/dockets/comments/COMMENT So I am attaching them to this E mail and am providing a text copy below. I hope you find them of help in preparing the final rule. Comments on Docket Number 1996N-0417 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients Submitted by: Nutrition Now, Inc. 6350 NE Campus Drive Vancouver WA 98661 August 11, 2003 Michael Cleary, Ph.D. Director of Scientific Affairs m.cleary@nutritionnow.com Introduction As an active member of the National Nutritional Foods Association, we have contributed to their workgroup in preparing NNFA's response, submitted to FDA on August 7, 2003. We took part in the American Herbal Products Association forum in Portland OR, whose aim was to coalesce the concerns of herbal products users about the Proposed Regulation. Finally, we also participated in an FDLI teleconference with FDA presenters, in which the genesis and issues contained within the Proposed Regulation were described. We fully endorse the comments made in the NNFA response and wish to present comments specific to our organization. Our specific concerns involve Testing of Components and Products, FDA's Economic Analysis of the impact of the Proposed Regulation, and the use of Qualified Vendors to help assure the identity, strength, quality, composition and purity of our dietary supplement products. Testing In constructing the proposed regulation, the FDA underestimated the amount of testing, mostly due to: 1. the estimated number of batches, and 2. the complexity of operations for companies that are not vertically integrated. For small companies like ours, FDA has estimated that we produce 554 batches of products annually. Following strict definitions of batches, we produce 1500 to 2000 batches annually. Addressing the second point: we have products for which we purchase materials; contract to have them processed; contract to have them blended (commonly, up to 15 components); contract to have them incorporated into a final dosage form; and bottle and label them at our facility. In other words, we may receive the product at 5 separate stages in the production scheme. For ingredient and microbiological testing, the proposed regulations require us to perform more than 70 tests for each batch of such product. Economic Analysis The economic impact on our organization would far outstrip FDAs estimates of $76,000 for the first year and $47,000 annually for small companies. We disagree with this estimate. Currently we spend in excess of $100,000 for component and microbiological testing of finished products and intermediates. Most of those tests are contracted through outside laboratories; and we also run tests in house. We do no testing of materials (bottles, caps, bags and seals) that might also affect the identity, strength, quality, composition and purity of our products. Under the proposed regulation, we expect our testing to burden to increase 3- to 5-fold. While the number of tests and the cost of using outside laboratories will lead us to bring more tests "in house" with resultant cost reduction, the testing alone will consume in excess of $350,000 operating costs, annually. Since we anticipate laboratory equipment capital costs of $500,000 (see below), some of which we already own, we also expect to spend 20% per year on maintenance and replacement of that equipment -- an additional $100,000 per year. FDA estimates $29,000 (the difference between first year and annual costs) for the cost of upgrading laboratory space, purchasing equipment and validating methods. Our costs will be significantly higher, even though we recently spent $50,000 implementing in house HPLC analyses. We will expand our laboratory, bring microbiological analyses in house, purchase specialized equipment (ranging. from an automatic moisture analyzer for $4000 to an ICP-MS aa unit for $40,000), hire additional technicians, and develop and validate methods. During the transition period (from using outside laboratories to running analyses in house) and development of methods we will need to run multiple replicate analyses with reference laboratories. We expect to spend a total of $300,000 to $400,000 on new laboratory equipment. As noted in FDA's analysis, costs are not limited to laboratory testing. They also include additional calibration and maintenance of production equipment, record keeping, retention of product samples, data retention and maintenance, training, and general administration. We anticipate adding 2 people to our quality unit (in addition to the 3 now employed) and 2 people to our production unit to handle this burden, for a total of 7 for an annual salary and administrative cost of $350,000 ($450,000 first year). We also expect to add 4 new computer workstations, not included. Total Estimate of Financial Impact: $800,000 per year; additional $450,000 start up (over the first 2 to 3 years). Vendor Qualification The proposed regulations do not allow the use of vendor-supplied Certificates of Analyses to assure the identity, strength, quality, composition and purity of components used in the manufacture of dietary supplement products. The use of Certificates of Analysis is a common practice within the dietary supplement industry and the food industry; and we feel that not allowing them within this regulation will negatively impact our company, the industry, our retail customers and ultimately the end user. 1.. If companies are required by law to test incoming components for every specification, they will write the minimum number of requirements for each component to minimize testing. Fewer requirements will lead to lower quality components. 2.. Ingredient suppliers who have invested heavily in quality systems will lose a competitive advantage. As a company who purchases these products, we pay premium prices to assure the quality of raw material. If we are required to re-test to assure this quality, we will not see the need to pay a premium. 3.. The cost of re-testing is burdensome (discussed above). 4.. Small manufacturers will be at even more disadvantage than simple "economies of scale." We recently received a small shipment of zinc citrate (5 x 20 kg boxes) with 3 different manufacturer's lot numbers. As a minor customer, we are not in a position to demand a single lot number; but we will be required to perform 3 separate sets of tests. We suggest that FDA allow the use of vendor-supplied Certificates of Analyses provided that vendor is either 1. Certified by a third party as fully compliant with 21CFR211; or 2. The receiving company can document the reliability of that vendor by a combination of collaborative testing, multiple lot analyses and on-site audits. Thank you for your consideration. End of Comments