From: Dickens, Annie E Sent: Monday, August 11, 2003 3:59 PM To: Butler, Jennie C Subject: FW: Comment submitted via CFSAN QA-ASK Importance: High Another one having problems. -----Original Message----- From: Jim Daily III [mailto:Jim Daily III] Sent: Monday, August 11, 2003 3:55 PM To: Dickens, Annie E Subject: Comment submitted via CFSAN QA-ASK Personal Information Name: Jim Daily III, Ph.D. Email: jdaily3@yahoo.com Company: Daily Manufacturing, Inc. Address: 4820 Pless Rd Rockwell NC USA 28138 phone: 704-782-0700 fax: 704-784-8400 Comment: Note: I was unable to make the comment work on the section for sending comments to this docket. James W. Daily III, Ph.D. Daily Manufacturing, Inc. 4820 Pless Rd. Rockwell, NC 28138 August 11, 2003 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, rm. 1061 Rockville, MD 20852 RE: Docket No. 96N-0417; Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements. Dear Sir or Madame, I support the introduction of the establishment of reasonable current good manufacturing practices (cGMPs) as mandated in the Dietary Supplement Health and Education Act (DSHEA) of 1994. However, I feel that the current proposal is not consistent with guidelines established by DSHEA and is in violation of current law. Most estimates, including those by FDA, suggest that the new cGMP regulations would result in 150-300 small and very small manufacturers going out of business. FDA must be very sure that no unnecessary or redundant regulations are imposed, and that all new regulations address clearly identified problems that put the public health and safety at risk. Our facility is located in Cabarrus County, North Carolina where a major textile mill has just closed resulting in a loss of over 4,000 jobs. Like the textile industry, the supplement industry is rapidly losing jobs to Asia. I fear that unnecessary regulations in this country will not be enforceable in other countries and result in even greater loss of American jobs We have given estimates of cost increases to the NNFA, so these figures will be part of their compilation and commentary. However, I would like to make a few observations that I believe would help improve the regulations. 1. Allow expiration dates to be based on reasonable data  not always stability testing. If the option is to either not use expiration dates or do stability testing on all products, most manufacturers will elect not to have expiration dates because stability testing is very expensive. In that case consumers will have difficulty determining the freshness of products. There is sufficient published data on the stability of many nutrients to make very good estimates of stability. On those products without good stability data, ingredient manufacturers, product manufacturers, and possibly trade organizations could make stability information available that would provide reliable stability data under a variety of conditions. This approach would serve the public very well. Finished product testing will greatly increase the cost of manufacturing many supplements, and in most cases will provide no real benefit to the consumer. Many times one batch of ingredient will go into multiple finished products. If there is something akin to a certified analysis on the raw ingredient, the amount added to a capsule or tablet should provide a very accurate estimation of the content of the finished product. This would especially be true for single ingredient products. In multiple ingredient products, there is the concern that the person blending the ingredi Dear Sir or Madame, I support the introduction of the establishment of reasonable current good manufacturing practices (cGMPs) as mandated in the Dietary Supplement Health and Education Act (DSHEA) of 1994. However, I feel that the current proposal is not consistent with guidelines established by DSHEA and is in violation of current law. Most estimates, including those by FDA, suggest that the new cGMP regulations would result in 150-300 small and very small manufacturers going out of business. FDA must be very sure that no unnecessary or redundant regulations are imposed, and that all new regulations address clearly identified problems that put the public health and safety at risk. Our facility is located in Cabarrus County, North Carolina where a major textile mill has just closed resulting in a loss of over 4,000 jobs. Like the textile industry, the supplement industry is rapidly losing jobs to Asia. I fear that unnecessary regulations in this country will not be enforceable in other countries and result in even greater loss of American jobs We have given estimates of cost increases to the NNFA, so these figures will be part of their compilation and commentary. However, I would like to make a few observations that I believe would help improve the regulations. 1. Allow expiration dates to be based on reasonable data  not always stability testing. If the option is to either not use expiration dates or do stability testing on all products, most manufacturers will elect not to have expiration dates because stability testing is very expensive. In that case consumers will have difficulty determining the freshness of products. There is sufficient published data on the stability of many nutrients to make very good estimates of stability. On those products without good stability data, ingredient manufacturers, product manufacturers, and possibly trade organizations could make stability information available that would provide reliable stability data under a variety of conditions. This approach would serve the public very well. 2. Finished product testing will greatly increase the cost of manufacturing many supplements, and in most cases will provide no real benefit to the consumer. Many times one batch of ingredient will go into multiple finished products. If there is something akin to a certified analysis on the raw ingredient, the amount added to a capsule or tablet should provide a very accurate estimation of the content of the finished product. This would especially be true for single ingredient products. In multiple ingredient products, there is the concern that the person blending the ingredients might make an error in the formulation  but good records of the ingredients added should reveal that kind of mistake. My experience in a research laboratory suggests that laboratory analysis that are 5% are quite good. However, that kind of variation in a multi-ingredient product would assure that most products would not meet specifications even if they are accurately formulated. If suppliers provide accurate analysis of products, an identity test as suggested in the 1997 proposed guidelines would be sufficient. Third party testing of ingredients, with certificates for each lot provided by the labs to manufacturers would be an excellent approach to testing of raw materials. Laboratories could test a large lot and supply analysis to manufacturers who would pay them for test results for products received from that lot. Again, I would urge FDA to implement only those regulations which are essential to assure that consumers receive high quality and safe products. DSHEA stipulates that cGMPs should be based on food cGMP standards  not pharmaceutical. That would be reasonable. Although supplements often have a similar appearance to pharmaceuticals, they are in fact food concentrates and are used to bolster the nutritional quality of diets. Please use great care in developing cGMP standards that are reasonable and cost effective. 3. ents might make an error in the formulation  but good records of the ingredients added should reveal that kind of mistake. My experience in a research laboratory suggests that laboratory analysis that are 5% are quite good. However, that kind of variation in a multi-ingredient product would assure that most products would not meet specifications even if they are accurately formulated. If suppliers provide accurate analysis of products, an identity test as suggested in the 1997 proposed guidelines would be sufficient. Third party testing of ingredients, with certificates for each lot provided by the labs to manufacturers would be an excellent approach to testing of raw materials. Laboratories could test a large lot and supply analysis to manufacturers who would pay them for test results for products received from that lot. Again, I would urge FDA to implement only those regulations which are essential to assure that consumers receive high quality and safe products. DSHEA stipulates that cGMPs should be based on food cGMP standards  not pharmaceutical. That would be reasonable. Although supplements often have a similar appearance to pharmaceuticals, they are in fact food concentrates and are used to bolster the nutritional quality of diets. Please use great care in developing cGMP standards that are reasonable and cost effective. Sincerely, Jim Daily III, Ph.D.