From: Kevin Heisel [kheisel@jostchemical.com] Sent: Tuesday, August 12, 2003 10:06 AM To: fdadockets@oc.fda.gov Subject: Fw: Docket No. 96N-0417; Current Good manufacturing Practice in Manufacturing, Jost Chemical Co., Inc. 8130 Lackland Road St. Louis, MO 63114 8/11/03 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 FDA Administrator: Jost Chemical is a small dietary supplement manufacturer that supports the establishment of more stringent good manufacturing practices (cGMPs) than those found in the proposed rule. We have observed that voluntary quality controls have not established minimum standards that are industry wide or sufficiently protective to the consumer. Responsible companies who have already developed effective programs to ensure product quality are in direct competition with enterprises that have little or no regard for the final disposition of products bearing their label. Currently the consumer is left to determine the quality of the products they purchase with very little reliable information about the manufacture, packaging or storage of those products. We believe the proposed rule provides a description of the minimum requirements that should be included in the final rule. Further, we believe the dietary supplement industry would benefit from more rigorous guidelines than those found in the proposed rule. In response to the proposed rule we would like to offer comments on the following topics: 1.) Who should be subject to these regulations? 2.) The inclusion of requirements to develop written procedures for all of the various provisions in the final rule. 3.) The requirements for component quality testing and finished product testing. 4.) The verification of systems critical to product quality. Who Should Be Subject To These Regulations? We support the FDA’s proposal that this rule should apply to the entire dietary supplement industry. In order for this regulation to set a minimum quality standard for all dietary supplements each facet of the manufacture, packaging and storage of the dietary supplement must be regulated independent of a company’s size, product type (i.e. vitamin, mineral, amino acid or botanical) or location. Reducing the requirements for small companies or certain segments of the industry, such as vitamins and minerals, would not allow the development of minimum quality standards within the industry. Without minimum industry wide quality standards the burden of determining product quality will again fall on the consumer, a model that has already proven unsatisfactory. As a small manufacturer of dietary supplements we have found that the costs associated with implementing strict cGMPs are largely offset by the gains that can be attributed to increases in product quality as a direct result of operating in a cGMP environment. A point of concern for Jost is the application of the standards outlined in the final rule to foreign firms that manufacture, package or hold dietary supplements for import into the United States. While we are in agreement that domestic firms who distribute foreign product must share in the responsibility for ensuring materials they distribute were handled according to cGMP requirements we do not feel the burden can be placed solely on those who distribute foreign dietary supplement products. Without foreign oversight directly from the FDA it is unlikely significant compliance can be expected from foreign firms. Requirements for Written Procedures and Documentation As you are aware, in the proposed rule the FDA is proposing that manufacturers maintain records to ensure the identity, purity, quality, strength and composition of a given product. It has been our experience that in order to develop and maintain such records it is a necessary prerequisite to draft and maintain written procedures to guide the creation and use of such documentation. Written procedures offer rational for treatment of the specific cGMP compliance issues unique to every facility. In the absence of such procedures it would be impossible to demonstrate to the FDA that the provisions of the proposed rule had been considered and solutions to those provisions applied appropriately throughout the entire facility. As a result of the requirement for documentation that ensures product quality, the creation of written procedures would also be required. Omitting requirements for written procedures from the final rule will only decrease the clarity of the rule and increase the difficulty firms encounter when determining what documentation is truly required to be in compliance with the rule. Evidence of the necessity for written procedures to ensure product quality can be observed by the inclusion of requirements for written procedures in the dietary supplement cGMPs submitted by National Nutritional Foods Association, NSF International and USP. In addition to the need for written procedures the need for the creation of personnel and distribution records was questioned in the proposed rule. The question of personnel records can be addressed in a similar manner as written procedures. It is difficult to argue that the proper qualification and training of individuals responsible for the handling of dietary supplements does not impact the product quality, therefore in order to allow efficient enforcement of the final rule training records would be required. As with written procedures omitting this requirement in the final rule would only lead to confusion and the need for further clarification. The requirement for distribution records while not necessarily implied through the requirement for documentation that ensures product quality seems to be related to the requirement for documentation that allows efficient enforcement of the final rule. In the event that a recall was deemed necessary by the FDA due to adulterated product the execution of a recall would be greatly expedited by accurate distribution records. Requirements for Component and Finished Product Testing. The dietary supplement industry presents some unique problems with respect to analytical testing. While many dietary supplements available today do have accepted chemical and biological monographs, a large portion of the industry lacks the ability to perform meaningful analytical testing on their finished products. The most effective way to guarantee product quality is to follow cGMPs and test each lot of finished product against appropriate quality standards. This is not always possible in the dietary supplement industry due to the complex nature of many of the products. In the event that finished product testing is impossible, the focus of the quality testing must be shifted to in process critical control points and dietary supplement components. The qualification of component suppliers and the testing of each component lot is the only way to sufficiently guarantee finished product quality. Once the quality of the components has been established the processes under which the dietary supplements are handled must also be verified. This can be accomplished through the establishment of in process critical control points and appropriate operating ranges for each of those control points. It is our belief that the minimum standards that should be included in the final rule should include finished product testing on each lot when possible and a requirement for component and in process critical control point testing when finished product testing is not possible. It is our recommendation that critical control point testing, supplier qualification and some minimum standard for incoming component testing be included in the final rule even when finished product testing is performed. Verification of Systems Critical to Product Quality One of the key elements in cGMP manufacture is the requirement for systems to operate consistently and produce an outcome that meets a predetermined specification. Demonstration of system capability is best achieved through systems verification. In an industry where the complexity of the finished product often precludes finished product testing, the capability of the systems employed is of paramount importance. While requirements for system verification have the potential to impose additional cost on the industry, the gains realized as a result of improved quality should help to alleviate a large portion of that burden. The most substantial cost will be realized by firms with no current verification program in place, however, these firms are the most likely to realize substantial gains due to increased consistency and quality in the dietary supplements they market. Verification of systems integral to product quality should be a requirement that is included in the final rule. Conclusions Our company fully supports the creation of comprehensive cGMP rules for the entire dietary supplement industry. We are hopeful the final rule will give clear guidance on the expectations the FDA has for firms in the dietary supplement industry. If the intent of the proposed rule is to require firms to take measures to ensure product identity, purity, quality, strength and composition and allow efficient enforcement of the final rule then the inclusion of written procedures, increased testing and systems verification will be required. Further treatment of these items should be included in the final rule to more clearly convey the expectations the FDA has for the dietary supplement industry. Respectfully submitted, Kevin Heisel Jost Chemical