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Statement of Need: FDA published the CGMP rule for dietary supplements because FDA is concerned that some firms may not be taking appropriate steps during the manufacture of dietary supplements to ensure the quality of dietary supplement. FDA is aware of products that contain potentially harmful contaminants because of apparently inadequate manufacturing controls and quality control procedures. There also have been cases of misidentified ingredients harming consumers using dietary supplements. The Agency believes that a system of CGMPs is the most effective and efficient way to ensure the quality of dietary supplements. With respect to the specific requirement for 100 percent identity testing of dietary ingredients, FDA recognizes that it may be possible for a manufacturer to demonstrate, through various methods and processes in use over time for its particular operation, that a system of less than 100 percent identity testing would result in no material diminution of assurance of the identity of the dietary ingredient as compared to the assurance provided by 100 percent identity testing. To provide an opportunity for a manufacturer to make such a showing and reduce the frequency of identity testing of components that are dietary ingredients from 100 percent to some lower frequency, FDA is adding to the CGMP rule an exemption from the requirement of 100 percent identity testing when a manufacturer petitions the agency for such an exemption to 100 percent identity testing and the agency grants such exemption. Such a procedure would be consistent with FDA's stated goal, as described in the CGMP final rule, of providing flexibility in the CGMP requirements. FDA is providing an opportunity for interested persons to comment on whether this exemption procedure should be modified, and if so, whether there is any additional information that may be helpful to articulate with respect to what a petition needs to show that may inform future guidance.

Summary of the Legal Basis: Under the CGMP rule, failure to manufacture, pack, label or hold dietary supplements under CGMPs renders the dietary supplement adulterated under section 402(g) of the Act.

Alternatives: The two principal alternatives to comprehensive CGMPs are end product testing and Hazard Analysis Critical Control Points (HACCP). The Agency asked whether different approaches may be better able to address the needs of the broad spectrum of firms that conduct one or more distinct operations, such as the manufacture of finished products, or solely the distribution and sale of finished products at the wholesale or retail level.

Anticipated Costs and Benefits: The costs of the CGMP rule will include the value of resources devoted to increased sanitation, process monitoring and controls, testing, and written records. The benefits of the CGMP rule are to improve product quality. We estimate that the regulation will reduce the number of sporadic human illnesses and rare catastrophic illnesses from contaminated products. The current quality of these products is highly variable. The CGMP rule will have a significant impact on a substantial number of small businesses, so it is significant under the Regulatory Flexibility Act. We anticipate that small businesses will bear a proportionately larger cost than large businesses. The IFR, as one piece of the CGMP rule, is not an economically significant regulatory action as defined under Executive Order 12866. FDA has identified 1,460 establishments that may apply to FDA for an exemption from dietary ingredient identity testing as provided for by this IFR. FDA expects some cost savings from reduced dietary ingredient identity testing depending on the number of firms that successfully apply to FDA for exemption. The IFR provisions will cause no net change in the benefits of dietary supplement current good manufacturing practices as outlined in the final rule.

Risks: Any potential for consumers to be provided adulterated (e.g., contaminated with industrial chemicals, pesticides, microbial pathogens, or dangerous misidentified ingredients or toxic components of ingredients) products must be considered a very serious risk because of the possibility that such contamination could be widespread, affecting whole segments of the population, causing some severe long-term effects and even loss of life. Dietary supplements are used by a large segment of the American public. Moreover, they are often used by segments of the population that are particularly vulnerable to adulterated products, such as the elderly, young children, pregnant and nursing women, and persons who may have serious illnesses or are taking medications that may adversely interact with dietary supplements. FDA has adopted manufacturing controls for a number of foods and commodities that present potential health hazards to consumers if not processed properly, including seafood, juice products, and fruits and vegetables, and it is appropriate that FDA consider whether manufacturing controls are necessary to assure consumers that dietary supplements are not adulterated during the manufacturing, packing, labeling or holding process. If an incorrect dietary ingredient is added to a dietary supplement, consumers could be exposed to a biologically active substance without their knowledge. For example, FDA is aware of a case in which Digitalis lanata was misidentified as plantain and, as a result, a young woman experienced a life-threatening abnormal heart function after consuming a dietary supplement containing D. lanata in lieu of plantain. Manufacturers who petition FDA for an exemption from the requirement for 100 percent identity testing would be required to show that a system of less than 100 percent identity testing would result in no material diminution of assurance of the identity of the dietary ingredient as compared to the assurance provided by 100 percent identity testing.