View Rule

Statement of Need: FDA is considering whether to develop regulations establishing current good manufacturing practice (CGMP) for dietary supplements and dietary supplement ingredients for several reasons. First, FDA is concerned that some firms may not be taking appropriate steps during the manufacture of supplement products to ensure that products are properly formulated and not adulterated. There have been cases of misidentified ingredients harming consumers using dietary supplements. FDA is also aware of products or ingredients that contain potentially harmful contaminants or ingredients because of apparently inadequate manufacturing controls and quality control procedures. The agency believes that a system of CGMP or other preventive manufacturing controls may be the most effective and efficient way to ensure that these products will not be adulterated during the manufacturing process.

Summary of the Legal Basis: If CGMP regulations were adopted by FDA, failure of a manufacturer to implement and follow CGMP would render the dietary supplement or dietary supplement ingredients of that manufacturer adulterated under section 402(g) of the act.

Alternatives: The two principal alternatives to comprehensive CGMP are end-product testing and Hazard Analysis Critical Control Points (HACCP). In the ANPRM, FDA asked for public comment on approaches to ensuring that dietary supplements and dietary supplement ingredients are not adulterated during the manufacturing process. The agency asked whether HACCP may be a more effective approach than a comprehensive CGMP, and 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. FDA will consider the information it received in response to the ANPRM and from other sources, such as public meetings and small business outreach meetings, in its consideration of whether CGMP or other approaches are most appropriate.

Anticipated Costs and Benefits: A comprehensive CGMP (or other system of ensuring the safety of dietary supplements and dietary supplement ingredients) would permit more effective and efficient oversight by Federal, State, and local governments. It would place primary responsibility for ensuring that these products are not adulterated on the manufacturer/distributor by requiring that they develop and implement a rational, scientific-based system to control their manufacturing process. FDA anticipates that costs to industry generated by implementing a comprehensive manufacturing process, whether CGMP or other plan, would be offset in four ways: (1) by reducing the amount of supplement-associated illnesses or adverse events; (2) by increasing public confidence in dietary supplements marketed in the United States; (3) by enabling U.S. supplements companies to compete more effectively in the world market; and (4) by decreasing the number of future product recalls.

Risks: Any potential for consumers to be provided adulterated (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 supplement components. FDA has adopted or proposed 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 process.