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HHS/FDA RIN: 0910-AB88 Publication ID: Fall 2004 
Title: Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements 
Abstract: The Food and Drug Administration proposed in the Federal Register of March 13, 2003 (68 FR 12158), current good manufacturing practice (CGMP) regulations for dietary ingredients and dietary supplements. The proposed rule was published to establish the minimum CGMPs necessary to ensure that, if firms engage in activities related to manufacturing, packaging, or holding dietary ingredients of dietary supplements, they do so in a manner that will not adulterate and misbrand such dietary ingredients or dietary supplements. FDA also proposed to require manufacturers to evaluate the identity, purity, quality, strength, and composition of their dietary ingredients and dietary supplements. The proposed rule also responds to concerns that such regulations are necessary to ensure that consumers are provided with dietary supplement products which have not been adulterated as a result of manufacturing, packing, or holding, e.g., which have the identity and provide the quantity of dietary ingredients declared in labeling. 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Yes  Unfunded Mandates: Private Sector 
CFR Citation: 21 CFR 111 
Legal Authority: 21 USC 321; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 371; 21 USC 374; 21 USC 381; 21 USC 393; 42 USC 264 
Legal Deadline:  None

Statement of Need: FDA intends to publish a final rule to establish CGMP for dietary supplements and dietary ingredients for several reasons. First, FDA is concerned that some firms may not be taking appropriate steps during the manufacture of dietary supplements and dietary ingredients to ensure that products are not adulterated as a result of manufacturing, packing, or holding. There have been cases of misidentified ingredients harming consumers using dietary supplements. FDA is also aware of products that contain potentially harmful contaminants because of apparently inadequate manufacturing controls and quality control procedures. The agency believes that a system of CGMPs is the most effective and efficient way to ensure that these products will not be adulterated during manufacturing, packing, or holding.

Summary of the Legal Basis: If CGMP regulations were adopted by FDA, failure to manufacture, pack, or hold dietary supplements or dietary ingredients under CGMP regulations would render the dietary supplement or dietary ingredients 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 regulation will include the value of resources devoted to increased sanitation, process monitoring and controls, testing, and written records. The benefits of the proposed regulation are to improve both product safety and quality. We estimate that the proposed 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, and consumers lack information about the potential hazards and variable quality of these products. The product quality benefits occur because there will be fewer product recalls and more uniform products will reduce consumer search for preferred quality products. The proposed rule will have a significant impact on a substantial number of small businesses, so it will be significant under the Regulatory Flexibility Act. We anticipate that small businesses will bear a proportionately larger cost than large businesses.

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 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, packing, or holding process.

Timetable:
Action Date FR Cite
ANPRM  02/06/1997  62 FR 5700 
ANPRM Comment Period End  06/06/1997   
NPRM  03/13/2003  68 FR 12157 
NPRM Comment Period End  08/11/2003   
Final Action  03/00/2005   
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: Undetermined 
Included in the Regulatory Plan: Yes 
Agency Contact:
Linda Kahl
Senior Policy Analyst
Department of Health and Human Services
Food and Drug Administration
HFS-206, Center for Food Safety and Applied Nutrition (HFS-024), 5100 Paint Branch Parkway,
College Park, MD 20740
Phone:301 436-2784
Fax:301 436-2657
Email: linda.kahl@fda.hhs.gov

 
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