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HHS/FDA

RIN: 0910-AB88

Publication ID: Spring 2008

Title: Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements
Abstract: The Food and Drug Administration published a final rule in the Federal Register of June 25, 2007 (72 FR 34752), on current good manufacturing practice (CGMP) regulations for dietary supplements. The final rule (the CGMP rule) was published to establish the minimum CGMPs necessary to ensure that, if firms engage in activities related to manufacturing, packaging, labeling, or holding dietary supplements, they do so in a manner that will ensure the quality of the dietary supplements i.e., to ensure that the dietary supplement consistently meets the established specifications for identity, purity, strength, and composition, and limits on contaminants, and has been manufactured, packaged, labeled, and held under conditions to prevent adulteration under section 402(a)(1), (a)(2), (a)(3), and (a)(4) of the act. FDA also published an interim final rule (IFR) in the June 25, 2007 Federal Register (72 FR 34959) that sets forth a procedure for requesting an exemption from the requirement in the final rule described above that the manufacturer conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient. This IFR allows for submission to, and review by, FDA of an alternative to the required 100 percent identity testing of components that are dietary ingredients, provided certain conditions are met. This IFR also establishes a requirement for retention of records relating to the FDA's response to an exemption request.
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

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	06/25/2007	72 FR 34752
Interim Final Rule	06/25/2007	72 FR 34959
Interim Final Rule Comment Period End	10/24/2007
Final Action	06/00/2008

Regulatory Flexibility Analysis Required: Yes	Government Levels Affected: Undetermined
Small Entities Affected: Businesses	Federalism: No
Included in the Regulatory Plan: Yes
RIN Data Printed in the FR: 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:240 402-2784 Fax:240-402-2657 Email: linda.kahl@fda.hhs.gov