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Guidance Issuing OfficeCenter for Food Safety and Applied NutritionCenter for Veterinary MedicineOffice of Regulatory Affairs
This guidance document provides updated information pertaining to the Food and Drug Administration’s (FDA) authority to order the administrative detention of human or animal food under section 304(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. 334(h)]. Congress originally established this authority in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and amended it in January 2011 as part of the FDA Food Safety Modernization Act (FSMA).
FDA prepared this guidance to restate the legal requirements in section 304(h) of the FD&C Act. Previously, this guidance restated the legal requirements for FDA’s administrative detention regulation at 21 CFR Part 1, Subpart K, implementing section 304(h) of the FD&C Act. This guidance also served as FDA’s Small Entity Compliance Guide (SECG) for 21 CFR Part 1, Subpart K in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121). However, as explained above, section 304(h) was amended by FSMA in 2011. Accordingly, in October 2011, FDA updated this document to provide guidance intended to help any entity comply with the requirements of section 304(h) of the FD&C Act, including the amendments to section 304(h) of the FD&C Act made by section 207 of FSMA. This update clarifies that this document continues to serve as FDA’s SECG for 21 CFR Part 1, Subpart K.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2011-D-0643.