Docket Number:
FDA-2004-D-0042
Issued by:
Guidance Issuing Office
Office of Regulatory Affairs

For questions regarding this document contact Food and Drug Administration, Office of Regulatory Affairs, Office of Enforcement and Import Operations, Division of Food Defense Targeting, Element Bldg., HFC-180, 12420 Parklawn Dr., Rockville, MD 20857-20993, e-mail: prior.notice@fda.hhs.gov, phone number: 866-521-2297.

This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) and U.S. Customs and Border Protection (CBP) on this topic. It does not establish any rights for any person and is not binding on FDA, CBP, or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page.

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