FDA Publishes Guidance for Bioterrorism Recordkeeping Requirements

(Silver Spring, MD) -- In the September 12 Federal Register, FDA announced the publication of a guidance document on the recordkeeping requirements of the Bioterrorism Act. Among other things, that act (formally known as the Bioterrorism Preparedness and Response Act of 2002) requires that companies that “manufacture, process, pack, transport, distribute, receive, hold, or import food,” including dietary supplements, keep certain records and have them available “to allow for the identification of the immediate previous sources and the immediate subsequent recipients of food.” The intent of this requirement to enable the FDA to trace products quickly in the event that there is a reasonable belief that an article of food is adulterated and presents a public health threat.

The guidance document is posted on FDA’s website: http://www.cfsan.fda.gov/~dms/recguid.html. In a Question-and-Answer format, the guidance topics include who must comply with and who is excluded from the rule, and what information is required to be kept and made available to FDA during a Bioterrorism investigation. The guidance document describes FDA’s current thinking and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should” in the guidance means that something is suggested or recommended, but not required.

AHPA recommends that members download and print a copy of this guidance document and keep it with other FDA inspection related materials that the company keeps on file so that it can be referred to in the event FDA seeks to perform a Bioterrorism investigation at the member's facility.


The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal supplement industry, the only trade association devoted solely to herbal issues. AHPA is the recognized leader in representing the responsible center of the botanical trade, and is comprised of the finest growers, processors, manufacturers and marketers of herbal products. AHPA’s mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of responsibility with respect to the way herbs are manufactured, labeled and sold. Website: www.ahpa.org


Karen Robin, Director of Communications
Telephone: (301) 588-1171, x-107
Email: [email protected]
Website: www.ahpa.org

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