FDA Launches Meetings on Bioterrorism Regs

(Silver Spring, MD) -- Earlier today, the Food and Drug Administration (FDA) held its first meeting in a series of seven to educate industry on final recordkeeping rules in the Bioterrorism Act of 2002. Section 306 of that law “requires the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food, including dietary supplements, in the United States. Such records are to allow for the identification of the immediate previous sources and immediate subsequent recipients of food.” The Records Maintenance section is just one aspect of the act, which, among other things, also requires the registration of processing facilities and advance notice of imported ingredients/products.

Today’s meeting reviewed 12 major changes made in the final rule, based upon input from comments to the proposed rule. A “sliding scale” deadline schedule for implementation of the new regulations is based on the size of the company, ranging from by the end of this year for large companies to a two-year timeframe for small companies.

In case of a public health emergency, FDA expects companies to provide specific information within 24 hours or less on where foods/ingredients came from and went to. For manufacturers, this requirement means that you must have and be able to provide records regarding the source of ingredients used in your products and the destination of finished product. The requirements vary according to how each company is involved in the storage, processing, transport, etc. of products. Records retention requirements vary according to product perishability/stability.

FDA has scheduled six other outreach meetings to provide an overview of the records requirements, scheduled for late January and early February:

January 25: Chicago and Seattle
January 27: San Francisco and Orlando
February 1: Philadelphia and Boston
Meeting location details are at: http://www.cfsan.fda.gov/~dms/fsbtac24.html. Participants may register online at: https://register.grad.usda.gov/conferences/fda/fdabt_reg_form.cfm, or onsite.

FDA intends to create a CD-ROM of the meetings for those who cannot attend. FDA is also soliciting questions about specific scenarios, which they will answer online as they have in extensive detail for other sections of the law. AHPA member companies may submit their questions to American Herbal Products Association's Director of Education Natasha Hall (email: [email protected]), who will relay on your behalf, or directly to the FDA, to Nega Beru, PhD (email: [email protected]).


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
American Herbal Products Association
Telephone: (301) 588-1171, x-107
Email: [email protected]

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