a briefing held today, the Food and Drug Administration (“FDA”)
announced the release of its interim final regulations on food
facility registration (Docket No. 2002N-0276) and prior notice
of food imports (Docket No. 2002N-0278) (“the Regulations”).
Regulations, and related fact sheets, are now available on the
FDA’s web site.
The Regulations will be published in tomorrow’s Federal
Regulations, which will be effective and enforceable on December
12, 2003, reflect FDA responses to some of the 350 comments submitted
by industry after the release of the proposed regulations in February
to today’s briefing, in order to allow time for facilities
to register by the December 12th deadline, the FDA
will begin accepting online registrations on October 16, 2003,
at 6:00 p.m. (EST). The FDA strongly encourages electronic registration,
but will also accept paper registrations.
FDA made clear that the interim final regulations will become
effective on December 12, 2003. The FDA is expected, however,
to exercise its enforcement discretion during the initial implementation
phase of the Regulations.
the Regulations are published in the Federal Register, a seventy-five
(75) day comment period will begin. The FDA anticipates issuing
final regulations in the spring of 2004.
connection with its issuance of the Regulations, the FDA will
offer several outreach opportunities to industry, starting with
a public meeting via satellite on October 28, 2003 from 1:00 p.m.-3:00
p.m. (EST). [Details on viewing the satellite downlink public
meeting are available in the FDA’s October 1 Federal Register
notice (68 Fed. Reg. 56600)]. The FDA has invited interested
parties to submit questions on the regulations prior to this meeting.
Parties interested in submitting questions may do so directly,
in accordance with the instructions set forth in the FDA’s
October 1 notice, or they may submit their questions to us for
subsequent transmission to the FDA.
How To Find Out More
you would like more specific information on FDA’s new regulations
on food facility registration (Docket No. 2002N-0276) and prior
notice of food imports (Docket No. 2002N-0278), and how they will
effect the importation of food products, please contact
us and we will add you to our FDA Import Regulation news service.
Please contact George Tuttle, III, at firstname.lastname@example.org if you have any questions regarding FDA
or other Customs law matters.
R. Tuttle, III is an attorney with the Law
Offices of George R. Tuttle in San Francisco. The information
in this article is general in nature and is not intended to
constitute legal advice or to create an attorney-client relationship
with respect to any event or occurrence, and may not be considered