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U.S. reiterates “soft enforcement” policy for FDA regs

OTTAWA, Ont. The U.S. embassy in Ottawa yesterday reiterated U.S. Customs' "soft enforcement" policy on new prior n...


OTTAWA, Ont. The U.S. embassy in Ottawa yesterday reiterated U.S. Customs’ “soft enforcement” policy on new prior notice requirements for FDA regulated imports.

“The announcement of new U.S. regulations regarding the importation of food products has caused concern that food gifts mailed from Canada will not be allowed into the United States during the holiday season. These regulations are not intended to interfere with food shipments by individuals or commercial establishments.

As of December 12, 2003, anyone mailing or shipping store-bought food, including candies, chocolates, or canned goods, to the United States from Canada or other foreign countries, will be required to provide advance notification ("Prior Notice") to the U.S. Food and Drug Administration (FDA),” said the announcement.

“However, the U.S. Food and Drug Administration, and their partners in Customs and Border Protection intend to exercise broad discretion for the Prior Notice rule for the first few months after implementation (December 12, 2003). During this initial phase a food shipment will not be stopped at the border simply due to lack of Prior Notice. This information has also been provided to Canada Post and other Government of Canada agencies.
“… Over the course of the following months the Prior Notice requirement will be more strictly enforced and those shipping food to the United States will be expected to comply with this requirement. Prior Notice can only be submitted electronically, beginning December 12th, either through a customs broker or through the FDA Prior Notice Internet portal at: http://www.access.fda.gov

The information required includes:

-The identity of the article, which includes the common name, trade or brand name, quantity, etc. and the FDA product code (if known),
-The country from which the article originates and is shipped or mailed,
– The manufacturer, shipper, or growers’ name and address, e-mail address, telephone and fax number (if known).
For additional information on the Public Health Security and Bioterrorism Preparedness and Response Act regulations and prior notice requirements, please contact the Food and Drug Administration, from outside the United State call (301) 575-0156 or fax to (301) 210-0247.

The FDA is accepting comments, until December 24th, regarding the impact and efficacy of these regulations. If you wish to make comments you may submit your comments to FDA Docket 2002N-0278 electronically at: http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm

For more information check the U.S. Embassy Web site: www.usembassycanada.gov


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