“The CPG has been revised to provide additional guidance regarding
prior notice submissions that do not provide information about the identity of the manufacturing facility of food
no longer in its natural state, articles of food imported or offered for import by express courier, prior notice
submission time frames, and lastly, gift packs purchased or otherwise acquired by an individual and imported or
offered for import for nonbusiness purposes,” FDA explained in its Federal Register notice.
Within the new CPG, which replaces the December 2003 version, FDA makes clear that it will use its own
discretion when deciding how to deal with facilities that refuse to register once they are instructed to do so.
“Unregistered facilities will be reminded of the registration requirement at least three times before a legal action
is considered,” according to an offi cial at FDA’s Center for Food Safety and Applied Nutrition. FDA also noted
that the new CPG addresses several problems submitters have encountered when trying to provide FDA with the
required information, or when trying to keep within the fi ve-day timeframe for submitting prior notice.
• FDA said the revised CPG leaves room for the exercise of enforcement discretion as follows: providing
an alternative means for providing the identity of the manufacturer when the manufacturer’s registration
number is not known
• for articles of food imported or offered for import via express courier, the submitter can provide a tracking
number in lieu of anticipated arrival and/or planned shipment information
• if the item is a gift pack purchased or otherwise acquired by an individual and is being imported for nonbusiness
purposes, one prior notice may be submitted and may include the identity of the facility that
packed the gift pack in lieu of the identity of the manufacturer
• the prior notice may be submitted up to 10 days before the anticipated date of arrival of the food.
Source: Food Chemical News Daily 11/4/04 |