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Proprietary Rights

Can a notifier's proprietary right to an FCN expire?

Mar 2001

Question: Can a notifier's proprietary right to an FCN expire?

Answer: FDA has the power to cancel an FCN if, at any time after the FCN becomes effective, FDA determines that the substance is unsafe.

In advising the FCN submitter that its FCN is effective, FDA may warn the notifier that it must alert FDA if the notifier becomes aware of data that raise questions about the safety of the intended use of the food-contact substance. In the event such data develops, the notifier's FCN could be cancelled.

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