The U.S. Food and Drug Administration (FDA) typically provides one of several possible responses after a Prior Notice (PN) submission has been made to the agency. The specific response that the FDA provides may depend on the specific details of the PN submission. Some possible responses that you may receive after submitting a PN to the FDA include:

Acceptance: This response indicates that the PN has been accepted by the FDA and will be reviewed.

Rejection: This response indicates that the PN has been rejected by the FDA and cannot be processed further. This may occur if the PN is incomplete, contains errors, or does not meet the FDA’s requirements.

Request for additional information: This response indicates that the FDA requires additional information or clarification in order to properly review the PN. The FDA will provide specific instructions on what additional information is needed and how it should be provided.

Review in progress: This response indicates that the FDA is currently reviewing the PN and will provide further feedback at a later date.

Approval: This response indicates that the FDA has reviewed the PN and has determined that it meets the agency’s requirements.

Denial: This response indicates that the FDA has reviewed the PN and has determined that it does not meet the agency’s requirements.

It is important to note that a PN approval does not guarantee that the food product will be allowed into the United States. The FDA may still take action to detain or refuse the product at the border if it determines that the product is adulterated or misbranded, or presents a risk to public health.