GroundRules
21 CFR 170.103: Withdrawal without prejudice of a premarket notification for a food contact substance (FCN).
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION
- PART 170—FOOD ADDITIVES
- Subpart D—Premarket Notifications
A manufacturer or supplier may withdraw an FCN without prejudice to a future submission to the Food and Drug Administration (FDA) if FDA has not completed review of the FCN. For the purpose of this section, FDA's review is completed when FDA has allowed 120 days to pass without objecting to the FCN or FDA has issued an objection letter.
Collected 2026-08-27T02:24:47Z. Source file · JSON