Anticaries Drug Products for Over-the-Counter Human Use; Partial Stay of Final Rule; Enforcement Policy

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The Food and Drug Administration (FDA) is staying part of a final rule that established conditions under which over-the-counter (OTC) anticaries drug products (products that aid in the prevention of dental cavities) are generally recognized as safe and effective and not misbranded (60 FR 52474, October 6, 1995). This final rule stays the testing procedures for fluoride dentifrice drug products to provide manufacturers an additional 12 months to comply with these testing requirements. This action is being taken in response to a citizen petition requesting this stay and is part of the ongoing review of OTC drug products conducted by FDA.