21 CFR §355.1

1. (a)An over-the-counter anticaries drug product in a form suitable for topical administration to the teeth is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in § 330.1 of this chapter.
2. (b)References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.