FDA WARNING_LETTER - Walgreen Company

This FDA Warning Letter, CHI-10-10, addresses Walgreen Company regarding its "Walgreen Mouth Rinse Full Action" product. The product is classified as a drug due to claims like "Helps prevent cavities" and "Helps fight visible plaque above the gum line." While sodium fluoride 0.0221% (0.01% w/v fluoride ion) is an active ingredient covered by the Anticaries Drug Products for Over-the-Counter Use Monograph (21 CFR Part 355) for cavity prevention, the antiplaque/antigingivitis claims are not. Sodium fluoride is not listed in the Advanced Notice of Proposed Rulemaking (ANPR) for Oral Healthcare Products for Antigingivitis/Antiplaque (68 Fed. Reg 32232), making the product a "new drug" under Section 201(p) of the Act [21 U.S.C. § 321(p)]. Marketing this new drug without an FDA-approved application violates Section 505(a) of the Act [21 U.S.C. § 355(a)].

Furthermore, the product's labeling, including the name "Full Action" and comparison to "Listerine Total Care Anticavity Mouthwash," suggests comprehensive benefits beyond anticavity effects, which are not supported and render the product misbranded under Section 502(