FDA WARNING_LETTER - CVS Pharmacy, Inc.

This FDA Warning Letter, dated September 27, 2010, addresses CVS Corporation regarding its "CVS Complete Care Anticavity Mouthwash." The product is classified as a "drug" due to claims like "Helps prevent cavities," "Promotes healthy gums," and "Strengthens teeth."

The primary violation is that the product is an unapproved new drug. While its active ingredient, (b)(4), is recognized for anticavity purposes under 21 CFR Part 355, the label's "promotes healthy gums" claim is a disease claim (suggesting prevention of gum diseases like gingivitis) not covered by this monograph. Furthermore, (b)(4) is not among the active ingredients under consideration for antigingivitis/antiplaque claims in the Advanced Notice of Proposed Rulemaking (ANPR) for Oral Healthcare Products. Therefore, the product is not generally recognized as safe and effective for its antigingivitis/antiplaque indications and requires an FDA-approved application, which it lacks, violating 21 U.S.C. § 355(a).

Additionally, the letter notes inconsistencies between the product label and the CVS website. The website lists (b)(4) as a second active ingredient, which is not included in any relevant monograph for anticavity or other uses. If (b)(4) is an active ingredient, its omission from the product label violates 21 U.S