| Public Health Service Food and Drug Administration |
| New England District One Montvale Avenue Stoneham, Massachusetts 02180 (781) 596-7700 FAX: (781) 596-7896 |
Department of Health and Human Services
WARNING LETTER
NWE-20-10W
Hand Delivered
September 27, 2010
Tom Ryan
CEO
CVS Corporation
One CVS Drive
Woonsocket, RI 02895
Dear Mr. Ryan:
This letter concerns CVS Complete Care Anticavity Mouthwash distributed by your firm. The label for this product makes the following claims: “Helps prevent cavities, Kills germs that cause bad breath, Rebuilds enamel and strengthens teeth, and Promotes healthy gums.”
Based on the labeled claims, CVS Complete Care Anticavity Mouthwash is a “drug,” as defined by as defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 321(g)(1)), because it is intended for use in the prevention or mitigation of disease, or is intended to affect the structure or function of the human body, namely by preventing cavities and promoting healthy gums, which represents and suggests it will prevent gum disease, including gingivitis and plaque, and by strengthening teeth. The active ingredient listed in the Drug Facts panel is (b)(4). This product is subject to the Final Monograph for Anticaries Drug Products for Over-the-Counter Use [“Anticaries”], 21 CFR Part 355, which covers the product’s disease claim of helping “prevent cavities.”
While (b)(4) is an active ingredient listed in the Anticaries Final Monograph for anticavity purposes, that monograph does not include any claims that (b)(4) (or any other ingredient) promotes healthy gums, one of the claims on the label of CVS Complete Care Anticavity Mouthwash. This statement is considered a disease claim because it represents and suggests that the CVS product will promote healthy gums and therefore prevent gum diseases, such as gingivitis. This claim or any gum disease claim is not covered by the Anticaries Final Monograph. Such antigingivitis/antiplaque claims are, however, addressed in the Advanced Notice of Proposed Rulemaking (ANPR) for Oral Healthcare Products for Antigingivitis/Antiplaque (68 Fed. Reg 32232 (May 29, 2003)). In that ANPR, the Food and Drug Administration (FDA) identified active ingredients under consideration for inclusion in an Antigingivitis/Antiplaque monograph; however, (b)(4) is not among them.
Thus, no mouthwash with (b)(4) as the active ingredient has been included or proposed for inclusion in any monograph for promoting healthy gums, which represents and suggests it will prevent gum diseases, such as gingivitis claimed in CVS Complete Care Anticavity Mouthwash; that ingredient is not included among those under evaluation in the ANPR for antigingivitis/antiplaque drug products, nor does the anticaries monograph at 21 CFR part 355, which does include the active ingredient of (b)(4) , include antigingivitis/antiplaque as recognized claims. As formulated and labeled, CVS Complete Care Anticavity Mouthwash is not generally recognized as safe and effective for the antigingivitis/antiplaque indications in its labeling, and it is, therefore, a new drug under section 201(p) of the Act (21 U.S.C. § 321(p)). Under section 505(a) of the Act (21 U.S.C. § 355(a)), a new drug may not be introduced or delivered for introduction into interstate commerce unless it is the subject of an FDA approved application. The marketing of CVS Complete Care Anticavity Mouthwash without an FDA-approved application violates this provision of the Act.
Furthermore, we note that on your website, www.cvs.com, you state that CVS Complete Care Anticavity Mouthwash has two active ingredients, namely (b)(4). The active ingredient (b)(4) is not included in the Anticaries Final Monograph for anticavity uses or for or any other uses. The (b)(4) ingredient and related gum disease (antigingivitis) claims are, however, addressed in the Advanced Notice of Proposed Rulemaking (ANPR) for Oral Healthcare Products for Antigingivitis/Antiplaque (68 Fed. Reg. 32232 (May 29, 2003)). In that ANPR, the agency, considered Antigingivitis claims, and stated in relevant part:
The Subcommittee recommended the following as rational oral health care combination products: (1) An antigingivitis/antiplaque active ingredient combined with an anticaries active ingredient, (2) an antigingivitis/antiplaque active ingredient combined with a tooth desensitizer active ingredient, and (3) an antigingivitis/antiplaque active ingredient combined with an anticaries active ingredient and a tooth desensitizer active ingredient.
However, the agency is not aware of any marketing history of such combination products eligible for the OTC drug review, nor were such combinations submitted to the Subcommittee. Therefore, the agency is dissenting from these recommendations at this time. Data are needed to establish the safety and effectiveness of these combination products. Accordingly, none of the combination products described above may be marketed OTC at this time under this advance notice of proposed rulemaking. The agency invites supporting data and information demonstrating that these combination products can be generally recognized as safe and effective for OTC use.
68 Fed. Reg. 32232
According to the ANPR, products that combine an antiplaque/antigingivitis ingredient with an anticaries ingredient may not currently be marketed without an approved application. According to your website, this product does contain this combination of ingredients and it does assert the claims addressed by the ANPR. We further note that (b)(4) is not an active ingredient under consideration in the ANPR for antiplaque/antigingivitis indications.
As described above, as described by labeling on your website, CVS Complete Care Anticavity Mouthwash is not generally recognized as safe and effective as an OTC anticaries drug product or for preventing or mitigating gum diseases including gingivitis and plaque, and it is, therefore, a new drug under section 201(p) of the Act (21 U.S.C. § 321(p)).
If (b)(4) is in fact an active ingredient, as stated on your website, then (b)(4) should appear on your product label as an active ingredient. The failure to so list (b)(4) on the product label violates section 502(e)(1)(A)(ii) of the Act (21 U.S.C. § 352(e)(1)(A)(ii). In addition, the listing of (b)(4) as an active ingredient in labeling on your website contradicts the label of your product, which indicates that (b)(4) is an inactive ingredient. Thus, the product's labeling is false or misleading and accordingly causes it to be misbranded within the meaning of section 502(a) of the Act. (21 U.S.C. § 352(a)).
The violations cited in this letter are not an all-inclusive list of deficiencies. You are responsible for investigating and determining the causes of these violations and for preventing their recurrence and the occurrence of other violations. You are to assure that your firm complies with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the referenced violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your reply should be addressed to Anthony P. Costello, Compliance Officer, at the above address.)
Sincerely,
/s/
William S. Boivin
Acting District Director
New England District
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