Department of Health and Human Services
Public Health Service
September 27, 2010
DELIVERED BY HAND
Mr. Gregory D. Wasson
President and CEO
200 Wilmot Road
Deerfield, IL 60015-4620
Dear Mr. Wasson:
This letter is in reference to the Walgreen Mouth Rinse Full Action distributed by your firm. The label for this product makes the following claims: "Freshens breath, Helps prevent cavities, Restores enamel, Helps strengthen teeth, Helps kill germs that cause bad breath, Helps fight visible plaque above the gum line."
Based on the labeled claims including "Helps prevent cavities" and "Helps fight visible plaque above the gum line," Walgreen Mouth Rinse Full Action is a drug as defined in Section 201(g) of the Federal Food, Drug, and Cosmetic Act (Act) [21 U.S.C. § 321(g)] because the product is intended for use in preventing or mitigating disease, or to affect the structure or function of the body, by preventing cavities and removing plaque. Sodium fluoride 0.0221% (0,01% w/v fluoride ion) for the purpose of "Anticavity" is the sole ingredient identified on the label as an active ingredient for this product. This product is subject to the Final Monograph for Anticaries Drug Products for Over-the-Counter Use, 21 CFR Part 355, which covers the product's disease claim of helping "prevent cavities," and includes this active ingredient.
However, another claim on the label of Walgreen Mouth Rinse Full Action is "Helps fight visible Plaque Above the Gum Line." This statement represents that the product fights plaque, a well-known precursor to gum disease, including gingivitis. Antiplaque/antigingivitis claims are not covered by the Anticaries Final Monograph. Such antiplaque/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 identified active ingredients under consideration for inclusion in an antigingivitis/antiplaque monograph; however, sodium fluoride is not among them.
Thus, no mouthwash with sodium fluoride as the active ingredient has been included or proposed for inclusion in any monograph for the antiplaque/antigingivitis indications claimed for Walgreen Mouth Rinse Full Action. That ingredient is not included among those under evaluation in the ANPR for antiplaque/antigingivitis drug products, nor does the anticaries monograph at 21 CFR part 355, which does include the active ingredient of sodium fluoride, include antiplaque claims as recognized claims. As formulated and labeled, Walgreen Mouth Rinse Full Action is not generally recognized as safe and effective for the 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 Walgreen Mouth Rinse Full Action without an FDA-approved application violates this provision of the Act.
In addition, the label of your product includes several statements suggesting that the product provides oral health benefits beyond anticavity effects, including the antiplaque/antigingivitis benefits. These include the product name: "Walgreen Mouth Rinse Full Action," the statement "Compare to Listerine Total Care Anticavity Mouthwash active ingredient" and the statement "Helps fight visible plaque above the gum line." The claims described in the above paragraphs combined with the descriptive term "Full Action" and the suggestion to compare the product to another product with the name "Total Care" suggests that the product is comprehensive in function, and will provide benefits, including the antiplaque benefits declared in the labeling, We are not aware of any support for the antiplaque/antigingivitis claims or other statements suggesting that the product is comprehensive in function, providing benefits beyond those related to prevention of cavities. Thus, the product's labeling claims that it will provide all of the benefits listed are misleading and accordingly make it misbranded within the meaning of Section 502(a) of the Act, [21 U.S.C. § 352(a)].
We note additionally that your principal display panel (PDP) describes your product as "Sodium Fluoride and Acidulated Phosphate Topical Solution." The Drug Facts panel lists the sole active ingredient as "Sodium fluoride 0.0221% (0.01% fluoride ion)." These representations are inconsistent. Based on the information in your Drug Facts panel, it appears that the PDP should refer to either "Sodium Fluoride Acidulated Phosphate Solution" or just "Sodium Fluoride Solution." The Sodium fluoride listed in the drug facts panel should be listed at 0.02%; not 0.0221%.
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, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (IS) working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your written response should be directed to Lorelei Jarrell, Compliance Officer, at the address of the letterhead. If you have any questions regarding this letter, please contact Ms. Jarrell at 312-596-4216.
Scott J. MacIntire
This page was posted on October 3, 2010.