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WARNING LETTER

September 12, 2023

RE: WL 2512

Dear Elena Kraus and Danielle Gray:

This letter concerns your firm’s drug listing information provided to FDA’s electronic Drug Registration and Listing System (eDRLS) for your drug product, Walgreens Sensitive Extra Whitening, NDC 0363-1588.¹ Your firm has not fulfilled its listing obligations under section 510(j) of the Federal Food Drug and Cosmetic Act (FD&C Act), 21 U.S.C 360(j), which is a prohibited act under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). In addition, the failure to properly list Walgreens Sensitive Extra Whitening with FDA renders it misbranded under section 502(o) of the FD&C Act, 21 U.S.C 352(o). Introduction or delivery for introduction of such a product into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C 331(a). These violations are described in more detail below.

Registration and Drug Listing Violations

Section 510(j) of the FD&C Act, 21 U.S.C 360(j), and 21 CFR Part 207 outline the requirements for registration and listing of drug products. The listing file for Walgreens Sensitive Extra Whitening, NDC 0363-1588 must include the name and quantity of each active pharmaceutical ingredient as required under section 510(j)(1)(C) of the FD&C Act, 21 U.S.C 360(j)(1)(c), and 21 CFR 207.49(a)(4). In the listing file submitted to FDA, the active ingredient list included in the labeling does not match the active ingredient list included in the electronic listing file in SPL. Specifically, the active ingredients described under the Drug Facts section and in the Principal Display Panel image of the labeling include potassium nitrate and sodium fluoride with the fluoride ion as the active moiety. However, the electronic listing file in SPL only includes sodium fluoride (with the active moiety of fluoride ion as the basis of strength).

Also, the listing for Walgreens Sensitive Extra Whitening, NDC 0363-1588, must include the name and quantity of each active pharmaceutical ingredient as required under section 510j(1)(C) of the FD&C Act, 21 U.S.C 360(j)(1)(c), and 21 CFR 207.49(a)(4). According to the labeling, the quantity or strength of the active moiety, fluoride ion, the basis of strength, does not match the strength included in the SPL. Specifically, according to the labeling the strength of the fluoride ion as the active moiety is “0.15 gm in 100 gm,” however, strength in the SPL for the fluoride ion, which is listed to be the basis of strength, is stated as “0.24 g in 100 g.” This strength corresponds to the strength of the sodium fluoride in the labeling, not to the strength of the fluoride ion for the listed product.

Therefore, your firm has not fulfilled its listing obligations under section 510(j) of the FD&C Act, 21 U.S.C 360(j), which is a prohibited act under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). In addition, failure to properly list a drug with FDA renders it misbranded under section 502(o) of the FD&C Act, 21 U.S.C 352(o). Introduction or delivery for introduction of such a product into interstate commerce is prohibited under section 301(a) of the FD&C Act, 331(a).

Complete, accurate and up-to-date establishment registration and drug listing information is essential to promote and protect patient safety. FDA relies on establishment registration and drug listing information for several key programs, including drug establishment inspections, supply chain security, and post-market surveillance. Drug registration and listing information is also widely used outside FDA for purposes such as electronic prescribing and electronic health records, insurance reimbursement, and patient education.

We note that this warning letter only addresses registration and listing issues associated with your product. It is not intended to be an all-inclusive statement of violations that may exist in connection with your product. Your firm should investigate and determine the causes of any violations and take prompt actions to correct the violations and bring the product into compliance. It is also your responsibility to correct listing deficiencies with all other products distributed by your firm.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any 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 actions within 15 working days, state the reason for the delay and the time within which you will do so. In absence of a corrective action, the deficient listing data will not be available for certification under 21 CFR 207.57(b)(2) requirements and will be ultimately inactivated by FDA. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.

Your response should be sent to U.S. Food and Drug Administration, Center for Drug Evaluation and Research/Office of Compliance/Office of Unapproved Drugs and Labeling Compliance by e-mail to eDRLS@fda.hhs.gov. Please be aware that a manual override may be required for certain types of revisions made to an existing drug listing file. If you receive a validation error or have any questions regarding the contents of this letter, please contact us at eDRLS@fda.hhs.gov. for further assistance. Include the case identification number 2512 on all correspondence.

Sincerely,
/S/
Tina Smith
Director (Acting), Office of Unapproved Drugs & Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

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1 On December 6, 2022, we sent you a drug listing deficiency letter notification describing the observed listing deficiencies in the information you submitted. On January 20, 2023, we sent you a data removal email notification informing you of a data removal action. As stated in this email, the continued deficiencies resulted in your product’s data removal from FDA’s Online NDC Directory. FDA sends data deficiency letters and data removal notifications to the contact person found in the labeler code SPL submitted by your firm to FDA. If this information has changed, it is your responsibility to update this within 30 days of any change, under 21 CFR 207.33(c).