Shenzhen Hengkaifeng Commerce and Trade Co., Ltd

This letter concerns your firm’s drug listing information provided to FDA’s electronic Drug Registration and Listing System (eDRLS) for your drug product, Sensitivity Toothpastes (NDC 84117-013).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, your drug product, Sensitivity Toothpastes, is not properly listed with FDA, causing it to be a misbranded drug under section 502(o) of the FD&C Act, 21 U.S.C. 352(o). Introduction or delivery for introduction of a misbranded drug 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.

Section 510(j) of the FD&C Act, 21 U.S.C. 360(j), and 21 CFR Part 207 outline the requirements for establishment registration and drug listing. Under 21 CFR 207.49(a)(4), a firm must include in the listing submission to FDA the name and quantity of each active pharmaceutical ingredient in the listed drug. The listing for Sensitivity Toothpastes states that the name of the active ingredient(s) is hydrated silica but the labeling lists the active ingredients as potassium nitrate 5% and sodium fluoride 0.1%.

Furthermore, under 21 CFR 207.49(a)(6) & (11), each registrant must provide the dosage form and the route of administration for the listed drug. Your listing submission for Sensitivity Toothpastes states its dosage form and route of administration as liquid and oral, respectively. However, the product label states it is a foam for dental administration.

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, Sensitivity Toothpastes is not properly listed with FDA causing it to be a misbranded drug 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).

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. Establishment registration and drug 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 listing issues associated with your product.

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your product(s). You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

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 numbers (2793) (CMS 706318) on all correspondence.