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WARNING LETTER

March 25, 2024

RE: 3028143571

Dear Jung Woo Shin:

This letter concerns your firm’s distribution of the drug products NumbSkin 5% Lidocaine Numbing Cream (15 grams), NumbSkin 5% Lidocaine Numbing Cream (30 grams), and NumbSkin 10.56% Lidocaine Numbing Cream for use as external analgesics prior to sensitive cosmetic procedures. The United States Food and Drug Administration (FDA) reviewed your website in October 2023 at the Internet address https://numbskin.com/, where these products are available for purchase.

Based on our review, NumbSkin 5% Lidocaine Numbing Cream (15 grams), NumbSkin 5% Lidocaine Numbing Cream (30 grams), and NumbSkin 10.56% Lidocaine Numbing Cream are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). NumbSkin 5% Lidocaine Numbing Cream (15 grams), NumbSkin 5% Lidocaine Numbing Cream (30 grams), and NumbSkin 10.56% Lidocaine Numbing Cream are also misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). These violations are described in more detail below. Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. 331(a) and (d).

Your firm markets the above listed drug products as, among other things,¹ external analgesics to be used before, during, and/or after various sensitive cosmetic procedures such as tattooing, piercing, microdermabrasion, laser hair removal, and others. These products are marketed without an approved application under section 505 of the FD&C Act for indications that are not included in a final administrative order issued under section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application. Furthermore, your drug products include lidocaine concentrations that exceed what is permissible for over-the-counter (OTC) external analgesic drug products marketed without an approved application that do not conform with the conditions of marketing in the external analgesics final administrative order issued under section 505G.²

FDA has safety concerns about your external analgesic drug products, which include certain active ingredients at concentrations that exceed levels currently permitted in such nonprescription drug products, because they are intended to be used before or during certain cosmetic procedures in ways that could lead to increased absorption of the drug product through the skin. FDA is aware that use of these products before and/or during a cosmetic procedure may not be supervised by trained health professionals. Without this supervision, large amounts of topical analgesics may be applied to a person’s skin. FDA has specifically warned in multiple public health advisories³ about the use of similar lidocaine and other “-caine” type ingredient products when applied over large areas of skin, particularly on irritated or broken skin, for prolonged periods of time, and when the skin is covered after application. These uses increase the amount of active ingredient that passes into the bloodstream and, if used improperly, may cause serious injury.

Unapproved New Drug Violations

NumbSkin 5% Lidocaine Numbing Cream (15 grams), NumbSkin 5% Lidocaine Numbing Cream (30 grams), and NumbSkin 10.56% Lidocaine Numbing Cream are drugs as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body. Specifically, these products are intended for use as topical external analgesic drug products for pain-sensitive cosmetic procedures, as well as for anorectal use.

Examples of claims observed on the product labeling, including your product website https://numbskin.com/ and your social media account on Facebook, that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the products include, but are not limited to, the following:

NumbSkin 5% Lidocaine Numbing Cream (15 grams):

    “Drug Facts . . . Active Ingredient . . . Lidocaine 5% . . . Purpose . . . Anorectal (Hemorrhoidal) . . . Uses . . . For temporary relief of local discomfort, itching, pain, soreness, or burning in the perianal area associated with anorectal disorders.” [from your NumbSkin 5% Lidocaine Numbing Cream (15 grams) carton labeling]

    “Imagine getting a piercing or tattoo without any pain. The lidocaine cream 5% will make it possible. . . . Tattoo topical numbing lotion lidocaine 5% will prevent pain for up to 4 hours. . . . “PROTECT YOUR SKIN DURING LASER HAIR REMOVAL . . . This pain cream works in 15-30 minutes. . . . USAGES OF LIDOCAINE 5% . . . PAIN RELIEF . . . PIERCING . . . LASER HAIR REMOVAL . . . HEMORRHOIDS . . . MICROBLADING . . . HOW TO USE NUMBING CREAM? . . . Apply a thick amount of cream and rub it in. . . . Cover with plastic wrap & keep it on for 30-45 minutes.” [from your website https://numbskin.com/numbskin-5-lidocaine-numbing-cream-15-grams/]

NumbSkin 5% Lidocaine Numbing Cream (30 grams):

    “Drug Facts . . . Active Ingredient . . . Lidocaine 5% . . . Purpose . . . Anorectal (Hemorrhoidal) . . . Uses . . . For temporary relief of local discomfort, itching, pain, soreness, or burning in the perianal area associated with anorectal disorders.” [from your NumbSkin 5% Lidocaine Numbing Cream (30 grams) carton labeling]

    “Imagine getting a piercing or tattoo without any discomfort. The lidocaine cream 5% will make it possible. . . . Tattoo topical numbing lotion lidocaine 5% can prevent discomfort for up to 4 hours. . . . “PROTECT YOUR SKIN DURING LASER HAIR REMOVAL . . . This NumbSkin numbing cream works in 15-30 minutes. . . . USAGES OF LIDOCAINE 5% . . . PAIN RELIEF . . . PIERCING . . . LASER HAIR REMOVAL . . . HEMORRHOIDS . . . MICROBLADING . . . HOW TO USE NUMBING CREAM? . . . Apply a thick amount of cream and rub it in. . . . Cover with plastic wrap & keep it on for 30-45 minutes.” [from your website https://numbskin.com/numbskin-5-lidocaine-numbing-cream-30-grams/]

NumbSkin 10.56% Lidocaine Numbing Cream:

    “NumbSkin CREAM . . . Licocaine 10.56% . . . Fast Acting Formulation . . . needle injection, botox, anorectal . . . Long Lasting Effect . . . tattoo, waxing, laser, minor surgery . . . Active Ingredient . . . Lidocaine . . . Purpose . . . Local Anesthetic . . . Uses: . . . For temporary relief of pain and itching associated with anorectal disorders, or a local anesthetic for minor surgery, and cosmetic procedures. . . . Directions: . . . 1. Use thick amount of the cream on the treatment area. 2. Use plastic wrap to cover the cream on the treatment area. 3. Lidocaine is volatile ingredient so you should cover them with the plastic wrap to help absorbing the lidocaine into the skin. 4. After 30~60 minutes, remove plastic wrap and the cream as well. Leave the cream on the skin longer for better result. Don’t remove the plastic wrap until you feel the numbing effect. 5. As soon as you remove them, go to the operation right away.“ [from your NumbSkin 10.56% Lidocaine Numbing Cream carton labeling]

    “Efficacy/Effectiveness: . . . – topical anesthetic cream for . . . laser, waxing, tattoo, cosmetic procedures . . . – cosmetic procedures, microdermabrasion, cosmetic procedures involving needles, microneedle therapy . . . Using NumbSkin™ cream: . . . Apply before injection, or laser surgery . . . Results are obtained as little as 15 minutes. . . . Procedures such as Tattoo and Hair removal may need longer application times to achieve desired numbing. (15minutes to 1hour)” [from your NumbSkin 10.56% Lidocaine Numbing Cream package insert]

    “Imagine getting a piercing or tattoo without any discomfort. The lidocaine cream 10.56% will make it possible. . . . Tattoo topical numbing lotion lidocaine 10.56% can prevent discomfort for up to 4 hours. . . . “PROTECT YOUR SKIN DURING LASER HAIR REMOVAL . . . This pain cream works in 15-30 minutes. . . . USAGES OF LIDOCAINE 10.56% . . . PAIN RELIEF . . . PIERCING . . . LASER HAIR REMOVAL . . . HEMORRHOIDS . . . MICROBLADING . . . HOW TO USE NUMBING CREAM? . . . Apply a thick amount of cream and rub it in. . . . Cover with plastic wrap & keep it on for 30-45 minutes.” [from your website https://numbskin.com/numbskin-10-56-lidocaine-numbing-cream-30-grams/]

All products:

    “One of the most important aspects of getting a tattoo is making sure that you are well-numbed before the artist begins work. NumbSkin is the most trusted brand that provides topical anesthetic products. Trusted by tattoo artists worldwide. . . . Buy it now from our official website: . . . https://bityl.co/Di50 . . . https://bityl.co/Di51 . . . https://bityl.co/Di56” [from your Facebook social media account https://www.facebook.com/NumbSkin/posts/pfbid02iSRPin6Ucg4haRzinafPnzors4TXpUuPec2tFeSXaTjhV6wsHgQPS6ronxhmjWPpl]

Your NumbSkin 5% Lidocaine Numbing Cream (15 grams), NumbSkin 5% Lidocaine Numbing Cream (30 grams), and NumbSkin 10.56% Lidocaine Numbing Cream drug products are external analgesic drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application. Under section 505G(a)(1) of the FD&C Act, 21 U.S.C. 355h(a)(1), certain nonprescription drugs marketed without an approved application may be legally marketed if they meet applicable requirements. With respect to OTC external analgesic drug products, such products are deemed to be generally recognized as safe and effective (GRASE) and not new drugs if, among other things, they conform to the conditions of use set forth in the final administrative order, Over-the-Counter Monograph M017: External Analgesic Drug Products for Over-the-Counter Human Use (hereinafter “M017” or the “external analgesic monograph”). However, your products do not conform to the conditions of use specified in the external analgesic monograph for the reasons described below.

The labeled concentrations for the active ingredient identified in product labeling for NumbSkin 5% Lidocaine Numbing Cream (15 grams), NumbSkin 5% Lidocaine Numbing Cream (30 grams), and NumbSkin 10.56% Lidocaine Numbing Cream do not conform to the conditions of use set forth in M017. Specifically, lidocaine, the active ingredient labeled to be in these products, is listed as lidocaine 5% and 10.56%, respectively. These concentrations are above the 0.5% to 4% concentration range of lidocaine permitted by M017.

Furthermore, labeling for NumbSkin 5% Lidocaine Numbing Cream (15 grams), NumbSkin 5% Lidocaine Numbing Cream (30 grams), and NumbSkin 10.56% Lidocaine Numbing Cream include indications that are not consistent with the indications for external analgesic drug products. Claims on your products described above related to the temporary relief of pain and swelling due to tattooing, laser hair removal, or other pain sensitive procedures go beyond merely describing the general intended uses for external analgesic drug products. Indications related to tattooing and piercing are not included in M017 or any other final administrative order in accordance with section 505G.⁴ We note that these products also appear to be indicated to relieve pain associated with anorectal disorders. OTC anorectal drug products are deemed to be GRASE and not new drugs if, among other things, they conform to the conditions of use set forth in the final administrative order, Over-the-Counter Monograph M015: Anorectal Drug Products for Over-the-Counter Human Use. Indications related to tattooing and piercing are not included in M015. As stated in the introduction to this letter, we have safety concerns related to the use of these products for these indications due to the potential for greater absorption of the active ingredients through irritated or broken skin.

Thus, NumbSkin 5% Lidocaine Numbing Cream (15 grams), NumbSkin 5% Lidocaine Numbing Cream (30 grams), and NumbSkin 10.56% Lidocaine Numbing Cream do not comply with the external analgesic monograph described above, and they are not otherwise marketed in accordance with the requirements of section 505G. Therefore, these products are new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), and are unapproved new drugs marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C 355(a). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d).

Misbranded Drug Violations

Further, NumbSkin 5% Lidocaine Numbing Cream (15 grams), NumbSkin 5% Lidocaine Numbing Cream (30 grams), and NumbSkin 10.56% Lidocaine Numbing Cream are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because they are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are not the subjects of applications approved under section 505 of the FD&C Act, 21 U.S.C. 355.

The 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).

Conclusion

The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. 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 believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will cmplete the correction. Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov and include your firm name in the subject line of your email.

Sincerely,
/S/

Jill Furman, J.D.
Director
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

_______________________

1 We note that your NumbSkin 5% Lidocaine Numbing Cream (15 grams), NumbSkin 5% Lidocaine Numbing Cream (30 grams), and NumbSkin 10.56% Lidocaine Numbing Cream products also appear to be indicated to relieve pain associated with anorectal disorders. OTC anorectal drug products are deemed to be GRASE and not new drugs if, among other things, they conform to the conditions of use set forth in the final administrative order, Over-the-Counter Monograph M015: Anorectal Drug Products for Over-the-Counter Human Use. Your products do not conform to the conditions set forth in this monograph. Your products are labeled as both external analgesics and anorectal products. Your products cannot meet the requirements of both M017 and M015 with lidocaine as an active ingredient at or above a concentration of 5%.

2 Section 505G(a)(1) of the FD&C Act specifies criteria under which certain nonprescription drugs without an approved application are deemed GRASE and not "new drugs," notably, conformance with conditions detailed in applicable OTC monograph documents issued by FDA under 21 CFR part 330 prior to enactment of the CARES Act. In the case of OTC external analgesic drug products, relevant documents were deemed under section 505G to be a final administrative order, Over-the-Counter Monograph M017: External Analgesic Drug Products for Over-the-Counter Human Use. (See Order ID OTC000033, available at FDA’s website OTC Monographs@FDA, https://dps.fda.gov/omuf).

3 Refer to FDA public health advisories Life-Threatening Side Effects with the Use of Skin Products Containing Numbing Ingredients for Cosmetic Procedures, Potential Hazards of Skin Products Containing Numbing Ingredients for Relieving Pain from Mammography and Other Medical Tests and Conditions, and Improper Use of Skin Numbing Products Can Be Deadly.

4 FDA is not aware of any adequate and well-controlled clinical studies in the published literature that support a determination that NumbSkin 5% Lidocaine Numbing Cream (15 grams), NumbSkin 5% Lidocaine Numbing Cream (30 grams), and NumbSkin 10.56% Lidocaine Numbing Cream are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling.