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WARNING LETTER

March 25, 2024

RE: 3015204327

Dear Messrs. Ether and Hoy:

This letter concerns your firm’s distribution of the drug products INK EEZE Original B NUMB NUMBING GEL, INK EEZE B NUMB NUMBING SPRAY BLACK LABEL and INK EEZE B NUMB NUMBING FOAM SOAP for use as external analgesics prior to sensitive cosmetic procedures. The United States Food and Drug Administration (FDA) reviewed your website in November 2023 at the Internet address https//www.inkeeze.com, where these products are available for purchase.¹

Based on our review, INK EEZE Original B NUMB NUMBING GEL, INK EEZE B NUMB NUMBING SPRAY BLACK LABEL, and INK EEZE B NUMB NUMBING FOAM SOAP 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). INK EEZE Original B NUMB NUMBING GEL, INK EEZE B NUMB NUMBING SPRAY BLACK LABEL, and INK EEZE B NUMB NUMBING FOAM SOAP 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 INK EEZE Original B NUMB NUMBING GEL, INK EEZE B NUMB NUMBING SPRAY BLACK LABEL and INK EEZE B NUMB NUMBING FOAM SOAP as external analgesics, among other things,² to be used before, during and/or after sensitive cosmetic procedures such as tattooing. 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 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, INK EEZE Original B NUMB NUMBING GEL and INK EEZE B NUMB NUMBING SPRAY BLACK LABEL drug products include lidocaine concentrations that exceed what is permissible for over-the-counter (OTC) external analgesic drug products marketed without an approved application in the external analgesics final administrative order issued under section 505G.³

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 the 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 advisories⁴ 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

INK EEZE Original B NUMB NUMBING GEL, INK EEZE B NUMB NUMBING SPRAY BLACK LABEL, and INK EEZE B NUMB NUMBING FOAM SOAP 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 primarily intended for use as topical external analgesic drug products for pain-sensitive cosmetic procedures. INK EEZE Original B NUMB NUMBING GEL and INK EEZE B NUMB NUMBING SPRAY BLACK LABEL are also intended for anorectal drug use.

Examples of claims observed on the product labeling, including your product website https://inkeeze.com and your social media account on Instagram 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:

INK EEZE Original B NUMB NUMBING GEL:

    “INK EEZE Original B NUMB PROFESSIONAL NUMBING GEL . . . HEMORRHOID GEL.” [from your product label]

    “DRUG FACTS . . . ACTIVE INGREDIENTS: Lidocaine 5% . . . USES . . . For the temporary relief of local itching and discomfort in the perianal area.” [from your product label]

    “INK EEZE TATTOO PRODUCTS . . . This product is perfect to NUMB the skin to create the best experience possible. . [from your INK EEZE Original B NUMB NUMBING GEL product website at https://inkeeze.com]

    “CUSTOMER REVIEWS . . . Used it for my 4th arm tattoo . . . Applied a ton of gel, then wrapped arm in plastic 90 min before session. . . If you get a tattoo that only takes 2-3 hours, why not use it and experience ZERO pain?” [from your INK EEZE Original B NUMB NUMBING GEL product website at https://inkeeze.com]

    “INKEEZE B Numb has you covered! Make your next tattoo session more comfortable with our pre tattoo numbing gel.” [from your Instagram social media account https://www.instagram.com/p/CrzROhbtpv4/]

    “Make that next tattoo session comfortable with INKEEZE B Numb! . . . Apply to skin and wrap before your tattoo session and take that tattoo pain away.” [from your INK EEZE Original B NUMB NUMBING GEL website at https://inkeeze.com]

INK EEZE B NUMB NUMBING SPRAY BLACK LABEL:

    “BLACK LABEL . . . B NUMB PROFESSIONAL NUMBING SPRAY . . . HEMORRHOIDAL SPRAY . . . ACTIVE INGREDIENTS: Lidocaine HCL . . . 5% . . . PURPOSE: External Anesthetic . . . USES: EXTERNAL USE ONLY. For temporary relief of pain.” [from your product label]

    “This powerful lidocaine liquid anesthetic is for use for temporary pain relief of the minor cuts and scrapes. . . . Purpose . . . External Analgesic . . . Uses . . . For External Use Only. . . . Directions . . . Apply to skin. Wait until anesthetic (numbing effect occurs. (90 seconds)” . . . ACTIVE . . . Lidocaine HCL . . . 5%” . . . REMOVES UP TO 50% OF PAIN IN MINUTES . . . APPLICATION DURING TATTOO SESSION.” [from your INK EEZE B NUMB NUMBING SPRAY BLACK website at https:/inkeeze.com]

    “CUSTOMER REVIEWS . . . Really helps me get through my tattoo sessions . . . This is a great Numbing spray works for both getting tattooed and for the aftercare when the tattoo is sore” [from your INK EEZE B NUMB NUMBING SPRAY BLACK website at https:/inkeeze.com]

INK EEZE B NUMB NUMBING FOAM SOAP:

    “TATTOO ARTIST OWNED . . . INK EEZE TATTOO PRODUCTS . . . B NUMB NUMBING FOAM SOAP . . . LIDOCAINE . . . DRUG FACTS . . . USES: ● For cleansing and conditioning the skin . . . ● For temporary relief of pain and itching associated with skin irritations . . . ACTIVE INGREDIENTS: . . . Lidocaine – 4% . . . PURPOSE: External Analgesic” [from your product label)

    “Lidocaine based cleansing foam soap featuring: . . . sanitize and decrease bacteria on the skin (before, during, and after the tattoo process) . . . Temporarily relieve pain and/or itching associated with minor skin irritations . . . Remove ink and blood” ” [from your INK EEZE B NUMB NUMBING FOAM SOAP website at https://inkeeze.com/]

Your INK EEZE Original B NUMB NUMBING GEL, INK EEZE B NUMB NUMBING SPRAY BLACK LABEL, and INK EEZE B NUMB NUMBING FOAM SOAP 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 concentration for the active ingredient identified in product labels for INK EEZE Original B NUMB NUMBING GEL and INK EEZE B NUMB NUMBING SPRAY BLACK LABEL do not conform to the conditions of use set forth in M017. Specifically, lidocaine HCl and lidocaine are active ingredients labeled to be in INK EEZE B NUMB NUMBING SPRAY BLACK LABEL and INK EEZE B NUMB NUMBING GEL, respectively, at a concentration of 5%. This concentration is above the 0.5% to 4% concentration range of both lidocaine and lidocaine HCl permitted by M017.

Furthermore, labeling for INK EEZE Original B NUMB NUMBING GEL, INK EEZE B NUMB NUMBING SPRAY BLACK LABEL, and INK EEZE B NUMB NUMBING FOAM SOAP 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 due to tattooing go beyond merely describing the general intended uses for external analgesic drug products. Indications related to tattooing are not included in M017, or any other final administrative order in accordance with section 505G⁵. 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 ingredient through irritated or broken skin.

Thus, INK EEZE Original B NUMB NUMBING GEL, INK EEZE B NUMB NUMBING SPRAY BLACK LABEL, and INK EEZE B NUMB NUMBING FOAM SOAP do not comply with the external analgesic monograph described above nor are they marketed in accordance with 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). Accordingly, these products 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).

Misbranding Violations

INK EEZE Original B NUMB NUMBING GEL, INK EEZE B NUMB NUMBING SPRAY BLACK LABEL, and INK EEZE B NUMB NUMBING FOAM SOAP are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because INK EEZE Original B NUMB NUMBING GEL, INK EEZE B NUMB NUMBING SPRAY BLACK LABEL, and INK EEZE B NUMB NUMBING FOAM SOAP 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 fifteen working days of receipt of this letter, of the specific steps you have taken to correct 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 fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to the 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 as of March 22, 2024, these products no longer appear on your firm’s website: https//www.inkeeze.com, but they are available for online purchase through third-party vendors.

2 We note that your INK EEZE Original B NUMB NUMBING GEL and INK EEZE B NUMB NUMBING SPRAY BLACK LABEL products also appear to be indicated to relieve pain associated with anorectal disorders. OTC anorectal drug 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 M015: Anorectal Drug Products for Over-the-Counter Human Use. Your products do not conform to the conditions set forth in this monograph. Your INK EEZE Original B NUMB NUMBING GEL and INK EEZE B NUMB NUMBING SPRAY BLACK LABEL are labeled as both external analgesics and anorectal products. Your products cannot meet the requirements of both M017 and M015 with lidocaine or lidocaine HCl as an active ingredient at or above a concentration of 5%. Additionally, INK EEZE B NUMB NUMBING FOAM SOAP also appears to be indicated to decrease bacteria on the skin. Under 505G(a)(3) of the FD&C Act, OTC consumer antiseptic drugs that were classified as Category III for safety or effectiveness in a TFM that is the most recently applicable proposal or determination for such drug issued under 21 CFR Part 330 – and that were not classified as Category II for safety or effectiveness – are not required to have an approved application under section 505 in order to be marketed, as long as they are in conformity with the relevant conditions of use outlined in the applicable TFM, including the active ingredient, and comply with all other applicable requirements. Your product does not conform to the conditions set forth in the most recent applicable proposal.

3 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).

4 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.

5 FDA is not aware of any adequate and well-controlled clinical studies in the published literature that support a determination that INK EEZE Original B NUMB NUMBING GEL, INK EEZE B NUMB NUMBING SPRAY BLACK LABEL, and INK EEZE B NUMB NUMBING FOAM SOAP are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling.