WARNING LETTER
Tattoo Numbing Cream Co.
MARCS-CMS 672467 —
March 25, 2024
Reference #:
3028008119
Product:
Cosmetics
Drugs
Recipient:
Tattoo Numbing Cream Co.
United Kingdom
info@tattoonumbingcream.com.au
info@tattoonumbingcream.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Secondary Issuing Offices
United States
WARNING LETTER
March 25, 2024
RE: 3028008119
Dear Sir/Madam:
This letter concerns your firm’s distribution of the drug products, SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB SPRAY 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://tattoonumbingcream.com/ where these products are available for purchase.
Based on our review, SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB SPRAY 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). SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB SPRAY 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 external analgesics to be used before, during, and/or after various 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 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 and/or include combinations of active ingredients that do not conform with the conditions of marketing in the external analgesics final administrative order issued under section 505G.
1
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 that could lead to increased absorption of the drug product through the skin. FDA has specifically warned in multiple public health advisories
2
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
SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB SPRAY 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 external analgesic drug products for tattooing procedures.
Examples of claims observed on the product labeling, including your product website https://tattoonumbingcream.com/ and your social media accounts on Facebook and 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:
SIGNATURE TATTOO NUMBING CREAM:
“Designed by Tattoo Artists in Australia. Used for numbing local area prior to tattooing…Join our pain free tattoo revolution!...For numbing a localized topical area to ease pain during tattoo procedures.” [from your product label]
“Our Signature Tattoo Numbing Cream is your secret weapon for your next tattoo appointment. Imagine getting tattooed pain free. That’s totally possible using this cream…Using this numbing cream for tattoos you can: Numb an area for up to 3 hours (some people say it works for longer).” [from your product website https://www.tattoonumbingcream.com/products/signature- tattoo-numbing-cream]
“
Steps for use:
…3. Cover tightly with cling film or our patented Numbing Garments”…“Your skin should remain numb for 3-4 hours, on average, once cream is removed depending on your skin type and location on the body. If using on broken skin, although our Miracle Numb Spray is much more suitable for this, only leave on broken skin for a maximum of 20 minutes at a time.” [from your product website https://www.tattoonumbingcream.com/pages/directions-of-use]
“You mean to tell me I can get tatted up and not feel a thing? Order it right now! Tattoo Numbing Cream” [from your Facebook social media account https://www.facebook.com/photo/?fbid=670068798487576&set=pb.100064533858343.- 2207520000]
“#NewGearsForPainFreeTattoo.” [from your Instagram social media account https://www.facebook.com/tattoonumbingcreamco/photos/pb.100064533858343.- 2207520000/1940516569621408/?type=3]
“Numb Dad for Fathers Day. Heres 20% off your order so you can gift dad a peaceful, pain-free tattoo session this fathers day.” [from your Facebook social media account https://www.instagram.com/p/CwoNinPOoFD/]
MIRACLE NUMB SPRAY:
“Whether you forgot to use our Signature Tattoo Numbing Cream or it’s starting to wear off, Miracle Numb Spray is perfect to apply mid-session (even on broken skin). Be sure to get a bottle so you don’t tap out and can finish your tattoo.” [from your product website https://www.tattoonumbingcream.com/products/miracle-numb-spray]
“This product is designed for use during a tattoo, after the skin has been broken (the tattoo has started) although most people typically achieve a level of numbness if sprayed on unbroken skin 10-20 minutes before being tattooed.”…“
Steps for use:
…2. Spray sparingly on broken skin throughout tattoo session. 3. Allow to absorb for 5-10 minutes. 4. Re-apply as needed”…“ The skin will typically remain numb for 1-2 hours. Only administer 1-2 sprays at a time on the area that is currently being tattooed, then move on to other areas as needed throughout the session.” [from your product website https://www.tattoonumbingcream.com/pages/directions-of-use]
“#NewGearsForPainFreeTattoo.” [from your Facebook social media account https://www.facebook.com/tattoonumbingcreamco/photos/pb.100064533858343.- 2207520000/1940516569621408/?type=3]
“Numb Dad for Fathers Day. Here’s 20% off your order so you can gift dad a peaceful, pain- free tattoo session this fathers day.” [from your Instagram social media account https://www.instagram.com/p/CwoNinPOoFD/]
Your SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB SPRAY 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”).
3
However, your products do not conform to the conditions of use specified in the external analgesic monograph for the reasons described below.
The labeled combinations and/or concentrations for the active ingredients identified in product labels for SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB SPRAY do not conform to the conditions of use set forth in M017. Specifically, lidocaine, an active ingredient labeled to be in both of these products, is listed as lidocaine 5%. This concentration is above the 0.5% to 4% concentration range of lidocaine permitted by M017. In addition, these drug products also include a combination of lidocaine and other active ingredients that are not permitted by M017. Specifically, SIGNATURE TATTOO NUMBING CREAM identifies 5% prilocaine and 1% epinephrine as additional active ingredients, and MIRACLE NUMB SPRAY identifies 4% prilocaine, 1% epinephrine, propylamine, glycerol, and purified water all as additional active ingredients. However, the external analgesic monograph does not permit a combination of more than one “-caine” type active ingredient in a single drug product, and epinephrine, propylamine, glycerol, and purified water are not permitted as active ingredients by M017.
Furthermore, labeling for SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB SPRAY include indications that are not consistent with the indications for external analgesic drug products. Claims on your SIGNATURE TATTOO NUMBING CREAM product such as “Our Signature Tattoo Numbing Cream is your secret weapon for your next tattoo appointment” and statements on your MIRACLE NUMB SPRAY product such as “[w]hether you forgot to use our Signature Tattoo Numbing Cream or it’s starting to wear off, Miracle Numb Spray is perfect to apply mid-session (even on broken skin). Be sure to get a bottle so you don’t tap out and can finish your tattoo,” go beyond merely describing the general intended uses for an external analgesic drug product. Indications related to tattooing are not included in M017, or any other final administrative order in accordance with section 505G. 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, SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB SPRAY do not comply with the external analgesic monograph described above, nor are they otherwise marketed in accordance with section 505G.
4
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
SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB SPRAY 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 complete 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
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.)
2
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.
3
See Order ID OTC000033, available at FDA’s website OTC Monographs@FDA, https://dps.fda.gov/omuf.
4
FDA is not aware of any adequate and well-controlled clinical studies in the published literature that support a determination that SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB SPRAY are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling.
Content current as of:
03/26/2024
Regulated Product(s)
Cosmetics
Drugs