The U.S. Food and Drug Administration (FDA) has issued a warning letter to Tattoo Numbing Cream Co., a firm distributing drug products marketed as external analgesics for use before sensitive cosmetic procedures like tattooing. The FDA’s Center for Drug Evaluation and Research (CDER) reviewed the company’s website, tattoonumbingcream.com, in November 2023 and determined that two of their products, SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB SPRAY, are unapproved new drugs and are misbranded under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Unapproved New Drug Violations
According to the warning letter issued on March 25, 2024, the FDA states that SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB SPRAY are in violation of section 505(a) of the FD&C Act because they are being introduced or delivered for introduction into interstate commerce as unapproved new drugs. These products are marketed as external analgesics for use before, during, and after cosmetic procedures, including tattoos.
The FDA clarifies that these products require approved applications under section 505 of the FD&C Act, especially for indications not covered under section 505G of the FD&C Act, which governs nonprescription drugs marketed without prior approval. Furthermore, the FDA highlights that the lidocaine concentrations in these products exceed the permissible limits for over-the-counter (OTC) external analgesic drugs marketed without approved applications. The combinations of active ingredients also do not align with the conditions outlined in the external analgesics final administrative order under section 505G.
The FDA expresses significant safety concerns regarding these external analgesic drug products. The products contain active ingredients, including lidocaine at concentrations surpassing currently allowed levels in nonprescription drugs. These concerns are amplified because the products are intended for use before or during cosmetic procedures, potentially leading to increased drug absorption through the skin. The FDA has previously issued public health advisories warning against similar lidocaine and “-caine” type products, particularly when applied over large skin areas, on irritated or broken skin, for extended periods, or when covered after application. Such uses can drastically increase the amount of active ingredient absorbed into the bloodstream, potentially causing serious harm if misused.
Evidence of Intended Use
The FDA’s warning letter details examples from the company’s website and social media platforms that demonstrate the intended use of SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB SPRAY as external analgesics for tattooing.
SIGNATURE TATTOO NUMBING CREAM:
- Product Label Claim: “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.”
- Product Website: “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).”
- Directions for Use: “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.”
- Facebook Social Media: “You mean to tell me I can get tatted up and not feel a thing? Order it right now! Tattoo Numbing Cream”
- Instagram Social Media: “#NewGearsForPainFreeTattoo.”
- Facebook Social Media: “Numb Dad for Fathers Day. Heres 20% off your order so you can gift dad a peaceful, pain-free tattoo session this fathers day.”
MIRACLE NUMB SPRAY:
- Product Website: “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.”
- Directions for Use: “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.”
- Facebook Social Media: “#NewGearsForPainFreeTattoo.”
- Instagram Social Media: “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.”
Non-Compliance with OTC Monograph
The FDA emphasizes that SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB SPRAY, as external analgesic drugs, must comply with section 505G of the FD&C Act, which governs nonprescription drugs marketed without approved applications. To be considered generally recognized as safe and effective (GRASE) and not new drugs, these products must adhere to the conditions outlined in the final administrative order, Over-the-Counter Monograph M017: External Analgesic Drug Products for Over-the-Counter Human Use (M017).
However, the FDA found that Tattoo Numbing Cream Co.’s products fail to meet these conditions. Specifically, both products list lidocaine at a 5% concentration, which exceeds the monograph’s permitted range of 0.5% to 4%. Moreover, the products contain combinations of active ingredients not allowed by M017. SIGNATURE TATTOO NUMBING CREAM includes 5% prilocaine and 1% epinephrine, while MIRACLE NUMB SPRAY contains 4% prilocaine, 1% epinephrine, propylamine, glycerol, and purified water. The external analgesic monograph does not allow for more than one “-caine” type active ingredient in a single product, and epinephrine, propylamine, glycerol, and purified water are not approved active ingredients under M017.
Furthermore, the FDA notes that the labeling for both products includes indications beyond the scope of approved external analgesic drug products. Claims related to tattooing, such as using the creams as a “secret weapon for your next tattoo appointment” or to “finish your tattoo,” are not consistent with the general intended uses defined in M017 or any other final administrative order under section 505G. The FDA reiterates its safety concerns about using these products for tattoo-related pain relief due to the increased risk of active ingredient absorption through irritated or broken skin during tattooing procedures.
Because of these violations, SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB SPRAY are classified as new drugs under section 201(p) of the FD&C Act and are unapproved new drugs marketed in violation of section 505(a). Their introduction or delivery for introduction into interstate commerce is therefore prohibited under section 301(d) of the FD&C Act.
Misbranding Violations
In addition to being unapproved new drugs, SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB SPRAY are also considered misbranded under section 502(ee) of the FD&C Act. This is because they are nonprescription drugs subject to section 505G of the FD&C Act but do not comply with its requirements and lack approved applications under section 505. The introduction or delivery of misbranded drugs into interstate commerce is prohibited under section 301(a) of the FD&C Act.
Call to Action
The FDA warning letter emphasizes that the identified violations are not exhaustive and Tattoo Numbing Cream Co. is responsible for investigating and rectifying all violations to prevent recurrence. The company is required to respond in writing within 15 working days of receiving the letter, outlining the specific steps taken to address the violations and prevent future occurrences. Failure to adequately address these issues may result in further legal action, including seizure and injunction.
Tattoo Numbing Cream Co. must notify the FDA of their corrective actions, including supporting documentation, or provide reasoning and supporting information if they believe their products are not in violation. Responses should be directed to the FDA’s CDER/OC/Office of Unapproved Drugs and Labeling Compliance.
This warning serves as a critical reminder of the FDA’s regulatory oversight of drug products, including topical analgesics like tattoo numbing creams. Consumers should be aware of the regulatory status of products they use, especially those applied to the skin during procedures that may increase drug absorption.
