The U.S. Food and Drug Administration (FDA) has issued a warning letter to Tattoo Numbing Cream Co., a company based in the United Kingdom, regarding the distribution of their drug products SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB SPRAY. This action highlights significant regulatory concerns about tattoo numbing creams and their compliance with U.S. drug laws. This article delves into the details of the FDA’s warning, explaining why these products are considered unapproved and misbranded drugs, and what this means for consumers and the tattoo industry.
Unapproved New Drug Violations: Why FDA Flagged Tattoo Numbing Creams
According to the FDA’s warning letter, both SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB SPRAY are classified as unapproved new drugs. This categorization stems from the products being marketed as external analgesics for sensitive cosmetic procedures, particularly tattooing, without the necessary FDA approval. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), new drugs require pre-market approval to ensure safety and efficacy. These tattoo numbing creams have not gone through this rigorous process.
The FDA identifies the products as drugs under sections 201(g)(1)(B) and 201(g)(1)(C) of the FD&C Act because they are “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “intended to affect the structure or any function of the body.” The marketing claims made by Tattoo Numbing Cream Co. clearly position these products as pain relief solutions for tattooing, thus falling under the FDA’s drug definition.
Examples of claims cited by the FDA include:
- SIGNATURE TATTOO NUMBING CREAM:
- “Designed by Tattoo Artists in Australia. Used for numbing local area prior to tattooing…”
- “Imagine getting tattooed pain free. That’s totally possible using this cream…”
- “Numb an area for up to 3 hours…”
- MIRACLE NUMB SPRAY:
- “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.”
- “The skin will typically remain numb for 1-2 hours.”
These statements, found on the company’s website and social media platforms, explicitly promote the tattoo numbing creams for their pain-relieving effects during tattoo procedures. This intended use triggers the FDA’s regulatory oversight for drug products.
Exceeding Over-the-Counter Limits and Unapproved Ingredients
The FDA further elaborates that these tattoo numbing products fail to comply with Over-the-Counter (OTC) drug regulations, specifically the external analgesic monograph (M017). This monograph sets conditions for OTC external analgesic drug products to be generally recognized as safe and effective (GRASE) without requiring pre-approval.
Key issues identified by the FDA include:
- Lidocaine Concentration: Both products list lidocaine at a 5% concentration. The OTC monograph M017 permits lidocaine concentrations only up to 4%. This higher concentration raises safety concerns, especially given the intended use on skin undergoing cosmetic procedures.
- Unapproved Combinations and Ingredients:
- SIGNATURE TATTOO NUMBING CREAM contains lidocaine, prilocaine (5%), and epinephrine (1%).
- MIRACLE NUMB SPRAY includes lidocaine, prilocaine (4%), epinephrine (1%), propylamine, glycerol, and purified water.
- The monograph does not allow combinations of more than one “-caine” type active ingredient. Additionally, epinephrine, propylamine, glycerol, and purified water are not approved active ingredients under M017.
These deviations from the OTC monograph render the tattoo numbing creams non-compliant and further solidify their status as unapproved new drugs.
Misbranded Drug Violations: Beyond Approved Indications
In addition to being unapproved new drugs, SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB SPRAY are also deemed misbranded under section 502(ee) of the FD&C Act. This misbranding violation occurs because the products are nonprescription drugs that do not meet the requirements for marketing under section 505G of the FD&C Act and lack approved applications under section 505.
The FDA emphasizes that the labeling and marketing of these tattoo numbing creams include indications that are not consistent with approved uses for external analgesic drug products. Claims specifically related to tattooing are not covered under the external analgesic monograph or any other final administrative order.
This focus on tattoo-specific indications is critical. The FDA expresses safety concerns regarding the use of these products for tattooing due to the potential for increased absorption of active ingredients through irritated or broken skin—conditions inherent in the tattoo process.
Safety Concerns: Risks Associated with High-Concentration Numbing Creams
The FDA’s warning letter underscores significant safety concerns associated with these tattoo numbing creams. The agency has issued multiple public health advisories about the risks of topicalLocal anesthetics, particularly those containing lidocaine and similar “-caine” ingredients, when used improperly.
The key dangers highlighted by the FDA include:
- Increased Absorption: Applying high-concentration numbing creams over large skin areas, on irritated or broken skin, for extended periods, and under occlusive dressings (like cling film, as recommended by Tattoo Numbing Cream Co.) can significantly increase the amount of active ingredient absorbed into the bloodstream.
- Potential for Serious Injury: Excessive absorption of lidocaine and similar anesthetics can lead to serious adverse effects, including:
- Seizures
- Coma
- Respiratory depression
- Cardiovascular collapse
- Death
The FDA’s concerns are amplified by the intended use of these products for tattooing. Tattooing inherently involves skin irritation and breakage, which can enhance drug absorption. The combination of high-concentration lidocaine, unapproved ingredients, and application practices recommended by the company creates a potentially unsafe scenario for consumers.
Implications for Consumers and the Tattoo Industry
This FDA warning letter serves as a critical alert for both consumers and professionals within the tattoo industry regarding tattoo numbing creams.
For Consumers:
- Be Aware of Risks: Understand that tattoo numbing creams, especially those with high concentrations of lidocaine or unapproved ingredients, carry potential health risks.
- Check for FDA Approval: Look for FDA-approved products. Unapproved products have not been evaluated for safety and efficacy. (Note: It’s important to clarify that topical anesthetics for tattoos are generally not FDA-approved for OTC use specifically for tattoos due to the nature of cosmetic procedures vs. medical necessity in OTC monographs. Consumers should consult healthcare professionals).
- Consult Professionals: Discuss pain management options with tattoo artists and healthcare providers. Explore safer alternatives and understand the risks before using any numbing cream.
For Tattoo Artists:
- Product Awareness: Be informed about the regulatory status and potential risks of tattoo numbing creams used in your studio.
- Client Education: Educate clients about the FDA warning and the potential dangers of unapproved numbing products.
- Consider Alternatives: Explore and offer clients safer pain management strategies.
- Regulatory Compliance: Ensure all products used in your studio comply with relevant regulations and prioritize client safety.
Conclusion: FDA Action Emphasizes Regulatory Oversight of Tattoo Numbing Creams
The FDA’s warning letter to Tattoo Numbing Cream Co. underscores the agency’s commitment to regulating drug products, including tattoo numbing creams, to protect public health. The letter clearly outlines violations related to unapproved new drugs and misbranding, driven by concerns over product safety and regulatory non-compliance.
This action should prompt increased scrutiny within the tattoo numbing cream market and serve as a reminder to companies to adhere to FDA regulations. For consumers and tattoo artists, it emphasizes the importance of being informed, prioritizing safety, and understanding the regulatory landscape surrounding topical anesthetics used in cosmetic procedures. The FDA requires Tattoo Numbing Cream Co. to respond within 15 working days, outlining corrective actions. Failure to comply could result in further legal action, including product seizure and injunction.
