The United States Food and Drug Administration (FDA) has issued a warning letter to Tattoo Numbing Cream Co., a company based in the United Kingdom, regarding their distribution of drug products, SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB SPRAY. This action, stemming from a review conducted in November 2023, highlights critical concerns about products marketed as external analgesics for cosmetic procedures like tattooing and available on their website tattoonumbingcream.com.
According to the FDA’s warning letter dated March 25, 2024, SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB SPRAY are classified as unapproved new drugs. This means they have been introduced into interstate commerce in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Furthermore, the FDA asserts that these products are misbranded under the same act. This article will delve into the specifics of the FDA’s warning, explaining what this means for consumers and the tattoo industry.
Unpacking the FDA’s Concerns: Unapproved New Drugs
The core of the FDA’s warning lies in the classification of SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB SPRAY as “unapproved new drugs.” Under the FD&C Act, a “drug” is defined as a substance intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body. External analgesic products, like numbing creams and sprays, fall under this definition as they are intended to relieve pain.
The FDA states that Tattoo Numbing Cream Co. markets these products as external analgesics for use before, during, and after cosmetic procedures, specifically tattooing. However, these products lack the required approval under Section 505 of the FD&C Act for these uses. For over-the-counter (OTC) external analgesic drugs marketed without prior approval, they must comply with specific regulations outlined in Section 505G of the FD&C Act, which refers to the Over-the-Counter Monograph M017. This monograph sets the standards for nonprescription external analgesic drug products.
The FDA clarifies that Tattoo Numbing Cream Co.’s products fail to meet these monograph conditions for several key reasons:
- Excessive Lidocaine Concentration: Both SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB SPRAY are labeled to contain 5% lidocaine. This concentration exceeds the monograph’s permitted range of 0.5% to 4% for OTC lidocaine products.
- Unpermitted Combinations of Active Ingredients: The monograph does not allow for combinations of more than one “-caine” type active ingredient in a single product. SIGNATURE TATTOO NUMBING CREAM includes prilocaine and epinephrine in addition to lidocaine. MIRACLE NUMB SPRAY lists prilocaine, epinephrine, propylamine, glycerol, and purified water alongside lidocaine. Epinephrine, propylamine, glycerol, and purified water are not recognized as permissible active ingredients in the monograph.
- Non-Monograph Indication (Tattooing): The FDA points out that the marketing claims for these products, specifically targeting tattooing procedures, are not included within the approved indications listed in Monograph M017. Claims such as “secret weapon for your next tattoo appointment” and “perfect to apply mid-session (even on broken skin)” directly promote use for tattooing, an indication not covered by the monograph.
The FDA emphasizes safety concerns related to these products, especially when used in conjunction with cosmetic procedures like tattooing. Applying numbing creams, particularly those with high concentrations of active ingredients, over large skin areas, on broken skin, or under occlusive dressings (like cling film, as suggested in product instructions) can significantly increase drug absorption into the bloodstream. The FDA has issued multiple public health advisories warning about the potential for serious adverse effects from improper use of such products, including “-caine” type ingredients like lidocaine.
Misbranding: A Further Violation
In addition to being unapproved new drugs, the FDA has determined that SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB SPRAY are also misbranded under section 502(ee) of the FD&C Act. This misbranding violation is a direct consequence of the products’ failure to comply with Section 505G and lacking approved new drug applications. Essentially, because they don’t meet the requirements for legal marketing as OTC drugs under the monograph and haven’t gone through the FDA approval process, they are improperly labeled and marketed, hence “misbranded.”
Implications and Required Actions
The FDA warning letter is a serious regulatory action. It notifies Tattoo Numbing Cream Co. of significant violations and demands a response within 15 working days. The company is expected to investigate the causes of these violations, prevent their recurrence, and outline specific corrective actions. Failure to adequately address the FDA’s concerns could lead to further legal actions, including product seizure and injunction.
For consumers and tattoo artists, this warning highlights the importance of understanding the regulatory landscape surrounding topical anesthetics. While numbing creams can be appealing for reducing tattoo pain, it’s crucial to use products that are legally compliant and safe. Products with excessively high concentrations of active ingredients or unapproved combinations pose potential health risks.
Key Takeaways:
- FDA Warning: Tattoo Numbing Cream Co. has been warned by the FDA regarding their SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB SPRAY products.
- Unapproved Drugs: The FDA classifies these products as unapproved new drugs and misbranded due to violations of the FD&C Act and non-compliance with OTC drug monographs.
- Safety Concerns: The FDA raises safety concerns about the high concentrations of lidocaine and unapproved ingredients, especially when used for tattooing, which may involve application to broken skin and large areas.
- Regulatory Compliance: This action underscores the FDA’s commitment to regulating drug products and ensuring consumer safety. Companies marketing topical anesthetics must adhere to FDA regulations, including OTC monographs and approval processes.
- Consumer Awareness: Consumers should be aware of the regulatory status of tattoo numbing products and potential risks associated with unapproved drugs.
This situation serves as a reminder of the importance of regulatory oversight in the cosmetic and tattoo industries, particularly concerning products that contain active drug ingredients. Consumers and professionals alike should seek out and utilize products from companies that prioritize regulatory compliance and product safety.
