Tattoo ink between beauty and risk: regulation in Switzerland, the EU and the USA

In this study, we collected voluntary recall records of tattoo and permanent makeup ink from the U.S. Food and Drug Administration (US FDA) Enforcement Report Database. The recall records contain information, such as recall date, manufacturer, ink color, reason for recall, and the microorganisms detected from the ink samples. Between 2003 and 2021, a total of 15 voluntary tattoo ink recalls occurred in the U.S. market, involving over 200 tattoo inks marketed by 13 manufacturers and one distributor. Fourteen recalls were due to microbial contamination, and one recall was due to allergic reaction. As follow-up, a microbiological survey of 28 tattoo inks of new batches from seven manufacturers having products that were previously recalled was conducted. Aerobic plate count (APC) and enrichment culture methods based on the FDA’s Bacteriological Analytical Manual (BAM) were used to detect microbial contamination. The results revealed that six out of 28 tattoo inks were contaminated with bacteria and were produced by two manufacturers. The level of microbial contamination was less than 250 CFU/g in three of the tattoo inks and between 1 × 103 and 1 × 105 CFU/g in the other three inks. Eleven bacterial isolates were identified, including spore-forming Bacillus-related species and potentially pathogenic species. Overall, this study shows that some tattoo ink products produced by manufacturers with a recall history continue to be contaminated with microorganisms. This highlights the need for ongoing monitoring and quality control of such products.

A rise in popularity of cosmetic tattoos has led to an increase in adverse reactions. Due to more pressing concerns, the Food and Drug Administration (FDA) has not traditionally enforced its authority over tattoo inks. To raise awareness of the dangers of cosmetic tattoos. We reviewed FDA policies regarding tattoo ink, different ink components, adverse reactions, and various treatment options for cosmetic tattoo removal. An increase in consumer complaints has prompted FDA investigation into tattoo inks and their safety. It is important that further complications be reported to the FDA to promote regulation of cosmetic tattoo inks.

Guidance recently released by the Food and Drug Administration (FDA) regarding tattoo inks describes tattooing as an injection process, but is injection the correct terminology to use when describing tattooing? This perspective aims to provide a brief overview of the core mechanics and science behind injection and tattoo processes, as well as emphasize the importance of using the correct terminology when referencing tattoos and the act of tattooing moving forward. STATEMENT OF SIGNIFICANCE: Due to a change in the FDA regulatory framework around cosmetics in December 2022, for the first time the FDA is in the process of actively regulating tattoo inks. Central to how tattoos will be regulated is whether tattoos and tattooing should be considered an injectable process. If tattoos are injectables, then tattoo inks would be considered within a medical device framework leading to a radical alteration tattoo industry in the US and globally. This perspective surveys the literature to understand what it means for something to be "injected" and then compares that to the state-of-the-art understanding about how tattoos are deposited in the skin. Based on this analysis, it is clear that tattooing should not be described as an injection process.

To Tattoo or Not: That is the Question

In a 2018 survey, U.S. Food and Drug Administration (FDA) identified microbial contamination in 42 (49%) of 85 unopened tattoo and permanent makeup (PMU) inks purchased from 13 manufacturers in the US between November 2015 and April 2016. To confirm the results of our previous survey, we evaluated the level of microbial contamination in an additional 27 samples from 10 manufacturers from September 2017 to December 2017, including 21 unopened tattoo and PMU inks which were selected based on our previous survey results and 6 ink diluents that were not previously analysed. Aerobic plate count and enrichment culture methods from the FDA's Bacteriological Analytical Manual revealed 11 (52%) out of 21 inks, from six manufacturers, were contaminated with micro-organisms, with contamination levels up to 3·6×108 CFU per gram, consistent with our previous survey results. We identified 25 bacterial strains belonging to nine genera and 19 species. Strains of Bacillus sp. (11 strains, 44%) were dominant, followed by Paenibacillus sp. (5 strains, 20%). Clinically relevant strains, such as Kocuria rhizophila and Oligella ureolytica, were also identified, as similar to the findings in our previous survey. No microbial contamination was detected in any of the six ink diluents.

Successful Investigational New Drug Preparation without Reinventing the Wheel

A 2003 Harris Poll reported that 16% of U.S. adults are tattooed, including over a third of those aged 25–29. Despite the art’s growing popularity, the toxicology of tattoos is poorly understood. Now some ink components—particularly heavy metals—have raised concerns. A lawsuit set to go to trial in October 2005 has been filed against nine tattoo ink companies for violations of California’s Proposition 65, which requires that Californians be warned before exposure to chemicals causing cancer, birth defects, or other reproductive harm. “One reason we started looking at tattoos is that the research we’ve done suggests teenage girls in particular are a huge market now for tattoos,” says Deborah Sivas, president of the nonprofit American Environmental Safety Institute (AESI), which filed the suit. The concern is not that the inks are acutely harmful, but rather that chronic exposure to some metals—especially lead—is a known problem. Titanium and aluminum are often used as colorants in tattoos; more worrisome, inks using nonmetal colorants may include traces of antimony, arsenic, beryllium, chromium, cobalt, lead, nickel, and selenium (AESI filed over the latter eight metals). Sivas says the ink used for a 3 by 5 inch tattoo contains 1–23 micrograms of lead, versus the 0.5 micrograms per day permitted under Proposition 65. Understanding exposure to lead and other metals once incorporated into a tattoo is not simple. A healed tattoo is a complicated array of ink particles trapped within dermal fibroblasts, macrophages, and mast cells. “One of the biggest problems is, over the period of time, how is exposure evaluated?” says Westley Wood, president of Unimax Supply, a tattoo equipment supplier and ink producer, which settled out of court in the AESI lawsuit. “Should it be counted every single day for the rest of your life, or is it dissipated in the body within a month?” “Metal toxicity has not been an observed problem,” asserts physician Linda Dixon, president of the American Academy of Micropigmentation, a cosmetic tattooing trade group and manufacturer of Kolorsource brand of cosmetic ink. However, she adds, “Information about pigments in traditional tattoo products is usually a trade secret and not shared. We need information which is scientifically based.” Dixon suggests publishing a list of pigments that are known to be safe and those known to be toxic. “Know your colors, know your pigments,” she says. “The scientists know what to avoid, and this should be common knowledge in the tattoo industries.” Though tattoo inks are subject to regulation by the Food and Drug Administration as cosmetics and color additives, that agency does not currently attempt to actually regulate tattooing or the pigments involved. Despite the upcoming court battle, among the 17% of tattooed Americans the Harris Poll say regret their indelible marks, the greatest reason for dissatisfaction is not the safety of the tattoo but having been inscribed with the wrong person’s name.

Bioanalytical evidence that chemicals in tattoo ink can induce adaptive stress responses

Introduction: Around 12% of Europeans and 20% of Americans have at least one tattoo. Tattoo inks, the substances used to create tattoos on the body, consist of chemicals that contain formaldehyde, which can be harmful to human health. The amount of formaldehyde present in commercially available tattoo inks and its causes are not well understood. Methods: We investigated the levels of formaldehyde in tattoo ink products sold in different countries and identified the factors contributing to its production. We also explored methods to reduce formaldehyde generation in tattoo inks. Seven tattoo inks from various brands were tested. Results: Formaldehyde release was predominantly associated with gamma radiation sterilization. Formaldehyde levels were observed to be higher in compositions containing organic components compared to those with inorganic components, irrespective of sterilization method and container type. Glycerin released over seven times more formaldehyde than other components during gamma-ray sterilization. Conclusion: The results suggest that the presence of hydroxyl groups in carbon organic compounds in tattoo ink leads to photodegradation during gamma-ray radiation sterilization, resulting in increased concentrations of formaldehyde. Further research is needed to examine the chemical reactions occurring during sterilization processes and identify alternative sterilization methods that minimize formaldehyde formation. Additionally, the development of tattoo inks with reduced formaldehyde content and the establishment of strict quality control measures can help ensure the safety of tattooing practices.

“Black box” 101: How the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk

The future of drug safety: What the IOM report may mean to the emergency department

Today's tattoo inks are no longer just simple solids in liquid suspension. Nowadays, these inks are high-tech dispersions made from finely spread pigments in a binder-solvent mixture. These so-called colour dispersions must follow the modern standards of tattooing, which are increasing every year. They must be rich in chromophoric pigments and yet fluid, they must not dry rapidly, and there should be no occurrence of any sedimentation, even during longer tattoo seasons. An innovative tattoo ink should enable long-lasting, brilliant tattoos without a negative impact on the artist's workflow and of course without endangering the consumer. The high standard in tattoos, regarding the motives and techniques, that is witnessed today could not be achieved by the artists without quality tools and modern tattoo ink. This article will give the reader a brief overview of the different ingredients of tattoo ink and of the function of binding agents and solvents in modern tattoo ink as well as describe what additives are used to achieve the desired behaviour during application. Furthermore, the article will take a look into the pigments that are used in tattoo ink and show why certain pigments are not suited for tattoo ink. The differences, advantages and disadvantages of organic and inorganic pigments will be explained.

British chef and food activist Jamie Oliver ignited a firestorm in January 2011 when he mentioned on the Late Show with David Letterman that castoreum, a substance used to augment some strawberry and vanilla flavorings, comes from what he described as “rendered beaver anal gland.”1 The next year, vegans were outraged to learn that Starbucks used cochineal extract, a color additive derived from insect shells, to dye their strawberry Frappuccino® drinks2 (eventually, the company decided to transition to lycopene, a pigment found in tomatoes3). Although substances like castoreum and cochineal extract may be long on the “yuck factor,”4 research has shown them to be perfectly safe for most people; strident opposition arose not from safety issues but from the ingredients’ origins. But these examples demonstrate that the public often lacks significant knowledge about the ingredients in foods and where they come from. This is not a new development; the public relationship to food additives has a long history of trust lost, regained, and in some cases lost again. The Federal Food, Drug, and Cosmetic (FD&C) Act of 19385 was passed shortly after the deaths of 100 people who took an untested new form of a popular drug, which contained what turned out to be a deadly additive.6 The new law was consumer oriented and intended to ensure that people knew what was in the products they bought, and that those products were safe. The law has been amended over the years in attempts to streamline and bring order to the sprawling task of assessing and categorizing the thousands of substances used in foods, drugs, and cosmetics. One result of this streamlining is that under current U.S. law, companies can add certain types of ingredients to foods without premarket approval from the thin-stretched Food and Drug Administration (FDA). In other words, there are substances in the food supply that are unknown to the FDA. In 2010 the Government Accountability Office (GAO) concluded that a “growing number of substances … may effectively be excluded from federal oversight.”7 Is this a problem? The answer depends on whom you ask.

Tattoo inks have been reported to elicit allergic contact dermatitis. To investigate the labels and the contents of metals and pigments in tattoo inks, considering restrictions within the European Union. Seventy-three tattoo inks currently available on the market, either bought or donated (already used), were investigated for trace metals and pigments by inductively coupled plasma mass spectrometry and by matrix-assisted laser desorption/ionization time of flight tandem mass spectrometry. Ninety-three percent of the bought tattoo inks violated European, legal requirements on labeling. Fifty percent of the tattoo inks declared at least one pigment ingredient incorrectly. Sixty-one percent of the inks contained pigments of concern, especially red inks. Iron, aluminium, titanium, and copper (most in green/blue inks) were the main metals detected in the inks. The level of metal impurities exceeded current restriction limits in only a few cases. Total chromium (0.35-139 μg/g) and nickel (0.1-41 μg/g) were found in almost all samples. The levels of iron, chromium, manganese, cobalt, nickel, zinc, lead, and arsenic were found to covary significantly. To prevent contact allergy and toxic reactions among users it is important for tattoo ink manufacturers to follow the regulations and decrease nickel and chromium impurities.

A recent Food and Drug Administration (FDA) proposal aims to speed the evaluation process for new high-risk medical devices that are intended to address unmet medical needs,1 much like existing expedited approval processes, such as the humanitarian device exemption rule for devices intended to treat rare diseases. Such programs are strongly supported by the medical device industry and some patient advocacy groups, which have criticized the FDA for being too stringent in its evidentiary requirements for investigational devices, leading to delays in the approval of potentially helpful products.2–4 For example, in 2011, the FDA approved a transcatheter aortic valve replacement system that demonstrated significant improvements over conventional treatment options for selected patients with severe aortic stenosis.5,6 However, the United States was the 43rd country to approve the device, roughly 4 years after the European Union.7 Yet expedited approval for high-risk medical devices raises the possibility that these devices will not be as effective as predicted in their limited premarket testing or that they could cause unanticipated harms after approval.8 Of course, well-studied devices may present unexpected safety concerns years after approval,9,10 and even the most rigorous conventional premarket approval process will result in some devices later found to be unsafe or ineffective.11–13 Safety of approved medical devices and the proper scope of premarket testing remain contentious issues after recalls of several widely used devices, including popular models of implantable cardioverter defibrillator leads14,15 and metal-on-metal hip implants.16 Inherent limitations in premarket testing, along with the prospect of lowered evidentiary standards for expedited device reviews, place greater pressures on postapproval monitoring of devices to follow clinical performance and to identify emerging public health problems. Medical device manufacturers routinely perform this sort of vigilance, …