The FDA is expected to increase its regulatory oversight of the safety of tattoo inks.
Nearly a third of Americans have a tattoo. Despite the persistent stigma against tattooed individuals, the popularity of tattoos has increased in recent years.
But are the safety rules adequate to protect the health of tattooed people?
The act of tattooing is associated with several health risks such as the risk of skin infections, blood-borne diseases and allergic reactions. People can reduce the risk of tattoo-related complications by going to a reputable, state-regulated tattoo artist and practicing proper hygiene and after-sales service.
Some risks associated with tattoos, however, are unavoidable. Although many states regulate the tattoo process by setting sterilization, hygiene, and safety standards for administering a tattoo, tattoo ink safety faces much less regulatory scrutiny.
Research into the safety of tattoo ink is limited. Although the link between tattoo ink and cancer is unclear, the pigments are made up of up to 100 different chemicals, including chemicals that can increase the risk of cancer. A 2017 study indicated that toxic elements in tattoo ink can migrate and lodge in the lymph nodes, which can increase the risk of chronic inflammation. Some scientists have criticized the lack of research into the safety of tattoo inks and advocate increased regulatory oversight.
In the United States, the tattoo ink industry is largely unregulated. The safety of tattoo ink is technically monitored by the U.S. Food and Drug Administration (FDA), but the FDA has taken a passive approach to regulating the safety of the ink.
Under the Federal Food, Drug, and Cosmetic Act, the FDA classifies tattoo ink as a cosmetic product. Some products, such as fluoride toothpaste, can be designated as both cosmetic and pharmaceutical products, so they are subject to stricter supervision. But tattoo ink is considered a purely cosmetic product, which means the FDA does not evaluate and approve tattoo ink products before they enter the market. Instead, the FDA only intervenes in the tattoo ink market when it becomes aware of a problem with a specific product.
Tattoo ink manufacturers are required to adhere to the labeling requirements set out in the Fair Packaging and Labeling Act. Tattoo ink manufacturers must include the ingredients, net content and safety warnings on their labels. The label requirements are intended to help consumers make informed decisions about their cosmetics purchases. But the vast majority of tattoo inks are bought in bulk from tattoo studios, so consumers rarely, if ever, have the opportunity to review tattoo ink labels.
Even when a problem occurs with a cosmetic product, the FDA has limited authority to detect and address it. The FDA only responds to reported incidents, so its response is only as effective as its reporting system. Scholars have criticized the cosmetics reporting system, arguing that a voluntary reporting system is insufficient. Additionally, the FDA does not have the authority to require a recall for cosmetic products. The FDA can only require that they do so.
For example, when the FDA learned in 2019 that three tattoo ink products had been contaminated with bacteria, it issued a warning and coordinated with ink manufacturers, who have voluntarily withdrawn their products, to remove the inks from the market.
This lack of FDA oversight doesn’t mean that all tattoo inks are toxic, but it should put tattoo artists and recipients on hold. It also raises an important question: Why is the FDA doing so little to intervene?
The FDA’s hands-on approach to tattoo ink safety may reflect the stigma associated with tattoos. Historically, people with tattoos in the United States were associated with negative stereotypes and faced social stigma. Although tattooing has become more prevalent in modern societies, many of the oldest stereotypes remain. For example, scholars have found that people consider tattooed individuals to be less competent, less sociable, and more promiscuous. People with tattoos also face discrimination in the workplace and during the hiring process.
A preliminary study indicated that people with tattoos face health inequalities. The study authors say that insurers are less likely to adequately cover the health care costs of people who are perceived to be responsible for their illness, such as people who eat unhealthy diets or smoke. They argue that this correlation between perceived responsibility and health care cost liability affects the tattooed community because tattooed people are perceived as choosing their stigma.
This perception may increase discrimination against the tattoo community and may be part of the reason the FDA has not increased its oversight of the tattoo ink industry. Because people with tattoos can be perceived as “responsible” for their health risks, the FDA may underestimate the importance of ensuring the safety of tattoo ink.
The FDA could increase its oversight of the tattoo ink industry through several paths.
The FDA could oversee at least some of the ingredients in tattoo ink using the regulatory authority it already has. While the FDA does not require most cosmetics to go through pre-market approval, it pre-approves color additives – substances that can impart color to a food, drug, cosmetic product, or human body – before they can be used in any food, drug or cosmetic product. Tattoo inks contain color additives, but the FDA has chosen not to exercise its regulatory authority “due to other competing public health priorities and a previous lack of evidence of safety concerns specifically associated with these pigments.”
Some scholars advocate new legislation to create a new category, commonly referred to as “cosmeceuticals,” which includes substances such as tattoo ink that do not qualify as drugs, but should be more heavily regulated by the FDA. This strategy would allow the FDA to investigate all ingredients in tattoo inks before they enter the market.
Alternatively, the United States could follow the European Union and regulate tattoo ink as a chemical rather than a cosmetic product. In the EU, tattoo ink is classified as a chemical and is regulated by the European Chemicals Agency. In 2020, the EU adopted legislation restricting the use of certain substances in tattoo ink. While many have criticized the EU for being too restrictive and harming the tattoo industry, others support the EU’s decision to step up its scrutiny.
Tattoos are here to stay. The FDA should support research into the short- and long-term effects of tattoo ink and invest more resources to ensure the safety of existing products to protect the health of tattooed people.