The (de)regulation of tattoo ink


The FDA should increase its regulatory oversight of tattoo ink safety.

Almost a third of Americans have a tattoo. Despite the lingering stigma against people with tattoos, the popularity of tattoos has grown in recent years.

But are the safety rules sufficient 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 visiting a reputable, state-regulated tattoo artist and practicing proper hygiene and aftercare.

Some risks associated with tattoos are unavoidable, however. Although many states regulate the tattooing process by setting sterilization, sanitation, and safety standards for administering a tattoo, the safety of tattoo ink comes under much regulatory scrutiny. less rigorous.

Research on 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 may increase the risk of cancer. A 2017 study indicated that toxic elements in tattoo ink can migrate and settle in the lymph nodes, which can increase the risk of chronic inflammation. Some scientists have criticized the lack of research on the safety of tattoo inks and are advocating for increased regulatory oversight.

In the United States, the tattoo ink industry is largely unregulated. Tattoo ink safety is technically controlled by the US Food and Drug Administration (FDA), but the FDA has taken a passive approach to regulating ink safety.

Under the Federal Food, Drug, and Cosmetic Act, the FDA classifies tattoo ink as a cosmetic product. Some products, such as fluoride toothpaste, may be designated as both a cosmetic product and a drug, so they are subject to stricter oversight. But tattoo ink is considered a purely cosmetic product, which means that the FDA does not evaluate or approve tattoo ink products before they enter the market. Instead, the FDA only intervenes in the tattoo ink market when it discovers a problem with a specific product.

Manufacturers of tattoo inks are required to follow labeling requirements set out in the Fair Packaging and Labeling Act. Manufacturers of tattoo inks must include ingredients, net contents, and safety warnings on their labels. The labeling requirements are intended to help consumers make informed decisions about their cosmetic purchases. But the vast majority of tattoo inks are purchased in bulk by tattoo studios, so consumers rarely, if ever, have a chance to review tattoo ink labels.

Even when a problem arises with a cosmetic product, the FDA has limited authority to detect and fix it. The FDA only responds to reported incidents, so its response is only as effective as its reporting system. Researchers have criticized the cosmetics reporting system, arguing that a voluntary reporting system is insufficient. Also, the FDA does not have the authority to require a recall for cosmetic products. The FDA can only ask them to do so.

For example, when the FDA learned in 2019 that three tattoo ink products had been contaminated with bacteria, it issued an alert and coordinated with ink manufacturers, who voluntarily recalled their products, to withdraw inks from the market.

This lack of FDA oversight doesn’t mean that all tattoo inks are toxic, but it should give tattoo artists and recipients pause. It also raises an important question: why is the FDA doing so little to intervene?

The FDA’s hands-off 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 older stereotypes remain. For example, researchers have found that people view people with tattoos as 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 insurers are less likely to adequately cover health care costs for people perceived to be responsible for their illness, such as people who eat poorly or smoke. They argue that this correlation between perceived responsibility and health care cost responsibility affects the tattooed community because tattooed people are seen to choose their stigma.

This perception may increase discrimination against the tattooed community and may partly explain why the FDA has not increased its oversight of the tattoo ink industry. Since people with tattoos may be perceived as “responsible” for the risks to their health, the FDA may be underestimating the importance of ensuring the safety of tattoo ink.

The FDA could increase its oversight of the tattoo ink industry in several ways.

The FDA could oversee at least some of the ingredients in tattoo ink using the regulatory authority it already has. Although the FDA does not require most cosmetics to be pre-market approved, it does pre-approve color additives – substances capable of imparting color to a food, drug, cosmetic product, or the body. human – before they can be used in any food, drug or cosmetic product. Tattoo inks contain color additives, but the FDA chose not to exercise regulatory authority “due to other competing public health priorities and a previous lack of evidence of safety concerns specifically associated with these pigments. “.

Some researchers are advocating new legislation to create a new category, commonly referred to as “cosmeceuticals,” that would encompass substances such as tattoo ink that aren’t considered drugs but would need to be regulated more heavily by the FDA. This strategy would allow the FDA to investigate all tattoo ink ingredients 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. In the EU, tattoo ink is classified as a chemical and is regulated by the European Chemicals Agency. In 2020, the EU passed legislation that restricts the use of certain substances in tattoo ink. Although many have criticized the EU for being too restrictive and hurting the tattoo industry, others support the EU’s decision to increase its surveillance.

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 people with tattoos.


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