Ink on the Brink

When my dad was a teenager and in the Marine Corps, he got a tattoo of a seahorse, the logo for the U.S.S. Princeton, the aircraft carrier he was stationed on. He paid 80¢ for it. My dad was lucky – a lot of the guys’ tattoos got infected, but his did not.

When I was a kid, my dad was one of very few people I knew with a tattoo. Almost all of them served in the military. Today, however, if I go to a water park, I feel like I’m definitely in the minority, for it seems that almost everyone has some ink.

Thankfully, artists have come a long way in sanitary practices for tattooing customers since my dad got his ink. But, the industry is far from perfect.

That’s why the Modernization of Cosmetics Regulation Act came to be. It was signed into law on December 29, 2022, and became effective a year later (although the U.S. Food and Drug Administration announced that it does not intend to enforce the law until July 1, 2024). The Act significantly expands the FDA’s authority to regulate cosmetic products and related businesses. It is the first major reform of cosmetic product regulation since 1938.

One of the biggest impacts of the law is for the first time, body art, including tattooing, piercing, and permanent makeup, is defined as cosmetics under federal regulations. This means that all products used by body art practitioners, such as tattoo ink, ointments, machines, needles, etc., will now be regulated by the FDA to enhance safety and standardization in the tattoo industry.

Under the new law, owners or operators of facilities that manufacture and process a cosmetic product for distribution in the U.S. must have registered the facility with FDA by December 29, 2023, and every two years thereafter. They must also update the agency within 60 days of any changes.

In addition, a responsible person must have identified each marketed cosmetic product, along with its ingredients, with the FDA by December 29, 2023. The Act defines a “responsible person” as “a manufacturer, packer, or distributor whose name, U.S. address, telephone number, and electronic information appear on the label and who will serve as the point of contact with the FDA.” As a result, foreign companies will need to have a U.S. contact.

Each cosmetic product, in turn, must have a label that includes a domestic address, domestic phone number, or electronic contact information, such as a website, for the product’s responsible person. A responsible person for a cosmetic product shall ensure, and maintain records supporting, that there is “adequate substantiation of safety” of the cosmetic products. However, if a consumer has an adverse reaction to using a cosmetic product, they can now notify the responsible person.

Manufacturers, packers, and distributors are mandated to report “serious adverse events” to the FDA within 15 business days after the report is received by the responsible person. A serious adverse event includes significant medical conditions, including death. Records of adverse events must also be maintained for a prescribed period of time.

The Act broadens the FDA’s authority to regulate cosmetic companies and their products. The agency has the authority for mandatory recalls of any cosmetic product that FDA determines is adulterated, misbranded, or is the cause of death or serious health consequences. The FDA can even suspend a facility’s registration, effectively prohibiting it from selling or distributing a cosmetic product in the U.S.

I don’t have a tattoo because I don’t like needles. I’m even wary of our ink jet printer.

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Reg P. Wydeven

Elder Law and Estate Planning Attorney at McCarty Law LLP
Hoping to follow in his father’s footsteps from a young age, Reg’s practice primarily consists of advising individuals on estate planning, estate settlement and elder law matters. As Reg represents clients in matters like guardianship proceedings and long-term care admissions, he feels grateful to be able to offer families thorough legal help in their time of need.

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