A hot new filler made from dead people's fat is being 'smuggled' into New York, state regulators say

An injectable fat product that has become popular with high-end plastic surgeons and their well-heeled clientele is under investigation by New York state health officials, according to court filings.

Tiger Aesthetics began distributing alloClae, which is derived from sterilized cadaver fat and regulated by the Food and Drug Administration, to a select group of plastic surgeons in 2024. Some of them raved to Business Insider about its potential to smooth out hip dips and fill out breasts — with no general anesthesia or lengthy recovery needed.

Those lunchtime boob jobs may soon come to a halt, at least in New York.

State health regulators have said Tiger is distributing alloClae in the state without a license, according to a May lawsuit filed by Tiger and a letter from the state attorney general. At least one doctor had his supply of the product seized, while four surgeons' offices that Business Insider called said they're still offering it.

Tiger and its affiliates engaged in "a year-long scheme to smuggle their product, alloClae (derived from human adipose tissue), into New York State despite being denied licenses to distribute it here," a lawyer for the state said in a May 29 court filing about what it called a "confidential investigation."

Larry Wood, Tiger's chief legal officer, said in an email to Business Insider on June 8 that alloClae is "legally sold throughout the United States, including in New York." In a June 1 letter to customers, the company said it "has decided temporarily to pause" distribution of the product in New York, citing the lawsuit.

Many doctors still advertise the product, which can cost up to $100,000 per procedure, on their websites. ME Plastic Surgery, which has locations on Manhattan's Fifth Avenue and in Queens, calls the product "revolutionary" on its website — beneath a bold-text announcement that says "AlloClae is currently not approved by the New York State Department of Health." The practice declined to comment.

Another clinic told Business Insider in late May that it was still offering alloClae; a receptionist declined to confirm that when called a week later, citing the regulatory crackdown.

Tiger, the sole manufacturer and distributor of alloClae, said in its lawsuit that the Health Department took too long to decide on its distribution license. It added that the product isn't a "tissue" that New York can regulate, and that state law doesn't require licenses for sterilized products like alloClae. It is instead regulated by the FDA under rules that don't require premarket approval, the company said.

Hermes Fernandez, a lawyer who represents healthcare-industry clients in New York regulatory matters and is not involved in the dispute, said the case could go either way.

If no other state has taken issue with alloClae, as Tiger claims, that might give a judge pause, he said. If the company voluntarily submitted to the permitting process before distributing alloClae without a license, that could cut against it.

"Regulators tend not to like that," he said.

A 'lunchtime augmentation'

Soon after alloClae hit the market, patients and surgeons became enamored with its potential: a breast lift during a lunch break, a butt bump without going under the knife.

Fueled by the GLP-1 boom and greater acceptance of plastic surgery, demand for alloClae skyrocketed, outpacing supply and resulting in waitlists.

Dr. Tommaso Adonna, president of the New York Plastic Surgery Group medical practice, told Business Insider he thinks alloClae and similar products have potential, but said he will not inject it for breast treatments without further study.

He turned away a potential client who had seen social-media content about the potential for a "lunchtime augmentation," he said.

"I'm told — and I know the people at Tiger pretty well — the company itself is trying to do their due diligence," he said. Still, his practice won't stock alloClae because it has a tissue bank license issued by the Health Department that he doesn't want to put "at risk."

The American Society of Plastic Surgeons declined to comment on alloClae's regulatory status. The society's spokesperson said it encourages patients considering any procedure involving tissue products to consult with a board-certified plastic surgeon.

Tiger told Business Insider in 2025 that it planned to scale up production this year.

Tiger told customers in April that it was "aware of a recent circumstance involving the Department of Health and a particular physician in New York," according to a letter seen by Business Insider. That was a reference to a seizure of alloClae, a person familiar with the matter said.

Days later, Tiger offered at least one New York doctor a promotion for bulk purchases of alloClae, according to a memo seen by Business Insider.

Then, on June 1, the company circulated the new memo seen by Business Insider explaining its positions in the lawsuit and saying that it would cease distribution of the product in New York.

A judge ruled on May 29 that New York should not prevent the distribution of a separate tissue-derived wound treatment that Tiger has also feuded about with the state. The judge declined the company's request to halt the alloClae crackdown, though, calling for both sides to further flesh out the dispute in court filings and oral arguments. A hearing is scheduled for later this month.

The state health department wouldn't comment on specific cases but said that it follows the law to protect New Yorkers.

In an emailed statement, the co-CEOs of Tiger's parent company said it "strongly disagreed" with the state health department's actions but wouldn't get into specifics about the litigation.

They said Tiger is "routinely and successfully inspected by the FDA" and said alloClae is "regulated solely under federal law by the FDA."

Until this is worked out, New Yorkers interested in alloClae may have to look into taking the PATH train in between meetings.