China is shipping ‘super-Ozempic’ to American teenagers. The FDA’s response? Stern notes

OpinionChina is shipping ‘super-Ozempic’ to American teenagers. The FDA’s response? Stern notes

There is a new black-market drug sweeping the nation, especially among teenagers, but it doesn’t get its users high. Retatrutide, a powerful, unapproved weight loss drug, is being peddled illicitly on TikTok, in medical spas, and through the mail. While it is being studied for treating obesity and Type 2 diabetes, it has no regulatory or legal approval for human use anywhere in the world. It’s time for federal regulators to get serious about cracking down on the bad actors selling this potent medication.

Selling retatrutide violates the Federal Food, Drug, and Cosmetic Act, and no doctor can legally prescribe it. The Food and Drug Administration has told every pharmacy board in the country, in writing, that compounding it is prohibited. Some bad actors slap a “research-use only” label on the vial to try to skirt the law, yet they include dosing instructions for consumers. The people illegally selling this drug online know exactly what they’re doing.

The supply chain for this drug is effectively an international smuggling operation. First, Chinese manufacturers ship the raw peptide under false customs labels. For example, one shipment was declared as an industrial resin additive, another as $5 “PVC resin” on an invoice totaling $350. The product gets routed through Hong Kong and South Korea to obscure its Chinese origin, relabeled at American office parks, and shipped out under fraudulent labels such as “for prescription compounding only.” In reality, retatrutide can’t be legally prescribed or compounded at all.

When the FDA catches a vendor, the agency issues a warning letter, but often, the company will simply rename the product and keep selling.

The FDA isn’t the only agency that is aware of the scheme. Customs and Border Protection is catching these illegal shipments by the thousands. One Cincinnati operation alone intercepted roughly 5,000 individual shipments in a matter of months.

This would be alarming enough as a story about regulatory failure, but the much greater concern is over who is buying these illicit products. Children as young as 13 are posting peer-to-peer dosing advice for these illegal products online. Fifteen-year-olds are sharing before-and-after photos of their rapid weight loss. Children are hiding vials from their parents, and when they get caught, are posting videos titled “When your mom finds your peptides in your fridge.” When one teenager asked online how to help a 16-year-old brother who was already using it, the advice they got from commenters was to “be his hero” and help him use the illicit products “safely.”

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We do not need to pass a new law to stop the flow of retatrutide and other unapproved drugs into our country. The FDA has an import “Green List” and detention authority at the border. Thirty-four state attorneys general, Republicans and Democrats alike, have already asked the agency to use them. Instead, enforcement has consisted almost entirely of warning letters. Meanwhile, the manufacturer of the drug has taken matters into its own hands by identifying more than 14,000 marketing listings for retatrutide across more than 100 countries.

Retatrutide is in Phase 3 trials. By all accounts, it is a more powerful drug than GLP-1 drugs such as Ozempic. We must shut down this dangerous black market. Failing to stop the bad actors selling this drug puts the public, especially teenagers, at risk. It’s time for federal regulators to go beyond “strongly worded letters” and end the black market for retatrutide.

Jennifer Nunez is the former director of emergency for LRGHealthcare. 

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