38 Attorneys General Urge FDA To Offer Protection From Fake Weight Loss Drugs

Authored by Naveen Athrappully via The Epoch Times (emphasis ours),

The U.S. Food and Drug Administration (FDA) must act to protect Americans from fake versions of GLP-1 weight loss and diabetes drugs such as Ozempic and Mounjaro and take “decisive action” against bad actors engaged in such trade, a letter from a bipartisan coalition of attorneys general from 38 U.S. states said.

“My fellow attorneys general and I are urging the FDA to protect consumers from the growing threat posed by adulterated or counterfeit versions of these drugs,” California Attorney General Rob Bonta, a signatory of the letter, said in a Feb. 20 statement.

“From inspections to enforcement actions, the FDA has several important tools at its disposal to help put an end to this unlawful and deceptive conduct. A federal response is necessary because many of the counterfeit drugs are shipped from outside of the country.”

The bilateral letter, issued a day earlier, said that demand for GLP-1 medications such as Mounjaro, Zepbound, Ozempic, and Wegovy has “skyrocketed.” The high costs of these medications and supply shortages “have created opportunities for wrongdoers to cash in and endanger consumers,” it said.

Fake GLP-1 drugs have entered the U.S. supply chain from nations such as China, Turkey, and India, the attorneys general said.

“These counterfeits can contain contaminants, other unknown drugs, or dangerously high amounts of active ingredient(s). Scammers have also repackaged injectable insulin and falsely sold it as Ozempic,” they said.

Injecting counterfeit drugs “can lead to serious side effects for consumers, sometimes necessitating hospitalization,” the letter said, adding that most consumers cannot identify fake from legitimate variants.

The letter raised the issue of retailers illegally selling active ingredients of GLP-1 medications directly to consumers online without any prescriptions. These active ingredients come from unregulated sources and pose a risk of contamination, it said.

Consumers use the ingredients to formulate drugs without adequate knowledge of safely dissolving the active ingredients, drawing it into syringes, and then injecting the substance into the body, the attorneys general wrote.

There are also compounding pharmacies that produce GLP-1 medications on their own, with some choosing to “cut corners” in pursuit of profits, the letter says. Last year, Eli Lilly and Company, the manufacturer of Mounjaro and Zepbound, said it had identified compounded drugs that have “safety, sterility, and efficacy problems.”

“Some have contained bacteria, high impurity levels, different colors (pink, instead of colorless), or a completely different chemical structure than Lilly’s FDA-approved medicines,” the company said.

Novo Nordisk, which manufactures Ozempic and Wegovy, has filed lawsuits against several pharmacies, weight loss clinics, and medical spas in multiple U.S. states for selling compounded drugs claiming to contain semaglutide, the active ingredient in Wegovy and Ozempic.

The letter called on the FDA to “work with federal partners like the Department of Homeland Security to intercept counterfeit GLP-1 drugs before they reach unsuspecting consumers.”

It asked the agency to send warning letters to sellers supplying active ingredients directly to people and “follow up with enforcement action if companies continue to act unlawfully.”

“The FDA should also ramp up enforcement against any compounding pharmacies that may be illegally participating in this market,” the attorneys general wrote. “The FDA must work in partnership with state pharmacy boards to ensure compounded GLP-1 drugs are produced in a safe, sanitary way.”

Health Risks and Shortages

There have been multiple instances of fake GLP-1 drugs creating health issues for people.

In October 2023, Austria’s Federal Office for Safety in Health Care said it received reports of several people who had to be treated at a hospital after they used suspected counterfeit Ozempic. The patients suffered seizures and hypoglycemia, which occurs when the blood sugar level is very low.

Authorities in the UK issued a warning the same month about fake Ozempic being distributed in the country. Side effects included hypoglycemic shock and coma.

In December 2023, the FDA announced the seizure of thousands of units of counterfeit Ozempic that were discovered in a “legitimate U.S. drug supply chain.”

On Feb. 21, the FDA announced that the shortage of semaglutide injections has been resolved. These products have been in shortage since 2022 in the face of rising demand.

“FDA confirmed with the drug’s manufacturer that their stated product availability and manufacturing capacity can meet the present and projected national demand,” the agency said.

“Patients and prescribers may still see intermittent and limited localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies.”

Novo Nordisk said that all doses of its FDA-approved semaglutide drugs—Wegovy and Ozempic—were being “continuously shipped, meeting or exceeding expected U.S. demand.”

“FDA’s decision means that making or selling a knockoff compounded drug that is essentially a copy of Ozempic or Wegovy is illegal, under compounding laws, with rare exceptions,” it said.

Meanwhile, real GLP-1 drugs can also pose health risks. A recent study found a higher risk of a rare eye condition among individuals with Type 2 diabetes who used semaglutide.

The condition, called non-arteritic anterior ischemic optic neuropathy, occurs when blood flow to the optic nerve, which sends signals from the eyes to the brain, gets blocked. This can lead to sudden vision loss.

“In the absence of a known mechanism for this association, we urge clinicians to weigh the concern for an increased risk of a rare but potentially blinding eye condition with the many therapeutic benefits of semaglutide,” authors of the study wrote.

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