FDA warns companies selling semaglutide and tirzepatide as research chemicals
Federal warnings target sellers of unapproved semaglutide and tirzepatide, after reports that some products contained bacteria or impurities or were not the drug at all.
The FDA has issued warning letters to companies that sell semaglutide and tirzepatide as "research chemicals," saying the labeling does not match how the products are actually used. The agency said some unapproved versions have contained bacteria, high impurity levels or chemical structures different from the approved medicines [1][2].
In February 2024, the FDA sent warning letters to two online marketers — US Chemlabs of Miami and Synthetix Inc., doing business as Helix Chemical Supply in the Bronx, New York — for selling unapproved, untested semaglutide and tirzepatide to consumers through their websites [2]. Both letters used similar wording: "Despite statements on your product labeling marketing your products as 'research chemicals only' and 'not for human consumption,' evidence obtained from your website establishes that your products are intended to be drugs for human use" [2]. The letters gave the companies 15 business days to respond and said failure to adequately address the agency's concerns could result in legal action [2].
Those are not the only sellers the FDA has flagged. Since late 2023, the agency has issued 10 warning letters about misbranded, adulterated or illegal sales of semaglutide and tirzepatide. Besides US Chemlabs and Synthetix, the letters went to AnuMed International and to the websites gorillahealing, semaspace, Ozempen and dashpct [1]. All of those online retailers' websites are currently unreachable, and none of the companies' facilities is registered with the FDA as a human drug compounding outsourcing facility under section 503B of the Federal Food, Drug and Cosmetic Act [1].
Eli Lilly, which makes tirzepatide, said it found compounded drugs advertised as tirzepatide with safety, sterility and effectiveness problems. Some contained bacteria or high impurity levels, some were pink rather than colorless, and some had a completely different chemical structure from Lilly's FDA-approved medicines; in at least one case, the product was nothing more than sugar alcohol [1]. Dan Skovronsky, Lilly's chief scientific and medical officer, said on an August 8, 2024 earnings call that in most instances the material his company tested "isn't [our] kind of tirzepatide at all" [1]. Former FDA commissioner Scott Gottlieb said many compounded GLP-1 versions are a "salt" formulation that is likely to be more soluble and may not provide the extended release of the weekly brand versions [1].
The FDA told the Washington Post that between August 2021 and mid-July 2024 it reviewed 288 reports of patients having bad reactions to compounded semaglutide and 108 such reports for tirzepatide. Some patients required hospitalization [1]. In July 2023, the agency warned about dosing errors with compounded semaglutide after reports of adverse effects; some patients needed medical attention or were hospitalized [1]. On May 21, 2024, Australia banned compounded tirzepatide and other compounded diabetes and weight loss medicines, citing reports of patients coming to harm, including the hospitalization of a patient there [1].
In August 2024, Endpoints News reported that Novo Nordisk had filed 11 new lawsuits against medical spas, weight loss clinics and telehealth companies advertising compounded semaglutide. The suits were filed in California, Florida, Michigan, New Jersey, Oklahoma, Pennsylvania and Washington. Novo has now filed 34 legal actions against compounders, six of which resulted in permanent injunctions [1]. Novo Nordisk is the only company in the United States with FDA-approved products containing semaglutide, and no FDA-approved generic versions exist [2].
Why it matters for patients
Compounded drugs do not go through pre-market review by the FDA for safety, effectiveness or quality, which the agency says makes them a higher risk than approved drugs [1]. A "research chemical" or "not for human consumption" label does not mean a product has been checked for use in people; in the Synthetix letter, the FDA said the company's own website showed the products were meant for human use [2].
People often turn to compounding pharmacies when a shortage, cost or insurance coverage keeps them from getting a brand-name medicine [1]. Shortage status matters for another reason: the FDA allows compounders to make their own version of a drug while it is in shortage, and that flexibility can change once the shortage ends [1]. Ozempic and Wegovy were added to the FDA's shortage list in May 2023, and shortages have lessened since then [1].
The FDA has also described ways to spot counterfeit Ozempic pens: a counterfeit pen may extend in length when the dose is set, its label may be poor quality or not stick well, its carton may lack perforation or contain spelling errors, and its batch number may not match the strength printed on the box and pen [2]. How many of the flagged products reached patients, or whether any illnesses have been linked to the specific companies named in the warning letters, has not been disclosed.
What happens next
The February 2024 letters gave US Chemlabs and Synthetix 15 business days to respond, with possible legal action if they did not [2]. Whether the FDA has taken further action against either company has not been reported. Novo Nordisk's compounding-related lawsuits are continuing; six of its 34 actions have ended in permanent injunctions [1].
Sources
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