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FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
www.fda.gov
Most relevant quotes:
"FDA is aware that some patients and health care professionals may look to unapproved versions of GLP-1 (glucagon-like peptide-1 (GLP-1) receptor agonists) drugs, including semaglutide and tirzepatide, as an option for weight loss. This can be risky for patients, as unapproved versions do not undergo FDA’s review for safety, effectiveness and quality before they are marketed."
"Retatrutide cannot be used in compounding
Retatrutide cannot be used in compounding under federal law. Additionally, it is not a component of an FDA-approved drug and has not been found safe and effective for any condition."
"Illegally marketed versions of these drugs
Counterfeit Ozempic
FDA is aware of counterfeit Ozempic marketed in the U.S. Counterfeit drugs claim to be authentic, but could contain the wrong ingredients, contain too little, too much or no active ingredient at all or other harmful ingredients, and are illegal."
"The agency investigates reports of suspected counterfeit drugs to determine the public health risks and the appropriate regulatory response. FDA remains vigilant in protecting the U.S. drug supply from these threats.
Illegal online sales of these drugs
FDA monitors the internet for fraudulent or unapproved drugs and has issued warning letters to stop the distribution of illegally marketed semaglutide and tirzepatide. These illegally marketed drugs:
may be counterfeit
could contain the wrong ingredients or harmful ingredients
could contain too little, too much or no active ingredient at all
The agency urges consumers to be vigilant when purchasing drugs online and only purchase from state-licensed pharmacies.
Versions sold falsely for research purposes or not for human consumption
FDA has warned companies that have illegally sold unapproved drugs containing semaglutide, tirzepatide or retatrutide that are falsely labeled “for research purposes” or “not for human consumption.” These products have been sold directly to consumers for human use with dosing instructions. The agency urges consumers not to purchase these products which are of unknown quality and may be harmful to their health."
FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
Most relevant quotes:
"FDA is aware that some patients and health care professionals may look to unapproved versions of GLP-1 (glucagon-like peptide-1 (GLP-1) receptor agonists) drugs, including semaglutide and tirzepatide, as an option for weight loss. This can be risky for patients, as unapproved versions do not undergo FDA’s review for safety, effectiveness and quality before they are marketed."
"Retatrutide cannot be used in compounding
Retatrutide cannot be used in compounding under federal law. Additionally, it is not a component of an FDA-approved drug and has not been found safe and effective for any condition."
"Illegally marketed versions of these drugs
Counterfeit Ozempic
FDA is aware of counterfeit Ozempic marketed in the U.S. Counterfeit drugs claim to be authentic, but could contain the wrong ingredients, contain too little, too much or no active ingredient at all or other harmful ingredients, and are illegal."
"The agency investigates reports of suspected counterfeit drugs to determine the public health risks and the appropriate regulatory response. FDA remains vigilant in protecting the U.S. drug supply from these threats.
Illegal online sales of these drugs
FDA monitors the internet for fraudulent or unapproved drugs and has issued warning letters to stop the distribution of illegally marketed semaglutide and tirzepatide. These illegally marketed drugs:
may be counterfeit
could contain the wrong ingredients or harmful ingredients
could contain too little, too much or no active ingredient at all
The agency urges consumers to be vigilant when purchasing drugs online and only purchase from state-licensed pharmacies.
Versions sold falsely for research purposes or not for human consumption
FDA has warned companies that have illegally sold unapproved drugs containing semaglutide, tirzepatide or retatrutide that are falsely labeled “for research purposes” or “not for human consumption.” These products have been sold directly to consumers for human use with dosing instructions. The agency urges consumers not to purchase these products which are of unknown quality and may be harmful to their health."
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