www.gorillahealing.com
FDA issued a warning letter to www.gorillahealing.com for selling unapproved and misbranded semaglutide and tirzepatide drug products to U.S. consumers via the internet. The site marketed these prescription GLP-1 drugs without FDA-approved applications, without adequate directions for use, and without required safety warnings such as the black box warning for thyroid C-cell tumor risk. FDA demanded the company cease sales of these products and respond within 15 working days, warning that failure to comply could result in seizure and injunction.
Flagged claims (4)
Semaglutide (GLP-1 Analogue)
Tirzepatide is a synthetic derivative of gastric inhibitory polypeptide (GIP) that has simultaneous glucagon-like peptide-1 (GLP-1) functionality as well. This combination allows Tirzepatide to lower blood glucose levels, increase insulin sensitivity, boost feelings of satiety, and accelerate weight loss. Tirzepatide was developed to fight Type 2 diabetes, but has additionally been shown to protect the cardiovascular system and act as a potent weight loss agent.
This is a derivative of the naturally occurring GLP-1, a peptide known to lower blood sugar levels and enhance insulin secretion. Research shows that this may also improve heart, liver, and lung function while helping to slow or prevent the effects of Alzheimer's disease. This has been shown to significantly decrease appetite by delaying gastric emptying and reducing intestinal motility.
Tirzepatide 10mg
Required actions (3)
FDA requests that www.gorillahealing.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers.
Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence.
Failure to adequately address this matter may result in legal action, including, without limitation, seizure and injunction, without further notice.
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