FDA WARNING_LETTER - www.gorillahealing.com - October 10, 2023

The FDA issued a Warning Letter to www.gorillahealing.com on October 2, 2023, for unlawfully selling unapproved and misbranded semaglutide and tirzepatide drug products to U.S. consumers over the internet. The FDA's review of the website revealed violations of sections 301(a), 301(d), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The products, including "Semaglutide (GLP-1 Analogue)" and "Tirzepatide 10mg," are considered unapproved new drugs because they lack FDA approval under section 505(a) of the FD&C Act, despite being marketed for uses such as lowering blood sugar, enhancing insulin secretion, improving organ function, and weight loss. The FDA emphasizes that approved semaglutide and tirzepatide products are prescription-only and carry boxed warnings for serious risks like thyroid C-cell tumors.

Furthermore, these drugs are deemed misbranded under section 502(f)(1) of the FD&C Act because their labeling fails to provide adequate directions for use by a layperson. As prescription drugs, they require supervision by a licensed practitioner, and the website does not provide instructions for preparation or dosing, especially for injectable products, increasing public health risks.

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