FDA WARNING_LETTER - iVisitDoc, Inc. dba iVisitDoc - August 01, 2025

On September 9, 2025, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to iVisitDoc, Inc., doing business as iVisitDoc, following a review of the company"s website in August 2025. The regulatory action centers on the company’s marketing of compounded semaglutide products, which the FDA found to be in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). Specifically, the agency identified violations of sections 502(a) and 502(bb), which categorize drugs as misbranded if their labeling or advertising is false or misleading. iVisitDoc’s website featured claims suggesting its compounded products contained the same active ingredients as the FDA-approved medications Wegovy and Ozempic and utilized "clinically validated ingredients." The FDA clarified that since compounded drugs are not FDA-approved, implying they are identical to approved products is deceptive. Such misbranding makes the distribution of these products a prohibited act under section 301(a) of the FDCA. To achieve compliance, iVisitDoc must immediately address these violations, including ceasing the use of misleading promotional language. The company is required to provide a written response within 15 working days outlining the corrective steps taken and its plan to prevent future recurrences. Failure to rectify these issues may result in legal action, such as product seizures or injunctions.