Hello Cake, Inc. dba Hello Cake – FDA Warning Letter, Aug 1, 2025

The U.S. Food and Drug Administration (FDA) issued a warning letter dated September 9, 2025, to Hello Cake, Inc. (dba Hello Cake) following a review of the company’s website in August 2025. The investigation revealed that the company is marketing compounded drug products containing sildenafil and tadalafil—the active ingredients in brand-name erectile dysfunction medications—using false or misleading claims. According to the FDA, Hello Cake’s promotional materials incorrectly suggested that its compounded products are identical to FDA-approved versions. Under the Federal Food, Drug, and Cosmetic Act, drug products are misbranded if their advertising or labeling is deceptive. Because compounded drugs do not undergo the same FDA approval process for safety and efficacy as brand-name medications, any marketing that implies they are equivalent to approved drugs is considered misleading and a violation of federal law. To address these violations, Hello Cake is required to immediately stop using the deceptive marketing language and conduct a thorough investigation to ensure all operations meet federal standards. The company must provide a written response within 15 working days outlining the specific steps taken to correct the issues and prevent their recurrence. Failure to take adequate corrective action could result in further legal consequences, including product seizures or injunctions.