FDA WARNING_LETTER - Hello Cake, Inc. dba Hello Cake - August 31, 2025

**FDA Warning Letter Summary**

**Company:** Hello Cake **Inspection Dates:** August 2025 **Main Violations/Issues:** The FDA reviewed Hello Cake"s website and identified that the company offers compounded drug products containing sildenafil and tadalafil. These products are misbranded under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) due to false or misleading claims. The claims suggest these compounded products are equivalent to FDA-approved drugs, which they are not. This constitutes a violation of section 301(a) of the FDCA, as these misbranded products are introduced into interstate commerce.

**Regulatory Framework:** The violations fall under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and 352(bb)], and section 301(a) [21 U.S.C. § 331(a)]. The compounded products are considered "new drugs" under section 201(p) of the FDCA [21 U.S.C. § 321(p)] because they are not recognized as safe and effective for their labeled uses.

**Required Actions:** Hello Cake must take immediate corrective actions, including ceasing the use of misleading language that results in misbranding. The company is required to submit a written response within 15 working days to the Office of Compounding Quality and Compliance (OCQC), detailing the steps taken to rectify the violations and prevent recurrence. Failure to comply may result in legal actions such as seizure or injunction. If Hello Cake believes their products are not in violation, they must provide supporting information for FDA consideration. If unable to address the issues within the specified timeframe, they must explain the delay and provide a timeline for resolution.