FDA WARNING_LETTER - Dermacare LLC dba BlueChew - August 01, 2025

On September 9, 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter to Dermacare LLC, operating as BlueChew, following a review of the company’s website in August 2025. The FDA identified significant violations concerning the promotion of compounded drug products containing sildenafil and tadalafil. The primary issue involves false or misleading claims that suggest BlueChew’s compounded medications are equivalent to FDA-approved drugs like Viagra and Cialis. The company’s marketing stated their products use the "same active ingredients" as these well-known medications. However, the FDA emphasized that compounded drugs are not FDA-approved, and asserting they are the same as approved products is deceptive to consumers. Under the Federal Food, Drug, and Cosmetic Act (FDCA), specifically sections 502(a) and 502(bb), these products are considered misbranded because their labeling and advertising are misleading. Introducing such misbranded drugs into interstate commerce violates Section 301(a) of the Act. The FDA has required BlueChew to take immediate action to correct these violations, including removing the misleading language from its promotional materials. The company must provide a written response within 15 working days detailing the specific steps taken to address the issues and prevent their recurrence. Failure to comply may lead to legal action, such as product seizure or injunctions.