FDA WARNING_LETTER - Dermacare LLC dba BlueChew - August 31, 2025

The FDA issued a warning letter to BlueChew on September 9, 2025, following a review of their website in August 2025. The inspection revealed that BlueChew offers compounded drug products, including sildenafil and tadalafil, with misleading claims. The website suggests these products are equivalent to FDA-approved drugs like Viagra and Cialis, which is false. This misbranding violates sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA), leading to the illegal introduction of these products into interstate commerce, contravening section 301(a) of the FDCA.

The FDA requires BlueChew to take immediate corrective actions, including ceasing the use of misleading language. BlueChew must submit a written response within 15 working days to the Office of Compounding Quality and Compliance, detailing steps taken to rectify the violations and prevent recurrence. Failure to comply may result in legal action, including product seizure and injunctions. BlueChew is also advised to provide a rationale if they believe their products are not in violation, along with supporting information. The FDA warns that non-compliance could lead to further regulatory actions, including notifying foreign regulatory bodies if applicable.