FDA WARNING_LETTER - Julian Naya Beauty LLC - April 01, 2026

On April 2, 2026, the FDA issued a warning letter to Beauty of Aztlan LLC following a review of its website, which revealed the sale of unapproved and misbranded injectable drug products. Specifically, the company offered botulinum toxin products, such as Botulax and Innotox, to U.S. consumers without required federal approvals. These activities violate several sections of the Federal Food, Drug, and Cosmetic Act, which governs the safety and marketing of medications in the United States. The FDA highlighted significant safety risks, noting that unapproved injectable drugs can bypass the body"s natural defenses and cause life-threatening conditions like sepsis. Furthermore, botulinum toxin is a prescription-only medication that carries a "black box warning" for serious side effects; selling it without medical supervision or a prescription prevents users from receiving critical safety information and professional administration. The company"s products are considered misbranded because they lack adequate directions for safe use by a layperson. Beauty of Aztlan LLC is required to immediately cease the sale of these unapproved products and must provide a written response to the FDA within 15 working days. This response must detail the specific steps taken to correct these violations and prevent their recurrence. Failure to comply may result in legal action, including product seizures or injunctions.