FDA WARNING_LETTER - PureRawz - August 31, 2025

The FDA issued a Warning Letter to PureRawz on September 8, 2025, following its August 2025 review of the company"s website and social media. The agency observed that PureRawz is offering various Tianeptine products, including "Tianeptine Ethyl Ester Sulfate," "Tianeptine Sodium," and "Tianeptine Ultimate," for sale in the U.S. Despite labels stating "for laboratory and research use only," the FDA found extensive evidence from product webpages, social media posts, and customer testimonials that these products are intended for human use. PureRawz marketed them with claims of treating conditions such as major depressive disorder, anxiety, Parkinson"s disease, PTSD, asthma, and irritable bowel syndrome. The FDA highlights that Tianeptine is not an FDA-approved drug in the U.S. and is associated with serious adverse events and addiction risks. Based on these findings, the FDA classified PureRawz"s Tianeptine products as "unapproved new drugs" under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This constitutes a violation of sections 505(a) and 301(d) of the FD&C Act, which prohibit the introduction or delivery of unapproved new drugs into interstate commerce. The company is required to immediately cease these violations and provide a written response detailing the specific corrective actions taken.