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PureRawz was cited for selling unapproved new drugs containing tianeptine in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act, including products labeled "Tianeptine Ethyl Ester Sulfate," "Tianeptine Free-Acid," "Tianeptine Sodium," "Tianeptine Sulfate," and "Tianeptine Ultimate" through its website and social media accounts. Despite labeling claims that products were "for laboratory and research use only," the FDA determined based on website content and marketing statements that the products were intended for human consumption to prevent, treat, mitigate, or cure disease conditions or affect body functions. The FDA had previously warned consumers about tianeptine products due to serious adverse event reports and the potential for addiction, as tianeptine is not FDA-approved in the United States despite being used as a prescription drug in some European, Asian, and Latin American countries.