FDA WARNING_LETTER - Xanos Holdings Inc.

The FDA issued a Warning Letter to the operator of multiple websites, including direct-pharm.com and us-value-pharm.com, for offering unapproved and misbranded drugs for sale, violating the Federal Food, Drug, and Cosmetic Act. The products, such as "Acomplia (Generic)," "Acomplia (Brand)," "Rimonabant," "Viagra (Brand)," "Cialis (Brand)," "Prozac (Generic)," and "Levitra (Brand)," are considered drugs under section 201(g) of the Act.

The firm is cited for selling "unapproved new drugs," specifically "Acomplia (Generic)," "Acomplia (Brand)," and "Rimonabant," which are "new drugs" under section 201(p) and require FDA approval before interstate commerce introduction per sections 301(d) and 505(a). Rimonabant (Acomplia) was explicitly rejected by the FDA due to safety concerns, including neurological and psychiatric side effects.

Additionally, the websites are selling "misbranded drugs" under section 503(b)(1) by not requiring a prescription for products like "Viagra (Brand)" and "Cialis (Brand)," violating sections 301(a), 301(b), and 301(k). Furthermore, the claim of FDA approval on the websites for these non-