FDA WARNING_LETTER - Krest Holdings, Panama S.A.

The FDA issued a Warning Letter after reviewing multiple websites, including approved-swiss-drugstore.com and swiss-meds.com, which were found to be offering violative drug products for sale. The products, such as "Acomplia (Brand)," "Acomplia (Generic)," "Rimonabant," "Viagra (Brand)," "Cialis (Brand)," "Prozac (Generic)," and "Levitra (Brand)," are considered drugs under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act).

The firm is in violation of the Act for marketing and distributing unapproved new drugs, specifically "Acomplia (Brand)," "Acomplia (Generic)," and "Rimonabant." These are "new drugs" under section 201(p) of the Act, and their introduction into interstate commerce without an FDA-approved application violates sections 301(d) and 505(a). Rimonabant was previously rejected for FDA approval due to safety concerns, including neurological and psychiatric side effects.

Additionally, the websites are selling misbranded drugs, including "Viagra (Brand)," "Cialis (Brand)," "Prozac (Generic)," and "Levitra (Brand)," without requiring a prescription from a licensed practitioner, violating section 503(b)(1) and sections 301(a), 301(b),