FDA WARNING_LETTER - Lorna Hillier

The FDA issued a Warning Letter to buyonlinemedications.com for offering unapproved and misbranded drugs for sale, violating the Federal Food, Drug, and Cosmetic Act. The website sells products like "Generic Valium Anxiety Medication," "Ambien Sleeping Pills," "Cialis (Brand)," "Acomplia (Generic) New Weight Loss Pill," "Rimonabant Weight Loss," "Herbal Xanax," and "Herbal Viagra."

These products are classified as drugs under Section 201(g) of the Act due to their intended use in disease treatment or affecting body structure/function. The FDA cited the inherent risks of unapproved prescription drugs from unregulated sources, including contamination, counterfeiting, and inconsistent active ingredients.

Specific violations include: - **Unapproved New Drugs:** Products like "Acomplia (Generic) New Weight Loss Pill," "Rimonabant Weight Loss," "Herbal Xanax," and "Herbal Viagra" are unapproved new drugs under Section 201(p) and violate Sections 301(d) and 505(a) of the Act. Rimonabant (Acomplia) was specifically rejected by the FDA due to safety concerns. - **Misbranded Drugs:** "Generic Valium Anxiety Medication," "Ambien Sleeping Pills," and "Cialis (Brand)" are sold without requiring a prescription, misbranding them under Section 503(b