FDA WARNING_LETTER - Pro West Marketing Ltd.
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
The FDA issued a Warning Letter after reviewing numerous websites, including doctorphentermine.com and trusted-tabs.us, which are offering products in violation of 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 classified as drugs under section 201(g) of the Act.
The firm is cited for marketing unapproved new drugs, specifically "Acomplia (Generic)," "Acomplia (Brand)," and "Rimonabant," which are new drugs under section 201(p) of the Act. The sale of these products without FDA-approved applications violates sections 301(d) and 505(a) of the Act. Rimonabant (Acomplia) was explicitly rejected for FDA approval due to safety concerns, including neurological and psychiatric side effects.
Additionally, many websites are selling prescription drugs like "Viagra (Brand)," "Cialis (Brand)," "Prozac (Generic)," and "Levitra (Brand)" without requiring a prescription from a licensed practitioner, rendering them misbranded under section 503(b)(1) of the Act and violating sections 301(a), 301(b), and 30
- Company
- Pro West Marketing Ltd.
- Product Type
- Drugs
ID · 390d4b28-38a1-4366-84c6-c8bc672df98b
Full citation text and observation details available on the Dashboard.