FDA WARNING_LETTER - BUZZ, LLC
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The FDA issued a Warning Letter to cheap-phentermine-online.net after reviewing its website and determining that the firm is illegally offering products for sale in violation of the Federal Food, Drug, and Cosmetic Act. Products such as "Acomplia," "Rimonabant," "Herbal Ambien," "Herbal Xanax," "Viagra," "Phentermine," "Xanax," "Valium," and "Ambien" are considered drugs under Section 201(g) of the Act. The firm is marketing unapproved new drugs, including "Acomplia (Brand/Generic)," "Rimonabant," "Herbal Ambien," and "Herbal Xanax," which are defined as "new drugs" under Section 201(p). Their sale without FDA-approved applications violates Sections 301(d) and 505(a). Rimonabant was specifically rejected by FDA due to severe neurological and psychiatric side effects. Additionally, the firm sells misbranded drugs like "Viagra," "Phentermine," "Xanax," "Valium," and "Ambien" without requiring a prescription, violating Section 503(b)(1) and Sections 301(a), 301(b), and 301(k). The website also falsely claims products are FDA-approved and misleads consumers by suggesting "Herbal Ambien" and "Herbal Xanax" contain active ingredients of approved drugs, making them misbranded under Section 502(a). The introduction of these misbranded products into interstate commerce violates Section 301(a). The FDA requires the firm to immediately cease marketing violative products and respond within 15 working days, detailing corrective actions to prevent recurrence. Failure to comply may result in regulatory actions like seizure or injunction.
- Company
- BUZZ, LLC
- Product Type
- Drugs
ID · bf4b6a2c-ce55-4a1b-9055-36239edf94d3
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