FDA WARNING_LETTER - Akyuz, Sinan

The FDA issued a Warning Letter to goask.org after reviewing its website, identifying the sale of violative drug products. Products cited include "Acomplia (Brand/Generic)," "Rimonabant," "Herbal Ambien," "Ambien (Brand)," "Xanax (Brand)," "Diazepam," and "Valium (Brand)."

The FDA determined these products are drugs under Section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act) due to their intended use in disease treatment/prevention or affecting body structure/function.

Violations include marketing unapproved new drugs, specifically "Acomplia (Brand/Generic)," "Rimonabant," and "Herbal Ambien." Rimonabant (Acomplia) was previously rejected for FDA approval due to safety concerns (neurological/psychiatric side effects). "Herbal Ambien" is considered a new drug due to its name implying a drug intended use. The sale of these products without FDA-approved applications violates Sections 301(d) and 505(a) of the Act.

Additionally, the website offers misbranded drugs. Products like "Ambien (Brand)," "Xanax (Brand)," "Diazepam," and "Valium (Brand)" are sold without requiring a prescription, violating Section 503(b)(1) and Sections 301(a), 3