FDA WARNING_LETTER - Health-science-report.com

The FDA issued a Warning Letter to Dr. Glickman regarding products Beta-mannan and Micronutrient, promoted on http://www.health-science-report.com. The FDA determined these products are unapproved new drugs under the Federal Food, Drug, and Cosmetic Act (the Act) because their website claims indicate they are intended for use in the cure, mitigation, treatment, or prevention of diseases like HPV-related illnesses, cervical dysplasia, genital warts, herpes, and vulvar vestibulitis syndrome.

Specific claims cited include Beta-mannan "safely eliminated HPV-related illnesses in only 90 days" and is an "effective treatment for HPV," while Micronutrient is "designed to help decrease the number of outbreaks of herpes." These claims, along with metatags like "HPV" and "herpes," classify the products as drugs.

Since these products are not generally recognized as safe and effective, they are considered "new drugs" requiring FDA approval, which they lack, violating sections 301(d) and 505(a) of the Act. Furthermore, despite being labeled as dietary supplements, their disease treatment claims are not authorized health claims, making them drugs. The FDA also found the products misbranded under section 502(f)(1) of the Act because they lack adequate directions for use by a layman for conditions not amenable to self-diagnosis and treatment.

Dr. Glickman must respond within