FDA WARNING_LETTER - Natural Biology, Inc.

The FDA issued a Warning Letter to Natural Biology after reviewing their website, www.naturalbiology.com. The FDA determined that the products "Nano HGH" and "Vintage Resveratrol" are promoted for conditions that classify them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). The therapeutic claims on the website, such as "fighting cancer," "restoring sexual function in impotent men," "anti-cancer," "antiviral," "Type II diabetes," and "Alzheimer's disease," establish the products' intent for use in the cure, mitigation, treatment, or prevention of disease.

These products are considered "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their promoted uses and lack prior FDA approval as required by section 505(a). Furthermore, "Nano HGH" and "Vintage Resveratrol" are misbranded under section 502(f)(1) of the Act due to the absence of adequate directions for use in their labeling.

The FDA noted numerous other unlawful disease treatment and prevention claims for various products on the website. The company is required to take prompt action to correct these violations and prevent recurrence. Failure to comply may result in enforcement actions, including seizure of illegal products and injunctions. Natural Biology must respond in writing within fifteen working days, detailing corrective