FDA WARNING_LETTER - Renewal Research

The FDA reviewed Renewal Research's website, www.renewalresearch.com, and determined that products "DHEA (10mg, 25mg, 50mg)," "Folixor Folic Acid 5mg," "Green Tea Extract," "Lycopene," and "Vitamin D3 5000" are promoted for conditions that classify them as drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act). Therapeutic claims on the website, such as "Decreases the risk of heart disease" for DHEA and "Prevention of several common cancers" for Folixor Folic Acid, establish these products as drugs intended for disease cure, mitigation, treatment, or prevention.

These products are considered "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for the claimed conditions. Marketing new drugs without prior FDA approval, as required by section 505(a) of the Act, is illegal. Additionally, the products are misbranded under section 502(f)(1) of the Act because their labeling lacks adequate directions for use.

The FDA noted numerous other unlawful disease treatment and prevention claims on the website. Renewal Research is responsible for ensuring all marketed products comply with the Act and its regulations. The company must take prompt action to correct these violations and prevent recurrence. Failure to comply may