FDA WARNING_LETTER - New Capstone, Inc - May 31, 2017

The FDA issued a Warning Letter to Dr. Carolyn Dean regarding products sold on her website, www.rnareset.com, specifically ReMyte, ReAline, ReMag, ReStructure, and ReCalcia Pico Meter Calcium. An FDA review in May 2017 found that claims and testimonials on the website establish these products as unapproved new drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), as they are intended for disease diagnosis, cure, mitigation, treatment, or prevention.

Examples of drug claims include ReMyte for "cancer protection," "arthritis," and "hypothyroidism"; ReAline for "reduces brain inflammation" and "detoxification of mercury"; ReMag for "treats heart disease," "muscle pain," and "insomnia"; ReStructure for "controlling blood sugars in hypoglycemia, prediabetes, or diabetes" and "reducing the risk of heart disease"; and ReCalcia Pico Meter Calcium for "heart 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 stated uses and lack prior FDA approval. Furthermore, they are deemed "misbranded" under section 502(f)(1) of the Act because they lack adequate directions for use by a layperson, as their intended uses require supervision by a licensed practitioner.