FDA WARNING_LETTER - Years to Your Health, Inc. - April 30, 2017

The FDA issued a Warning Letter to Years to Your Health after reviewing their website (www.yearstoyourhealth.com) in January and April 2017 and product labels for Arthritis, Tumor, Eyes, and Bone Rejuvenation products.

The FDA determined that claims on the website and product labels for Arthritis and Tumor products establish them as unapproved new drugs under section 201(g)(1)(B) of the Act, as they are intended for disease cure, mitigation, treatment, or prevention. Numerous examples of drug claims were cited, including those for "Infection," "Food Poisoning," "Ulcer/Wound," "Asthma/Hay Fever," "Diabetes," "Tumor," "Seizure Relief," and various "Teas" for conditions like "Cataract," "Gout," and "Herpes/Virus Support." These products are considered "new drugs" under section 201(p) and require FDA approval before interstate commerce.

Furthermore, several products (Ulcer/Wound, Energy Pick-Up, Chest & Lung, Eyes, Asthma/Hay Fever, Memory & Mental Alertness, Diabetes & Pancreas, Seizure Relief, Gluco Tea, Bronchitis Blend Tea, and Memory & Emotional Uplift Tea) are misbranded under section 502(f)(1) because they lack adequate directions for use by a layperson, as they treat conditions not amenable to self