FDA WARNING_LETTER - Chaya Herbal Food Inc - August 31, 2015

The FDA issued a Warning Letter to Chaya Herbal Food Inc. after reviewing their website, www.chayaherbal.com, in August 2015. The FDA determined that the company's products, including "Chaya Capsules," "Chaya Tea," "Chaya and Aloe Tea," "Omega 3-6-9," "Chaya Deodorant," "Chaya Foot Creme," and "Chaya Aloe Gelee," are unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act (the Act).

The claims on the website establish that "Chaya Capsules," "Chaya Tea," "Chaya and Aloe Tea," and "Omega 3-6-9" are intended for use in the cure, mitigation, treatment, or prevention of diseases such as diabetes, cancer, hypertension, varicose veins, obesity, osteoporosis, arthritis, Alzheimer's, anemia, and cardiovascular problems, among others. Similarly, "Chaya Aloe Gelee," "Chaya Foot Crème," and "Chaya Deodorant" are marketed for conditions like psoriasis, burns, cuts, diabetic foot, athlete's foot, and regulating skin perspiration.

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 claimed uses and lack prior FDA approval. Their introduction into interstate commerce without approval violates sections 301(