CreAgri, Inc. – FDA Warning Letter, Aug 1, 2014

The FDA issued a Warning Letter to CreAgri, Inc. after reviewing their websites (www.olivenolplus.com and www.creagri.com) in November 2013 and August 2014. The agency determined that the firm's products, including "Olivenol plus Easeflex," "Olivenol plus Essence Capsules," "Olivenol plus Essence Elixer," and "Olivenol plus Healing Moisturizer," are promoted for conditions that classify them as unapproved new drugs under sections 201(g)(1)(B), 201(g)(1)(C), and 201(p) of the Federal Food, Drug and Cosmetic Act. Website claims, such as reducing joint inflammation, helping with chronic arthritis, boosting the immune system, aiding severe skin disorders like psoriasis, and protecting against sun damage, establish the products' intended use in the cure, mitigation, treatment, or prevention of disease, or to affect the body's structure/function. Additionally, personal testimonials on the "Success Stories" webpage further support these drug claims. Since these products are not generally recognized as safe and effective for their intended uses, they are considered "new drugs" and cannot be legally introduced into interstate commerce without prior FDA approval, violating sections 505(a) and 301(d) of the Act. CreAgri, Inc. must take prompt action to correct these violations and respond in writing within 15 working days, detailing corrective steps and providing documentation. The FDA also recommended reviewing product labels, noting similar claims found during a March 2013 facility inspection. Failure to comply may result in regulatory actions like seizure or injunction.