FDA WARNING_LETTER - Moringa Nativa

The FDA issued a Warning Letter to Mrs. Ivette Veiga of Moringa Nativa following a November 2015 review of her website and linked Facebook page. The agency determined that claims made for "Moringa Nativa Powder" and "Pure Moringa Capsules" establish them as unapproved new drugs and misbranded drugs. Claims such as "Fights many types of Cancers," "Reduces sugar in the blood," and "Combats Arthritis" indicate the products are intended for disease treatment, classifying them as drugs under 21 U.S.C. § 321(g)(1)(B). As they are not generally recognized as safe and effective for these uses, they are considered "new drugs" under 21 U.S.C. § 321(p). Introducing new drugs into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act. Additionally, the products are misbranded under section 502(f)(1) because they lack adequate directions for use, as their intended therapeutic purposes require professional supervision, making safe layperson use impossible. Introducing these misbranded drugs into interstate commerce violates section 301(a). Moringa Nativa must respond in writing within fifteen working days, detailing specific corrective actions and providing supporting documentation.