FDA WARNING_LETTER - Nature's Mojo Inc - June 22, 2015

The FDA conducted an inspection of Nature's Mojo, Inc. from June 17-22, 2015, and reviewed their website, identifying serious violations of the Federal Food, Drug and Cosmetic Act.

Several products, including "Alfalfa Leaf Liquid Extract" and "Ginkgo Biloba Leaf Liquid Extract," were deemed unapproved new drugs due to therapeutic claims on the company's website, such as easing arthritis pain, improving blood flow, and enhancing the immune system. These claims establish the products' intent for disease treatment, making them "new drugs" requiring FDA approval, which they lack. Additionally, some products were cited as misbranded because they are intended for conditions not amenable to self-diagnosis, thus lacking adequate directions for layperson use.

Even if not unapproved drugs, "Ginkgo Biloba Leaf Liquid Extract," "Echinacea Purpurea Herb Liquid Extract," and others were found to be adulterated dietary supplements. The company failed to comply with Current Good Manufacturing Practice (CGMP) requirements (21 CFR Part 111), specifically by not establishing product specifications, lacking written procedures for quality control operations, and failing to maintain records of product distribution.

Furthermore, "Echinacea Purpurea Herb Liquid Extract" and "Ginkgo Biloba Liquid Extract" were misbranded dietary supplements due to labeling violations. These included failing to identify the product as a "dietary supplement," lacking a "Supplements