FDA WARNING_LETTER - Evig LLC dba Balance of Nature - February 08, 2019

On August 20, 2019, the FDA issued a Warning Letter to Balance of Nature following an inspection from February 4-8, 2019, and a review of their website and YouTube channel in July 2019. The inspection and review revealed serious violations of the Federal Food, Drug, and Cosmetic Act.

The FDA determined that Balance of Nature's Whole Food Fruits, Whole Food Veggies, and Whole Food Fiber & Spice products are unapproved new drugs and misbranded drugs. This is based on therapeutic claims made on product labels, the company website (www.balanceofnature.com), and YouTube channel (www.youtube.com/user/balanceofnature1), which indicate the products are intended for the cure, mitigation, treatment, or prevention of disease. These products are not generally recognized as safe and effective for these uses and lack FDA approval. Furthermore, they are misbranded because they fail to bear adequate directions for use, as their intended uses are not amenable to self-diagnosis or treatment by a layperson.

Even if not classified as unapproved new drugs, the products would be adulterated dietary supplements under 21 CFR Part 111 (CGMP requirements). As a distributor, Balance of Nature failed to establish a system of production and process controls to ensure product quality and compliance with CGMP, and did not provide documentation for quality control or product complaint procedures.

Additionally, the products are