CK Management, Inc. – FDA Warning Letter, Aug 20, 2014

The FDA inspected CK Management, Inc.'s warehouse and distribution center from August 19-20, 2014, and reviewed product labeling and websites (www.whole5.com, www.viaviente.com, www.fruitspirit.com, www.fruitofthespirit.net) in November 2014 and March 2015. The inspection revealed serious violations of the Federal Food, Drug and Cosmetic Act.

The products "Whole5," "Fruit of the Spirit," and "ViaViente" are deemed unapproved new drugs under section 201(g)(1)(B) of the Act because their labeling and websites make therapeutic claims for disease cure, mitigation, treatment, or prevention (e.g., anti-inflammatory, anti-cancer, heart disease, diabetes, Alzheimer's). These products are not generally recognized as safe and effective for these uses and lack FDA approval. They are also misbranded under section 502(f)(1) as they lack adequate directions for layperson use for their intended drug purposes.

Furthermore, the products are misbranded foods under section 403 of the Act due to several violations: - **Unauthorized Nutrient Content Claims:** Claims like "Low in calories," "No Sugar Added" (without proper disclaimers), "Low in... Carbs," "Low sugar," "good levels of B-complex group of vitamins," and