FDA WARNING_LETTER - Nutrition Coalition Inc - February 11, 2019

The FDA issued a Warning Letter to Nutrition Coalition Inc. and Kolleen A Sunde following a review of their websites, www.nutritioncoalition.com and www.willardswater.com, in October 2018. The FDA determined that products sold on these websites, including Alpha-Lipoid Acid, Colloidal Silver, CoQ10, and others, are unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act.

The products are deemed drugs because website claims establish their intended use in the cure, mitigation, treatment, or prevention of disease. Examples of such claims were found on product pages and in newsletters. As these products are not generally recognized as safe and effective for their claimed uses, they are considered "new drugs" requiring prior FDA approval, which they lack.

Furthermore, many products, including Alpha-Lipoid Acid, CoQ10, and others, are intended for diseases not amenable to self-diagnosis or treatment, making it impossible to provide adequate directions for layperson use. This renders them misbranded under section 502(f)(1) of the Act. Specifically, any OTC product with colloidal silver promoted for disease treatment/prevention is a "new drug" requiring an approved application.

The letter requires Nutrition Coalition Inc. to take prompt action to correct these violations and notify the FDA in writing within fifteen working days of the specific steps taken to correct violations and prevent recurrence. Failure