CAJ Food Products Inc. – FDA Warning Letter, Dec 31, 2021

The FDA issued a Warning Letter to Mr. Herzog on March 11, 2022, following a review of Amazon.com storefronts (Biotta and Juice Performer) and websites (www.drinkbeetjuice.com, www.biottajuices.com, www.juiceperformer.com) in November-December 2021. The FDA determined that products including Biotta Apple Beet Ginger Juice, Biotta Beet Juice, and various Juice Performer Beet Juices are unapproved new drugs and misbranded.

The claims on the websites, such as "Helps fight cancer," "Reduces blood pressure," "Treats respiratory illness," and "Prevents gout," establish the products' intent for use in the cure, mitigation, treatment, or prevention of disease, classifying them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). Since these products are not generally recognized as safe and effective for their claimed uses, they are considered "new drugs" under section 201(p) of the Act, requiring prior FDA approval for interstate commerce introduction.

Furthermore, the products are misbranded under section 502(f)(1) of the Act because they lack adequate directions for use by a layperson for conditions not amenable to self-diagnosis or treatment, which require supervision by a licensed practitioner. The introduction of these misbranded