CAJ Food Products Inc.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

The claims on your websites establish that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease.

Passage 2

Your Biotta Apple Beet Ginger Juice, Biotta Beet Juice, Biotta Carrot Juice, Biotta Elderberry Juice, Biotta Golden Beet Juice Blend with Turmeric, Biotta Celery Root Juice, Biotta Breuss Vegetable Juice, Biotta Tart Cherry Juice, Juice Performer Beet Juice with Pineapple Juice, Juice Performer Beet Juice with B12, and Juice Performer Beet Juice with Passion Fruit Juice products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)].

Passage 3

Your products Biotta Apple Beet Ginger Juice, Biotta Beet Juice, Biotta Carrot Juice, Biotta Elderberry Juice, Biotta Golden Beet Juice Blend with Turmeric, Biotta Celery Root Juice, Biotta Breuss Vegetable Juice, Biotta Tart Cherry Juice, Juice Performer Beet Juice with Pineapple Juice, Juice Performer Beet Juice with B12, and Juice Performer Beet Juice with Passion Fruit Juice are intended for prevention or treatment of one or more diseases that are not amenable to self-diagnosis, prevention, or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your Biotta Apple Beet Ginger Juice, Biotta Beet Juice, Biotta Carrot Juice, Biotta Elderberry Juice, Biotta Golden Beet Juice Blend with Turmeric, Biotta Celery Root Juice, Biotta Breuss Vegetable Juice, Biotta Tart Cherry Juice, Juice Performer Beet Juice with Pineapple Juice, Juice Performer Beet Juice with B12, and Juice Performer Beet Juice with Passion Fruit Juice products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)].