The Truth Company, LLC

Selected passages from the FDA letter

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

Passage 1

Your Betaine, Immune, Redwood, Sensolin, Thyrite, zuRelief, Kino Aminos, Kino Collagen Protein, and Kino Gains 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 2

Your Betaine, Immune, Redwood, Sensolin, Kino Aminos, and Kino Gains products are intended for treatment of one or more diseases that are not amendable to self-diagnosis 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, Betaine, Immune, Redwood, Sensolin, Kino Aminos, and Kino Gains fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act.