Wholly Liquid Nutritional Supplements 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 products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act [21 U.S.C. 321(p)].

Passage 2

Your SpiroLaze, BioLaze, LiquiLaurin, Vit-B12, DeStress, Omega Plus, and Ionized Silver are intended for treatment of one or more diseases that are not amenable 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, SpiroLaze, BioLaze, LiquiLaurin, Vit-B12, DeStress, Omega Plus, and Ionized Silver fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. 352(f)(1)].