Intelligent Remedies, Inc.

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, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)].

Passage 2

Accordingly, your Pryenda, CHAGAplus, Anxiety Support, VIRAsol, Curecumin, and HEMEflow O2 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)].