Half Hill Farm 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 website establish that the products are drugs under section 201(g)(1)(B) of 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 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

Accordingly, your Turkey Tail Mushroom Extract, Chaga Mushroom Extract, and Red Reishi Mushroom Extract 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)].

Passage 4

In your response, you stated that you **(b)(4)**. However, you did not provide documentation to support that those changes to the label have been made.