New Sun 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 CBD products cannot be dietary supplements because they do not meet the definition of a dietary supplement under section 201(ff) of the Act [21 U.S.C. 321(ff)]. FDA has concluded, based on available evidence, that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the Act [21 U.S.C. 321(ff)(3)(B)(i) and (ii)].

Passage 2

your New Sun products are drugs under section 201(g)(1) of the Act [21 U.S.C. 321(g)(1)], because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.

Passage 3

it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Advanced Liver Plus, Advanced U-Tract, Calcium Magnesium Liquid, Lymphatic Cleanser, Ultra CBD Oil (Hemp Oil), CBD Gummies, Advanced CBD Oil (Hemp Oil), NKC, and Kidz DHA 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

your website includes the statement that “New Sun Hemp Classic CBD Oil and Advanced Hemp CBD Oil are made . . . in an FDA approved facility.” Although certain facilities must register with FDA, FDA does not approve facilities.