Richardson Nutritional Center, LLC/Nutriseeds, 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 Nutriseeds Fresh Bitter Apricot Seeds, Nutriseeds Natural Amygdalin Extract, Nutriseeds Natural B15 – Pangamic Acid, RNC Bitter Raw Apricot Seeds, and RNC Laetrile B17 products fail to bear adequate directions for their intended uses and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].