Orphic Nutrition

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 websites establish that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (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 Apple Cider Vinegar Capsules, Ashwagandha Capsules, Garcinia Cambogia Capsules, Premium Collagen Peptides Capsules, Elderberry Gummies, Omega 3 Fish Oil Softgels, and Turmeric Curcumin with Bioperin Capsules 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, Apple Cider Vinegar Capsules, Ashwagandha Capsules, Garcinia Cambogia Capsules, Premium Collagen Peptides Capsules, Elderberry Gummies, and Omega 3 Fish Oil Softgels 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)].