APG SEVEN, 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 product labels and other labeling establish that your products BioMoringa, BioDiabetin, Maca Plus, BioProstate, Immune Support, HongoTrap, Honbacterol, BioFlex, Ginkgo Biloba, ProHerbal Plus, BioWoman, Hongocure, BioCell, and BioCollagen Complex 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 products BioMoringa, BioDiabetin, Maca Plus, Ginkgo Biloba and BioCell are intended for prevention or treatment of one or more diseases that are not amenable to self-diagnosis, prevention, or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your BioMoringa, BioDiabetin, Maca Plus, Ginkgo Biloba and BioCell 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)].