Duoc Thao Tre Xanh, LLC

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 Food, Drug, Cosmetic Act (the Act), [21 U.S.C 321(g)(1)(B)] because they are intended for the use in the cure, mitigation, treatment, or prevention of disease.

Passage 2

Your products Immune Health, Ganoderma Lucidum Red Reishi Mushroom, Papaya Leaf Extract and Fucoidan are intended for treatment of one or more diseases that are not amenable to self-diagnosis 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, Immune Health, Ganoderma Lucidum Red Reishi Mushroom, Papaya Leaf Extract and Fucoidan fail to bear adequate directions for their intended use and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].