FDA WARNING_LETTER - Duoc Thao Tre Xanh, LLC - March 30, 2021

The FDA issued a Warning Letter to Mr. Huynh regarding products sold on www.duocthaotrexanh.com, specifically Immune Health, Ganoderma Lucidum Red Reishi Mushroom, Papaya Leaf Extract, and Fucoidan. An FDA review from October to December 2020 found that claims on the website establish these products as drugs under section 201(g)(1)(B) of the Act, as they are intended for the cure, mitigation, treatment, or prevention of disease.

The "Immune Health" product is cited for claims related to mitigating, preventing, treating, diagnosing, or curing COVID-19, which is an unapproved and unauthorized use. All listed products are considered "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their intended uses and lack prior FDA approval.

Furthermore, these products are deemed "misbranded" under section 502(f)(1) of the Act because they fail to bear adequate directions for use by a layperson. As they are intended for diseases not amenable to self-diagnosis or treatment, they require supervision by a licensed practitioner, making it impossible to provide adequate directions for lay use.

The introduction or delivery of these unapproved new drugs and misbranded drugs into interstate commerce violates sections 301(d), 505(a), and 301(a) of