What happened
Original notice title
Duoc Thao Tre Xanh, LLC MARCS-CMS 611685, March 16, 2021
From the archived source record
An alternative treatment for skin wounds that don’t heal quickly…Lowers risk of emphysema in smokers and passive smokers thanks to high vitamin D content…” “[A]nti-cancer/anti-tumor activities…” Fucoidan product: “New Frontier in Cancer Treatment” “Fucoidan is a powerful anticancerous supplement from the Sea.” “Fucoidan…triggers the natural immune system to attack and kill cancer cells.” “Fucoidan suppresses the generation of new blood vessels around cancer cells, cutting off their nutrient supply. We request that you take immediate action to cease the sale of such unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. The claims on your website www.duocthaotrexanh.com , that establish the intended use of your product and misleadingly represent them as safe and/or effective for the treatment or prevention of COVID-19 include: Immune Health product: “COVID-19 Influenza” “Helps Boost Your Immune System Against: Coronavirus…Influenza…Bronchitis…Dyspnea…Common Cold” Your products are not generally recognized as safe and effective for the above referenced use and, therefore, the product is “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). 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)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)]. The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your marketed products.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 2ef4ccf10f2a
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage →