Duoc Thao Tre Xanh, LLC
FDA issued a warning letter to Duoc Thao Tre Xanh, LLC (Tampa, FL) in March 2021 after reviewing the company's website and finding that four products — Immune Health, Ganoderma Lucidum Red Reishi Mushroom, Papaya Leaf Extract, and Fucoidan — were marketed with disease-treatment and cure claims that rendered them unapproved new drugs under the FD&C Act. The claims included assertions that the products could treat cancer, diabetes, HIV, Alzheimer's disease, and COVID-19, none of which had FDA approval. FDA determined the products were also misbranded for lacking adequate directions for use, and demanded corrective action within 15 working days, warning that failure to comply could result in injunction or seizure.
Flagged claims (12)
Fucoidan provides an anticancer effect by way of inducing apoptosis.
Over 2,000 years of study, Lucid Ganoderma as a dietary supplement, is proven to be effective in treating many diseases including: High blood pressure…Diabetes…Asthma…Hypertension…Alzeiheimer's [sic] disease…Chronic fatigue syndromes…Insomnia…Leukemia (Increase white blood cell)…Hepatitis A, B, C…Cancer treatment…Fight HIV infection..Depress [sic], Neurosis diseases…Anti-tumor…
Fucoidan is a powerful anticancerous supplement from the Sea.
Research shows that papaya leaf in exact [sic] form is a powerful prevention and treatment of cancer. It can kill viral-infected cells and cancerous cells tumor cells from various cancers including cervix, breast, liver, lung, and pacreatic [sic] while aiding the cardiovascular and gastrointestinal systems.
Fucoidan reduces side effects of chemotherapy and radiation.
COVID-19 Influenza
Helps Boost Your Immune System Against: Coronavirus…Influenza…Bronchitis…Dyspnea…Common Cold
Fucoidan suppresses the generation of new blood vessels around cancer cells, cutting off their nutrient supply. This also prevents the cancer cells from spreading.
[A]nti-cancer/anti-tumor activities…
THE WONDER MUSHROOM THAT CURES MANY DISEASES AT ONCE
Fucoidan…triggers the natural immune system to attack and kill cancer cells.
New Frontier in Cancer Treatment
Required actions (3)
We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a COVID-19-related use or other medical diseases for which they have not been approved by FDA and that you do not make claims that misbrand the products in violation of the FD&C Act.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, injunction or seizure.
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