WARNING LETTER
Duoc Thao Tre Xanh, LLC
MARCS-CMS 611685 —
March 16, 2021
Delivery Method:
VIA Electronic Mail
Product:
Drugs
Recipient:
Recipient Name
Mr. Tin Huynh
Recipient Title
Registered Agent
Duoc Thao Tre Xanh, LLC
9724 N. Armenia Ave. Suite 401a
Tampa
,
FL
33612-7550
United States
TinHuynh@gmail.com
Issuing Office:
Division of Human and Animal Food Operations East IV
United States
WARNING LETTER
21-HAFE4-WL-02 / CMS No. 611685
Dear Mr. Huynh:
This is to advise you that from October to December 2020, the United States Food and Drug Administration (FDA) reviewed your website at https://www.duocthaotrexanh.com and has determined that you take orders there for the products Immune Health, Ganoderma Lucidum Red Reishi Mushroom, Papaya Leaf Extract and Fucoidan. 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. As explained further below, introducing or delivering these products into interstate commerce for such uses violates the Act. You may find the Act and FDA regulations through links in FDA's homepage at www.fda.gov.
New and Misbranded Drugs
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
On your website www.duocthaotrexanh.com :
Ganoderma Lucidum, Red Reishi Mushroom product:
“THE WONDER MUSHROOM THAT CURES MANY DISEASES AT ONCE”
“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…”
Papaya Leaf Extract High Potency product:
“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. Other healing properties papayas provide are: Increases platelet count…alleviates inflammation. 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. This also prevents the cancer cells from spreading.”
“Fucoidan provides an anticancer effect by way of inducing apoptosis.”
“Fucoidan reduces side effects of chemotherapy and radiation.”
In addition, the FDA has observed that your website offers “Immune Health” for sale in the United States, which is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.
There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19)
1
. On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS
2
. In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19
3
.
Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described below, you sell a product that is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. 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)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
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). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
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)]. 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. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
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.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, injunction or seizure.
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. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your reply should be directed to Mr. Ramon Hernandez, District Director/Program Division Director, Food and Drug Administration, 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding this letter, please contact LCDR Laura Kennedy, Compliance Officer, at
(813) 915-7948
or Laura.Kennedy@fda.hhs.gov.
Sincerely,
/S/
Ramon A. Hernandez
District Director, San Juan District
Program Division Director,
Office of Human and Animal Food Operations,
East Division IV
____________________
1
As explained in the next paragraph, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).
2
Secretary of Health and Human Services Alex M. Azar II, Determination that a Public Health Emergency Exists. Jan. 31, 2020. (Accessible at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx). The declaration has been renewed for an additional 90 days three times. The most recent renewal went into effect on October 23, 2020. Secretary of Health and Human Services Alex M. Azar II, Renewal of Determination that a Public Health Emergency Exists. October 2, 2020. (Accessible at https://www.phe.gov/emergency/news/healthactions/phe/Pages/covid19-2Oct2020.aspx).
3
President Donald J. Trump, Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19). Mar. 13, 2020. (Accessible at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerningnovel-coronavirus-disease-covid-19-outbreak/).
Content current as of:
03/30/2021
Regulated Product(s)
Drugs