WARNING LETTER
Anna Health, LLC
MARCS-CMS 613294 —
March 16, 2021
Delivery Method:
VIA Electronic Mail
Product:
Dietary Supplements
Drugs
Recipient:
Recipient Name
Mr. Tin Huynh
Recipient Title
Registered Agent
Anna Health, LLC
9724 N. Armenia Ave. Suite 400
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-03 / CMS No. 613294
Dear Mr. Huynh:
This is to advise you that from October 2020 to March 2021, the United States Food and Drug Administration (FDA) reviewed your website at https://www.annahealth.com, and has determined that you take orders there for the products Fucoidan, Prostate Health, Children Liquid Vitamins, and Immune Health. In addition, we observed that the product Immune Health is intended to mitigate, prevent, treat, diagnose, or cure COVID-19
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in people. The claims on your website establish that the products Fucoidan, Prostate Health, Children Liquid Vitamins, and Immune Health are drugs under section 201 (g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 U.S.C 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA's homepage at
www.fda.gov.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
On the website www.annahealth.com:
Fucoidan product:
“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.”
Prostate Health product:
“Improves…urinary flow.”
“Relieves symptoms of BPH (Enlarged Prostate).”
“Protects against prostate cancer.”
“Reduces urinary urgency.”
Under the tab “Main Ingredients”:
“Fritillaria Bulb (Zhe bei mu) …dissipates nodules…antitussive…reduces blood pressure”
“Serenoa Repens (Saw palmetto) …treatment of benign prostatic hyperplasia (BPH)…reduces urinary problems…useful with prostate cancer”
“Rhizoma Chuanxiong (Chuan xiong) …relieves headache…”
“Angelica Sinensis (Dang gui) …treats painful obstructive syndromes…treats headache”
“Cinnamonum Zeylanicum (Gui zhi) …reduces cholesterol level…antimicrobial…regulates blood sugar…reduces arthritis pain, joints [sic] pain”
“Amur Corktree (Huang bai) …prevents prostate enlargement…reduces inflammation…anti-cancer”
“Panax Quinquefolius (Xi yang shen) …repairs internal damage due to prolong stress…”
“Radix Glycyrrhizae Uralensis (Gan cao) …reduces cough…relieves fever…”
Children Liquid Vitamins product:
“Eliminates children symptoms of anemia, anorexia…”
“[R]educes anxiety and attention deficit.”
Under the tab “Main Ingredients”:
“Dipsacus Asper Radix (Xu duan)…relieves back pain”
“Radix Rehmanniae Preparata (Sheng di) …treats anemic symptoms…antiinflammation… reduces hypertension, hyperlipidemia”
“Radix Polygoni Multiflori (He shou wu) … treats anemia…calms hyperactive, treats insomnia…”
“Ganoderma Lucidum (Fruit bodies with Opened Spores, Ling zhi) …antiviral…anticancer”
“Fresh Royal Jelly (non-freeze dried) …anti-depression”
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 uses and, therefore, the products are “new drugs” 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 Fucoidan, Prostate Health, Children Liquid Vitamins, and Immune Health 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, the Fucoidan, Prostate Health, Children Liquid Vitamins, and Immune Health products fail to bear adequate directions for their intended use and, therefore, the products are 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)].
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action, including, without limitation, seizure and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your reply should be directed to Mr. Ramon A. 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
__________________________
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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). 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. In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-19. 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 any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
Content current as of:
03/30/2021
Regulated Product(s)
Dietary Supplements
Drugs