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  5. Crown Wellness, Inc - 610844 - 04/29/2021
  1. Warning Letters

WARNING LETTER

Crown Wellness, Inc MARCS-CMS 610844 —

Delivery Method:
VIA Electronic Mail
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Kevin Lockhart/David Black
Recipient Title
President
Crown Wellness, Inc

118 Middle Street, Suite 1020
Lake Mary, FL 32746
United States

Issuing Office:
Center for Food Safety and Applied Nutrition

United States

Center for Drug Evaluation and Research

WARNING LETTER

April 29, 2021

Crown Wellness, Inc.
David Black, President
421 Grand Concourse #1
Miami Shores, FL 33183

Crown Wellness, Inc.
David Black, President
9999 NE 2 Ave, Suite 209E
Miami Shores, FL 33138

Re: 610844

Dear Mr. Lockhart and Mr. Black:

This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.crownwellness.com in February and March 2021 and has determined that you take orders there for the products Clinic’s Choice CLO2, E3 Renew Me/B.G. Blue Green Algae, Diatomaceous Earth Powder (DE), E3 Digestive Enzymes Supreme, Karma Cleanse, and Iodine Detoxified. The claims on your website and product labels establish that the products are drugs under section 201(g)(1)(B) and/or (g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B) and/or (g)(1)(C)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or any function of the body. Furthermore, your Clinic’s Choice CLO2 is intended to mitigate, prevent, treat, diagnose, or cure COVID-191 in people. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Examples of some of the claims on your website and product labels that provide evidence that your products are intended for use as drugs include:

Clinic’s Choice CLO2:

• On your product’s page at https://crownwellness.com/product/clo2/:

o There is a video on that webpage, titled “Over 100 Recoverded [sic] from Covid-19 with CLO2.” This video is also posted on your website at https://crownwellness.com/over-100-recoverded-from-covid-19-with-clo2/:2

 [At 00:23] “with this video I want to publish officially the first success of treatment against coronavirus or COVID-19 with more than 100 affected people recovered after only four days.”
 [At 00:53] “Chlorine Dioxide or CLO2 is a substance known as the best disinfectant against viruses, fungi, bacteria . . .”
 [At 03:08] “. . . and this is the true reason for the success of CDS against coronavirus.”
 [At 03:45] “a few months ago I published the fact that Chlorine Dioxide in the form of CDS works perfectly in the most serious problem of today which is the so-called coronavirus pandemic, it is not a theory it is an irrefutable fact . . .”
 [At 06:50] “. . . showing in an irrefutable way that Chlorine Dioxide does work for the treatment of coronavirus and does not cause negative side effects . . .”

o The product is listed as being in the following categories, “Arthritis/Inflammation” and Autism”.
o “Our proprietary product CLO2 (also known as Chlorine Dioxide) is a powerful anti-viral, anti-fungal and anti-bacterial liquid. It helps eradicate the weak blood cells from your body that are susceptible to infection.”
o “This product is used for bacterial /fungal infections and for the possible eradication of yeast, parasites and Morgellon’s.”

• On your product’s label:

o “Clinic’s Choice CL O2 PRIME DEFENSE . . . Bacterial/Fungal Forms and Parasite Eradication”

• Clinic’s’ Choice CLO2 is listed under the “Autism” tab on your Shop page at https://crownwellness.com/product-category/autism/.

Diatomaceous Earth Powder (DE):

• On your product’s page at https://crownwellness.com/product/diatomaceous-earth-de-1-gallon/:

o The product is listed as being in the following categories, “Arthritis/Inflammation” and “Fungal”.

• On your product’s label:

o BENEFITS
 “Kills worms or parasites”
 “Lowers Bad Cholesterol”
 “Sweeps Bacteria”
 “Maintains Elasticity of Lung Tissue”
 “Reduces Inflammation”
 “Tones Respiratory Tract”
 “Positive Action on the Lymphatic System”
 “Helps Prevent Kidney Stones and Heal Infections of the Urinary Tract”
 “Reduces inflammation of Intestines”
 “Helps with Stomach and Intestinal mucus and ulcers”
 “Clears up Diarrhea and its opposite constipation”
 “Helps Normalize Hemorrhoidal Tissue”
 “Normalize Bowels”
 “Effective with Female discharge, abscesses and ulcer in the Genital area and Cervix”
 “Helps with inflammation of the Middle Ear”
 “Helps Reduce swelling of the Lymph nodes in the throat”
 “Circulation and Regulates High Blood Pressure (hypertension)”
 “Vertigo, Tinnitus (buzzing of the ears) and Insomnia”
 “Helps with Diabetes”
 “Arterial Disease by Strengthening the Blood Vessels”
 “Helps Prevent Tuberculosis”
 “Elasticity of the Joints, Silica helps Rheumatism”
 “Coronary Diseases”
 “Alzheimers [sic]”

E3 Renew Me/B.G. Blue Green Algae

• On your product’s page at https://crownwellness.com/product/e3live-renew-b-g-algae-300-caps/:

o The product is listed as being in the “Fungal” category.

• On your “About Us” page at https://crownwellness.com/about-clinics-choice/, which links to your online shop:

o “The Body has an amazing ability to Heal itself – cancer and most chronic degenerative diseases are not only preventable but also reversible. . . .

If someone has cancer it is true that the bad cells have overtaken the good ones. We use natural supplements to stimulate the good cells to overtake the bad. For example, Renew Me (from blue-green algae) is a multimineral that helps stimulate Healthy white blood cells, which even traditional medicine believes is your immune system’s first line of defense.”

E3 Digestive Enzyme Supreme:

• On your product’s page at https://crownwellness.com/product/e3live-enzymes-supreme-240-caps-2/:

o The product is listed as being in the following categories, “Arthritis/Inflammation” and ”Fungal”
o “relief for . . . indigestion . . .”

This website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of your products for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:

• “. . . I was diagnosed with COPD stage 3…I was blessed to find a product that worked within one week for me… I started with 5 or 6 products from this company . . . On the first week HALF of my COPD systems [sic] went away . . . I will CONTINUE . . . to take . . . E3 Renew Me..Bio Command 4, Diatomaceous Earth powder (DE), . . . E3 Probiotics & Iodine Detoxified . . .”

• “. . . I had fatigue and digestive problems after my gall bladder removal. I have been using DE, E3Live Renew Me, E3 Digestive Enzymes, CLO2, Karma Cleanser . . . on and off for the past year and everytime I stop for a couple months my body aches and my digestive problems begin . . .”

• “The RenewMe is amazing (I have barely suffered a flu or cold for two years).”

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 the 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 Clinic’s Choice CLO2, E3 Renew Me/B.G. Blue Green Algae, Diatomaceous Earth Powder (DE), and Iodine Detoxified 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, Clinic’s Choice CLO2, E3 Renew Me/B.G. Blue Green Algae, Diatomaceous Earth Powder (DE), and Iodine Detoxified fail to bear adequate directions for their intended uses 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 written reply should be directed to FDAAdvisory@fda.hhs.gov. If you have questions regarding any issues in this letter, please contact this e-mail address.

Sincerely,
/S/

Michael W. Roosevelt
Acting Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration

/S/

Donald D. Ashley
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

_________________________

1 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. Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020, and subsequently renewed), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx. In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-19. Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), available at https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/. 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 products that are 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.

2 We note that, as of the date of this letter, the claims cited above regarding COVID-19 appear to have been removed. Due to the serious public health concerns related to the marketing and sale of unapproved drugs for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, it is essential that these violations do not recur. 

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