WARNING LETTER

Date: March 6, 2020

TO: david@vivifyholistic.ca – David Raes, Vivify Holistic Clinic 

272 Wellington Street 

Sarnia, ON, Canada, N7T 1H2

RE: Unapproved and Misbranded Products Related to Coronavirus Disease 2019 

(COVID-19)

This is to advise you that the United States Food and Drug Administration (FDA) and the 

Federal Trade Commission reviewed your website at the Internet address 

https://coronavirusdefense.com in February 2020. We also reviewed your Facebook website at 

https://www.facebook.com/vivifyholistic/ where you direct consumers to your website 

https://coronavirusdefense.com to purchase your products. The FDA has determined that your 

website offers products for sale in the United States and that these products are intended to 

mitigate, prevent, treat, cure or diagnose COVID-191 in people. 

FDA has determined that these products are unapproved new drugs sold in violation of section 

505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). 

Furthermore, these products are misbranded drugs under section 502 of the FD&C Act, 21 

U.S.C. 352. The introduction or delivery for introduction of these products into interstate 

commerce is prohibited under section 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and 

(d).

The Secretary of Health and Human Services, under section 319 of the Public Health Service 

Act, 42 U.S.C. § 247d, has determined that a public health emergency exists nationwide as a 

result of confirmed cases of 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 

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. 

Some examples of the claims on your websites that establish the intended use of your products 

and misleadingly represent them as safe and/or effective for the treatment or prevention of 

COVID-19 include: 

• “Regarding the Wuhan Coronavirus: Stephen Buhner . . . has done extensive research 

on coronaviruses . . . He has treated them very successfully using his protocols. A few 

days ago he posted on facebook a 4 part protocol specific for the Wuhan outbreak. The 

last few days I have been working very hard to set up a website coronavirusdefense.com

up to sell Mr. Buhner’s protocol.” [from a January 27, 2020 post on your Facebook 

website https://www.facebook.com/vivifyholistic/]

 1 COVID-19 is the official name for the disease that is causing the 2019 novel coronavirus outbreak, first identified 

in Wuhan, China.
Vivify Holistic Clinic Warning Letter Page 2 of 3 pages

• “With active infection: very strong boneset tea, to 6x day. I have used this with other corona 

virus infections, including SARS, it works well." [from a January 27, 2020 post on your 

Facebook website https://www.facebook.com/vivifyholistic/]

• “As the deadly cornavirus [sic] rapidly spreads across the globe with no antidote available . . 

. Stephen Harrod Buhner has created an updated coronavirus protocol specifically for the 

Wuhan outbreak.” [from your website https://coronavirusdefense.com]

• “Formula # 4 – Loose Leaf Tea 

Boneset

(Only use if infected)

Acute Dosage: 1 cup 6x /day

Chronic Dosage: 2 cup 4x /day

Antiviral action” [from your website https://coronavirusdefense.com]

• “Each 100 ml of product will last 16 days for a preventative dose and 8 days for an 

infection dosage. . . .Take Extracts #1 through #3 as preventative. . . .If you are infected, 

take all 4 products and use the infection dosage.” [from your website 

https://coronavirusdefense.com]

You should take immediate action to correct the violations cited in this letter. The violations cited 

in this letter are not meant to be an all-inclusive list. It is your responsibility to ensure that the 

products you sell are in compliance with the FD&C Act and FDA's implementing regulations. We 

advise you to review your websites, product labels, and other labeling and promotional materials 

to ensure that you are not representing your products for a COVID-19 related use 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 48 hours, please send an email to COVID-19-Task-ForceCDER@fda.hhs.gov describing the specific steps you have taken to correct these violations. 

Include an explanation of each step being taken to prevent the recurrence of violations, as well 

as copies of related documentation. Failure to immediately correct the violations cited in this 

letter may result in legal action, including, without limitation, seizure and injunction. 

FDA is advising consumers not to purchase or use certain products that have not been 

approved, cleared, or authorized by FDA and that are being misleadingly represented as safe 

and/or effective for the treatment or prevention of COVID-19. Your firm will be added to a 

published list on FDA's website of firms and websites that have received warning letters from 

FDA concerning the sale or distribution of COVID-19 related products in violation of the FD&C 

Act. This list can be found at http://www.fda.gov/consumers/health-fraud-scams/fraudulentcoronavirus-disease-covid-19-products. Once you have taken corrective actions and such 

actions have been confirmed by the FDA, the published list will be updated to indicate that your 

firm has taken appropriate corrective action.

If you cannot complete corrective action within 48 hours, state the reason for the delay and the 

time within which you will complete the corrections. 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 are not located in the United States, please note that products that appear to be 

misbranded or unapproved new drugs are subject to detention and refusal of admission if they 

are offered for importation into the United States. We may advise the appropriate regulatory 

officials in the country from which you operate that FDA considers your product(s) listed above 

to be unapproved and misbranded products that cannot be legally sold to consumers in the 

United States.
Vivify Holistic Clinic Warning Letter Page 3 of 3 pages

Please direct any inquiries to FDA at COVID-19-Task-Force-CDER@fda.hhs.gov. 

In addition, it is unlawful under the FTC Act, 15 U.S.C. 41 et seq., to advertise that a product 

can prevent, treat, or cure human disease unless you possess competent and reliable scientific 

evidence, including, when appropriate, well-controlled human clinical studies, substantiating that 

the claims are true at the time they are made. To make or exaggerate such claims, whether 

directly or indirectly, through the use of a product name, website name, metatags, or other 

means, without rigorous scientific evidence sufficient to substantiate the claims, violates the 

FTC Act. 

There currently are no vaccines, pills, potions, lotions, lozenges or other prescription or overthe-counter products available to treat or cure coronavirus disease 2019 (COVID-19). Thus, the 

claims cited above are not supported by competent and reliable scientific evidence. You must 

immediately cease making all such claims. In addition, you are advised to review all claims for 

your products and immediately cease making claims that are not supported by competent and 

reliable scientific evidence. Violations of the FTC Act may result in legal action seeking a 

Federal District Court injunction and an order may require that you pay back money to 

consumers. Within 48 hours, please send an email to Richard Cleland, Assistant Director of the 

FTC’s Division of Advertising Practices, via electronic mail at rcleland@ftc.gov describing the 

specific actions you have taken to address the FTC’s concerns. If you have any questions 

regarding compliance with the FTC Act, please contact Mr. Cleland at 202-326-3088. 

 

Sincerely, 

_________________

Donald D. Ashley

Director

Office of Compliance

Center for Drug Evaluation and Research

Food and Drug Administration

Sincerely,

 

 

________________

 Richard A. Quaresima

Acting Associate Director 

Division of Advertising Practices

 Federal Trade Commission

cc: sales@herbies-herbs.com - Herbie’s Herbs