WARNING LETTER 

RE: 647390 

Date: January 5, 2023 

TO: info@pharmacanna.us Johnny H. Meier 

 PharmaCanna 

 2615 State Road 7 Suite B530 

 Wellington, FL 33414 

 

RE: Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID19) 

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

Trade Commission (FTC) reviewed your website at the Internet address 

https://www.pharmacanna.com on November 30, 2022, and January 3, 2023, respectively. We also 

reviewed your Facebook and YouTube social media websites at 

https://www.facebook.com/pharmacanna and 

https://www.youtube.com/@pharmacannacbdbypharmacist543, where you direct consumers to your 

website, https://www.pharmacanna.com to purchase your cannabinoid products, including the 

CBDefense 2000 product. The FDA has observed that your website offers the CBDefense 2000 

product for sale in the United States and that this product is intended to mitigate, prevent, treat, 

diagnose, or cure COVID-191 in people. Based on our review, this product is an unapproved new 

drug 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, this product is a misbranded drug under section 502 of the FD&C Act, 

21 U.S.C. § 352. The introduction or delivery for introduction of this product into interstate commerce 

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

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.2 In addition, on March 13, 2020, 

there was a Presidential declaration of a national emergency in response to COVID-19.3 Therefore, 

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, 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. 3 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/proclamationdeclaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/. 
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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. 

Some examples of the claims on your website and social media 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: 

 “CBDefense 2000 - Virus Protective Formula . . . 

This revolutionary virus fighting product contains the two cannabinoids, CBDa & CBGa, that 

has been shown through a published study to keep covid from infecting human cells. These 

two acidic hemp molecules assist in blocking the ability of the virus to attach to human cells.” 

[From your product webpage https://www.pharmacanna.com/products/cbdefense-2000] 

 “COVID prevention with CBD? Canada study shows it's possible. Might be time to start a daily 

dose of PharmaCanna's all-natural pharmaceutical grade CBD products.... USE CODE: 

COV19” [from a May 15, 2020, post on your Facebook social media webpage 

https://www.facebook.com/pharmacanna] 

 “ATTN: PHARMACY OWNERS RE: COVID 

If you are dealing with patients looking for covid vaccines, covid tests, and anything related to 

anti-covid, then PharmaCanna may have the revolutionary product for your patients. We 

introduce CBDefense 2000 with 1000mg of CBD/CBDA and 1000mg of CBG/CBGA. . . . 

From the recently published study. . . : ‘Two cannabinoids with the highest affinities for the 

spike protein, cannabidiolic acid (CBDA) and cannabigerolic acid (CBGA), were confirmed to 

block infection of human epithelial cells by a pseudovirus expressing the spike protein. More 

importantly, both CBDA and CBGA block infection of the original live SARS-CoV-2 virus and 

variants of concern, including the B.1.1.7 and B.1.351.’” [from a February 3, 2022, post on 

your Facebook social media webpage https://www.facebook.com/pharmacanna] 

 “Our CBDefense 2000, anti-covid formula, is Now Available. . . Use Code: DEFENSE” [from a 

March 9, 2022, post on your Facebook social media webpage 

https://www.facebook.com/pharmacanna] 

 “[S]o we’ve announced recently about our CBDefense which is the that [sic] contains the two 

active ingredients that’s in that product is the acidic version of cbd and cbg which would be 

cbda and cbga and those are two ingredients according to a published study that came out of 

Oregon state university that has shown that those two cannabinoids are attaching to the 

protein spikes or I should say the spike proteins of covid so basically not allowing covid to 

infect human cells so we’re super excited.” [From a March 10, 2022, video titled 

“PharmaCanna Phamily Update #3 - FREE CBD for a Year,” posted on your YouTube social 

media website https://www.youtube.com/watch?v=UPMOp8zlljU] 

 “[F]or those of you out there that are interested in uh just boosting your covid fighting uh 

properties in your body uh we’ll be doing CBDefense at 30 percent off using the code defense 

so [it will] be DEFENSE.” [From a March 10, 2022, video titled “PharmaCanna Phamily Update 

#3 - FREE CBD for a Year,” posted on your YouTube social media website 

https://www.youtube.com/watch?v=UPMOp8zlljU] 

You should take immediate action to address this matter. This letter is not meant to be an allinclusive list of violations that exist in connection with your products or operations. It is your 
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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 misleadingly representing your products as safe 

and effective 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-Force-CDER@fda.hhs.gov describing the specific steps 

you have taken to address any violations. Include an explanation of each step being taken to prevent 

the recurrence of any violations, as well as copies of related documentation. Failure to adequately 

correct any violations 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/fraudulent-coronavirus-disease-covid-19-products. 

Once you have taken actions to address the sale of any unapproved and unauthorized products for 

the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, and any appropriate corrective 

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

has taken such corrective actions. 

This letter notifies you of our concerns and provides you with an opportunity to address them. If you 

cannot take action to address this matter completely within 48 hours, 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 

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 may be detained or refused 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) referenced above to be unapproved and misbranded 

products that cannot be legally sold to consumers in the United States. 

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

FTC Cease and Desist Demand: 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. For COVID-19, no such study is 

currently known to exist for the product identified above. Thus, any coronavirus-related prevention or 

treatment claims regarding such product are not supported by competent and reliable scientific 

evidence. You must immediately cease and desist making all such claims. 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. In addition, pursuant to the COVID-19 Consumer Protection Act, 

Section 1401, Division FF, of the Consolidated Appropriations Act, 2021, P.L. 116-260, marketers 

who make deceptive claims about the treatment, cure, prevention, or mitigation of COVID-19 are 

subject to a civil penalty of up to $46,517 per violation and may be required to pay refunds to 

consumers or provide other relief pursuant to Section 19(b) of the FTC Act, 15 U.S.C. § 57b(b). Within 

48 hours, please send an email to Serena Viswanathan, Associate Director of the FTC’s Division of 

Advertising Practices, at sviswanathan@ftc.gov certifying that you have ceased making 

 
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unsubstantiated claims for the product identified above. If you have any questions regarding 

compliance with the FTC Act, please contact Ms. Viswanathan at 202-326-3244. 

 

Sincerely, Sincerely, 

 

CAPT Tina Smith Serena Viswanathan 

Acting Director Associate Director 

Office of Unapproved Drugs and Labeling Compliance Division of Advertising Practices 

Center for Drug Evaluation and Research Federal Trade Commission 

Food and Drug Administration