WARNING LETTER 

RE: 637158 

Date: August 4, 2022 

TO: info@fluxxlab.com Arend John Kuijvenhoven 

FluxxLab LLC 

1681 Niagara Rd. 

Montrose, CO 81401 

Arend John Kuijvenhoven 

FluxxLab LLC 

Arendis, LLC 

6124 County Road 5 

Ridgeway, CO 81432 

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 (FTC) reviewed your website at the Internet address https://fluxxlab.com/ on July 12, 2022, 

and August 1, 2022, respectively. The FDA has observed that your website offers the Covid-19 Immune 

Support Tincture and the CBDA+CBD Oil Tincture products for sale in the United States and that these 

products are intended to mitigate, prevent, treat, diagnose, or cure COVID-191 in people. Based on our 

review, 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 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, 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 

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/. 
    Page 2 of 3 pages

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 any unapproved and unauthorized products for the mitigation, 

prevention, treatment, diagnosis, or cure of COVID-19. 

Some examples of the claims on your website 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: 

 “CBD+CBDa 

Immune Support 

Special Formulation 

In a recent study, CBDa was examined to determine how cannabinoids interact with Covid-19. 

Researchers discovered that cannabidiolic acid, also known as CBDA, binds to the spike protein of 

SARS-CoV-2, the virus that causes Covid-19. 

As the compounds bind to the spike protein, they prevent the virus from infecting cells and causing 

infection, opening up new avenues for the prevention and treatment of the disease.” [From your 

webpage https://fluxxlab.com/product-category/cbda/] 

 “Special 

Immune Support Formulation 

See Covid-19 Research” 

“Researchers have very recently discovered that CBDa, and CBGa bind to the spike protein of 

SARS-CoV-2, the virus that causes Covid-19. 

As the compounds bind to the spike protein, they can prevent the virus from infecting cells and 

causing infection.” 

The product name: “Covid-19 Immune Support” [From your webpage 

https://fluxxlab.com/product/cbda-cbga-immune-support-special-formulation/] 

You should take immediate action to address the violations cited in this letter. This letter is not meant to 

be an all-inclusive list of violations that exist in connection with your products or operations. 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 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 these 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 your 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 
    Page 3 of 3 pages

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 products 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 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 Richard Cleland, 

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

certifying that you have ceased making unsubstantiated claims for the products identified above. If you 

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

 

 Sincerely, 

 Carolyn E. Becker 

Director 

Office of Unapproved Drugs and Labeling Compliance 

 Center for Drug Evaluation and Research 

Food and Drug Administration 

 Sincerely, 

 

 

 

Serena Viswanathan 

 Associate Director 

 Division of Advertising Practices 

 Federal Trade Commission