LEGAL ALERT: FDA and FTC warn 7 more companies for alleged COVID-19 claims (FDA)

Editor's Note

FDA and FTC sent six more warning letters to companies for alleged COVID-19-related claims used to market a range of products from silver and copper to vitamins, minerals, herb oils and a homeopathic drug product. FDA sent an additional letter to Quadrant Sales & Marketing for alleged claims for a non-alcohol-based hand sanitizer product intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. Four of the letters are to companies (CBD Gaze, Alternavita, Musthavemom.com and Careful Cents) participating in the Amazon associates program, which provides commissions for companies that promote products. The warning letters request that the companies immediately cease promoting and participating in the sale of unapproved and unauthorized products with COVID-19-related claims. The remaining two letters to Natural Solutions Foundation and StayWell Copper Products highlight alleged online claims related to COVID-19. The warning letters remind all the companies that FDA and FTC are 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.

June 2, 2020

Food and Drug Administration

FDA warning letter: CBD Gaze

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 www.cbdgaze.com on May 7, 2020 and May 21, 2020, respectively. While reviewing your website, FDA observed that you participate in the Amazon Associates program. As an Amazon associate, you earn commissions by promoting the sale of CBD products including Restorative Botanicals Ultra High Strength Hemp Oil Supplement and Serenity Hemp Liquid Dietary Supplement (hereinafter referred to as “Amazon associate products”) with claims on your website representing or implying that the products can mitigate, prevent, treat, diagnose, or cure COVID-19 in people. Based on our review, these claims cause the Amazon associate products purchased through links on your website to be unapproved new drugs under 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. Causing 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). In addition, it is a prohibited act under section 301(k) of the FD&C Act, 21 U.S.C. § 331(k), to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being misbranded.

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, the President declared 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 above, you promote and participate in the sale of products for use in mitigating, preventing, treating, diagnosing, or curing COVID-19 in people, as evidenced by the claims from your website quoted below. We request that you immediately cease promoting and participating in 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 website www.cbdgaze.com that establish the intended use of your Amazon associate products and misleadingly represent them as safe and/or effective for the treatment or prevention of COVID-19 include:

“Find the best CBD Oil to help fight Coronavirus.”
“Use CBD Oil to fight coronavirus, COVID-19!”
“Let the power of CBD help you combat your illness, covid-19, coronavirus…”

You should take immediate action to correct 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 your activities as an Amazon associate do not violate the FD&C Act. We advise you to review your websites and other labeling and promotional materials to ensure that you are not misleadingly representing your Amazon associate 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 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/fraudulent-coronavirus-disease-covid-19-products . Once you have taken corrective actions to cease promoting the sale of unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, 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 Amazon associate products and activities are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.

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. 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 products 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. 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.