LEGAL ALERT: FDA warns four more companies for promoting drugs, homeopathic products and supplements for COVID-19

Editor's Note

FDA sent four additional letters warning U.S and foreign companies to cease making unsubstantiated claims that their products can treat or prevent COVID-19. Two warning letters were sent by FDA and FTC to Honey Colony LLC and Dr. Shole's Sushanti Homeopathy Clinic relate to COVID-19 prevention claims for silver, vitamin C, and magnesium products (Honey Colony) and a homeopathic drug product called “Homeopathic Genus Epidemicus.” The other two letters were issued solely by FDA to Antroids.com and Foxroids.com for COVID-19 treatment claims made for drugs containing ingredients approved for use in HIV patients. The letters urge recipients to immediately cease making all COVID-19 related claims. The FTC and FDA have issued nearly 40 warning letters to entities selling products such as drugs, homeopathic drugs, cannabinol (CBD) products, essential oils, colloidal silver, traditional Chinese medicine, and salt therapy.

May 4, 2020

Food and Drug Administration

FDA Warning Letter: Dr. Dhole's Sushanti Homeopathy Clinic

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.homeopathyhelps.com, on April 23, 2020, and May 30, 2020, respectively. We also reviewed your social media website at www.twitter.com/DrNitinDhole, where you direct consumers to your website www.homeopathyhelps.com, to purchase your products. The FDA has observed that your website offers the “Homeopathic Genus Epidemicus” for sale in the United States and that this product is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 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 misbranded drug 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, 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 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:

“Homeopathy Treatments Available For: . . . Coronavirus (2019-nCov) Prevention” [from your website at www.homeopathyhelps.com]
“Role of Homeopathy in current Coronavirus disease (COVID-19) pandemic: . . . Epidemics and pandemics can be kept under control by boosting people's immune system using well selected ‘Homeopathic Genus Epidemicus.’ The homeopathy medicine which is selected as Genus Epidemicus is given to healthy people in that particular region to prevent the illness. In the past homeopathy has helped in pandemics many times in different parts of the world.” [from your website at www.homeopathyhelps.com]
"[W]hile talking about his experience and views on necessity of preventive Homeopathy Genus Epidemicus in current #COVID19 pandemic, makes a passionate argument in favour of #Homeopathy. #HomeopathyForCOVID19” [from a March 28, 2020 post on your Twitter page at www.twitter.com/DrNitinDhole]

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 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 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 the sale of your 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 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 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 .

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 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.