FDA issued warning letters to firms for selling fraudulent products with claims to prevent, treat, mitigate, diagnose or cure COVID-19

The U.S. Food and Drug Administration is issuing warning letters to firms for selling fraudulent products with claims to prevent, treat, mitigate, diagnose or cure coronavirus disease 2019 (COVID-19). We are actively monitoring for any firms marketing products with fraudulent COVID-19 prevention and treatment claims. The FDA is exercising its authority to protect consumers from firms selling unapproved products and making false or misleading claims, including, by pursuing warning letters, seizures, injunctions or criminal prosecutions against products and firms or individuals that violate the law.

NOTE: An asterisk (*) under the table column “Corrective Status” indicates the firm’s listed product(s) are no longer sold for the prevention, treatment, mitigation, diagnosis or cure of coronavirus disease 2019 (COVID-19). This status only concerns sale of the listed product(s) for the prevention, treatment, mitigation, diagnosis or cure of coronavirus disease 2019 (COVID-19) and in no way indicates whether the listed products otherwise comply with the laws and regulations enforced by FDA. FDA will monitor all listed firms for recurrence of the conduct cited in the warning letters.

SOURCE: FDA

WARNING LETTER

Recipient:
Mr. Puneet Nanda
GuruNanda LLC
6645 Caballero Blvd.
Buena Park, CA 90620
United States

contact@gurunanda.com

Issuing Office:
Center for Drug Evaluation and Research | CDER
United States

Date March 6, 2020

TO: contact@gurunanda.com – Mr. Puneet Nanda, GuruNanda, LLC
6645 Caballero Blvd.
Buena Park, CA 9062

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 [www.gurunanda.com] in February 2020. We have also reviewed your social media sites at [www.twitter.com/GuruNandaEO] and [www.facebook.com/gurunandaEO], where you direct consumers to your website [www.gurunda.com] to purchase your essential oil products. The FDA has determined that your website offers essential oil 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:

• “Modern drug therapy targets individual genes, with epidemics similar to CoronaVirus that are highly mutated and drug resistant; we need to use therapeutic benefits of essential oils to target the virus itself not just the specific gene type – GuruNanda #coronavirus” from a February 5, 2020 post on your Twitter website [www.twitter.com/GuruNandaEO]

• You link to the webpage “MY PERSONAL ANALYSIS OF ESSENTIAL OILS AGAINST PATHOGENS” on http://www.gurunanda.com with the hashtags “#essentialoils . . . #china #coronavirus . . . #prevention” from a February 5, 2020 post on your Facebook website [www.facebook.com/gurunandaEO]

• “Municipalities of Wuhan have declared that people should use Pure essential oils as a preventative therapy . . . #coronavirus #essentialoils” from a February 5, 2020 post on your Facebook website [www.facebook.com/gurunandaEO]

• “Essential oils have great potential in the field of biomedicine as they effectively destroy several bacterial, fungal, and viral pathogens. . . .the essential oils are effective against a diverse range of pathogens.” [from your website [www.gurunanda.com]

• “Against Virus Essential oils might interfere with virion envelopment, designed for entry into host cells. Possible mechanisms of actions include the inhibition of virus replication by hindering cellular DNA polymerase and alteration in phenylpropanoid pathways.” from your website [www.gurunanda.com]

• Since the flu is spreading so quickly, we want to give 50% off for the essential oils . . . Simply type “Corona” in the code box to save immediately.” from your website [www.gurunanda.com]

• “Just what is this new Coronavirus, and how can you prevent and/or treat it? After reading this article, you’ll be well equipped and informed to decrease your chances of becoming infected.” from your [website http://www.gurunanda.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-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 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.

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 over-the-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,
/S/
Donald D. Ashley
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

Sincerely,
/S/
Richard A. Quaresima
Acting Associate Director Division of Advertising Practices
Federal Trade Commission

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