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WARNING LETTER

Date: October 24, 2022

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://lakpura.com on September 26, 2022 and October 17, 2022, respectively. The FDA has observed that your website offers the products “Beam Suwa Dharani,” “Sethsuwa ‘Suwa Dharani’ Immune Enhancing Medicinal Drink,” “Siddhalepa Lakpeyawa,” “Siddhalepa Ayurveda Herbal Balm,” “Siddhalepa Cough Syrup,” “Siddhalepa Sarshapadi Oil,” “Siddhalepa Natural Asamodagam Spirit,” “Siddhalepa Kolaselesma Oil,” “Siddhalepa Live Long Healthy Pack,” and “Ceylon Teas” 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 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:

• “Beam Suwa Dharani . . . [A]pproved by the ayurvedic Department of Health, an immune-enhancing drink for the COVID-19 virus based on ancient indigenous prescription and treatment extracted from ancient ola leaf booklets.” [From your webpage https://lakpura.com/products/beam-suwa-dharani]
• “Sethsuwa ‘Suwa Dharani’ Immune Enhancing Medicinal Drink . . . [A]pproved by the ayurvedic Department of Health, an immune-enhancing drink for the COVID-19 virus based on ancient indigenous prescription and treatment extracted from ancient ola leaf booklets.” [From your webpage https://lakpura.com/products/sethsuwa-suwa-dharani-immune-enhancing-medicinal-drink-50g]
• “Covid 19 immunity boosting with ayurvedic products . . . Drink Siddhalepa Lakpeyawa twice a day to boost your immunity . . . Buy Siddhalepa Herbal Balm . . . Siddhalepa Cough Syrup for dry cough . . . Siddhalepa & Sharshapadi oil for respiratory discomforts . . . Gargle your throat thrice daily with Siddhalepa Asamodagam Spirit which has natural thymol derived from asamodagam seeds. Anticeptic [sic], antibacterial and antifungal activities of thymol helps [sic] to treat sore throat and minor oral inflammations . . . If you have symptoms of sore throat or throat infections, apply Kolaselesma oil on the sides of your neck . . . Energy booster – Siddhalepa healthy pack.” [From your webpage https://lakpura.com/pages/covid-19-immunity-boosting-with-ayurvedic-products]
• “While still in its preliminary findings, it has been noted that according to the latest research, the presence of theaflavin, a polyphenolic compound in black tea is said to have a medicinal value; thus acting as an inhibitor against several viruses, from influenza A and B, hepatitis C and even SARS-related viruses like COVID-19 . . . Shop online from our range of Ceylon black teas to reap the health benefits of this natural beverage.” [From your webpage https://lakpura.com/blogs/news/boost-your-immunity-with-ceylon-black-tea]

You should take immediate action to address this matter. 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 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 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 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 Richard Cleland, Assistant Director of the FTC’s Division of Advertising Practices, 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/

Carolyn E. Becker
Director
Office of Unapproved Drugs and Labeling Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

Sincerely,
/S/

Serena Viswanathan
Associate Director
Division of Advertising Practices
Federal Trade Commission

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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/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.