Ivermectin24h.com

FROM: The United States Food and Drug Administration

RE: Notice of Unlawful Sale of Misbranded Drugs to United States Consumers Over the Internet

DATE: February 25, 2022

This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) reviewed your website at the Internet address www.ivermectin24h.com on December 13, 2021. FDA has observed that your website offers drug products for sale in the U.S. and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID‐191 and a variety of other diseases such as malaria, lupus erythematosus, and rheumatoid arthritis. Based on our review, these products are misbranded drugs under section 503(b) of the FD&C Act [21 U.S.C. § 353(b)]. The introduction or delivery for introduction of these products into interstate commerce is prohibited under sections 301(a) and 301(k) of the FD&C Act [21 U.S.C. §§ 331(a) and 331(k)].

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, FDA has observed that your website offers drug products for sale in the U.S. that are intended to mitigate, prevent, treat, diagnose, or cure COVID‐19 in people.

There are inherent risks to consumers who purchase misbranded drugs. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. We request that you cease the sale of any misbranded products, whether for the mitigation, prevention, treatment, diagnosis, or cure of COVID‐19, or any other disease for which the drugs you are selling are not approved by FDA for distribution in the U.S.

Certain products offered for sale by www.ivermectin24h.com are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body.

For example, www.ivermectin24h.com offers hydroxychloroquine marketed as “Hydroxychloroquine.” Your website’s homepage features the question, “Worried about CORONAVIRUS?” accompanied by a “BUY NOW” button. From this “BUY NOW” button, your website directs customers to the product page for the “Hydroxychloroquine” offered by www.ivermectin24h.com. Your website states, “Hydroxychloroquine is a medication that can be used to treat multiple diseases including malaria, Lupus Erythematosus, and Rheumatoid Arthritis.” FDA‐approved hydroxychloroquine is labeled for the treatment of uncomplicated malaria, discoid and systemic lupus erythematosus, and acute and chronic rheumatoid arthritis and is only available by prescription. In addition, hydroxychloroquine has not been approved by FDA for use in the prevention, diagnosis, treatment, mitigation, or cure of COVID‐19.4

FDA‐approved drug products containing hydroxychloroquine (also marketed as Plaquenil) are limited by their approved applications to use under the supervision of a licensed practitioner to administer such drugs. Therefore, hydroxychloroquine is a prescription drug as defined in section 503(b)(1)(A) of the FD&C Act (21 U.S.C. § 353(b)(1)(A)), because, in light of its toxicity or potential for harmful effects, the method of its use, or the collateral measures necessary for its use, it is not safe for use except under the supervision of a practitioner licensed by law to administer such a drug. By offering the aforementioned drug without requiring a prescription, www.ivermectin24h.com jeopardizes patient safety and misbrands the drug under section 503(b)(1) of the FD&C Act. Dispensing a prescription drug without a prescription is an act which results in the drug being misbranded while held for sale, in violation of section 301(k) of the FD&C Act [21 U.S.C. § 331(k)]. By offering this drug for sale to U.S. consumers, www.ivermectin24h.com is also causing the introduction of a misbranded drug into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].

FDA is sending this Warning Letter to www.ivermectin24h.com because of the inherent risk to consumers who purchase misbranded drugs. This letter is not intended to identify all the ways in which your products or operations might be in violation of the law. It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded drugs other than the drugs noted above). 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 use for which they have not been approved by FDA and that you are not distributing misbranded products in violation of the FD&C Act.

Within 48 hours, please send an email to FDAInternetPharmacyTaskForce‐CDER@fda.hhs.gov and COVID‐19‐Task‐Force‐CDER@fda.hhs.gov describing the specific steps you have taken to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately address this matter may result in legal action, including, without limitation, seizure and injunction, without further notice. 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. This letter notifies you of our concerns and provides you with an opportunity to address them. 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 within 48 hours.

If you are not located in the U.S., please note that products that appear to be misbranded drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be misbranded products that cannot be legally sold to consumers in the U.S.

Please direct any inquiries to FDA at FDAInternetPharmacyTaskForce‐CDER@fda.hhs.gov and COVID‐19‐Task‐Force‐CDER@fda.hhs.gov.