WARNING LETTER
Ivermectin24h.com
MARCS-CMS 615637 —
February 25, 2022
Product:
Drugs
Recipient:
Ivermectin24h.com
United States
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
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
WARNING LETTER
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‐19
1
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.
Misbranded Drugs:
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.
Sincerely,
/S/
Donald D. Ashley
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
____________________________
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
President Donald J. Trump, Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID‐19) Outbreak. Mar. 13, 2020, 85 FR 15337, available at
https://www.federalregister.gov/documents/2020/03/18/2020‐05794/declaring‐a‐national‐emergency‐concerning‐the‐novel-coronavirus‐disease‐covid‐19‐outbreak
.
4
On March 28, 2020, FDA issued an Emergency Use Authorization (EUA), pursuant to section 564 of the FD&C Act [21 U.S.C. § 360bbb‐3], to permit the emergency use of hydroxychloroquine sulfate and chloroquine phosphate supplied from the Strategic National Stockpile to treat adults and adolescents who weigh 50 kg or more and are hospitalized with COVID‐19 for whom a clinical trial is not available, or participation is not feasible. On April 24, 2020, FDA issued a
Drug Safety Communication
cautioning against the use of hydroxychloroquine or chloroquine for COVID‐19 outside of either: (1) use in a hospital setting pursuant to FDA’s EUA; or (2) participation in a clinical trial investigating use of chloroquine or hydroxychloroquine for treatment of COVID‐19. FDA issued that Drug Safety Communication to remind patients and health care professionals of the known risk of serious heart rhythm problems associated with chloroquine and hydroxychloroquine. FDA
revoked
this EUA on June 15, 2020, based on FDA’s continuing review of available scientific evidence, including clinical trial results, that led FDA to determine that the statutory criteria for EUA as outlined in Section 564(c)(2) of the FD&C Act were no longer met. Specifically, FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID‐19 for the authorized uses under the EUA and that the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the formerly authorized uses. Authorizations and Revocation of Emergency Use of Drugs During the COVID‐19 Pandemic; Availability, 85 Fed. Reg. 56231 (Sept. 11, 2020) (available at
https://www.federalregister.gov/documents/2020/09/11/2020‐20041/authorizations‐and‐revocation‐of‐emergency‐use‐of‐drugs‐during‐the‐covid‐19‐pandemic‐availability
).
Content current as of:
03/15/2022
Regulated Product(s)
Drugs