- Issuing Office:
- Center for Drug Evaluation and Research | CDER
FROM: The United States Food and Drug Administration
RE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet
DATE: July 9, 2020
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.hydroxychloroquine‐online.com on June 23, 2020. The FDA has observed that your website offers drug products for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID‐191 and other diseases such as malaria in humans. 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, the President declared 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. In addition to other unapproved products offered on your website, FDA has observed that your website offers drug products for sale in the United States that are intended to mitigate, prevent, treat, diagnose, or cure COVID‐19 in people.
There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. 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 take immediate action to cease the sale of all such unapproved and 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 for distribution in the United States by the FDA.
Unapproved New Drugs:
As labeled, certain products offered for sale by www.hydroxychloroquine‐online.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. These drugs are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. No approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) [21 U.S.C. § 331(d)] and 505(a) of the FD&C Act.
For example, your website www.hydroxychloroquine‐online.com offers chloroquine phosphate, marketed as “Generic Aralen.” Your website states “Generic Aralen is an anti‐malaria medicine. . . . And on the 4th of February 2020, the lab researches (sic) showed that the drug was also effective in stopping the COVID‐2019 virus from spreading in human cells.” While there are FDA‐approved versions of chloroquine on the market in the United States, there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the
chloroquine phosphate or “Generic Aralen” offered by www.hydroxychloroquine‐online.com. FDA‐approved chloroquine is labeled for treatment of malaria and extraintestinal amebiasis, and is only available by prescription. Furthermore, 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 [insert chloroquine or hydroxychloroquine] for treatment of COVID‐19. FDA issued the recent Drug Safety Communication to remind patients and health care professionals of the known risk of serious heart rhythm problems associated with chloroquine and hydroxychloroquine.4 FDA warned that hydroxychloroquine and chloroquine can cause abnormal heart rhythms such as QT interval prolongation and a dangerously rapid heart rate called ventricular tachycardia. FDA also stated that hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID‐19.5 In addition, no drug has yet been approved by the FDA for use in the prevention, diagnosis, treatment, mitigation, or cure of COVID‐19.6
A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if it fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)] include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Because the aforementioned drug is a prescription drug intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the product safely for the intended uses. Consequently, the labeling for this drug fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1) of the FD&C Act. In addition, because this drug is not approved in the United States, it is also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering this drug for sale to United States' consumers, www.hydroxychloroquine‐online.com is 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 taking this action against www.hydroxychloroquine‐online.com because of the inherent risk to consumers who purchase misbranded and unapproved new drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.
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 correct the violation noted above as well as any other violations of the FD&C Act (which would include the offer for sale of any misbranded and/or unapproved new drug, not just the drug 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 do not make claims that misbrand the 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 correct these violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and 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, 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. 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 product that cannot be legally sold to consumers in the United States.
Please direct any inquiries to FDA at FDAInternetPharmacyTaskForce‐CDER@fda.hhs.gov and COVID‐19‐Task‐Force‐CDER@fda.hhs.gov.
Donald D. Ashley
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 Alex M Azar, Determination that a Public Health Emergency Exists. Jan. 31, 2020. (Accessible at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019‐nCoV.aspx). The declaration was renewed for another 90 days on April 21, 2020. Secretary of Health and Human Services Alex M. Azar II, Renewal of Determination that a Public Health Emergency Exists. April 21, 2020. (Accessible at https://www.phe.gov/emergency/news/healthactions/phe/Pages/covid19‐21apr2020.aspx).
3 President Donald J. Trump, Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease
(COVID‐19). Mar. 13, 2020. (Accessible at https://www.whitehouse.gov/presidential‐actions/proclamation‐declaring‐nationalemergency‐concerning‐novel‐coronavirus‐disease‐covid‐19‐outbreak/).
4 FDA Drug Safety Communication [04‐24‐2020] (Accessible at https://www.fda.gov/drugs/drug‐safety‐and‐availability/fdacautions‐against‐use‐hydroxychloroquine‐or‐chloroquine‐covid‐19).
6 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. FDA revoked this EUA on June 15, 2020, based on new information, including clinical trial results, leading the Biomedical Advanced Research and Development Authority (BARDA) to conclude that the drug may not be effective to treat COVID‐19 and that the drug’s potential benefits for such use do not outweigh its known and potential risks. FDA has also issued an EUA for remdesivir, which allows for remdesivir to be distributed in the United States and administered intravenously by health care providers to treat suspected or laboratory‐confirmed COVID‐19 in adults and children hospitalized with severe disease. Severe disease is defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator. Although the EUA for remdesivir is still in effect at this time, it does not constitute approval of this drug for a COVID‐19‐related use and does not authorize the sale of unapproved remdesivir directly to consumers over the internet to treat COVID‐19 or for any other use.