WARNING LETTER
4nrx.md
MARCS-CMS 606115 —
May 13, 2020
Product:
Drugs
Recipient:
4nrx.md
United States
inquiry@4nrx.md
www.4nrx.md
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
FROM: The United States Food and Drug Administration
RE:         Notice of Unlawful Sale of Unapproved and Misbranded Drugs Related to Coronavirus Disease 2019 (COVID-19) to United States Consumers Over the Internet
DATE:    May 13, 2020
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.4nrx.md on April 17, 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-19
[1]
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), 301(d), and 301(k) of the FD&C Act, 21 U.S.C. § 331(a), 331(d), 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, 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.  As described below, you sell unapproved drug products that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.
There are inherent risks 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.  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.
Unapproved New Drugs:
As labeled, certain products offered for sale by www.4nrx.md 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, www.4nrx.md, lists lopinavir + ritonavir, hydroxychloroquine sulfate, and ribavirin under the heading “Coronavirus Treatments.” Your website offers lopinavir + ritonavir marketed as “Hivus LR” and “Lopimune.” It also states that “Lopinavir + Ritonavir (Hivus-LR) is a HIV treatment that has been central to most treatment plans for COVID-19 (2019-nCov coronavirus).” Additionally, your website states under the product heading “Lopimune (Lopinavir/Ritonavir)” that “COVID-19 (Coronavirus) is a new virus with over 75,000 confirmed cases and over 2,000 deaths. . . .No vaccine is currently available, but hospitals have been using Lopinavir/Ritonavir. . .to treat patients.” While there are FDA-approved versions of lopinavir + ritonavir on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Hivus LR” or “Lopimune” offered by www.4nrx.md. FDA-approved lopinavir + ritonavir is labeled for treatment of HIV-1 infection in combination with other antiretroviral agents in adults and pediatric patients, and is only available by prescription. In addition, no drug has yet been approved by the FDA for use in the prevention, diagnosis, treatment, mitigation, or cure of COVID-19.
[4]
Your website, www.4nrx.md, also offers hydroxychloroquine sulfate 0.1 g tablets.  Your website states “Hydroxychloroquine Sulfate has recently shown positive results in treatment of symptoms of COVID-19 (coronavirus).”  Your website also offers “Plaquenil” 0.2 g tablets and states that “Plaquenil (Hydroxychloroquine Sulfate) has recently shown positive results in treatment of symptoms of COVID-19 (coronavirus).”  While there are FDA-approved versions of hydroxychloroquine and “Plaquenil” on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the hydroxychloroquine or “Plaquenil” offered by www.4nrx.md.  FDA-approved hydroxychloroquine and Plaquenil are labeled for the treatment of uncomplicated malaria, lupus erythematosus, and rheumatoid arthritis, and are 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 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.
[5]
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.
[6]
In addition, no drug has yet been approved by the FDA for use in the prevention, diagnosis, treatment, mitigation, or cure of COVID-19.
In addition, www.4nrx.md offers ribavirin, marketed as “Ribasure.” Your website states under the product heading “Ribasure (Ribavirin)” that “Ribavirin has been recommended to treat COVID-19 (coronavirus) by some experts due to its effect on MERS (Middle East Respiratory Syndrome).”  While there are FDA-approved versions of ribavirin on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Ribasure” offered on www.4nrx.md
.
FDA-approved ribavirin is labeled for treatment of chronic hepatitis C in combination with other antiviral drugs, and is only available by prescription.  In addition, no drug has yet been approved by the FDA for use in the prevention, diagnosis, treatment, mitigation, or cure of COVID-19.
Misbranded Drugs:
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 (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, as described above, lopinavir + ritonavir, hydroxychloroquine, and ribavirin are prescription drugs 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 products safely for their intended uses.  Consequently, the labeling for these drugs fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the FD&C Act.  In addition, because these drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act.  By offering these drugs for sale to U.S. consumers, www.4nrx.md is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
Furthermore, under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a healthcare practitioner licensed by law to administer prescription drugs.  By offering lopinavir + ritonavir
,
hydroxychloroquine, and ribavirin without requiring a prescription, www.4nrx.md jeopardizes patient safety and misbrands the drugs 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)].
You should take immediate action to correct the violations cited in this letter.  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 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.
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) 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
.
Sincerely,
/S/
Donald D. Ashley
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Cc: MoldData S.E.
[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).
[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-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/).
[4]
FDA has 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.  However, this EUA does not constitute approval of these drugs for a COVID-19-related use and does not authorize the sale of unapproved hydroxychloroquine sulfate or unapproved chloroquine phosphate directly to consumers over the internet to treat COVID-19 or for any other use.
[5]
FDA Drug Safety Communication [04-24-2020] (Accessible at https://www.fda.gov/drugs/drug-safety-and-availability/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19).
[6]
Id.
Content current as of:
05/20/2020
Regulated Product(s)
Drugs