WARNING LETTER
Extrapharma.com
MARCS-CMS 607931 —
September 02, 2020
Product:
Drugs
Recipient:
Extrapharma.com
Russia
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
DATE: September 2, 2020
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.extrapharma.com on August 10, 2020. The 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
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and a variety of other diseases, such as bacterial infections of the ear, skin, soft tissue, and airways, as well as sexually‐transmitted bacterial infections such as “chlamydia, non‐specific urethritis, ureaplasma urealyticum and mycoplasma genitalium.” 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). We note that there are numerous unapproved and misbranded drugs offered for sale on your website. The violative products listed in this letter are intended to be examples that are illustrative of the violations we observed on your website.
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.
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In addition, on March 13, 2020, the President declared a national emergency in response to COVID‐19.
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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 that are claimed to treat, for example, bacterial infections, 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 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 U.S. by the FDA.
Unapproved New Drugs:
As labeled, certain products offered for sale by www.extrapharma.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, www.extrapharma.com offers Arbidol and states that “ARBIDOL blocks viruses and helps to eliminate them” and that “Arbidol has proven activity against influenza A and B viruses (including “swine” and “avian”), parainfluenza, coronavirus, as well as other major causative agents of respiratory infections. . . .” There are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the Arbidol offered by www.extrapharma.com. In addition, no drug has yet been approved by the FDA for use in the prevention, diagnosis, treatment, mitigation, or cure of COVID‐19.
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Your website, www.extrapharma.com, also offers amoxicillin, marketed as “Amoxil”, under the heading of “ANTIBIOTICS.” While there are FDA‐approved versions of amoxicillin 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 amoxicillin or “Amoxil” offered by www.extrapharma.com. FDA‐approved amoxicillin is labeled for treatment of infections due to susceptible strains of designated microorganisms and is only available by prescription.
Another example of an unapproved new drug offered by www.extrapharma.com is azithromycin, marketed as “Zithromax,” which your website states “is highly effective in treating infections in the skin, ears, soft tissue. . . . “ Additionally your website states, “Azithromycin is used to treat bacterial infections such as chlamydia, non‐specific urethritis, ureaplasma urealyticum and mycoplasma genitalium.” While there are FDA‐approved versions of azithromycin 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 azithromycin or “Zithromax” offered by www.extrapharma.com. FDA‐approved azithromycin is labeled for use in treating mild to moderate infections caused by susceptible strains of designated microorganisms in specific conditions and is only available by prescription.
In addition, www.extrapharma.com offers additional unapproved new drugs to U.S. consumers that are under the category of “fitness and bodybuilding.” We note that the labeling for these drugs is not in English, thus demonstrating that these drugs are not intended for the U.S. market.
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 (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 drugs 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 fail 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.extrapharma.com 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)].
FDA is taking this action against www.extrapharma.com because of the inherent risk to consumers who purchase misbranded and unapproved new 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 correct the violations noted above as well as any other violations of the FD&C Act (which would include the offer for sale of similarly misbranded and/or unapproved new 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 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 U.S., 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 U.S. We may advise the appropriate regulatory officials in the country from which you operate that FDA considers your products referenced above to be unapproved and 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
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As explained in the next paragraph, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID‐19).
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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).
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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/).
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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 U.S. and administered intravenously by health care providers to treat suspected or laboratory confirmed COVID‐19 in hospitalized adult and pediatric patients irrespective of their severity of disease. 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.
Content current as of:
09/08/2020
Regulated Product(s)
Drugs