Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/antroidscom-606116-04222020
Timestamp: 2020-08-15 13:50:35
Document Index: 580619474

Matched Legal Cases: ['§ 355', '§ 352', '§ 331', '§ 321', '§ 321', '§ 355', '§ 331', '§ 360']

Antroids.com - 606116 - 04/22/2020 | FDA
Antroids.com - 606116 - 04/22/2020
Antroids.com MARCS-CMS 606116 — April 22, 2020
Antroids.com
admin@antroids.com
www.antroids.com
RE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs Related to Coronavirus Disease 2019 (COVID-19) to United States Consumers Over the Internet
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.antroids.com 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) 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. 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.
As labeled, certain products offered for sale by www.antroids.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.antroids.com offers lopinavir + ritonavir, marketed as “Lopimune 200mg/50mg,” under the heading “Coronavirus Treatment.” 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 “Lopimune 200mg/50mg” offered by www.antroids.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.[4]
In addition, www.antroids.com offers ritonavir, marketed as “Ritomune 100 mg,” under the heading “Coronavirus Treatment.” While there are FDA-approved versions of 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 “Ritomune 100 mg” offered by www.antroids.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.
Your website, www.antroids.com, also offers oseltamivir, marketed as “Fluvir 75 mg” and “Antiflu 75mg,” under the heading “Coronavirus Treatment.” While there are FDA-approved versions of oseltamivir 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 “Fluvir 75 mg” or “Antiflu 75mg” products offered by www.antroids.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.
[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.