During the global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2), appears treatments and tests, that don’t get The FDA (Food and Drug Administration) approvement and so considered to be coronavirus fraud.
On November 30, the Administration reported that Avazo-Healthcare, LLC was selling adulterated and misbranded COVID-19 test kits and unapproved drug products with fraudulent COVID-19 claims.
Warning Letter About Coronavirus Fraud
In the warning letter FDA point out that was observed that on Avazo-Healthcare website, www.covidtests.shop, offers two COVID-19 antigen test kit products for sale: “COVID-19 Ag Rapid Test Cassette (Box of 25) for Qualitative Detection of SARS-CoV-2 Antigen in Swabs. CE.” and “COVID-19 Coronavirus Spike Glycoprotein Antigen Ag Rapid Test Kit by Sputum or Stool. CE. Box of 25.” (collectively, “COVID-19 antigen tests”).
“The COVID-19 antigen tests are offered for sale and distributed in the United States without marketing approval, clearance, or authorization from FDA. Accordingly, these products are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g).
These products are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). The introduction or delivery for introduction of this product into interstate commerce is prohibited under section 301(a) of the Act, 21 U.S.C. § 331(a).
In addition, it is a prohibited act under section 301(k) of the Act, 21 U.S.C. § 331(k), to do any act with respect to a device while the device is held for sale after shipment in interstate commerce and results in the device being misbranded,”- The FDA said.
How To Protect From The Fraud
On November FDA send 4 another warning letters to ChromaDex, Innovative Medicine LLC, Red Moon Herbs, Sage Woman Herbs, Ltd. dba Sage Consulting & Apothecary. Fraudulent COVID-19 products can come in many varieties, including dietary supplements and other foods, as well as products claiming to be tests, drugs, medical devices, or vaccines.
Here are some tips to identify false or misleading claims:
- Be suspicious of products that claim to treat a wide range of diseases.
- Personal testimonials are no substitute for scientific evidence.
- Few diseases or conditions can be treated quickly, so be suspicious of any therapy claimed as a “quick fix.”
- If it seems too good to be true, it probably is.
- “Miracle cures,” which claim scientific breakthroughs or contain secret ingredients, are likely a hoax.
If you have symptoms of COVID-19, follow the Centers for Disease Control and Prevention’s guidelines, and speak to your medical provider. Your health care provider will advise you about whether you should get tested and the process for being tested in your area.
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