FDA: Fraudulent COVID-19 medical products abound
Numerous PPEs and testing kits also feature unproven coronavirus claims.
FDA has warned more than 40 companies that have made fraudulent medical claims relating to COVID-19.
The agency has sent 42 warning letters to companies making fake COVID-19 claims, including to a seller of fraudulent chlorine dioxide products, equivalent to industrial bleach, as a treatment for COVID-19.
Related: FDA, FTC warn suppliers of fraudulent COVID-19 products
The chorine dioxide products are frequently referred to as “Miracle Mineral Solution” or “MMS.”
"After the seller refused to take corrective action, a federal court issued a preliminary injunction requiring the seller to immediately stop distributing its unproven and potentially dangerous product,” FDA said in a press release.
FDA has also discovered hundreds of fraudulent drugs, testing kits and personal protective equipment (PPE) sold online with unproven claims.
“We continue to work with online marketplaces, domain name registrars, payment processors and social media websites to remove from their platforms products that fraudulently claim to mitigate, prevent, treat, diagnose, or cure COVID-19 and to keep those products from reappearing under different names,” the agency said.
“While we seek to ensure access to critical medical products, it is imperative that we continue our efforts to find and prevent the sale and distribution of products that may be harmful to the public health. Americans can rest assured that we’re leveraging our experience investigating, examining, and reviewing medical products, both at the border and within domestic commerce, to help ensure that the critical resources reaching the frontlines in the battle against COVID-19 are appropriate,” said FDA Associate Commissioner for Regulatory Affairs Judy McMeekin, PharmD.
Related: Drugmaker halts access to COVID drug as FDA approves novel test
FDA is also keeping unproven products out of the country. It recently intercepted and investigated a case of mislabeled COVID-19 “treatment kits” offered for import.
“As a result, special agents with the FDA’s Office of Criminal Investigations, with the help of domestic and international law enforcement counterparts in the United Kingdom, led the Department of Justice to bring a criminal complaint against a British man who sought to profit from this pandemic and jeopardize public health,” the FDA said.
FDA Approves Two More Denosumab Biosimilars, Conexxence and Bomyntra
March 27th 2025The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, as a result of a global settlement with Amgen, according to a company news release.
Read More
FDA Approves First Drug for Excess Hunger in Prader-Willi Syndrome
March 27th 2025Vykat XR will be available in April to treat the intense hunger that is a hallmark of the rare genetic disease Prader-Willi syndrome. The price is based on a patient’s weight, and the average patient in the clinical trials would have had an average annual cost of $466,200 for the first year.
Read More
FDA Approves Amvuttra for ATTR-CM in Extended Label
March 21st 2025This expanded indication for Amvuttra makes it the first and only FDA-approved treatment for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.
Read More
