Florida Dental Products Firm Fails Regulatory Checkup With COVID-19 Claims
ACON Labs Recalls At-Home Tests Approved In Europe But Sold In US
Products Iotech International sells to health care providers and consumers are deemed unapproved new drugs and are misbranded due to claims to prevent and treat COVID-19. ACON Laboratories determined Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) is for sale in US without approval.
You may also be interested in...
Counterfeit versions of diagnostics from ACON Laboratories and iHealth are being illegally imported and sold in US. Alert also tells consumers how to spot counterfeit tests.
The agency says the diagnostics could produce inaccurate results, which may delay proper treatment and further the spread of COVID-19.
“MacuHealth believes challenged claims are thoroughly supported by the multitude of peer reviewed, published scientific studies” but NAD review on Vision Elements challenge finds firm’s research doesn’t support its claims.