FDA News Release
FDA Roundup: June 10, 2022
- For Immediate Release:
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- Today, the FDA authorized the marketing of two new tobacco products through the Premarket Tobacco Product Application (PMTA) pathway. The FDA issued marketing granted orders to NJOY LLC for its tobacco-flavored Daily disposable e-cigarettes, specifically, NJOY Daily Rich Tobacco 4.5% and NJOY Daily Extra Rich Tobacco 6%. The FDA also issued marketing denial orders to NJOY for multiple other Daily branded e-cigarette products. Applications for two menthol-flavored Daily products remain under FDA review.
- On Thursday, the FDA warned about the potential dangers of products for treating moles, seborrheic keratoses, or skin tags. The agency is advising consumers to avoid these products because of their potentially harmful side effects and serious risks. These risks include skin injuries, infection requiring antibiotics, scarring, and delayed skin cancer diagnosis and treatment. Currently, there are no FDA-approved prescription or nonprescription drugs, or legally marketed over-the-counter (OTC) monograph drugs for treating these lesions.
- COVID-19 testing updates:
- As of today, 437 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 302 molecular tests and sample collection devices, 85 antibody and other immune response tests, 49 antigen tests, and 1 diagnostic breath test. There are 80 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 17 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
- The FDA has authorized 27 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1000 revisions to EUA authorizations.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- FDA Office of Media Affairs