- For Immediate Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- Today, the FDA revised its Emergency Use Authorization (EUA) to reflect changes in the distribution and allocation of the antiviral drug Veklury (remdesivir). More information about the revised EUA can be found here.
- The FDA has issued a warning letter to Kerri Rivera and her company KetoKerri, LLC, for the sale of unapproved and misbranded drugs related to the Coronavirus. Products “KK Black Seed Oil,” “KK Breakthrough Vitamin D with Chondroitin & Oleic”, “Stonebreaker,” “KK EDTA with Selenium and Minerals,” “Zeolite,” “Ultra Liquid Zeolite,” and “DR. FITT FIRE FIGHTERS” make fraudulent claims to mitigate, prevent, treat, or cure COVID-19 in people. The 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), and are also misbranded under section 502 of the FD&C Act, 21 U.S.C. § 352.
- Testing updates:
- As of today, 265 tests are authorized by FDA under EUAs; these include 210 molecular tests, 51 antibody tests, and 4 antigen tests.
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.