December 14, 2020
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
Yesterday, the FDA posted the review memorandum outlining the basis of the agency’s decision to authorize the Pfizer-BioNTech COVID-19 Vaccine. To ensure all Americans can have trust and confidence in the carefulness of FDA’s review, we have made, and will continue to make, the vaccine review process as transparent as possible.
As part of the FDA’s effort to protect consumers, the agency issued warning letters jointly with the Federal Trade Commission to Indigenous Products, Heavenly Natural Products and Health & Wellness Center International One, L.L.C. dba Hotze Vitamins, three firms that sell unapproved and misbranded products with fraudulent COVID-19 claims, and iThrive.Health, a firm that promotes and participates in the sale of such products. Consumers concerned about COVID-19 should consult with their health care provider.