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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 a manufacturing change for the Moderna COVID-19 Vaccine to include an additional presentation of the vaccine for booster vaccination doses only. The new presentation is supplied in multiple dose vials with dark blue caps and labels with a purple border. The Moderna COVID-19 Vaccine is now authorized for individuals 18 years of age and older in two presentations: 1) multiple dose vials with red caps and labels with a light blue border, formulated to provide doses for primary vaccination (each 0.5 mL dose containing 100 mg mRNA) or doses for booster vaccination (each 0.25 mL dose containing 50 mg mRNA); and 2) multiple dose vials with dark blue caps and labels with a purple border, formulated to provide doses for booster vaccination only (each 0.5 mL dose containing 50 mg mRNA).
- As part of the FDA’s effort to protect consumers, the agency issued warning letters jointly with the Federal Trade Commission to two companies for selling unapproved products with unproven COVID-19 claims. Consumers concerned about COVID-19 should consult with their health care provider. The companies that received warning letters are:
- Today, the FDA added information about leveraging validation data from a study on the adequacy of pediatric self-swabbing to collect a sample for COVID-19 diagnostic testing. The new information is found at COVID-19: Test Development and Review and includes:
- The addition of the following question and answer:
- I want to offer my COVID-19 diagnostic test for pediatric self-swabbing. Is validation data available to leverage to support this indication?
- An update to the following question and answer:
- Can I leverage validation data that has already been reviewed by the FDA for another test?
- On March 28, a federal judge entered a consent decree of permanent injunction between the FDA and Bravo Packing, Inc., prohibiting the company from selling, manufacturing and distributing adulterated pet food until the firm takes specific corrective measures and demonstrates to the FDA that they will comply with the Federal Food, Drug and Cosmetic (FD&C) Act. Bravo Packing Inc., of Carneys Point, New Jersey, has had numerous health and safety violations and was issued a warning letter in 2020. This is the first consent decree of permanent injunction against an animal food manufacturer for violating public safety standards under Part 507 (Current Good Manufacturing Practice (CGMP) requirements) of the Food Safety Modernization Act (FSMA) Preventive Controls for Animal Food Regulation. Part 507 requires, among other things, that animal food facilities take adequate precautions to prevent animal food from becoming contaminated and that all animal food manufacturing, processing, packing, and holding is conducted under the conditions necessary to minimize the potential for the growth of undesirable microorganisms to protect against the contamination of animal food.
- As part of the FDA’s effort to protect consumers, the agency issued warning letters jointly with the Federal Trade Commission to seven companies for selling CBD products using research studies to claim or imply misleadingly that their CBD products will cure, mitigate, treat or prevent COVID-19. Consumers concerned about COVID-19 should consult with their health care provider. The companies that received warning letters are:
The FDA has not approved or authorized any drug containing CBD for the treatment or prevention of COVID-19. The agency is concerned these deceptive and misleading product claims could cause people to delay or stop appropriate medical treatment for COVID-19, leading to serious and life-threatening harm. Learn more about how to protect yourself from Fraudulent Coronavirus Tests, Vaccines and Treatments and report suspected health fraud.
- COVID-19 testing updates:
- As of today, 425 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 293 molecular tests and sample collection devices, 84 antibody and other immune response tests and 48 antigen tests. There are 74 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, 15 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
- The FDA has authorized 28 antigen tests and 9 molecular tests for serial screening programs. The FDA has also authorized 906 revisions to EUA authorizations
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