FDA Roundup: March 28, 2023

SILVER SPRING, Md., March 28, 2023 /PRNewswire/ --Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

• Today, the FDA released an Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market. The strategy follows a months-long infant formula shortage sparked by unsanitary conditions at one of the nation’s largest infant formula facilities, which led to a significant voluntary recall and multiple-month production shutdown.
  • As directed by Congress in the Food and Drug Omnibus Reform Act of 2022, the national strategy describes immediate actions the FDA took to address the infant formula shortage and details the agency’s plans for improving the resiliency of the infant formula supply, while noting multiple issues beyond the purview of the FDA.
  • It also traces the events that led up to and followed the voluntary recall of infant formula by Abbott Nutrition in February 2022, the temporary pause in production at the facility in Sturgis, Michigan, and pantry loading that peaked in May 2022, likely driven in part by an overemphasis on other shortages being reported in the media, as well as numerous other factors that contributed to and exacerbated the shortages.
• On Monday, the FDA launched a new webpage about the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) and a related constituent update announcing that the FDA has stopped accepting and processing submissions to the Voluntary Cosmetic Registration Program (VCRP).
  • MoCRA is the most significant expansion of the FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938. This new law gives the FDA new authorities that will help ensure the safety of cosmetic products many consumers use daily. The webpage will house information about MoCRA and its implementation.

  • MoCRA requires certain companies to register their facilities and list their products with FDA. Because of this, FDA is creating a new system to handle the large number of submissions that will result. FDA therefore will no longer use the voluntary registration system and is no longer accepting and processing submissions to the VCRP.

    We request that cosmetics companies wait to register with FDA until we announce the availability of the new system. Information in the VCRP will not be transferred to the program being developed for facility registrations and product listings mandated by MoCRA.

• On Monday, the FDA published the FDA Voices: “Improving Health through Nutrition Requires Continued Progress,” by Susan Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition. The FDA is embracing White House’s National Strategy on Hunger, Nutrition and Health through the agency’s nutrition programs. Our work on sodium reduction is a prime example of how the FDA is contributing to the strategy of the White House conference. Even after 50 years, National Nutrition Month is more important than ever and FDA’s work to facilitate the reduction of sodium in the food supply, and to improve menu and nutrition labeling, is empowering consumers and increasing the availability of healthier foods for all.
• COVID-19 testing updates:
  • As of today, 445 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 300 molecular tests and sample collection devices, 84 antibody and other immune response tests, 60 antigen tests, and one diagnostic breath test. There are 78 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, two EUAs for antigen prescription at-home tests, 28 EUAs for antigen over-the-counter (OTC) at-home tests, and five for molecular OTC at-home tests.
  • The FDA has authorized 45 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 1324 revisions to EUA authorizations.

Additional Resources:

• FDA Newsroom

Media Contact: FDA Office of Media Affairs, 301-796-4540
Consumer Inquiries: 888-INFO-FDA

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.

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SOURCE U.S. Food and Drug Administration