FDA Accomplishments for the American People
We’ve done a lot in the first year—and we’re just getting started
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Removing artificial petroleum-based food dyes
Modernizing infant formula
Scrutinizing chemicals in food supply, such as BHT, BHA, and phthalates
Closing the "generally recognized as safe" (GRAS) loophole for food ingredients
Approving new natural food dyes
Writing new dietary guidelines
Ending the 70-year war on consuming natural fats
Creating a uniform definition for ultra-processed foods
Removing outdated orange juice regulations that hurt U.S. growers
Reviewing obsolete food identity standards
Initiated National Priority Vouchers
Cut red tape to accelerate biosimilars
Stopping unnecessary animal testing
Boosting domestic pharmaceutical manufacturing
Revised Covid-19 vaccine framework
Launched CEO listening tour with industry executives
Unleashing cutting-edge gene therapies
Approved first Alzheimer's blood test diagnostic
Removed restrictions on laboratory-developed tests
Expanded warnings about use of ADHD treatments in young children
Fixing opioid medication safety labeling
Removed boxed warning on HRT
Cracking down on misleading pharma ads
Addressed conflicts of interest on FDA advisory committees
Publishing FDA rejection letters
Banning Chinese gene editing of American cells and DNA
Seizing dangerous, illegal vapes
Removing non-FDA-approved fluoride tablets harming gut microbiome
Switching to surprise foreign factory inspections
Banning corporate limos from picking up FDA inspectors
Streamlining Canadian drug importation to fight high prices
Cracked down on falsified Chinese testing data
Issuing warnings against tianeptine, "gas station heroin"
Cracking down on concentrated 7-OH opioids
Launched FDA Direct for unscripted public communications
Provided a clear outline of priorities in JAMA article
Consolidating fragmented adverse event databases
Releasing adverse event reports in real time
Completed first AI-assisted scientific review pilot
Launched an internal AI tool - Elsa - to help FDA employees work more efficiently
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FDA Direct Podcast
Commissioner Makary and members of FDA Leadership, as well as other guests, engage in timely and frank discussions to bring you an inside look at the current happenings at the FDA.