FDA Accomplishments for the American People
We’ve done a lot in the first six months—and we’re just getting started
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Removing petroleum-based food dyes from the U.S. food supply
Facilitating new infant formula options without seed oils and heavy metals
Scrutinizing chemicals in food supply, such as BHT, BHA, and phthalates
Closing the "generally recognized as safe" (GRAS) loophole for food ingredients
Approved four new natural food dyes
Creating new dietary guidelines that address ultra-processed foods
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Removing outdated orange juice regulations that hurt U.S. growers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
Stopping unnecessary animal testing
Piloting program to reduce drug approval times from 10-12 months to 1-2 months
Launched FDA PreCheck to bring drug manufacturing back to the U.S.
Adopted a revised Covid-19 vaccine regulatory framework
Launched CEO listening tour with industry executives
Unleashing cell and 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
Revised labeling on opioid pain medications to accurately reflect risk
Cracking down on misleading pharmaceutical advertisements
Addressed conflicts of interest on FDA advisory committees
Started publishing FDA rejection letters
Banning Chinese gene editing of American cells and DNA
Seized $34 million worth of dangerous, illegal Chinese 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"
Initiated process to schedule concentrated 7-OH opioid products as a controlled substance
Launched FDA Direct for unscripted public communications
Provided a clear outline of priorities in JAMA article
Consolidating fragmented adverse event databases
Began releasing adverse event reports on daily basis
Completed first AI-assisted scientific review pilot
Launched an internal AI tool - Elsa - to help FDA employees work more efficiently
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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.