Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. is directing the FDA commissioner to revise its Substances Generally Recognized as Safe (GRAS) Final Rule, which critics say food manufacturers exploit to add new ingredients and chemicals into products.
"HHS Secretary Robert F. Kennedy Jr. is directing the acting FDA commissioner to take steps to explore potential rulemaking to revise its Substances Generally Recognized as Safe (GRAS) Final Rule and related guidance to eliminate the self-affirmed GRAS pathway. This will enhance the FDA's oversight of ingredients considered to be GRAS and bring transparency to American consumers," the HHS stated in a press release.
"For far too long, ingredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the U.S. food supply without notification to the FDA or the public," RFK Jr. said.
"Eliminating this loophole will provide transparency to consumers, help get our nation's food supply back on track by ensuring that ingredients being introduced into foods are safe, and ultimately Make America Healthy Again," he added.
"I am directing the FDA commissioner to start the process of changing the rules to eliminate the self-affirmed GRAS pathway for new ingredients. I am also calling on the @US_FDA and @NIH continue to conduct and improve post-market assessments of GRAS chemicals currently in our food so we can rapidly identify the compounds that are making Americans so sick, and so that American consumers and regulators can make informed decisions," RFK Jr. wrote on X.
"This is an important step in our pursuit to Make America Healthy Again," he added.
Currently, the FDA strongly encourages manufacturers to submit GRAS notices through the agency's GRAS Notification Program, but industry can self-affirm that the use of a substance is GRAS without notifying the FDA. The FDA has completed and published more than 1,000 GRAS notices and evaluates an average of 75 notices per year. The agency maintains a public inventory where all GRAS notices that have been filed by the agency, along with the supporting data, and FDA's final agency response letters are available for review and download by the public.
Eliminating the self-affirmation process would require companies seeking to introduce new ingredients in foods to publicly notify the FDA of their intended use of such ingredients, along with underlying safety data, before they are introduced in the food supply.
"The FDA is committed to further safeguarding the food supply by ensuring the appropriate review of ingredients and substances that come into contact with food," said Acting FDA Commissioner Sara Brenner, M.D., M.P.H. "The FDA will continue to follow our authorities and leverage our resources to protect the health of consumers to ensure that food is a vehicle for wellness."
Nearly 99% of new chemicals used in food or food packaging since 2000 were green-lit for use not by the FDA but by the food and chemical industry, according to a 2022 analysis.
During that period, food manufacturers asked the FDA's permission to introduce a new substance only 10 times, according to the analysis conducted by the Environmental Working Group, or EWG, an environmental and health advocacy organization based in Washington.
In related news, RFK Jr. told top executives of major food processing companies in a closed-door meeting that he wants them to remove artificial dyes from their products.