Generally Recognized as Safe (GRAS) is a determination that a substance added intentionally to food is deemed to be safe under its intended conditions of use. It is a notification process and not an approval process. Under the statute there are two options available to companies: One is to submit their safety data to the FDA. If the agency does not object to the determination, it will issue a letter of no objection, colloquially referred to as a “Good Day Letter”. Notifications to FDA are publicly available via the FDA’s GRAS inventory.
The FDA has completed and published more than 1,000 GRAS notices and reportedly evaluates approximately 75 notices per year.
The other option is to convene an independent panel of experts and have them assess the safety data. This is what is known as self-affirmed GRAS. A company is not required to notify FDA of its self-affirmed status, and there is no public database or listing of self-affirmed ingredients.
Secretary Kennedy discussed the GRAS pathways during his confirmation hearings and is now directing the acting FDA commissioner to take steps to explore potential rulemaking to revise its Substances GRAS Final Rule and related guidance to eliminate self-affirmed GRAS.
“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,” Secretary Kennedy stated in a press release.
“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.”
HHS also stated that it is seeking to work with Congress to explore ways legislation can “completely close the GRAS loophole.”
Don’t panic!
Commenting on the news, Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA), told NutraIngredients that this is “exploratory at this stage regarding “how the GRAS process can be ‘healthier’”, which deserves a look, especially as it relates to enforcement.
“We know some will likely rush to panic, I would caution against that as it doesn’t make for good policy: The tough discussions have been avoided for too long including aligned topics like state pre-emption as we now have states speaking up about what is in or out of the food supply which was never intended to be their role,” Dr. Fabricant said.
Ivan Wasserman, managing partner at Amin Wasserman Gurnani, LLP, told us: “There are a lot of things the new administration is doing that should cause panic. This is not one of them; not yet at least. A change to require all ingredients be approved by FDA before being added to foods or supplements would require Congress to change the law. This notice appears to be directed to possibly making mandatory the now-existing voluntary FDA GRAS notification program, where companies essentially submit their GRAS self-affirmations to FDA for its blessing.
“If and when that happens, which is as impossible to predict as anything in government these days, as always the devil will be in the details,” Wasserman added. “Would it only apply to ingredients going forward? If there is no grandfathering and FDA were to require all ingredients currently on the market be submitted for its review, how long would that process take? Years? Decades? Against the backdrop of massive layoffs and defunding programs, that certainly seems possible. Would FDA somehow triage ingredients and require notifications for some before others? Wholesale exempt some categories of ingredients? Outsource the reviews to private entities? The possibilities are endless.
“We will of course be actively monitoring for any developments, but in the meantime we should continue to ensure that the GRAS determinations of any ingredients used in foods or supplements will withstand the most rigorous scrutiny. Such determinations will most likely sail through a mandatory FDA notification process and, much more importantly, will ensure the continued safety of foods and supplements.”
CRN: Focus on strengthening enforcement mechanisms to ensure the GRAS process is used responsibly
“Rather than dismantling a system that allows scientifically reviewed ingredients to reach the market efficiently, FDA should focus on strengthening enforcement mechanisms to ensure the GRAS process is used responsibly,‘ said Andrea Wong, PhD, SVP of Scientific and Regulatory Affairs, for the Council for Responsible Nutrition (CRN).
“CRN shares the goal of increasing safety and transparency for consumers and stands ready to work with the FDA to achieve it. The solution is not to eliminate self-GRAS, which would stifle innovation, but to provide FDA with the resources and tools it needs to maintain an effective regulatory system that fosters both safety and progress.”
EWG: Our food chemical safety system is broken
In a statement, Scott Faber, senior vice president for government affairs for the Environmental Working Group, said: “The fact that chemical companies can conclude a chemical is safe to eat and then bring it onto the market without first notifying the FDA shows just how broken our food chemical safety system has become.
“Simply pledging to ‘take steps to explore’ changing a system that has been broken for more than 60 years is not the change consumers rightly expect. Until the FDA takes real action to put itself in charge of food chemical safety, this announcement is best seen as a ‘plan to plan,’ not real progress toward ensuring our food is safe.
“This announcement merely suggests that chemical companies must tell the FDA when the companies, not the FDA, have concluded the chemicals we eat are safe. This announcement will not in any way ensure that the food chemicals are reviewed by the FDA or that the chemicals we eat are actually safe. And it will not change the fact that 99% of food chemicals are reviewed for safety by the chemical companies, not the FDA.
“Congress intended that 99%, not 1%, of chemicals are reviewed for safety by the FDA, not the chemical companies. Sadly, the reverse is true. It remains to be seen whether the agency will restore the intent of Congress or will instead preserve a system that allows chemical companies to submit summaries of chemical industry science to the FDA for its ratification.”
This is a developing story and we will be updating this article as more comments are shared.
