Generally Recognized as Safe (GRAS) has been a subject of discussion for much of 2025 with Robert F Kennedy Jr. seeking to “close the loophole” on the ability of the food industry to self affirm a GRAS without notice to FDA.
The FDA recently published a Notice of Proposed Rulemaking to amend the GRAS regulations (21 CFR 170 & 570) to require the mandatory submission of GRAS notices for the use of human and animal food substances “purported to be GRAS.” The NPRM was included as part of the Spring 2025 Agency Rule List, but it was just released in early September.
Food substances are defined as both ingredients as well as substances which are added indirectly (such as from food packing). The rule, as proposed, would:
- Apply to both new GRAS notices as well as existing GRAS substances; however, those listed or affirmed as GRAS for the intended use by regulation and those for which FDA has already issued a GRAS no questions letter would be exempted.
- Detail a public-facing GRAS notice inventory, maintained and updated by FDA, for all substances that are the subject of mandatory GRAS notice for its conditions of intended use.
- Clarify the process under which FDA would determine that a substance is not GRAS.
It has been estimated that about 10% of GRAS substances used in food were self-determined as GRAS by the food company without notification to the FDA. While this is currently an accepted practice under the GRAS framework, and most companies using the option do conduct a very robust assessment, it has been questioned as a viable method for determining the safety of a substance. As discussed in a previous article, the use of a new food or color additive requires a scientific review and evaluation process conducted by the FDA. Although the GRAS process requires the same level of scientific evidence of safety, it does not (currently) require FDA notification. Instead, it must achieve a “general recognition of safety” by qualified experts based on scientific evidence that is widely known and/or publicly available.
There is already some controversy over the proposed rule, with some questioning whether FDA has the legal authority to mandate FDA notification, according to the statutory provisions cited in the NPRM. Additionally, even if it is determined to be legally viable, does FDA have the staff to conduct all the assessments that would be needed? Regardless, the dialogue on this potentially contentious issue will continue.
COVID Risk Matrix:
Influenza:
Public Health News:
- A recent meeting of animal health experts discussed ongoing research of highly pathogenic H5 avian influenza transmission among dairy cows, based on sampling of 14 California dairies. The work detected infectious viral particles in the air, which may lead to aerosol transmission, and in manure lagoons. They also suggested that milking equipment may play a role in transmission. Risk management efforts should primarily focus on the milking parlor and in waste management, as well as the use of effective personal protective equipment.
- Cases of Ebola virus disease have spread further in a remote part of the Democratic Republic of the Congo, with more than 60 suspect cases reported. 16 deaths have been reported.
- Alpha-Gal Syndrome has been named as a reportable condition in West Virginia.
- European health officials warn that the multidrug-resistant and deadly yeast Candida auris (Candidozyma auris) is spreading in some European hospitals. Since 2020, more than 3,000 cases have been reported, but since surveillance is not robust, it is suspected that many more cases are occurring. The five countries with highest C. auris case numbers were Spain, Greece, Italy, Romania, and Germany.
- Two new studies estimate the serious health and economic consequences if HIV prevention programs in the U.S. are reduced or defunded. The first study, led by Emory University, projects that even modest cuts to access to PrEP (a medication that prevents HIV) could result in over 8,600 new infections and $3.6 billion in healthcare costs over the next decade, with larger cuts potentially leading to nearly 27,000 additional infections. The second study, from Johns Hopkins, predicts that ending or interrupting services like the Ryan White HIV/AIDS Program could lead to up to 75,000 more infections by 2030, nearly a 50% increase overall, with some cities like Baltimore seeing infections more than double. Both studies emphasize that cutting HIV prevention and treatment programs now would reverse progress, increase healthcare costs, and worsen public health outcomes.
- The USDA APHIS NVSL confirmed a detection of highly pathogenic avian influenza H5N1 clade 2.3.4.4b, genotype B3.13 in a dairy cattle herd in Nebraska. This was found in pre-movement surveillance milk samples. This marks the first known case of HPAI in cattle in Nebraska.
