N※N

FDA to Overhaul 'Generally Recognized As Safe' System

  //food-wine.news-articles.net/content/2026/02/11 .. verhaul-generally-recognized-as-safe-system.html
  Published in Food and Wine on Wednesday, February 11th 2026 at 8:39 GMT by Associated Press
      Locales: District of Columbia, UNITED STATES

WASHINGTON (AP) -- The Food and Drug Administration is on the cusp of a significant overhaul of its 'Generally Recognized As Safe' (GRAS) system, a decades-old process for evaluating the safety of food additives. Mounting public and scientific pressure, fueled by recent health concerns linked to substances previously deemed safe under the GRAS system, has pushed the FDA to reassess the program and consider significantly stricter regulations. The current system, critics argue, allows food manufacturers too much latitude in determining the safety of ingredients without comprehensive, independent FDA review, potentially leaving consumers vulnerable to unforeseen health risks.

For years, the GRAS pathway has been a point of contention. Initially intended as a streamlined process for substances with a long history of safe use, it has evolved into a system where companies often self-determine safety based on their own data, simply notifying the FDA rather than seeking explicit approval. This contrasts sharply with the standard FDA approval process for new food additives, which demands extensive research, rigorous testing, and a thorough evaluation by agency scientists.

The core of the issue lies in the imbalance of power within the GRAS system. While the FDA is theoretically involved in reviewing GRAS notifications, the agency often relies heavily on industry-submitted data and hasn't consistently performed independent verification. This reliance has raised concerns about potential conflicts of interest and the possibility of flawed or incomplete safety assessments. Meredith Caroll, a prominent food safety advocate, explains, "We've seen too many instances where substances initially declared GRAS have later been associated with adverse health effects. The current system simply lacks the necessary safeguards to adequately protect the public."

The recent spotlight on erythritol, a sugar alcohol widely used in low-calorie and sugar-free products, has dramatically intensified these concerns. A recent study linked high levels of erythritol in the blood to an increased risk of heart attack and stroke, prompting a re-evaluation of its GRAS status. This case serves as a stark reminder of the potential dangers inherent in a system that prioritizes industry self-regulation over independent oversight.

The FDA announced its review earlier this year, acknowledging the growing concerns and signaling a willingness to address the systemic issues plaguing the GRAS process. The review's scope is broad, aiming to clarify the agency's role, establish more robust criteria for self-assessment, and implement increased oversight of the data submitted by companies. Central to the planned changes is a commitment to greater transparency. The FDA intends to publish clearer guidelines on what constitutes sufficient evidence for GRAS determination and to make more information about GRAS notifications publicly available.

However, the path forward isn't without challenges. Industry groups argue that overly stringent regulations could stifle innovation and raise costs for consumers. They maintain that the GRAS process, when properly implemented, is an efficient and effective way to ensure food safety. The FDA is attempting to strike a balance between protecting public health and fostering a thriving food industry. The agency expects to solicit extensive public comment on proposed changes, aiming to incorporate diverse perspectives into the final regulations.

The potential changes under consideration extend beyond simply increasing oversight of existing GRAS substances. The FDA is also exploring ways to proactively identify and assess the safety of new ingredients before they enter the food supply. This could involve establishing a pre-notification system, requiring companies to submit safety data before declaring an ingredient GRAS, and increasing the FDA's capacity to conduct independent research.

The outcome of the GRAS review is undoubtedly pivotal for the future of food safety regulation in the United States. While the details remain uncertain, one thing is clear: the FDA is at a critical juncture, and the decisions made in the coming months will have a lasting impact on the safety of the nation's food supply. The agency's commitment to "strengthening the GRAS process and protecting public health," as stated by an FDA spokesperson, will be closely watched by consumers, food manufacturers, and food safety advocates alike. The hope is that this review will usher in a new era of greater transparency, accountability, and, most importantly, consumer protection within the GRAS system.