What Is GRAS — and Why Is It Changing?
At the center of the change is the GRAS framework — short for Generally Recognized as Safe. GRAS is the regulatory pathway that allows food ingredients with a long history of safe use, or sufficient scientific backing, to be used in products without going through FDA’s formal food additive approval process. Since 1972, companies have been able to “self-affirm” GRAS status — essentially making their own safety determination without notifying the FDA or the public. Critics, including HHS Secretary Robert F. Kennedy Jr., have called this a statutory “loophole” that has allowed ingredients to enter the food supply without meaningful federal oversight.
That’s about to change. Under the agency’s 2026 Human Foods Program priorities, FDA plans to publish a proposed rule requiring mandatory GRAS notices for all food substances, effectively ending self-affirmation. Every company using GRAS-designated ingredients would need to formally notify the FDA and provide supporting safety data.
The Bigger Regulatory Picture
But GRAS reform is only part of the picture. February alone has seen a wave of MAHA-aligned regulatory activity: FDA initiated a comprehensive reassessment of BHA (butylated hydroxyanisole), with public comments due by April 13. The agency issued new guidance on “No Artificial Colors” labeling claims. Plans to phase out all remaining synthetic food dyes are moving forward. And front-of-package nutrition labeling, allergen disclosure updates, and new action levels for heavy metals in baby foods are all on the 2026 agenda.
The common thread? Regulators are demanding greater transparency and traceability across the food supply — from raw ingredient sourcing through finished product labeling.
Why OU Kosher Companies Are Already Ahead
For companies already certified by OU Kosher, much of this infrastructure is already in place. OU Kosher certifies more than 1.3 million products and ingredients in over 115 countries, and its certification process requires detailed ingredient-level documentation, rigorous supplier verification, and ongoing facility oversight — the same kind of traceability systems that regulators are now pushing the broader industry to adopt.
OU Direct: Built for Compliance
These aren’t just principles — they’re built into OU Kosher’s operational tools. OU Direct, the OU’s kosher program management portal, maintains records on approved ingredients and suppliers, bills of materials tied to production runs, and equipment status documentation. While OU Direct was designed for kosher compliance, the data it captures maps directly to many of the Key Data Elements the FDA now requires under FSMA 204 — the food traceability rule that major retailers like Walmart, Kroger, and Target are already enforcing ahead of federal deadlines. OU Kosher’s Rabbinic Coordinators can even help manufacturers identify the best OU Direct reports and standardize export processes into ERP or traceability systems.
A Global Network Ready for What’s Next
With a global footprint spanning 115 countries and an ingredient database containing millions of pre-vetted entries, OU Kosher is uniquely positioned to help manufacturers navigate a regulatory environment that increasingly demands the kind of supply chain visibility that kosher certification has required all along.
Companies looking for guidance on how their existing kosher certification data can support compliance with the new regulations are encouraged to connect with their Rabbinic Coordinator (RC), who can help identify the right OU Direct reports and tailor a traceability approach to their specific operations.
Don’t wait for the rules to catch you off guard. Reach out to your Rabbinic Coordinator.