On August 11, 2026, FDA published a proposed rule that would significantly change the process for introducing new food ingredients and products including them to the U.S. market. The current process requires that the substance be thoroughly evaluated for safety and is “Generally Recognized as Safe” or “GRAS”.

The GRAS process has been through several iterations but was initially created as part of the 1958 Food Additives Amendment to the FD&C Act.  Over the past 68 years the GRAS process has at times required FDA review, which proved to be burdensome to the agency.  A 1997 proposed rule that was at last finalized in 2016, ushered in a voluntary notification process for substances that had been demonstrated to be GRAS based on FDA criteria. Regulatory history buffs may enjoy reading the histories in the 1997, 2016, and 2026 Federal Register notices about the GRAS process.

The newly proposed rule makes notification to FDA mandatory. My initial take is that FDA does not have sufficient staff or resources to review mandatory GRAS notices. Prominent FDA & FTC Attorney Ashish Talati posted a 5 part analysis of the proposed GRAS rule on LinkedIN. Since his assessment is timely and thorough, I sought and was given permission to share it with  you here. (Thank you, Ashish Talati!)

Part 1: Does FDA Have the Legal Authority? (Maybe, maybe not)

Part 2: What FDA Didn’t Do May Be Just as Important (Notification is required but it is not premarket review/approval but how can that work?)

Part 3: The One-Time “Streamlined Pathway”: FDA Wants Proof of Commerce. But What About Proof of Self-GRAS?

Part 4: New GRAS Notice Not Required If an Existing No Questions Letter or Streamlined Listing Covers Your Substance. But How Should Companies Make That Determination?

Part 5: 10 Things Companies Should Be Doing Now

The rule is proposed and subject to public comment before it becomes final but it is still important to

  • Gain some understanding of what could change
  • If your company produces or uses any substances that have been affirmed as GRAS without a submission to FDA and receipt of a “no questions letter”, you should begin reviewing those GRAS dossiers.
  • It is important to review this latest proposed GRAS rule and comment on it by December 9, 2026.
  • See also Talati’s notes on FDA’s economic analysis of the impact of the proposed rule. FDA’s cost estimates seem low to me! This is a very important aspect of the rule. Be sure to comment on this if you have carried out a GRAS evaluation.
  • Contact us if you wish to submit comments without identifying your company.