On August 11, the FDA published its proposed rule on Substances Generally Recognized as Safe, 91 FR 51834, Docket No. FDA-2025-N-3262, with comments due December 9, 2026. HHS announced it the day before as a landmark food policy reform. The fact sheet describes it simply: manufacturers would have to tell FDA when they decide on their own that an ingredient is safe.
Page 51841 provides the agency’s example. In 2022, a popular at-home food-delivery company used tara flour in a human food product and recalled it after roughly 400 adverse event reports describing gastrointestinal distress, hepatotoxicity, and hospitalization. The company conducted its own root cause analysis and identified tara flour. FDA asked for records showing that the company had reached a GRAS conclusion on the ingredient and received none. Tara flour had never been the subject of a GRAS notice, or even a pre-submission meeting.
The company was Daily Harvest. Those roughly 400 adverse event reports are our clients. Marler Clark represented 339 of the approximately 470 people sickened by Daily Harvest’s French Lentil + Leek Crumbles[1], as well as 33 people sickened by Revive Superfoods’ Mango & Pineapple Smoothies—another product sold in the U.S. and Canada that contained tara flour. Nearly forty of them lost a gallbladder.
On December 27, 2023, I wrote to Jim Jones, then FDA’s Deputy Commissioner for Human Foods[2], and laid out the chain: tara flour milled by Molinos Asociados in Peru, imported by Smirk’s in Colorado, put into the Crumbles by Stone Gate Foods in Minnesota, and sold to consumers who had no way to know that the ingredient had never been evaluated for safety in the United States.
We asked FDA to determine whether anyone had ever sought GRAS status for tara flour. Our search of FDA records showed that nobody had. We also asked what Smirk’s had done to satisfy its Foreign Supplier Verification Program obligations, given that FDA’s own CORE incident summary said the importer had an FSVP plan for tara protein flour but that more information was needed. And we pointed FDA to what Canada had already done. On September 28, 2023, the Canadian Food Inspection Agency told Canadian businesses to stop buying and selling tara flour as an unassessed novel food[3].
Credit where it is owed. Ilana Korchia in our office built the regulatory spine of that work[4]. She is the one who took a mass personal injury case about a bag of frozen lentil crumbles and turned it into a question about 21 U.S.C. §§ 321(s), 342, 348 and 384a: whether the ingredient itself was lawful and who in the supply chain was responsible for verifying that it was.
On April 10, 2024, FDA’s Division of Food Ingredients issued a memorandum on tara flour derived from the seed germ of Caesalpinia spinosa[5], concluding that the use of tara flour in food did not meet the criteria for general recognition of safety; that there was no common use in food before 1958; that the available toxicity evidence was insufficient to establish safe use; and that, as a result, the ingredient was an unapproved food additive and food containing it was adulterated under section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act. FDA posted that determination on May 15, 2024, added tara flour to its post-market not-GRAS inventory, and began screening it at ports of entry.
That brings us back to the proposed rule. FDA is now using tara flour as its example of why the voluntary GRAS system is not enough.
The proposed rule is worth supporting, and I will file a comment saying so. It would make notification mandatory rather than optional, requiring companies to put their GRAS determinations on the public record. Notices would appear in a public, searchable GRAS notice inventory. That public record matters. A filed notice, or the conspicuous absence of one, is evidence. When a company later tells a jury it had no reason to know its ingredient was unsafe, the record will tell a different story.
But this is not premarket approval, and FDA says so plainly. A company can put a substance into interstate commerce and notify afterward. It can keep selling while its notice sits in the queue. It can keep selling even if it never files a notice at all. The stated consequence for skipping the requirement is simply that the violation becomes a factor in how FDA prioritizes substances for post-market review.
Run the facts of 2022 through the new rule and ask what actually changes. Daily Harvest still designs the product. Smirk’s still imports the flour. Stone Gate still puts it into the Crumbles. The product still ships in April. People still start getting sick in June. Somewhere in there a form gets filed, or not, and the only difference is that afterward we would have a better paper trail for the lawsuits. That is progress, not prevention.
The timeline is the second problem. Comments close in December. A final rule follows, whenever it follows. It takes effect 60 days after publication. Compliance with the notification requirement is proposed for 18 months after that. On the most optimistic schedule, the first year in which anyone is actually obligated to notify FDA about an ingredient is 2029.
The “legacy” pathway is the third problem. For substances already on the market under a self-affirmed conclusion, a streamlined submission asks for the identity of the substance, its conditions of use, and evidence it was already in commerce. It does not require the underlying safety documentation. A company that quietly self-affirmed an ingredient in 2015 can register it in 2029 without ever showing anyone why it believed the ingredient was safe.
Then there is the import problem, which is where our clients actually got hurt. Of the more than 1,200 GRAS notices FDA has filed, 617 came from foreign firms and 503 of those from countries where English is not the primary language. Tara flour traveled from a mill in Peru through an importer in Colorado to a manufacturer in Minnesota, and the law already required somebody in that chain to verify it. FSVP has been on the books since FSMA. It did not stop this. Layering a notification duty on top of a verification duty that no one audits does not produce verification.
What I will ask for in the comment period is straightforward. Notice should come before introduction into commerce, not after. Noncompliance should carry a stated legal consequence rather than a place in a prioritization queue. The streamlined pathway needs a minimum evidentiary requirement and a hard deadline to convert to a full notice. FDA also needs reviewers, and Congress needs to fund them. Finally, the public inventory should be designed for the public—not merely searchable, but understandable and usable by a parent standing in a grocery aisle.
[1]Daily Harvest, Inc., Daily Harvest Issues Voluntary Recall of French Lentil + Leek Crumbles Due to Potential Health Risk(company announcement posted by FDA, June 23, 2022), and Daily Harvest, Updates on Our Voluntary Recall of French Lentil + Leek Crumbles (advisory page, updated May 31, 2023).
[2]Letter from William D. Marler to James “Jim” Jones, Deputy Commissioner for Human Foods, U.S. Food & Drug Administration, Re: Status of Tara Flour, a Novel Ingredient not Generally Recognized As Safe, in the United States (Dec. 27, 2023). The letter collects the underlying record as attachments, including the CFIA notice, the FDA recall announcement, FDA’s CORE incident summary, and the Chittiboyina, Chan & Smith, and Choi et al. publications.
[3]Canadian Food Inspection Agency, Notice to Industry: Tara Protein Powder (Tara Flour) Not Assessed for Safety by Health Canada (Sept. 28, 2023), Attachment No. 1 to the December 27, 2023 letter.
[4]Marler Clark memorandum, Foreign Supplier Verification Program and Food Additive Authorities (May 14, 2024) (collecting 21 U.S.C. §§ 321(s), 342, 348, and 384a).
[5]Memorandum, U.S. Food & Drug Administration, Center for Food Safety and Applied Nutrition, Office of Food Additive Safety, Division of Food Ingredients, Regulatory status and review of available information pertaining to tara protein/flour derived from the seed germ of the plant, Caesalpinia spinosa: lack of general recognition of safety for its use in foods (Apr. 10, 2024).