Chapter 1

Defining Food

Abstract

The Food Additives Amendment of 1958 excluded from premarket review any substance "generally recognized" as safe by qualified experts. The statute does not say who the experts are or that a company must tell FDA of its conclusion, and FDA made notice voluntary in a 1997 proposal and a 2016 rule. GAO found in 2010 that FDA reviews only the conclusions companies submit and had issued no conflict-of-interest guidance for company panels. Two peer-reviewed studies, funded by the Pew Charitable Trusts (2013) and the Environmental Defense Fund (2023), found that manufacturers' employees, consultants or chosen panels made the determinations FDA received, and that a few individuals held many panel seats. FDA's own 2026 analysis states that the number of substances marketed on conclusions it was never told about is unknown and assumes 1,000 to 3,000. HHS directed FDA in March 2025 to explore ending the pathway, and FDA proposed a mandatory notice rule in August 2026 that creates no premarket approval. No federal definition of ultra-processed food exists, and a proposed definition sent to OMB in August 2026 had not been released by mid-October. The studies it cites report no disease outcome for any substance. The 1958 testimony it quotes describes an exemption for substances recognized as safe, such as table salt.

1.1 The 1958 exclusion

Finding AGR-1.1Primary record

The Food Additives Amendment of 1958 makes a food additive unsafe unless an FDA regulation or exemption covers it, and it excludes from the definition of food additive any substance generally recognized, among experts qualified by scientific training and experience, as safe for its intended use. The statute does not say who the experts are or that a company must tell FDA of its conclusion.

Section 2 of Public Law 85-929 (72 Stat. 1784) adds the definition of food additive to section 201 of the Federal Food, Drug, and Cosmetic Act. Section 4 adds section 409, which lets any person petition FDA for a regulation. The exclusion is now codified at 21 U.S.C. 321(s).

Evidence: Exhibit 558, Exhibit 561, Exhibit 559

§1.1.1

The excluded substance is one "generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures" to be safe under the conditions of its intended use. For a substance used in food before 1 January 1958, general recognition can rest on "either scientific procedures or experience based on common use in food."

§1.1.2

The text names no body of experts, no method of selecting them and no duty to inform the government. FDA's 2016 final rule describes the same gap: "Although the FD&C Act specifically provides for our review of food additives, it is silent with respect to industry submissions to us on the use of GRAS substances" (81 FR 54970).

§1.1.3

FDA's 2006 history of the provision excerpts the opening remarks of Commissioner Larrick in 1958. He said: "We believe only those chemicals should be automatically exempted from the new law which are recognized among competent experts as safe for their intended use. This would make it unnecessary, for example, to do studies on table salt, but would not approve the continued use, without proof of safety, of the synthetic emulsifiers now widely used in some fabricated foods." The excerpt gives no hearing citation.

§1.1.4

The House and Senate committee reports on the bill (H. Rept. 85-2284 and S. Rept. 85-2422) are quoted in FDA's 2006 history.

Exhibit 558 · Statute

Food Additives Amendment of 1958 (Public Law 85-929, 72 Stat. 1784)

if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use

Section 2 adds the definition of 'food additive' to section 201 of the Federal Food, Drug, and Cosmetic Act and excludes any substance generally recognized as safe by qualified experts. Section 4 adds section 409, which deems an additive unsafe unless it is covered by a regulation or exemption, and lets any person petition for a regulation. The text does not say who the experts are, how they are chosen, or that the government must be told of their conclusion.

Source: U.S. Congress
Date: 6 September 1958
Quoted from: 72 Stat. 1784, sec. 2 (new paragraph (s) of section 201)
Grade: Primary record
Document: https://www.govinfo.gov/content/pkg/STATUTE-72/pdf/STATUTE-72-Pg1784.pdf
Accessed: 2026-11-09
Cited by: Findings citing this exhibit
Note: Now codified at 21 U.S.C. 321(s).

Exhibit 559 · Agency web page

FDA's Approach to the GRAS Provision: A History of Processes

We believe only those chemicals should be automatically exempted from the new law which are recognized among competent experts as safe for their intended use. This would make it unnecessary, for example, to do studies on table salt, but would not approve the continued use, without proof of safety, of the synthetic emulsifiers now widely used in some fabricated foods.

FDA poster by CFSAN staff presented at the April 2006 FDA Science Forum. It gives FDA's own timeline of the GRAS provision, from the 9 December 1958 GRAS list to the 1969 removal of cyclamate and the 1997 proposal, and excerpts 1958 congressional testimony by FDA Commissioner Larrick.

Source: U.S. Food and Drug Administration, Office of Food Additive Safety
Date: 2006 (poster; page accessed 2026)
Quoted from: Section 'Excerpts from Legislative History', from Commissioner Larrick's opening remarks
Grade: Primary record
Document: https://www.fda.gov/food/generally-recognized-safe-gras/fdas-approach-gras-provision-history-processes
Accessed: 2026-11-09
Cited by: Findings citing this exhibit
Note: The page excerpts the testimony but does not cite the hearing volume.

1.2 Voluntary notification

Finding AGR-1.2Primary record

FDA's 1997 proposal and 2016 final rule made notification of a GRAS conclusion voluntary. The 2016 rule treats a conclusion kept by its maker the same in law as one submitted to FDA, and it states that FDA lacks express statutory authority to require notices.

FDA's proposed rule of 17 April 1997 (62 FR 18938) described its new notification procedure with the sentence "FDA recognizes that a decision to submit a notice is voluntary." The final rule of 17 August 2016 (81 FR 54960) took effect on 17 October 2016.

Evidence: Exhibit 560, Exhibit 561

§1.2.1

FDA gave its reason in 1997. The petition process required rulemaking, which "deters many persons who independently determine that use of a substance is GRAS from informing the agency of such determinations" (62 FR 18944).

§1.2.2

The 2016 rule rejected comments that voluntary notice violates the 1958 amendment. In response to a comment it states: "We agree that we lack express statutory authority to require companies to submit GRAS notices" (81 FR 54981-82). FDA added that Congress required notification only for food contact substances, in 1997.

§1.2.3

The rule also removed a distinction in terminology. It states that "there would be no distinction between a conclusion of GRAS status submitted to us as a GRAS notice and a conclusion of GRAS status that remains with its proponent as an independent conclusion (formerly referred to as a 'self-determination') of GRAS status" (81 FR 54984). FDA's term is independent conclusion. HHS's term is self-affirmed.

§1.2.4

FDA's 2026 proposal recounts the agency's position in 2016 that a voluntary system let it "evaluate more, and higher priority, substances" (91 FR 51842).

Exhibit 560 · Federal Register proposed rule

Substances Generally Recognized as Safe, proposed rule (62 FR 18938; Docket 97N-0103)

FDA recognizes that a decision to submit a notice is voluntary.

Proposed to replace the GRAS affirmation petition with a notification procedure in which any person may notify FDA of a GRAS determination. FDA states the decision to submit a notice is voluntary and that the rulemaking-based petition process deterred many persons who independently determine a use is GRAS from informing the agency.

Source: U.S. Food and Drug Administration
Date: 17 April 1997
Quoted from: 62 FR 18946, section 'B. Specific Requirements' (proposed 170.36(c))
Grade: Primary record
Document: https://www.govinfo.gov/content/pkg/FR-1997-04-17/pdf/97-9706.pdf
Accessed: 2026-11-09
Cited by: Findings citing this exhibit
Note: A second passage, 62 FR 18944: 'FDA believes that the lengthy rulemaking associated with the GRAS petition process deters many persons who independently determine that use of a substance is GRAS from informing the agency of such determinations.'

Exhibit 561 · Federal Register final rule

Substances Generally Recognized as Safe, final rule (81 FR 54960; Docket FDA-1997-N-0020)

We agree that we lack express statutory authority to require companies to submit GRAS notices.

Finalized the 1997 proposal as a voluntary notification procedure. FDA rejects comments that voluntariness violates the 1958 amendment, says there is no distinction in law between a conclusion submitted as a notice and one kept by its proponent (formerly called a 'self-determination'), and states that it lacks express statutory authority to require submission. It cites its 2010 caffeinated-alcohol letters as an example of enforcement without a notice.

Source: U.S. Food and Drug Administration
Date: 17 August 2016
Quoted from: 81 FR 54981-82 (Comment and Response 28)
Grade: Primary record
Document: https://www.govinfo.gov/content/pkg/FR-2016-08-17/pdf/2016-19164.pdf
Accessed: 2026-11-09
Cited by: Findings citing this exhibit
Note: The quoted sentence runs across the page break between 54981 and 54982. Response 1 (81 FR 54970): 'Although the FD&C Act specifically provides for our review of food additives, it is silent with respect to industry submissions to us on the use of GRAS substances.' Section on terminology (81 FR 54984): 'there would be no distinction between a conclusion of GRAS status submitted to us as a GRAS notice and a conclusion of GRAS status that remains with its proponent as an independent conclusion (formerly referred to as a “self-determination”) of GRAS status.' Effective 17 October 2016.

1.3 The 2016 court challenge

Finding AGR-1.3Reported

The Center for Food Safety and the Environmental Defense Fund challenged FDA's 2016 GRAS rule in the Southern District of New York. According to the Congressional Research Service, the court granted summary judgment to FDA because FDA's reading of the Act was reasonable, and the plaintiffs did not appeal.

The Congressional Research Service names the case Center for Food Safety v. Becerra in its Legal Sidebar of 5 October 2026. The court decided it under Chevron deference.

Evidence: Exhibit 572

§1.3.1

According to CRS, the plaintiffs did not appeal. The Sidebar gives neither the docket number nor the decision date.

§1.3.2

The Environmental Defense Fund, one of the two plaintiffs, funded the 2023 study of panel seats in section 1.6. The Center for Food Safety is the other plaintiff.

Exhibit 572 · CRS report

Food Additives and GRAS Substances: A Legal Framework (CRS Legal Sidebar LSB11445)

The preamble to the proposed regulations indicates that FDA would consider the failure to submit a GRAS notice as “a factor” in FDA’s prioritization of food substances for post-market review, and therefore marketed substances that are not the subject of a GRAS notice may face increased scrutiny from FDA.

Explains the statutory framework, FDA's 2016 statement that it lacks express authority to require notices, the unsuccessful challenge to the 2016 rule by the Center for Food Safety and the Environmental Defense Fund in the Southern District of New York (decided under Chevron, not appealed), the 2026 proposal, and how Loper Bright could change review of a final rule. Lists four pending bills.

Source: Congressional Research Service
Date: 5 October 2026
Quoted from: p. 4
Grade: Primary record
Document: https://www.everycrsreport.com/files/2026-10-05_LSB11445_224683c645df03271d453db38ec195f31490e3cf.pdf
Accessed: 2026-11-09
Cited by: Findings citing this exhibit
Note: Also p. 3-4: companies 'would be able to market products containing GRAS substances before submitting the notice and while FDA is reviewing the notice.' The Southern District case is named Center for Food Safety v. Becerra; docket number and decision date are not given in the Sidebar.

1.4 What GAO found in 2010

Finding AGR-1.4Primary record

GAO reported in 2010 that FDA reviews only the GRAS determinations companies submit, generally has no information about the others, and cannot estimate how many it was not told of. GAO also found that FDA had issued no conflict-of-interest guidance for the expert panels companies convene and did not ask for information on panelists' independence in GRAS notices.

The report is GAO-10-246, dated February 2010 on its cover. FDA's 2026 rule cites it as March 2010.

Evidence: Exhibit 562

Mechanism: The study not run, Oversight paid for by the overseen

§1.4.1

GAO's highlights page states: "FDA only reviews those GRAS determinations that companies submit to the agency's voluntary notification program—the agency generally does not have information about other GRAS determinations companies have made because companies are not required to inform FDA of them." About 180 companies had notified FDA from 1998 through 2008 (p. 13), and GAO reports that FDA cannot estimate the number of determinations it was not told of. Officials of one international food marketer said the company makes about five GRAS determinations each year without notifying FDA (p. 12).

§1.4.2

GAO recommended six actions. The first was a strategy to require any company making a GRAS determination to give FDA basic information about it. FDA generally agreed and raised concerns about parts of several recommendations.

§1.4.3

FDA's response states that without mandatory notification "it cannot ensure that GRAS determinations that are not submitted to the agency's notification program are rigorous, robust, or consistent with the agency's criteria" (p. 36). GAO read the response as a preference for mandatory notification and urged FDA to seek authority from Congress if needed. FDA objected to publishing basic information in a public database because it "might mislead the public into thinking FDA validated these determinations," and GAO answered that a disclaimer would prevent that (pp. 36-37).

§1.4.4

On conflicts, FDA recognized "the potential for a conflict of interest," said it could issue nonbinding guidance and said it would consider the issue in finalizing its 1997 proposal (p. 37). FDA also said its review of a notice does not depend entirely on the panel's conclusions (p. 16). On missing GRAS substances, FDA officials said they were "not significantly concerned about missing GRAS substances in the database because, as some food scientists have indicated, GRAS substances generally pose a relatively low risk to public health" (p. 13).

§1.4.5

GAO also found that FDA had not finalized the 1997 proposal and had not systematically reconsidered GRAS substances since the 1980s. FDA's own history records that a Select Committee on GRAS Substances reviewed more than 400 substances by 1982.

Exhibit 562 · GAO report

Food Safety: FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS) (GAO-10-246)

FDA only reviews those GRAS determinations that companies submit to the agency’s voluntary notification program—the agency generally does not have information about other GRAS determinations companies have made because companies are not required to inform FDA of them.

Found that FDA reviews only the GRAS determinations companies submit and generally has no information about the rest, that FDA had issued no conflict-of-interest guidance for company expert panels, that FDA had not finalized its 1997 proposal, and that FDA had not systematically reconsidered GRAS substances since the 1980s. Recommended six actions, the first a strategy to require any company making a GRAS determination to give FDA basic information about it. FDA generally agreed and raised concerns about parts of several recommendations.

Source: U.S. Government Accountability Office
Date: February 2010
Quoted from: Highlights, 'What GAO Found'
Grade: Primary record
Document: https://files.gao.gov/assets/gao-10-246.pdf
Accessed: 2026-11-09
Cited by: Findings citing this exhibit
Note: Other passages read: p. 12 ('officials representing one international marketer of food indicated the company makes about 5 GRAS determinations each year without notifying FDA'); p. 13 (about 180 companies notified FDA from 1998 through 2008; FDA cannot estimate the number of determinations it was not told of); pp. 14-15 (conflicts of interest); p. 34 (recommendations); pp. 36-37 (FDA's response). The cover date is February 2010; FDA's 2026 rule cites it as March 2010.

1.5 Who decided: the 2013 study

Finding AGR-1.5Peer-reviewed

Of the 451 GRAS notices FDA received from 1997 to 2012, 22.4 percent were decided by an employee of the manufacturer, 13.3 percent by an employee of a consulting firm the manufacturer selected, and 64.3 percent by an expert panel selected by the manufacturer or its consultant. None used a standing panel selected by a third party; the study was funded by the Pew Charitable Trusts.

The study is Neltner and colleagues in JAMA Internal Medicine 173(22):2032-2036 (online 7 August 2013). It applied Institute of Medicine conflict-of-interest criteria to the notices. The Pew Charitable Trusts funded it, and three of its authors were Pew employees.

Evidence: Exhibit 563, Exhibit 574

Mechanism: Oversight paid for by the overseen

§1.5.1

Expert panels made the determinations in 290 of the notices. Ten individuals served on 27 or more of those 290 panels, and one individual served on 128. At least one of the ten sat on 225 panels (77.6 percent).

§1.5.2

The authors state: "Our results do not prove that the conflicts of interest that we identified actually compromise the GRAS decision process, although they raise such concerns." They analyzed only employment relationships. They also lacked comparable data on determinations not submitted to FDA, and they did not evaluate the panel of the Flavor and Extract Manufacturers Association (FEMA).

§1.5.3

FEMA's own page describes that panel. It states that the panel has been "provided with financial support by FEMA" while maintaining "full independence." Members "have never been employees of FEMA member companies or employees of companies in the food industry," are barred from consulting for member companies on flavors and do not know the applicant's identity. The panel appoints its own members, and FEMA states that sending determinations to FDA does not constitute FDA approval. FDA's 2026 economic analysis counts 1,740 substances that rest on association expert-panel conclusions. FEMA's statements about its panel were not independently verified, and its page states no dollar amount.

Exhibit 563 · Peer-reviewed study

Conflicts of Interest in Approvals of Additives to Food Determined to Be Generally Recognized as Safe: Out of Balance (JAMA Internal Medicine 173(22):2032-2036)

Between 1997 and 2012, we found that financial conflicts of interest were ubiquitous in determinations that an additive to food was GRAS.

Applied Institute of Medicine conflict-of-interest criteria to the 451 GRAS notices FDA received from 1997 to 2012. 22.4 percent were decided by a manufacturer's employee, 13.3 percent by a consultant firm's employee, and 64.3 percent by an expert panel chosen by the manufacturer or its consultant; none by a standing panel chosen by a third party. Ten people served on 27 or more of the 290 panels and one served on 128. The authors state the results do not prove the conflicts compromised any decision. Funded by Pew; three authors were Pew employees.

Source: Neltner TG, Alger HM, O'Reilly JT, Krimsky S, Bero LA, Maffini MV (Pew Charitable Trusts; University of Cincinnati; Tufts; UCSF)
Date: 9 December 2013 (online 7 August 2013)
Quoted from: Discussion, first sentence
Grade: Peer-reviewed
Document: https://doi.org/10.1001/jamainternmed.2013.10559
Archived: https://web.archive.org/web/2019/https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/1725123
Accessed: 2026-11-09
Cited by: Findings citing this exhibit
Note: The publisher page is paywalled. Limitations stated by the authors: they lacked comparable data on determinations not submitted to FDA, did not evaluate the FEMA panel, and analyzed only employment relationships. Results, 'Assessment of GRAS Safety Determinations Not Submitted to the FDA': 'From 1997 to 2012, we found only 1 instance when the agency sought to obtain a GRAS safety determination that it had not received a notification for.' That instance was FDA's 2010 letters to four companies about caffeine in alcoholic beverages; none had made a GRAS determination.

Exhibit 574 · Trade association web page

About the FEMA GRAS Program

While the Expert Panel has been provided with financial support by FEMA it has always maintained its full independence in its operations and GRAS determinations and follows strict conflict of interest procedures.

FEMA describes its GRAS program, begun in 1959 with an expert panel from 1960. It states that the panel has FEMA's financial support, that members have never been employees of FEMA member companies, that members are barred from consulting for member companies on flavors, that panelists do not know the applicant's identity, that the panel is self-appointed, and that all determinations and supporting information go to FDA, which does not thereby approve them.

Source: Flavor and Extract Manufacturers Association of the United States (FEMA)
Date: Page accessed 2026-11-09
Quoted from: Introduction, third paragraph
Grade: Primary record
Document: https://www.femaflavor.org/gras
Accessed: 2026-11-09
Cited by: Findings citing this exhibit
Note: Second quote: 'Members of the Expert Panel have never been employees of FEMA member companies or employees of companies in the food industry.' (Qualified Experts).

1.6 Panel seats, 2015 to 2020

Finding AGR-1.6Peer-reviewed

A study of the 403 GRAS notices FDA filed from 2015 to 2020 found that seven people held 46 percent of the 732 panel positions and found no evidence that panels followed FDA's guidance on convening them. The Environmental Defense Fund funded the study, and EDF was a plaintiff in the 2016 challenge to FDA's GRAS rule.

The study is Matouskova, Neltner and Maffini in Environmental Health 22:59 (6 September 2023). It compared the notices with FDA's guidance on convening panels. The Environmental Defense Fund funded it, and two authors were paid by EDF as consultants. Neltner works for EDF.

Evidence: Exhibit 565

Mechanism: Oversight paid for by the overseen

§1.6.1

Notifiers relied on a panel in 57 percent of notices on average. Seven people held 340 of the 732 panel positions. The authors' abstract states: "We found no evidence that GRAS panels have adhered to FDA's guidance."

§1.6.2

EDF was a plaintiff in the 2016 challenge to FDA's GRAS rule (section 1.3). Both this study and the 2013 study analyzed only notices submitted to FDA, which the agency reviews.

Exhibit 565 · Peer-reviewed study

Out of balance: conflicts of interest persist in food chemicals determined to be generally recognized as safe (Environmental Health 22:59)

We found no evidence that GRAS panels have adhered to FDA’s guidance.

Assessed 403 GRAS notices FDA filed between 2015 and 2020 against FDA's guidance on convening GRAS panels. Notifiers relied on a panel in 57 percent of notices on average; seven people held 46 percent (340 of 732) of panel positions. Funded by the Environmental Defense Fund; two authors were paid by EDF as consultants. EDF was a plaintiff in the 2016-17 challenge to FDA's GRAS rule.

Source: Matouskova K, Neltner TG, Maffini MV (Environmental Defense Fund; independent consultants)
Date: 6 September 2023
Quoted from: Abstract, Results
Grade: Peer-reviewed
Document: https://doi.org/10.1186/s12940-023-01004-8
Accessed: 2026-11-09
Cited by: Findings citing this exhibit
Note: Abstract checked on PubMed (PMID 37670318); funding and panel counts read in the open-access full text (PMC10481496).

1.7 How many FDA has not seen

Finding AGR-1.7Primary record

FDA's 2026 economic analysis states that the exact number of substances marketed under independent GRAS conclusions is unknown and assumes 1,000 to 3,000 (primary estimate 2,000), against 1,309 notices filed from February 1998 to March 2025. The proposed rule states that FDA "cannot verify the accuracy of these estimates."

The figures come from FDA's preliminary regulatory impact analysis (August 2026) and its proposed rule of 11 August 2026. The proposed rule says of the estimates: "Although we cannot verify the accuracy of these estimates" (91 FR 51842).

Evidence: Exhibit 571, Exhibit 570, Exhibit 564

Mechanism: The study not run

§1.7.1

The analysis states that "the exact number of purported GRAS substances currently being used in human and animal foods is unknown." It takes a 2011 estimate of about 1,000 human-food substances as its low end and sets the high end at 3,000 because of the time since publication. The figure of 2,000 is the midpoint of that range and is an assumption.

§1.7.2

The 2011 study is Neltner and colleagues in Comprehensive Reviews in Food Science and Food Safety 10(6):342-368. The 2013 paper and FDA's documents describe its method. FDA's analysis states that the 2011 estimate excludes flavors in the FEMA library and substances in common use before 1958. The proposed rule states: "we have little, if any, information on independent conclusions of GRAS status." FDA also estimates that about 1,028 firms have not filed a notice.

FDA's count of GRAS notices filed, February 1998 to March 2025
Item	Count
Notices filed	1,309
Notifiers	673
Notices not pending	1,215
"No questions" letter	961
Ended at the notifier's request	231
Insufficient-basis letter	23
Assumed substances on independent conclusions (range)	1,000 to 3,000

Exhibit 571 · Agency economic analysis

Substances Generally Recognized as Safe: Preliminary Regulatory Impact Analysis (Docket FDA-2025-N-3262)

Although the exact number of purported GRAS substances currently being used in human and animal foods is unknown, a 2011 study estimated that there were 1,000 substances being used in human food that were the subject of an independent conclusion of GRAS status

FDA's own count and estimate. 1,309 GRAS notices filed from February 1998 to March 2025 (1,234 human food, 75 animal food) by 673 notifiers; of 1,215 not pending, 961 drew a 'no questions' letter, 231 ended at the notifier's request, and 23 drew an insufficient-basis letter. FDA assumes 1,000 to 3,000 substances (primary estimate 2,000) are on the market under independent GRAS conclusions, about 1,028 firms have not filed a notice, and 1,740 substances rest on association expert-panel (FEMA) conclusions. Present value of costs about $89.6 million at 3 percent.

Source: U.S. Food and Drug Administration, Office of Economics and Analysis
Date: August 2026
Quoted from: Section II.D.2 (Independent Conclusions of GRAS Status), PRIA p. 13
Grade: Primary record
Document: https://www.fda.gov/media/194138/download
Accessed: 2026-11-09
Cited by: Findings citing this exhibit
Note: FDA assumes the 2011 estimate (Neltner et al.) is the low end and sets 3,000 as the high end because of the time since publication.

Exhibit 564 · Peer-reviewed study

Navigating the U.S. Food Additive Regulatory Program (Comprehensive Reviews in Food Science and Food Safety 10(6):342-368)

assigning the more than 10000 substances currently allowed in human food to those categories

Source of the estimate, based on interviews with food-industry staff and review of public GRAS notices and reports, that as of January 2011 more than 10,000 additives were in use, including about 1,000 human-food substances whose makers had concluded GRAS status without telling FDA. FDA's 2026 economic analysis adopts it as the low end of its own range. The estimate excludes flavors in the FEMA library and substances in common use before 1958.

Source: Neltner TG, Kulkarni NR, Alger HM, Maffini MV, Bongard ED, Fortin ND, Olson ED (Pew Health Group)
Date: 25 October 2011
Quoted from: Abstract, Compr. Rev. Food Sci. Food Saf. 10(6), Nov. 2011 (Wayback snapshot of the journal page, 2023-01-09)
Grade: Peer-reviewed
Document: https://ift.onlinelibrary.wiley.com/doi/full/10.1111/j.1541-4337.2011.00166.x
Accessed: 2026-11-09
Cited by: Findings citing this exhibit
Note: Not opened. Known through the JAMA paper (which restates the estimate), FDA's 2026 proposed rule (refs. 6-7) and FDA's 2026 PRIA (ref. 4, footnote 2).

1.8 What FDA has acted on

Finding AGR-1.8Primary record

FDA's regulation says general recognition of safety through scientific procedures requires the same quantity and quality of scientific evidence as an additive approval. FDA removed cyclamate salts from the GRAS list in 1969, and in 2010 it sent warning letters to makers of caffeinated alcoholic beverages that had made no GRAS determination.

The regulation, 21 CFR 170.30(b), states that general recognition through scientific procedures "shall require the same quantity and quality of scientific evidence as is required to obtain approval of a food additive." FDA's position is that a use that is not GRAS is an unapproved additive and the food is adulterated.

Evidence: Exhibit 567, Exhibit 559, Exhibit 561, Exhibit 563

§1.8.1

FDA removed cyclamate salts from the GRAS list on 21 October 1969, after bladder tumors appeared in rats. The President directed a critical evaluation of GRAS substances on 30 October 1969, and FDA revoked informal GRAS opinion letters on 9 April 1970. A review contract with the Federation of American Societies for Experimental Biology began on 28 March 1972.

§1.8.2

In 2010 FDA wrote to four makers of caffeinated alcoholic beverages, none of which had made a GRAS determination. It then issued warning letters stating that the added caffeine was an unsafe food additive, and the companies stopped distributing the products. The 2013 study found that this was the only instance between 1997 and 2012 in which FDA sought a GRAS determination it had not received a notice for.

Exhibit 567 · Regulation

21 CFR 170.30, Eligibility for classification as generally recognized as safe (GRAS)

General recognition of safety based upon scientific procedures shall require the same quantity and quality of scientific evidence as is required to obtain approval of a food additive.

FDA's regulation on what general recognition of safety requires: the views of qualified experts based on scientific procedures or, for pre-1958 substances, common use in food, and 'common knowledge throughout the scientific community' that there is reasonable certainty of no harm.

Source: U.S. Food and Drug Administration
Date: In force 1 November 2026 (eCFR)
Quoted from: 21 CFR 170.30(b)
Grade: Primary record
Document: https://www.ecfr.gov/current/title-21/section-170.30
Accessed: 2026-11-09
Cited by: Findings citing this exhibit

Exhibit 561 · Federal Register final rule

Substances Generally Recognized as Safe, final rule (81 FR 54960; Docket FDA-1997-N-0020)

We agree that we lack express statutory authority to require companies to submit GRAS notices.

Source: U.S. Food and Drug Administration
Date: 17 August 2016
Quoted from: 81 FR 54981-82 (Comment and Response 28)
Grade: Primary record
Document: https://www.govinfo.gov/content/pkg/FR-2016-08-17/pdf/2016-19164.pdf
Accessed: 2026-11-09
Cited by: Findings citing this exhibit
Note: The quoted sentence runs across the page break between 54981 and 54982. Response 1 (81 FR 54970): 'Although the FD&C Act specifically provides for our review of food additives, it is silent with respect to industry submissions to us on the use of GRAS substances.' Section on terminology (81 FR 54984): 'there would be no distinction between a conclusion of GRAS status submitted to us as a GRAS notice and a conclusion of GRAS status that remains with its proponent as an independent conclusion (formerly referred to as a “self-determination”) of GRAS status.' Effective 17 October 2016.

1.9 Carboxymethylcellulose

Finding AGR-1.9Peer-reviewed

Sodium carboxymethylcellulose is listed in FDA's regulations as generally recognized as safe when used in accordance with good manufacturing practice (21 CFR 182.1745). In a double-blind controlled-feeding study of 16 healthy adults, 15 g per day of carboxymethylcellulose for 11 days reduced gut microbiota diversity and changed the fecal metabolome relative to controls, and the study reported no disease outcome.

The study is Chassaing and colleagues, Gastroenterology 162:743-756 (2022; online November 2021). Nine subjects ate an emulsifier-free diet and seven ate the same diet with the added emulsifier. The intake was chosen by the authors.

Evidence: Exhibit 568, Exhibit 566

§1.9.1

FDA's list in 21 CFR 182.1745 covers sodium carboxymethylcellulose and states: "This substance is generally recognized as safe when used in accordance with good manufacturing practice." The substance is listed by FDA regulation and was not a company's own conclusion.

§1.9.2

The authors' background states: "Despite lack of extensive safety testing, CMC was approved in the 1960s for use in foods at concentrations up to 2% (wt/wt) by regulatory agencies, including the US Food and Drug Administration and European Commission based on the GRAS (generally regarded as safe) designation developed by these agencies."

§1.9.3

Relative to controls, the CMC group reported modestly increased postprandial abdominal discomfort and showed lower microbiota diversity. Two of the seven CMC subjects had bacteria in the normally sterile inner mucus layer. The National Institutes of Health and the Max Planck Society, among others, funded the study.

§1.9.4

The study measured no disease outcome. The authors' discussion states a hypothesis about chronic inflammatory disease, and the study did not test it. The abstract of a later paper by the same group states that CMC disturbs the microbiota "in some, but not all, healthy individuals." The study does not show that carboxymethylcellulose or any other additive causes disease.

Exhibit 568 · Regulation

21 CFR 182.1745, Sodium carboxymethylcellulose

This substance is generally recognized as safe when used in accordance with good manufacturing practice.

FDA's GRAS list entry for sodium carboxymethylcellulose, a regulation in part 182 of title 21. The substance is listed by FDA and was not a company's own conclusion.

Source: U.S. Food and Drug Administration
Date: In force 1 November 2026 (eCFR)
Quoted from: 21 CFR 182.1745(b)
Grade: Primary record
Document: https://www.ecfr.gov/current/title-21/section-182.1745
Accessed: 2026-11-09
Cited by: Findings citing this exhibit
Note: Date and notice of the original listing not found. The Federal Register history of the listing would date it.

Exhibit 566 · Peer-reviewed study

Randomized Controlled-Feeding Study of Dietary Emulsifier Carboxymethylcellulose Reveals Detrimental Impacts on the Gut Microbiota and Metabolome (Gastroenterology 162:743-756)

Relative to control subjects, CMC consumption modestly increased postprandial abdominal discomfort and perturbed gut microbiota composition in a way that reduced its diversity.

Double-blind controlled-feeding study of 16 healthy adults for 11 days: 9 ate an emulsifier-free diet and 7 the same diet with 15 g per day of carboxymethylcellulose (CMC). CMC lowered gut microbiota diversity, changed the fecal metabolome and modestly increased abdominal discomfort; 2 of 7 CMC subjects showed bacteria in the normally sterile inner mucus layer. The study reports no disease outcome. Funded by NIH and the Max Planck Society, among others.

Source: Chassaing B, Compher C, Bonhomme B, et al. (Penn State; University of Pennsylvania; INSERM/Universite Paris Cite; others)
Date: November 2021 (online); March 2022 (print)
Quoted from: Abstract, Results
Grade: Peer-reviewed
Document: https://doi.org/10.1053/j.gastro.2021.11.006
Accessed: 2026-11-09
Cited by: Findings citing this exhibit
Note: Timewar's lead cites this as 160(7), 2021; the print citation is 162(3):743-756 (2022). The authors' background states: 'Despite lack of extensive safety testing, CMC was approved in the 1960s for use in foods at concentrations up to 2% (wt/wt) by regulatory agencies, including the US Food and Drug Administration and European Commission based on the GRAS (generally regarded as safe) designation developed by these agencies.' Read in PMC9639366.

1.10 The 2025 directive

Finding AGR-1.10Primary record

On 10 March 2025 HHS Secretary Kennedy directed FDA to explore rulemaking to eliminate the self-affirmed GRAS pathway. The September 2025 MAHA strategy committed FDA to "closing the 'GRAS loophole,' implementing a mandatory GRAS notification program."

The HHS release of 10 March 2025 states that "industry can self-affirm that the use of a substance is GRAS without notifying the FDA." The release also states that FDA has completed more than 1,000 GRAS notices and evaluates about 75 a year, and that HHS will work with Congress on legislation.

Evidence: Exhibit 569, Exhibit 136

§1.10.1

The Secretary is quoted: "For far too long, ingredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the U.S. food supply without notification to the FDA or the public." That is Secretary Kennedy's characterization. The pathway he describes is the one set by the 1958 statute and FDA's rules in sections 1.1 and 1.2.

§1.10.2

The MAHA strategy of 9 September 2025 repeats the wording on PDF page 8 under "GRAS Reform": "FDA will update regulations to reform the GRAS designation, within the scope of statutory authority, by closing the 'GRAS loophole,' implementing a mandatory GRAS notification program, and increasing consumer transparency with respect to substances found in our nation's food supply." The registered quotation for that exhibit concerns pesticides, which Medicine Chapter 4 covers.

Exhibit 569 · Agency press release

HHS Secretary Kennedy Directs FDA to Explore Rulemaking to Eliminate Pathway for Companies to Self-Affirm Food Ingredients Are Safe

industry can self-affirm that the use of a substance is GRAS without notifying the FDA

The Secretary directed the acting FDA commissioner to explore rulemaking to revise the GRAS final rule and eliminate the self-affirmed GRAS pathway. The release says industry can self-affirm without notifying FDA, that FDA has completed more than 1,000 GRAS notices and evaluates about 75 a year, and that HHS will work with Congress on legislation.

Source: U.S. Department of Health and Human Services
Date: 10 March 2025
Quoted from: Paragraph 4
Grade: Primary record
Document: https://www.hhs.gov/press-room/revising-gras-pathway.html
Archived: https://web.archive.org/web/20251230114701/https://www.hhs.gov/press-room/revising-gras-pathway.html
Accessed: 2026-11-09
Cited by: Findings citing this exhibit
Note: The Secretary is quoted: 'For far too long, ingredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the U.S. food supply without notification to the FDA or the public.'

Exhibit 136 · Commission report

Make Our Children Healthy Again: Strategy Report

EPA, partnering with food and agricultural stakeholders, will work to ensure that the public has awareness and confidence in EPA’s pesticide robust review procedures and how that relates to the limiting of risk for users and the general public and informs continual improvement.

The strategy required by Executive Order 14212, based on the May 2025 assessment. The text contains neither the word glyphosate nor the word atrazine. Its pesticides item commits EPA, with food and agricultural stakeholders, to public awareness of and confidence in EPA's pesticide reviews.

Source: President's Make America Healthy Again Commission
Date: 9 September 2025
Quoted from: Pesticides, PDF p. 16
Grade: Primary record
Document: https://www.whitehouse.gov/wp-content/uploads/2025/09/The-MAHA-Strategy-WH.pdf
Accessed: 2026-11-09
Cited by: Findings citing this exhibit

1.11 The 2026 proposed rule

Finding AGR-1.11Primary record

FDA's proposed rule of 11 August 2026 would require GRAS notices for substances purported to be GRAS, with a one-year streamlined submission for substances already on the market. The rule creates no premarket approval, lets companies market a substance before notifying and while FDA reviews the notice, and makes failure to notify "a factor" in FDA's prioritization for post-market review.

The proposal (91 FR 51834; Docket FDA-2025-N-3262) takes effect 60 days after a final rule, with 18 months to comply. Comments close on 9 December 2026. It exempts substances that already have a no-questions letter and substances listed in 21 CFR parts 182, 184 and 186.

Evidence: Exhibit 570, Exhibit 572, Exhibit 573

§1.11.1

FDA states its reason: "Today, an unknown number of substances are being introduced into the market under the GRAS provision of section 201(s) of the FD&C Act" (91 FR 51838). The preamble adds: "we find ourselves in a situation much like the years before the 1958 amendment's enactment." CRS reports a second reason, that under the 2016 rule a notifier can ask FDA to stop evaluating a notice and then market the product. FDA's analysis records 231 notices that ended at the notifier's request.

§1.11.2

The proposal rests FDA's authority on sections 409(a), 409(d) and 701(a) of the FD&C Act. FDA stated in 2016 that it lacks express authority to require notices (section 1.2). CRS notes that a court reviewing a final rule after Loper Bright would read the statute without deference to FDA and might weigh FDA's earlier statement. CRS lists four pending bills (H.R. 7291, S. 3122, H.R. 4958 and S. 2341).

Consumer Brands Association

An undated one-page sheet, dated August 2026 by its file name, states: "GRAS is not a loophole; it's a science-based regulatory pathway established by Congress and overseen by the FDA." It also states that the industry "welcomes GRAS reform as part of a national uniform standard for ingredient safety and transparency, including updated FDA regulations that require mandatory notification." The sheet states that GRAS ingredients must meet the same "reasonable certainty of no harm" standard as approved additives.

FDA's proposal

FDA proposes mandatory notice and states that the rule creates no premarket approval. Companies may market a substance before notifying and while FDA reviews the notice. Failure to notify would be "a factor" in FDA's prioritization of substances for post-market review, according to the preamble as CRS reports it.

Exhibit 570 · Federal Register proposed rule

Substances Generally Recognized as Safe, proposed rule (91 FR 51834; Docket FDA-2025-N-3262; RIN 0910-AJ02)

Today, an unknown number of substances are being introduced into the market under the GRAS provision of section 201(s) of the FD&C Act.

Proposes to convert the voluntary GRAS notification program to a mandatory one, with exceptions (existing no-questions letters, substances listed in 21 CFR parts 182, 184 and 186, and others) and a one-year streamlined submission for substances already on the market. Effective 60 days after a final rule, with 18 months to comply. Noncompliance would be a factor in FDA's prioritization for post-market review; the rule creates no premarket approval. It grounds authority in sections 409(a), 409(d) and 701(a) and compares today's position to the years before 1958. Comments close 9 December 2026.

Source: U.S. Food and Drug Administration
Date: 11 August 2026
Quoted from: 91 FR 51838, section I (Executive Summary)
Grade: Primary record
Document: https://www.govinfo.gov/content/pkg/FR-2026-08-11/pdf/2026-16296.pdf
Accessed: 2026-11-09
Cited by: Findings citing this exhibit
Note: Other passages read: 51835 ('Under our current regulations, a person who concludes that the use of a substance is GRAS under the conditions of its intended use may, but is not required to, notify FDA of this conclusion.'); 51838 ('we find ourselves in a situation much like the years before the 1958 amendment’s enactment.'); 51842 ('Although we cannot verify the accuracy of these estimates'); 51845-46 (legal authority); 51866 (compliance date); 51870 (PRIA counts).

Exhibit 573 · Trade association statement

Let's Mow Down the GRAS Myths (one-page fact sheet)

GRAS is not a loophole; it’s a science-based regulatory pathway established by Congress and overseen by the FDA.

Industry trade group's response to the August 2026 proposal. It supports mandatory notification as part of 'a national uniform standard,' says GRAS ingredients must meet the same 'reasonable certainty of no harm' standard as approved additives, and rejects the 'loophole' description.

Source: Consumer Brands Association
Date: August 2026 (file named GRAS_Onesheet_081326)
Quoted from: 'GRAS Is Just a Loophole' row
Grade: Primary record
Document: https://consumerbrandsassociation.org/wp-content/uploads/2026/08/GRAS_Onesheet_081326.pdf
Accessed: 2026-11-09
Cited by: Findings citing this exhibit
Note: The document carries no date; the date is inferred from the file name. Second quote: 'The CPG industry has consistently supported greater transparency and welcomes GRAS reform as part of a national uniform standard for ingredient safety and transparency, including updated FDA regulations that require mandatory notification.' (first paragraph).

1.12 No federal definition of ultra-processed food

Finding AGR-1.12Primary record

FDA and USDA published a joint request for information on 25 July 2025 stating there is "no single, universally accepted definition" of ultra-processed food. The comment period was extended to 23 October 2025.

The request was published at 90 FR 35305 (Docket FDA-2025-N-1793). It asks six groups of questions on ingredients, processing and nutrients.

Evidence: Exhibit 575, Exhibit 576, Exhibit 577

§1.12.1

The notice states: "There is no single, universally accepted definition of UPFs, and the definition of such foods has varied considerably over time." It describes the Nova classification and notes that foods such as whole-grain products or yogurt may be classed as ultra-processed under some systems. It lists state proposals that define the term by additives, processing steps or listed ingredients.

§1.12.2

The HHS release of 23 July 2025 states: "Currently, there is no single authoritative definition for ultra-processed foods for the U.S. food supply." It quotes the Secretary and the FDA Commissioner on the health risks of such foods. Those are the officials' statements. Any figure for the share of the food supply that is ultra-processed depends on which classification is used.

Exhibit 575 · Federal Register notice

Ultra-Processed Foods; Request for Information (90 FR 35305; Docket FDA-2025-N-1793)

There is no single, universally accepted definition of UPFs, and the definition of such foods has varied considerably over time

Joint FDA-USDA request for data to help develop a uniform federal definition of ultra-processed food. It describes the Nova system, notes that foods such as whole-grain products or yogurt may be classed as ultra-processed, lists state proposals (Pennsylvania, California, Massachusetts, Florida, Louisiana and others) that define the term by additives, processing steps or listed ingredients, and asks six groups of questions on ingredients, processing and nutrients.

Source: U.S. Food and Drug Administration; U.S. Department of Agriculture
Date: 25 July 2025
Quoted from: 90 FR 35306-07, section I (Background)
Grade: Primary record
Document: https://www.govinfo.gov/content/pkg/FR-2025-07-25/pdf/2025-14089.pdf
Accessed: 2026-11-09
Cited by: Findings citing this exhibit

Exhibit 576 · Federal Register notice

Ultra-Processed Foods; Request for Information; Extension of Comment Period (90 FR 45229)

In response to requests for an extension, we are extending the comment period until October 23, 2025, to allow interested persons additional time to submit comments.

Extends the comment period on the July 2025 request (90 FR 35305, Docket FDA-2025-N-1793) to 23 October 2025.

Source: U.S. Food and Drug Administration; U.S. Department of Agriculture
Date: 19 September 2025
Quoted from: 90 FR 45229, 19 Sept. 2025, SUMMARY
Grade: Primary record
Document: https://www.govinfo.gov/content/pkg/FR-2025-09-19/pdf/2025-18169.pdf
Accessed: 2026-11-09
Cited by: Findings citing this exhibit
Note: The 'no single, universally accepted definition' wording is in the RFI exhibit, not in this notice.

Exhibit 577 · Agency press release

HHS, FDA and USDA Address the Health Risks of Ultra-Processed Foods

Currently, there is no single authoritative definition for ultra-processed foods for the U.S. food supply.

Announces the joint request for information. States that there is no single authoritative definition, and that a uniform definition will allow consistency in research and policy. Quotes the HHS Secretary and FDA Commissioner on health risks of such foods; those statements are the officials' own and are not findings.

Source: U.S. Department of Health and Human Services
Date: 23 July 2025
Quoted from: Paragraph 3
Grade: Primary record
Document: https://www.hhs.gov/press-room/hhs-fda-usda-ultra-processed-foods-definition-rfi.html
Archived: https://web.archive.org/web/20260129045435/https://www.hhs.gov/press-room/hhs-fda-usda-ultra-processed-foods-definition-rfi.html
Accessed: 2026-11-09
Cited by: Findings citing this exhibit

1.13 The definition at OMB

Finding AGR-1.13Reported

A proposed federal definition of ultra-processed food went to OMB review as a white paper on 3 August 2026, according to OIRA's review record, and had not been released as of 13 October 2026. The Philadelphia Inquirer, carrying a Bloomberg article, reported on 10 August 2026 that food-company executives lobbied the Trump administration to delay or block its release, according to people familiar with the discussions. STAT reported on 22 October 2026 that the planned release was canceled at the last minute.

Trade press reports that HHS and FDA sent a white paper, "Proposed Definition of Ultra-Processed Food," to OIRA on 3 August 2026. A law firm alert reports that HHS and USDA announced on 10 August that a definition had gone to OMB for final review as a white paper, and that OMB's calendar lists Executive Order 12866 meetings in September and October.

Evidence: Exhibit 583, Exhibit 582, Exhibit 140, Exhibit 141

§1.13.1

The Philadelphia Inquirer (10 August 2026), carrying a Bloomberg article, reports that food-company executives lobbied the Trump administration to delay or withhold a proposed definition, according to people familiar with the discussions. The article states that the white paper had not been cleared by the White House budget office. It quotes an HHS spokesperson saying the policy is under interagency review and has not been finalized, and an administration official saying the effort remains on track. STAT (22 October 2026) reports that the planned release was canceled at the last minute, that the definition remained unreleased, that more than 80 nutrition researchers urged its release and that Dariush Mozaffarian of Tufts attributed the delay to industry pressure. The industry disputes that account.

§1.13.2

The law firm alert reports more than 5,000 comments on the 2025 request. OIRA's review page lists the white paper (RIN 0910-ZD60) as received on 3 August 2026 and pending as of 10 November 2026. The Medicine report records the same reporting in Chapter 6, section 6.6.

Exhibit 583 · Government record

OIRA review record: HHS/FDA ultra-processed food whitepaper (RIN 0910-ZD60)

OIRA's review page for the HHS/FDA whitepaper 'Proposed Definition of Ultra-Processed Food' (RIN 0910-ZD60): received 3 August 2026, stage Notice, pending as of 10 November 2026. OIRA's page for the GRAS rule 'Substances Generally Recognized as Safe' (RIN 0910-AJ02) shows receipt 1 December 2025 and conclusion 31 July 2026, 'Consistent with Change' (https://www.reginfo.gov/public/do/eoDetails?rrid=1194761).

Source: Office of Information and Regulatory Affairs, reginfo.gov
Date: August 2026
Grade: Primary record
Document: https://www.reginfo.gov/public/do/eoDetails?rrid=1495413
Accessed: 2026-11-09
Cited by: Findings citing this exhibit
Note: Food Safety Magazine (4 August 2026) reports the same two events.

Exhibit 582 · Law firm alert

More Than Research: Why the Coming Federal Definition of Ultra-Processed Foods Matters

Reports that more than 5,000 comments were filed on the 2025 request; that HHS and USDA announced on 10 August 2026 that a proposed definition had gone to OMB for final review as a white paper, not a regulation; that OMB's calendar lists Executive Order 12866 meetings on the white paper in September and October; and that the text had not been released as of 13 October 2026.

Source: Greenberg Traurig
Date: October 2026
Grade: Reported
Document: https://www.gtlaw.com/en/insights/2026/10/more-than-research-why-the-coming-federal-definition-of-ultra-processed-foods-matters
Accessed: 2026-11-09
Cited by: Findings citing this exhibit

Exhibit 140 · Journalism

Report on food-company lobbying over the federal ultra-processed food definition

Reports, on anonymous sourcing, that food-company executives lobbied the Trump administration to delay or block release of a proposed definition of ultra-processed food, that the white paper had not been cleared by the White House budget office, that an HHS spokesperson called the policy under interagency review and not finalized, and that an administration official said the effort remains on track. Does not report that a release was cancelled.

Source: The Philadelphia Inquirer
Date: 10 August 2026
Grade: Reported
Document: https://www.inquirer.com/business/ultra-processed-food-definition-ceos-delay-industry-costs-litigation-business-white-house-20260810.html
Accessed: 2026-11-09
Cited by: Findings citing this exhibit

Exhibit 141 · Journalism

Report on the stalled federal ultra-processed food definition

More than 80 nutrition researchers and experts are calling on the White House to release the federal government’s proposed definition of ultra-processed foods, after its unveiling in August was canceled at the last minute under pressure from major food companies.

Reports that the planned release of the definition was canceled at the last minute, that the definition remained unreleased in October 2026, that more than 80 nutrition researchers urged its release, and that Tufts nutrition scientist Dariush Mozaffarian attributed the delay to industry pressure, which industry disputes.

Source: STAT
Date: 22 October 2026
Quoted from: STAT, Sarah Todd, 22 Oct. 2026, first paragraph (STAT+ paywall; only the opening is readable)
Grade: Reported
Document: https://www.statnews.com/2026/10/22/ultra-processed-food-definition-maha-white-house/
Accessed: 2026-11-09
Cited by: Findings citing this exhibit

1.14 California and Texas

Finding AGR-1.14Primary record

California's AB 1264 (approved 8 October 2025) defines ultraprocessed food for school food by reference to a substance in FDA's Substances Added to Food database with one of eight listed technical effects, plus a nutrient threshold or a listed sweetener. On 11 February 2026 a federal court enjoined enforcement of Texas SB 25's warning-label requirement against four trade associations, including the Consumer Brands Association, and their members.

California's AB 1264 (Chapter 467, Statutes of 2025) was approved on 8 October 2025. Texas SB 25 requires a warning label on food containing any of 44 listed ingredients and took effect on 1 September 2025.

Evidence: Exhibit 578, Exhibit 579, Exhibit 580

§1.14.1

The California bill defines ultraprocessed food for school food as a food or beverage containing a substance in FDA's Substances Added to Food database with one of eight listed technical effects, such as emulsifier, stabilizer, color or flavoring agent. The food must also have high amounts of saturated fat, sodium or added sugar, or contain a nonnutritive sweetener or another listed substance. The Department of Public Health must define "ultraprocessed foods of concern" by regulation by 1 June 2028. The phase-out begins by 1 July 2029, and vendor sales end on 1 July 2032.

§1.14.2

The Texas label reads: "WARNING: This product contains an ingredient that is not recommended for human consumption by the appropriate authority in Australia, Canada, the European Union, or the United Kingdom." The law is a labeling statute and is not a GRAS rule. Section 431.0817 makes the requirement inoperative for an ingredient once FDA or USDA prohibits it, conditions its use or determines it safe.

§1.14.3

On 11 February 2026 the Western District of Texas granted a preliminary injunction against enforcement of Section 9 against four trade associations (including the Consumer Brands Association) and their members. The court found a substantial likelihood that the plaintiffs would succeed on a First Amendment compelled-speech claim. It found that the plaintiffs had not shown that the FDCA or the Nutrition Labeling and Education Act likely preempts the statute.

Exhibit 578 · State statute

Assembly Bill 1264 (Gabriel), Chapter 467, Statutes of 2025: Pupil nutrition: restricted school foods and ultraprocessed foods of concern

“ultraprocessed food” or “UPF” means any food or beverage that contains a substance described in paragraph (2) and either high amounts of saturated fat, sodium, or added sugar, as described in subparagraph (A) of paragraph (3), or a nonnutritive sweetener or other substance described in subparagraph (B) of paragraph (3).

Defines 'ultraprocessed food' for school food by a substance test (any substance in FDA's Substances Added to Food database with one of eight listed technical effects, such as emulsifiers, stabilizers, colors or flavoring agents) combined with a nutrient test or a listed sweetener. The Department of Public Health must define 'ultraprocessed foods of concern' by regulation by 1 June 2028; phase-out begins by 1 July 2029 and vendor sales end 1 July 2032.

Source: State of California
Date: 8 October 2025
Quoted from: Cal. Health & Safety Code sec. 104661(a)(1) (added by sec. 8)
Grade: Primary record
Document: https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=202520260AB1264
Archived: https://web.archive.org/web/20260904131500/https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=202520260AB1264
Accessed: 2026-11-09
Cited by: Findings citing this exhibit

Exhibit 579 · State statute

Senate Bill 25 (89th Legislature, Regular Session), enrolled

WARNING: This product contains an ingredient that is not recommended for human consumption by the appropriate authority in Australia, Canada, the European Union, or the United Kingdom.

Section 9 (Health & Safety Code 431.0815) requires a warning label on food containing any of 44 listed ingredients. It is a labeling law, not a GRAS rule. Section 431.0817 makes the label requirement inoperative for an ingredient once FDA or USDA prohibits it, conditions its use, or 'determines an ingredient or class of ingredients is safe.'

Source: State of Texas
Date: Signed June 2025; effective 1 September 2025
Quoted from: Tex. Health & Safety Code sec. 431.0815(b)(1)
Grade: Primary record
Document: https://capitol.texas.gov/tlodocs/89R/billtext/html/SB00025F.htm
Accessed: 2026-11-09
Cited by: Findings citing this exhibit

Exhibit 580 · Court order

American Beverage Association et al. v. Paxton, No. 6:25-cv-00566 (W.D. Tex.), order on motion for preliminary injunction

The Court finds that Plaintiffs have shown that they are substantially likely to succeed on the merits of their claim that Section 9 violates the First Amendment by unconstitutionally compelling speech.

Grants a preliminary injunction against enforcement of Section 9 of SB 25 against the plaintiffs (American Beverage Association, Consumer Brands Association, National Confectioners Association, FMI) and their members, finding a substantial likelihood of success on a First Amendment compelled-speech claim.

Source: U.S. District Court, Western District of Texas (Waco Division)
Date: 11 February 2026
Quoted from: Order, Part III.A (Likelihood of Success on the Merits)
Grade: Primary record
Document: https://www.wlf.org/wp-content/uploads/2025/12/TX-Order-Granting-PI-2_11_26.pdf
Accessed: 2026-11-09
Cited by: Findings citing this exhibit
Note: Copy hosted by the Washington Legal Foundation; the docket (CourtListener/PACER) is the more primary copy. The order enjoins enforcement of Section 9 'against Plaintiffs or their members' (Part IV) and finds the preemption claims (FDCA, NLEA) not shown likely to succeed (Part III.A).

1.15 New York

Finding AGR-1.15Reported

The New York legislature passed S1239F in March and April 2026. The bill would require companies to report GRAS substances to the state for a public database.

The bill would also ban Red No. 3, potassium bromate and propylparaben. The Senate passed it 60-0 on 23 March 2026.

Evidence: Exhibit 581

§1.15.1

The reporting exemptions cover substances with an FDA no-questions letter or a federal GRAS listing. The text exempts businesses of ten or fewer employees. As of 10 November 2026 the bill page shows no delivery to the Governor, signature or veto.

Exhibit 581 · State bill

New York Senate Bill S1239F (2025-26), Food Safety and Chemical Disclosure Act

Bill S1239F would ban Red No. 3, potassium bromate and propylparaben and would require companies to report GRAS substances to the state agriculture commissioner for a public database before sale, with exemptions for substances with an FDA no-questions letter or a federal GRAS listing and for businesses of ten or fewer employees. Passed the Senate 60-0 on 23 March 2026 and the Assembly on 21 April 2026. As of 10 November 2026 the bill page shows no delivery to the Governor, signature or veto.

Source: New York State Legislature
Date: 21 April 2026 (Assembly passage)
Grade: Primary record
Document: https://www.nysenate.gov/legislation/bills/2025/S1239
Accessed: 2026-11-09
Cited by: Findings citing this exhibit

1.16 An open question

Finding AGR-1.16Open question

Whether California's database-based definition of ultraprocessed food reaches additives marketed on independent GRAS conclusions is unanswered. The definition relies on FDA's Substances Added to Food database, and FDA states that it has "little, if any, information on independent conclusions of GRAS status."

California's definition names the Substances Added to Food database as its reference. FDA's proposed rule states that it has little information on independent conclusions.

Evidence: Exhibit 578, Exhibit 570

§1.16.1

The California statute identifies substances by that database and by Chemical Abstracts Service numbers. The documents cited do not say whether the database lists additives marketed only on independent conclusions. FDA's 2026 estimate of 1,000 to 3,000 such substances (section 1.7) is an assumption, and no cited document describes the database's coverage of them.

§1.16.2

No count exists of the determinations FDA was never told of. FEMA's page states no position on the 2026 proposal, and comments in Docket FDA-2025-N-3262 close on 9 December 2026.