For decades, food manufacturers have relied on a regulatory pathway known as Generally Recognized as Safe—or GRAS—to introduce substances into the food supply without formal FDA approval. Under this framework, a substance may bypass the agency’s premarket review process if qualified experts generally recognize it as safe for its intended use. That practice is now under increasing scrutiny, and the GRAS framework has become the focus of a rapidly developing reform effort at the federal and state levels.
Background
The Federal Food, Drug, and Cosmetic Act (FFDCA) requires premarket review and approval of any substance intentionally added to food as a food additive, unless the substance is GRAS or otherwise excepted from the definition of a food additive. Historically, FDA affirmed substances as GRAS on its own initiative or by petition. Today, that responsibility largely rests with industry.
Companies may voluntarily submit a GRAS notification to FDA, which may respond that there is insufficient basis for a GRAS conclusion or issue a “no questions” letter leaving the determination unchallenged. But this is not required: FDA regulations also allow a company to “self-affirm” a substance as GRAS without notifying the agency, allowing it to enter the food supply without FDA premarket review.
Closing this self-affirmation “loophole” has become a priority for federal officials, lawmakers, and advocacy groups. FDA, Congress, and state legislators are all pursuing reform, as described below.
FDA Actions
FDA is developing a proposed rule to eliminate self-affirmed GRAS by mandating GRAS notification for substances purported to be GRAS. The proposal is expected to exempt substances listed or affirmed as GRAS for the intended use by regulation, or for which FDA has issued a no questions letter. It would also require FDA to maintain a public-facing GRAS inventory and clarify the process under which FDA would determine that a substance is not GRAS.
The Office of Management and Budget has been reviewing the proposed rule since December 1, 2025. FDA leadership reportedly projects publication late this spring or early summer of this year.
In parallel, FDA is working to implement a post-market review program for substances already in the food supply, including those designated as GRAS. Historically conducted on an ad hoc basis, these reviews are expected to follow a structured prioritization framework. FDA released a draft framework for public comment last summer.
As part of that effort, this March, FDA launched a post-market review of butylated hydroxyanisole (BHA) by publishing a request for information in the Federal Register. BHA is a chemical preservative listed as GRAS and authorized as a direct food additive when used as an antioxidant.
Legal uncertainty remains. In 2021, the Southern District of New York denied a challenge to FDA’s self-affirmed GRAS scheme brought by a coalition of NGOs, noting that it is “unclear whether FDA even has the authority to make GRAS notifications mandatory” under FFDCA. “The remedy Plaintiffs seek lies with Congress,” the court said.
Federal Legislation
Perhaps anticipating that litigation may jeopardize FDA’s rulemaking, Congress has introduced at least three bills to eliminate self-affirmed GRAS.
2341 – Ensuring Safe and Toxic-Free Foods Act of 2025 (Sen. Markey, D-MA) would mandate GRAS notifications supported by scientific evidence, including for substances currently self-affirmed on the market, within two years of enactment. Although not highlighted in the bill’s accompanying materials, the legislation also appears to sunset the GRAS pathway altogether after that two-year period. It would require FDA to post notices for public comment, eliminate the GRAS pathway for new substances, exclude from GRAS eligibility substances that are carcinogenic or show evidence of reproductive or developmental toxicity, require FDA to review at least 50 GRAS notices per year until the backlog is cleared, and require FDA to reassess at least 10 food substances or substance classes every three years.
H.R. 4958 – GRAS Act (Rep. Pallone, D-NJ-6) would mandate GRAS notifications for new substances and new uses going forward, with notifications required to demonstrate that the weight of evidence shows the substance is neither carcinogenic nor associated with reproductive or developmental toxicity. The bill would require a written “no objection” response from FDA before a substance may be used as GRAS, mandate a public comment period, require triennial reassessment of at least 10 food substances or substance classes, and authorize FDA to collect user fees.
3122 – Better FDA Act of 2025 (Sen. Marshall, R-KS) would require notifications within two years of enactment for currently self-affirmed substances and at least 120 days before first use for new substances. It would require FDA to maintain a public GRAS list and automatically approve a use as GRAS if FDA fails to respond within 180 days. The bill would also allow FDA to reevaluate a food additive upon petition, state request, or on its own initiative, and would require that reevaluations be conducted by career scientists rather than political appointees.
Two additional bills impose post-market review requirements without revising the broader GRAS framework. H.R.4306 (Rep. Schakowsky, D-IL-9), would require FDA to reassess the safety of at least 10 food substances or substance classes every three years and suggests the first 10 substances for reassessment. H.R.7291 (Rep. Lawler, R-NY-17), would assemble an interagency review board to reassess pre-2000 manufacturer GRAS determinations, including self-affirmations, and recommend revocation where safety has not been demonstrated.
All of these bills are currently pending in committee. None have attracted a cosponsor from the opposing party.
State Legislation
Notably, none of the federal proposals includes preemption provisions, even as states move aggressively in this space. Numerous states have enacted or are considering restrictions on specific additives, including West Virginia, whose ban on synthetic food dyes is currently being litigated.
Other states are targeting self-affirmed GRAS more directly. Bills introduced in Pennsylvania, New Jersey, New York, and California would each require manufacturers of self-affirmed GRAS to report information supporting the determination to the state, which would be made publicly available online. Failure to report would render the additive unlawful for use in that state.
Pennsylvania and California would require the same information and data required as part of a federal GRAS notice. Although New Jersey’s reporting requirement would apply only prospectively to new uses of an additive, the other three bills appear to also cover existing self-affirmed substances.
Additional provisions vary by state. New York would ban three specific substances and prohibit the sale of foods containing certain synthetic color additives in public schools. California would approve existing additives upon report submission, but would subject substances and uses introduced after July 1, 2027, to evaluation by state regulators with an opportunity for public objection. California would also declare additives and dietary ingredients unsafe if they are found to induce cancer when ingested and require systematic post-market reviews.
Of these bills, only New York’s has passed a legislative chamber this session—the state senate, on March 23, 2026. That bill, as well as Pennsylvania’s, has sponsors from both parties.
Verdant Law closely monitors these developments and their implications for the evolving regulation of food additives and the GRAS framework. Please contact us with any questions.
Senator Introduces CRA Resolution to Nullify EPA’s PFAS Reporting Extension
/in EPA, PFAS, TSCASenator Sheldon Whitehouse (D-RI) has introduced a joint resolution to disapprove EPA’s April extension of the start PFAS Reporting Rule’s reporting period start date.
The Congressional Review Act resolution, filed as S.J.Res. 187 on April 27, 2026, would immediately nullify EPA’s extension rule if passed. The resolution currently has no cosponsors.
EPA’s extension pushed the start of the reporting period to January 31, 2027, or 60 days following the effective date of amendments narrowing the rule’s scope, whichever is earlier. EPA proposed those amendments in November 2025, which would add exemptions for de minimis concentrations and imported articles, among others.
The extension was published on April 13, the same day the reporting period was scheduled to open. EPA had already delayed the start of the period twice before, citing technical difficulties.
The PFAS Reporting Rule is a one-time PFAS reporting obligation under TSCA section 8(a)(7) for persons who manufactured or imported PFAS for commercial purposes between 2011 and 2022. More on the rule is available in our archive.
EPA to Host May 6 Webinar on TSCA CBI Claim Expirations
/in CBI, EPA, TSCAOn May 6, 2026, at 4:00 p.m. EDT, EPA will host a webinar on expiring confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA).
According to EPA, the webinar will help companies, stakeholders, and the public understand the regulatory requirements governing the lifecycle of CBI claims, including how to determine whether a claim is expiring and how to request an extension. EPA will also demonstrate the Central Data Exchange (CDX) application that TSCA submitters must use to request extensions, address frequently asked questions, and outline effective ways to communicate with the agency about the CBI claim expiration process.
Registration is available here.
Last week, EPA released the first list of expiring CBI claims and announced the deployment of the CDX extension request tool in advance of the first expirations, which begin on June 22, 2026. Additional details on the list of expiring claims and the CDX tool are available in a previous post.
Texas AG Investigates Lululemon Over PFAS Concerns
/in Enforcement, PFASOn April 13, 2026, Texas Attorney General Ken Paxton announced the issuance of a civil investigative demand against Lululemon as part of an investigation into the potential presence of PFAS in the activewear company’s apparel.
The investigation will examine whether Lululemon has misled consumers about the safety, quality, and health impacts of its products, prompted by “emerging research and consumer concerns” that “raised questions about the potential presence of certain synthetic materials and chemical compounds in their apparel.” According to the press release, the company’s health-conscious customers would not expect PFAS in its products given Lululemon’s sustainability- and performance-focused marketing.
As part of the investigation, the office of the attorney general says it will review “the company’s Restricted Substances List, testing protocols, and supply chain practices to determine whether Lululemon’s products comply with its stated safety standards.”
Three days later, on April 16, Lululemon published a webpage entitled “Created without PFAS: What to know about lululemon’s products,” stating that the company does not use PFAS in its products today and requires vendors to conduct regular testing. “Our ongoing focus is to help prevent the unintentional reintroduction of PFAS into our products through ongoing testing, monitoring, and collaboration with suppliers and third parties,” the page says.
The webpage also links to Lululemon’s restricted substances list, which sets a 50 ppm limit on all PFAS as measured by total organic fluorine and more stringent limits on specific compounds such as PFOS and PFOA.
EPA Releases List of Expiring CBI Claims, CDX Tool for Extensions
/in CBI, EPA, TSCAOn April 23, 2026, EPA announced the release of the first list of expiring confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA).
Each claim on the list is identified by TSCA case number, expiration date, and submission type. The inaugural list includes 294 claims that are set to expire between June 22 and August 1, 2026. EPA says it will update the list monthly.
The list is intended to help meet TSCA’s requirement that EPA notify submitters at least 60 days before a claim expires.
According to the press release, EPA has also deployed a new “TSCA Section 14(e) CBI Claim Extension Request” tool in CDX, its electronic filing system. Companies can use this tool to request a 10-year extension for an expiring claim, which must include substantiation of the need for continued CBI protection.
Requests for extension must be submitted at least 30 days before a claim’s expiration date. EPA warns that failure to submit a timely request may result in public disclosure of the CBI without further notice to the submitter.
In addition to publishing the list, EPA is notifying submitters directly through CDX as claim expirations approach. EPA advises companies to ensure their contact information in CDX is current to receive these notices.
CBI claims appear across a wide range of TSCA submissions. The first list includes claims made on new chemical applications (such as PMNs and LVEs), Chemical Data Reporting submissions, import and export materials, and section 8(e) substantial risk notifications, among others.
Expiration Dates
As discussed in detail in a previous post, 2016 amendments to TSCA now mean most CBI claims expire ten years after assertion. Because those amendments were enacted on June 22, 2016, the first expirations under the revised statute will occur on June 22, 2026.
Companies should be mindful, however, that CBI claims for specific chemical identities can expire less than 10 years after assertion if another company has also asserted a claim for the same chemical. That is because expiration dates for chemical identity claims are set 10 years from the first approved confidentiality claim for the chemical identity.
Companies should also note that certain CBI claims are exempt from expiration: specifically, those that are statutorily exempt from substantiation requirements and EPA CBI review.
More information on CBI expirations can be found in a January 2026 Federal Register notice and on EPA’s website.
Pet Food Brand to Modify ‘Made in USA’ and ‘All Natural’ Claims After NAD Review
/in Green Marketing, Made in USASundays for Dogs will discontinue certain “Made in USA” and “all natural ingredients” claims following recommendations from the Better Business Bureau’s National Advertising Division (NAD), the industry self-regulatory body announced April 17, 2026.
According to NAD, the dog food manufacturer sources most of its ingredients domestically. However, because “certain key ingredients, including beef bone and fish oil, are sourced from New Zealand,” NAD recommended that Sundays add qualifying language to its “Made in USA” representations.
“Consistent with Federal Trade Commission guidance, NAD determined that because these ingredients are essential to the product’s function, an unqualified ‘Made in USA’ claim is not appropriate, even if the amount of foreign content is small,” the decision summary states.
Other contested claims included “all natural ingredients” and “100% meat and superfoods.” When accompanied by imagery suggesting whole fruits and vegetables, NAD found those claims misleading because Sundays uses nutrient extracts rather than whole-food ingredients. Similar claims were deemed acceptable in other contexts, however.
NAD also found adequate substantiation for the brand’s “no synthetic additives” claim, but recommended that Sundays stop implying that competing products contain synthetic additives.
The challenge, which concerned claims on the company’s website and social media channels, was brought by rival pet food maker The Farmer’s Dog, Inc. Sundays agreed to comply with NAD’s recommendations.
California Bill Would Strip ‘Compostable’ Label from Plastic Products
/in California, Green Marketing, State PolicyCalifornia lawmakers are weighing legislation targeting plastics in organic waste streams, characterizing plastic as a contaminant in the composting process.
Beginning January 1, 2027, Assembly Bill 1812 would prohibit the sale of products labeled with the terms “compostable” or “home compostable” that are made wholly or partially of plastic. It would also update the requirements for those representations by eliminating references to ASTM standards for plastic compostability, instead limiting the labels to products that are “OK compost HOME” certified or meet a different standard adopted by CalRecycle.
Fiber products that are demonstrated to not incorporate any plastics or polymers would not be required to meet those requirements, unless CalRecycle adopts or approves a compostability standard specifically for fiber products.
Under existing California law, products making compostability claims must already satisfy all of the following conditions:
AB 1812 was introduced February 10, 2026, and amended March 23. On April 13, the bill passed the Assembly Committee on Natural Resources and was re-referred to the Committee on Appropriations.
Minnesota Delays PFAS Reporting Requirements
/in PFAS, State PolicyMinnesota has extended the deadline for manufacturers to file initial reports on intentionally added PFAS in products from July 1 to September 15, 2026.
According to the Minnesota Pollution Control Agency (MPCA), the extension is intended to give manufacturers more time to:
Manufacturers may also request a 90-day extension request for the initial reporting requirement, which now corresponds with a deadline of December 14, 2026.
Additional information, including guidance on using PRISM, is available on the MPCA website. Further details on the reporting requirements, which were finalized last December, are covered in a previous post.
MPCA is also developing new rules governing currently unavoidable uses of PFAS. Information on that rulemaking is discussed in the latter half of a previous post.
Keurig Hit with Class Action over ‘Recyclable’ K-Cups
/in Green MarketingA California consumer has launched a putative class action against Keurig Dr. Pepper, alleging that the beverage giant’s single-serve coffee pods are deceptively labeled as “recyclable” because most recycling centers are unable to accept them.
According to the complaint, filed April 7, 2026, Keurig K-Cups are virtually non-recyclable due to their small size, multi-material design, residual coffee grounds and liquids, and limited economic value in recycling streams.
“Despite these facts, Keurig promotes its K-Cup pods as ‘recyclable’ because they are made from polypropylene #5 plastic,” the complaint alleges. “However, the company relies on a purely theoretical definition of recyclability that ignores the fundamental principles outlined in the FTC’s Green Guides and does not align with consumer understanding.”
The challenged representations are allegedly made on product packaging, Keurig’s website, online retail listings, and social media alongside the “chasing arrows” recyclability symbol.
The complaint further alleges that recycling centers serving at least 60 percent of US consumers do not accept K-Cups—the threshold for making unqualified recyclability claims under the Green Guides, which provide guidance for environmental marketing claims and are incorporated into California law. Qualifying language telling consumers to “check locally” or noting that the pods “are not recycled in many communities” is shown in fine print that is difficult to read, the complaint says.
“If Plaintiff had known that the Products were not recyclable, Plaintiff would not have purchased the Products,” the complaint states. “At a minimum, Plaintiff would not have paid as much as he did if he had known the Products could not be recycled.”
The lawsuit also notes that Keurig’s recyclability claims have previously been challenged. In 2023, Keurig settled similar allegations for $10 million but allegedly made only “minor modifications” to its marketing. The complaint also references a civil penalty imposed by the Securities and Exchange Commission because the company failed to disclose recyclability concerns raised by recycling facilities.
The plaintiff alleges violations of California’s Unfair Competition Law, False Advertising Law, and Consumers Legal Remedies Act, as well as for negligent misrepresentation and unjust enrichment.
The case is Dixon v. Keurig Dr Pepper, Inc., No. 26-cv-2172 (S.D. Cal.), filed 4/7/2026.
Update (April 15, 2026)
On April 10, 2026, an almost identical putative class action was filed against Keurig in New York. That case is Sulli v. Keurig Dr Pepper, Inc., No. 26-cv-6420 (W.D.N.Y.), filed 4/10/2026.
PFAS Reporting Rule Delayed Again Amid Ongoing Rulemaking
/in EPA, PFAS, TSCAEPA has delayed the start of the PFAS Reporting Rule reporting period for the third time as the agency finalizes amendments that would narrow the rule’s scope.
The reporting period will now begin January 31, 2027, or 60 days following the effective date of the final rule implementing the amendments, whichever is earlier. EPA says that it expects to release the final rule “well before” the January 31, 2027, fallback date.
The extension will be published in the Federal Register on April 13, 2026, the same day the reporting period had been scheduled to begin.
Background
Promulgated under section 8(a)(7) of the Toxic Substances Control Act (TSCA), the PFAS Reporting Rule requires all persons who manufactured or imported PFAS for commercial purposes between 2011 and 2022 to report chemical information to EPA. For most manufacturers and importers, the original reporting deadline was May 13, 2023. However, EPA delayed the start of the reporting period in 2024 and again in 2025, citing technical difficulties with the reporting tool.
In the 2025 postponement, EPA also signaled that it was considering reopening the rule’s reporting requirements. Subsequently, in November 2025, EPA released a proposed rule introducing various exemptions to the reporting requirements. These include exemptions for mixtures and products containing de minimis PFAS concentrations, imported articles, and certain byproducts and impurities.
More on the PFAS Reporting Rule can be found in our topic archive.
GRAS Reform Update: Where Do Things Stand?
/in FDA, FFDCA, State PolicyFor decades, food manufacturers have relied on a regulatory pathway known as Generally Recognized as Safe—or GRAS—to introduce substances into the food supply without formal FDA approval. Under this framework, a substance may bypass the agency’s premarket review process if qualified experts generally recognize it as safe for its intended use. That practice is now under increasing scrutiny, and the GRAS framework has become the focus of a rapidly developing reform effort at the federal and state levels.
Background
The Federal Food, Drug, and Cosmetic Act (FFDCA) requires premarket review and approval of any substance intentionally added to food as a food additive, unless the substance is GRAS or otherwise excepted from the definition of a food additive. Historically, FDA affirmed substances as GRAS on its own initiative or by petition. Today, that responsibility largely rests with industry.
Companies may voluntarily submit a GRAS notification to FDA, which may respond that there is insufficient basis for a GRAS conclusion or issue a “no questions” letter leaving the determination unchallenged. But this is not required: FDA regulations also allow a company to “self-affirm” a substance as GRAS without notifying the agency, allowing it to enter the food supply without FDA premarket review.
Closing this self-affirmation “loophole” has become a priority for federal officials, lawmakers, and advocacy groups. FDA, Congress, and state legislators are all pursuing reform, as described below.
FDA Actions
FDA is developing a proposed rule to eliminate self-affirmed GRAS by mandating GRAS notification for substances purported to be GRAS. The proposal is expected to exempt substances listed or affirmed as GRAS for the intended use by regulation, or for which FDA has issued a no questions letter. It would also require FDA to maintain a public-facing GRAS inventory and clarify the process under which FDA would determine that a substance is not GRAS.
The Office of Management and Budget has been reviewing the proposed rule since December 1, 2025. FDA leadership reportedly projects publication late this spring or early summer of this year.
In parallel, FDA is working to implement a post-market review program for substances already in the food supply, including those designated as GRAS. Historically conducted on an ad hoc basis, these reviews are expected to follow a structured prioritization framework. FDA released a draft framework for public comment last summer.
As part of that effort, this March, FDA launched a post-market review of butylated hydroxyanisole (BHA) by publishing a request for information in the Federal Register. BHA is a chemical preservative listed as GRAS and authorized as a direct food additive when used as an antioxidant.
Legal uncertainty remains. In 2021, the Southern District of New York denied a challenge to FDA’s self-affirmed GRAS scheme brought by a coalition of NGOs, noting that it is “unclear whether FDA even has the authority to make GRAS notifications mandatory” under FFDCA. “The remedy Plaintiffs seek lies with Congress,” the court said.
Federal Legislation
Perhaps anticipating that litigation may jeopardize FDA’s rulemaking, Congress has introduced at least three bills to eliminate self-affirmed GRAS.
2341 – Ensuring Safe and Toxic-Free Foods Act of 2025 (Sen. Markey, D-MA) would mandate GRAS notifications supported by scientific evidence, including for substances currently self-affirmed on the market, within two years of enactment. Although not highlighted in the bill’s accompanying materials, the legislation also appears to sunset the GRAS pathway altogether after that two-year period. It would require FDA to post notices for public comment, eliminate the GRAS pathway for new substances, exclude from GRAS eligibility substances that are carcinogenic or show evidence of reproductive or developmental toxicity, require FDA to review at least 50 GRAS notices per year until the backlog is cleared, and require FDA to reassess at least 10 food substances or substance classes every three years.
H.R. 4958 – GRAS Act (Rep. Pallone, D-NJ-6) would mandate GRAS notifications for new substances and new uses going forward, with notifications required to demonstrate that the weight of evidence shows the substance is neither carcinogenic nor associated with reproductive or developmental toxicity. The bill would require a written “no objection” response from FDA before a substance may be used as GRAS, mandate a public comment period, require triennial reassessment of at least 10 food substances or substance classes, and authorize FDA to collect user fees.
3122 – Better FDA Act of 2025 (Sen. Marshall, R-KS) would require notifications within two years of enactment for currently self-affirmed substances and at least 120 days before first use for new substances. It would require FDA to maintain a public GRAS list and automatically approve a use as GRAS if FDA fails to respond within 180 days. The bill would also allow FDA to reevaluate a food additive upon petition, state request, or on its own initiative, and would require that reevaluations be conducted by career scientists rather than political appointees.
Two additional bills impose post-market review requirements without revising the broader GRAS framework. H.R.4306 (Rep. Schakowsky, D-IL-9), would require FDA to reassess the safety of at least 10 food substances or substance classes every three years and suggests the first 10 substances for reassessment. H.R.7291 (Rep. Lawler, R-NY-17), would assemble an interagency review board to reassess pre-2000 manufacturer GRAS determinations, including self-affirmations, and recommend revocation where safety has not been demonstrated.
All of these bills are currently pending in committee. None have attracted a cosponsor from the opposing party.
State Legislation
Notably, none of the federal proposals includes preemption provisions, even as states move aggressively in this space. Numerous states have enacted or are considering restrictions on specific additives, including West Virginia, whose ban on synthetic food dyes is currently being litigated.
Other states are targeting self-affirmed GRAS more directly. Bills introduced in Pennsylvania, New Jersey, New York, and California would each require manufacturers of self-affirmed GRAS to report information supporting the determination to the state, which would be made publicly available online. Failure to report would render the additive unlawful for use in that state.
Pennsylvania and California would require the same information and data required as part of a federal GRAS notice. Although New Jersey’s reporting requirement would apply only prospectively to new uses of an additive, the other three bills appear to also cover existing self-affirmed substances.
Additional provisions vary by state. New York would ban three specific substances and prohibit the sale of foods containing certain synthetic color additives in public schools. California would approve existing additives upon report submission, but would subject substances and uses introduced after July 1, 2027, to evaluation by state regulators with an opportunity for public objection. California would also declare additives and dietary ingredients unsafe if they are found to induce cancer when ingested and require systematic post-market reviews.
Of these bills, only New York’s has passed a legislative chamber this session—the state senate, on March 23, 2026. That bill, as well as Pennsylvania’s, has sponsors from both parties.
Verdant Law closely monitors these developments and their implications for the evolving regulation of food additives and the GRAS framework. Please contact us with any questions.