Recent Federal Developments for June 2025
TSCA/FIFRA/TRI
TSCA Section 21 Petition Seeks Reconsideration Of 2024 Rule Regarding Procedures For Chemical Risk Evaluation: On May 15, 2025, the Center for Environmental Accountability (CEA) filed a petition under Section 21 of TSCA requesting that the U.S. Environmental Protection Agency (EPA) reconsider the 2024 final rule regarding procedures for chemical risk evaluation under TSCA and initiate a rulemaking to amend certain provisions in 40 C.F.R. Part 702, subpart B. The petition states that EPA’s risk evaluation procedural regulations should:
Provide additional definitions for key terms, offering increased transparency and clarity regarding methods and goals of the risk evaluation process;
Bolster intra- and interagency collaboration throughout the risk evaluation process, including requirements that EPA document the outcome of those efforts;
Confirm EPA’s authority to determine which conditions of use (COU) fall within the scope of a risk evaluation;
Explain the criteria EPA may use in determining the COUs it expects to consider;
Provide for a de minimis level below which EPA may exclude COUs from the scope of the risk evaluation;
Explicitly require consideration of existing regulations administered by EPA and other agencies when determining exposure estimates for each COU for a chemical substance;
Require that any assumptions, uncertainty factors, models, and/or screening approaches used in the risk evaluation reasonably reflect the COUs of the chemical substance in practice;
Require EPA to make an unreasonable risk determination for each COU of a chemical substance assessed in a risk evaluation;
Clarify when determinations regarding unreasonable risk or no unreasonable risk are considered final agency actions;
Explicitly require peer review for all risk evaluations;
Create a clear regulatory pathway for the development and submission of draft risk evaluations by requesting manufacturers and other interested persons; and
Extend applicable comment periods and include opportunities for further extensions.
Chemical Coalition Withdraws TSCA Section 21 Petition Seeking Revisions To TSCA Section 8(a)(7) PFAS Reporting Rule: As reported in our May 4, 2025, blog item, on May 2, 2025, a coalition of chemical companies petitioned EPA for an amendment of the TSCA Section 8(a)(7) rule requiring reporting for per- and polyfluoroalkyl substances (PFAS). The petitioners ask that EPA revise the reporting rule to exclude imported articles, research and development (R&D) materials, impurities, byproducts, non-isolated intermediates, and PFAS manufactured in quantities of less than 2,500 pounds (lb.). According to a May 22, 2025, letter from EPA, on May 16, 2025, the coalition withdrew its petition via e-mail to EPA Administrator Lee Zeldin and “EPA now considers this petition closed.” After the coalition submitted its petition, EPA published an interim final rule to postpone the data submission period to April 13, 2026, through October 13, 2026. 90 Fed. Reg. 20236. Small manufacturers reporting exclusively as article importers would have until April 13, 2027, to report. Comments on the interim final rule were due June 12, 2025.
EPA Proposes To Extend Certain Compliance Deadlines To Ensure Lab Compliance With Final Methylene Chloride Risk Management Rule: On May 27, 2025, EPA proposed to extend certain compliance dates in the final risk management rule for methylene chloride under TSCA. 90 Fed. Reg. 22214. The proposed rule would extend the Workplace Chemical Protection Program (WCPP) compliance dates for non-federal laboratories by an additional 18 months to align with the dates allowed for federal laboratories and their contractors. If issued in final, the rule would extend the following compliance dates for non-federal laboratories: for initial monitoring from May 5, 2025, to November 9, 2026; for establishing regulated areas and ensuring compliance with the Existing Chemical Exposure Limit (ECEL) from August 1, 2025, to February 8, 2027; and for ensuring the methods of compliance as well as developing and implementing an exposure control plan from October 30, 2025, to May 10, 2027. Comments are due June 26, 2025.
DOD RFI Seeks Information On Certain Chemicals Undergoing TSCA Section 6 Risk Evaluation: On May 27, 2025, the U.S. Department of Defense (DOD) issued a request for information (RFI) to gather information to identify and assess critical applications for DOD and the defense industrial base (DIB) that necessitate the use of existing chemicals undergoing EPA’s TSCA Section 6 risk evaluation process. The RFI states that it will help the Office of the Assistant Secretary of Defense for Energy, Installations, and Environment (OASD (EI&E)) Chemical and Material Risk Management Program (CMRMP) better understand the use of TSCA existing chemicals in products leading into the defense supply chain. The RFI is focused on receiving information related to the following existing chemicals:
1,3-Butadiene (Chemical Abstracts Service Registry Number® (CAS RN®)106-99-0);
1,1-Dichloroethane (CAS RN 75-34-3);
1,2-Dichloroethane (CAS RN 107-06-2);
Butyl benzyl phthalate (1,2-benzene-dicarboxylic acid, 1-butyl 2(phenylmethyl) ester) (BBP) (CAS RN 85-68-7);
Dibutyl phthalate (1,2-benzene- dicarboxylic acid, 1,2- dibutyl ester) (DBP) (CAS RN 84-74-2);
Dicyclohexyl phthalate (DCHP) (CAS RN 84-61-7);
Di-ethylhexyl phthalate (1,2-benzene-dicarboxylic acid, 1,2-bis(2-ethylhexyl) ester) (DEHP) (CAS RN 117-81-7);
Di-isobutyl phthalate (1,2-benzene-dicarboxylic acid, 1,2-bis-(2methylpropyl) ester) (DIBP) (CAS RN 84-69-5);
Di-isodecyl phthalate (1,2-benzenedicarboxylic acid, 1,2-diisodecyl ester) (DIDP) (CAS RNs 26761-40-0; 68515-49-1);
Diisononyl phthalate (1,2-benzenedicarboxylic acid, 1,2-diisononyl ester) (DINP) (CAS RNs 28553-12-0; 68515-48-0); and
Octamethylcyclotetra-siloxane (D4) (CAS RN 556-67-2).
DOD seeks to understand better applications that require the use of these chemicals and the criticality of these chemicals for industry and supply. The RFI notes that DOD will continue to issue RFIs to consider additional TSCA chemicals. Responses are due June 20, 2025.
ACC Files TSCA Section 21 Petition Seeking Reconsideration Of TCE Risk Management Rule: On May 27, 2025, the American Chemistry Council (ACC) petitioned EPA under TSCA Section 21 for reconsideration of the final risk management rule for trichloroethylene (TCE). ACC requests that EPA reconsider and amend two provisions of the rule:
Revise the byproduct exclusion in 40 C.F.R. Section 751.301(c) by removing the “site-limited” restriction that requires byproduct TCE to be reused as a “part of the same overall manufacturing process.” The petition states that this would allow facilities to continue reusing/processing byproduct TCE either at the same facility where the byproduct was generated or at another facility; and
Delete the last sentence from the “regulatory threshold” provision in 40 C.F.R. Section 751.301(b), allowing facilities to continue discharging wastewater that contains TCE at less than 0.1 percent by weight pursuant to their valid, existing Clean Water Act (CWA) National Pollutant Discharge Elimination System (NPDES) permits.
Draft Risk Evaluations Determine That DBP And DEHP Present Unreasonable Risks To Human Health And The Environment: On June 5, 2025, EPA announced the release of the draft TSCA risk evaluations for DBP and DEHP. 90 Fed. Reg. 23931. EPA states that it used the best available science to prepare the draft risk evaluations and to determine preliminarily, based on the weight of scientific evidence, that DBP and DEHP present unreasonable risk to health and the environment driven primarily by certain COUs analyzed in the draft evaluations. Comments on the draft risk evaluations are due August 4, 2025. The Science Advisory Committee on Chemicals (SACC) will peer review the documents at a meeting on August 4-8, 2025. Comments submitted by July 21, 2025, will be considered by SACC during its peer review meeting. More information will be available in a forthcoming memorandum.
EPA Extends Deadline To Report Health And Safety Data For 16 Chemicals: EPA issued a final rule on June 9, 2025, that extends the reporting deadlines for a rule under TSCA Section 8(d) requiring manufacturers (including importers) of 16 chemicals to report data from unpublished health and safety studies to EPA. 90 Fed. Reg. 24228. EPA notes that these health and safety studies “will help inform EPA’s prioritization, risk evaluation, and risk management of chemicals under TSCA. ” The reporting deadline in EPA’s December 13, 2024, final rule was March 13, 2025. In March 2025, EPA extended the reporting deadline to June 11, 2025, for vinyl chloride and to September 9, 2025, for the other chemicals covered under the rule. The rule extends the reporting deadlines for all 16 chemicals to May 22, 2026. According to EPA, the extension will provide it additional time to prepare final guidance for companies on issues related to complying with the rule, including those related to templates required for submissions containing confidential business information. The chemicals subject to the TSCA Section 8(d) rule are:
Acetaldehyde;
Acrylonitrile;
2-anilino-5-[(4-methylpentan-2-yl) amino]cyclohexa-2,5-diene-1,4-dione (6PPD-quinone);
Benzenamine;
Benzene;
Bisphenol A (BPA);
Ethylbenzene;
Hydrogen fluoride;
4,4-Methylene bis(2-chloraniline) (MBOCA);
N-(1,3-Dimethylbutyl)-N′-phenyl-p-phenylenediamine (6PPD);
Naphthalene;
Styrene;
4-tert-octylphenol(4-(1,1,3,3-Tetramethylbutyl)-phenol);
Tribromomethane (bromoform);
Triglycidyl isocyanurate; and
Vinyl chloride.
More information on EPA’s December 2024 rule is available in our December 23, 2024, memorandum.
EPA Issues Final SNURs For Certain Chemicals: EPA issued final significant use rules (SNUR) on June 13, 2025, for certain chemical substances that were the subject of premanufacture notices (PMN) and are also subject to an Order issued by EPA pursuant to TSCA. 90 Fed. Reg. 24977. The SNURs require persons to notify EPA at least 90 days before commencing the manufacture (including import) or processing of any of these chemical substances for an activity that is designated as a significant new use in the SNUR. In addition, the manufacture or processing for the significant new use may not commence until EPA has conducted a review of the required notification; made an appropriate determination regarding that notification; and taken such actions as required by that determination. The final SNURs are effective August 12, 2025.
RCRA/CERCLA/CWA/CAA/PHMSA/SDWA
CEQ Withdraws NEPA Interim Guidance On Consideration Of Greenhouse Gas Emissions And Climate Change: On May 28, 2025, the Council on Environmental Quality (CEQ) announced the withdrawal of its interim guidance entitled “National Environmental Policy Act Guidance on Consideration of Greenhouse Gas Emissions and Climate Change,” for which notice was published in the Federal Register on January 9, 2023. 90 Fed. Reg. 22472. According to CEQ, it has concluded that the interim guidance is inconsistent with the policy objectives in Executive Order (EO) 14154, Unleashing American Energy. The withdrawal was effective May 28, 2025.
PHMSA Seeks Stakeholder Feedback On Whether To Amend Or Repeal Hazardous Materials Rulemaking Procedures, Program Procedures, Or Regulations: On June 4, 2025, the Pipeline and Hazardous Materials Safety Administration (PHMSA) published an advance notice of proposed rulemaking (ANPRM) to solicit stakeholder feedback on whether to repeal or amend any requirements in the Hazardous Materials Rulemaking Procedures and Program Procedures or the Hazardous Materials Regulations (HMR), as well as any letters of interpretation, guidance documents, or other material, “to eliminate undue burdens on the identification, development, and use of domestic energy resources and to improve government efficiency.” 90 Fed. Reg. 23656. PHMSA states that it seeks stakeholder feedback regarding opportunities to identify widely used hazardous material special permits with established safety records for conversion into deregulatory provisions with broader applicability. PHMSA also seeks stakeholder feedback regarding opportunities to introduce efficiencies to its petitions process. Finally, PHMSA also solicits stakeholder feedback on whether to amend the HMR to require PHMSA to conduct periodic, mandatory regulatory reviews. Comments are due August 4, 2025. PHMSA notes that it will consider late-filed comments to the extent practicable.
FDA
FDA Advances Post-Market Chemical Review Program: On May 15, 2025, the U.S. Food and Drug Administration (FDA) announced the launch of “a stronger, more systematic review process for food chemicals already on the market — especially those that concern consumers most.” Over the coming months, FDA will roll out the following key actions:
A modernized, evidence-based prioritization scheme for reviewing existing chemicals. According to FDA, it will soon release a draft for public comment;
A final, systematic post-market review process shaped by stakeholder input. More information on FDA’s 2024 Discussion Paper Development of an Enhanced Systematic Process for the FDA’s Post-Market Assessment of Chemicals in Food is available in our August 22, 2024, blog item; and
An updated list of chemicals under review, including butylated hydroxytoluene (BHT); butylated hydroxyanisole (BHA); and azodicarbonamide (ADA). FDA states that it will also take steps to expedite its review of chemicals currently under review like phthalates, propylparaben, and titanium dioxide. FDA notes that it will continue to share information about the status of its work on its public website as part of its push for greater transparency.
FDA notes that until now, it has conducted post-market reviews “on a case-by-case basis, often in response to citizen petitions or new scientific evidence.” FDA states that the new framework “will be proactive, science-based, and built for long-term impact.”
NANOTECHNOLOGY
NASEM Releases Quadrennial Review Of NNI, Recommends Renewed And Expanded Infrastructure: On May 20, 2025, the National Academies of Sciences, Engineering, and Medicine (NASEM) announced the release of a report entitled Quadrennial Review of the National Nanotechnology Initiative (2025): Securing U.S. Global Leadership Through Renewed and Expanded Infrastructure. Requested by Congress as part of the 21st Century Nanotechnology Research and Development Act, the report focuses on the infrastructure of the National Nanotechnology Initiative (NNI). The Committee on the Quadrennial Review of the NNI “recommends a new focus on renewing and expanding the nanotechnology infrastructure, including instruments, facilities, and people, so that the intellectual capital of nanotechnology can be converted into economic, social, and national security gains for the United States.” More information is available in our May 23, 2025, blog item.
PUBLIC POLICY AND REGULATION
When States Step In: PFAS Policy Innovation Or Fragmentation?: While federal regulators continue to lay the groundwork for a comprehensive response, including through the PFAS Strategic Roadmap, states are increasingly positioning themselves as policy innovators in this space. The recent announcement that EPA will issue additional guidance and extend the compliance deadline for the TSCA Section 8(a)(7) PFAS reporting rule underscores a broader dynamic: in the absence of fast-moving federal action that states perceive as comprehensive, states are setting the pace, even if their approaches do not always (or ever) mirror the federal approach to regulation and risk mitigation. While this federal delay, and retreat in other PFAS areas, is recent, states have not waited for federal action. Over the past few years, several states have increasingly framed PFAS regulation as a space for environmental leadership, and their regulatory approaches diverge significantly from federal approaches to PFAS regulation.
Congress And The Feds — The Impact Of Nonperformance: Ponder the following existential question: Who does their job less effectively? Members of Congress or employees of federal agencies? Congress has not been able to reauthorize environmental statutes for years, with some (most) needing significant attention. Many of the “problems” often cited by critics of Agency behavior can be traced back to the fact that demands to fix current problems are being made of a program that does not quite fit the text of the authorizing statute. To address action demanded by state and federal legislative members, the bureaucracy has to rely on fitting the law they implement to often unforeseen problems that they now confront.
Many observers fear the fallout of the demise of the Chevron doctrine — concern that, without deference to agency interpretations, important problems may remain unaddressed (or worse, for some, resolution may fall to federal judges). But consistent with the court opinion, interpretations of legislative text is the domain of judges or, heaven forfend, the responsibility of Congress to define or refine clearly the extent and intent of the legislation.
The current result to fill effectively the legislative effort can be called “rubber-suiting” — stretching the colorable authority already granted to address a new problem not originally anticipated by the legislative authors. An example in the environmental space is the EPA authority to regulate biotechnology products: TSCA and FIFRA can reach (stretch) to cover most of the waterfront about regulatory issues identified needing regulation.
Over the past decades, Congress and different administrations have made intermittent attempts to craft a new, broad, and modern statute to coordinate and regulate government review and approval of biotechnology products. The current government allocation of responsibilities across agencies, reliant on authority legislated mostly long before biotechnology products were developed, is governed by policies first crafted during the Reagan and H.W. Bush Administrations.
Jurisdiction remains fragmented, relying on statutes drafted before modern methods of biotech engineering were even developed, and holes in the rubber-suit remain. In addition to the jurisdictional difficulties and holes, especially acute in the last decade or three, is the bitter partisanship besetting congressional deliberation. There are continued calls for “regular order,” but apparently little appetite for the same. “Regular order” would see legislation introduced, deliberated by the assigned subcommittee(s) and committee(s), moving to floor consideration in each chamber, and differences between House and Senate resolved by a conference committee. Such a schematic is about as currently relevant as having new members watch Jimmy Stewart’s Mr. Smith Goes to Washington as part of orientation.
Our April 2, 2025, blog post discussed how the call to reorganize EPA has been a long-standing idea to “reform” the Agency to better achieve its mission. Likewise, the point here is to suggest that Congress might benefit from a version of “doctor, heal thyself” should any serious attempt be made to make government work better, be more efficient, and give more meaning to the phrase “your tax dollars at work.” More information is available in our May 21, 2025, blog item.
Chemical Policy Crossroads: MAHA Report’s Assessment Calls For Reform Amid Deregulatory Trends: In response to President Trump’s February 13, 2025, EO 14212, “Establishing The President’s Make America Healthy Again Commission,” the White House issued part of what is being called “The MAHA Report” (with MAHA an acronym for Make America Healthy Again), entitled “Make Our Children Healthy Again: Assessment” (the Assessment), on May 22, 2025. Section One of the Assessment, “The Shift to Ultra-Processed Foods,” includes the Commission’s thoughts on the U.S. agricultural system, food additives, food industry regulation, and government food programs, while Section Two of the Assessment, “The Cumulative Load of Chemicals in our Environment,” includes its take on chemical exposures and pathways, corporate influence, and highlights some top concerns. The Assessment’s core messages add yet another element of business uncertainty that chemical stakeholders would be wise to note. For our thoughts on the Assessment, please read our June 2, 2025, blog. More information on the Assessment is also available in our June 11, 2025, blog item.
Big Beautiful Bill Means Big Cuts For Clean Energy Manufacturers: On March 20, 2025, House Republicans passed the “Big Beautiful Bill” (BBB) as part of H.R. 1, a sweeping legislative package that includes dramatic rollbacks of many of the clean energy tax credits established under the Inflation Reduction Act (IRA). While the bill has little chance of advancing in the Senate in its current form, its proposed cuts offer a window into shifting political priorities and could have significant implications for the U.S. clean energy manufacturing sector. Subtitle C of the bill, titled “Make America Win Again,” proposes to sunset, repeal, or restrict nearly every major clean energy tax credit under the IRA. Among those affected are credits for clean vehicle purchases (Section 25E), commercial clean vehicles (Section 45W), alternative refueling infrastructure (Section 30C), residential energy efficiency improvements (Sections 25C and 25D), new energy efficient homes (Section 45L), and advanced manufacturing (Section 45X).
For manufacturers, the most potentially damaging proposals are those that target the clean electricity production and investment credits under Sections 45Y and 48E, and the advanced manufacturing production credit under Section 45X. The bill would not only accelerate the phase-out dates for these credits but would also impose new restrictions on facilities and companies that receive any form of “material assistance” from so-called “prohibited foreign entities,” including entities with even minor Chinese ownership or influence. In addition to severing incentives for manufacturers with foreign ties, the BBB repeals the ability to transfer clean energy tax credits under IRA Section 6418 — a key tool for helping smaller developers and manufacturers monetize credits and attract financing.
Although the BBB is unlikely to become law in its current form, its provisions could resurface in future negotiations or budget bills. Industry participants should monitor legislative developments closely and consider how foreign ownership structures, supply chain dependencies, and tax credit planning may need to adapt to an evolving policy landscape. More information is available in our June 6, 2025, blog item.
Clearing Regulatory Roadblocks: How Smarter Implementation Can Help Supply Chain Modernization: On June 5, 2025, the Joint Economic Committee (JEC) of the U.S. Congress convened a hearing titled “Barriers to Supply Chain Modernization and Factor Productivity Enhancements.” Throughout the hearing, members and witnesses alike underscored the role of “regulatory friction” — especially in the form of fragmented and unpredictable requirements — as a key factor slowing investment in domestic manufacturing and threatening supply chain resilience. While EPA and TSCA were not named directly, the concerns raised map closely onto the compliance challenges companies face under TSCA Section 5 and Section 6 and related programs.
The JEC hearing makes clear that regulatory clarity and coordination are essential to rebuilding a productive and resilient industrial base. Even without mentioning TSCA by name, the hearing highlighted the very pressures companies face under EPA’s chemical management programs: unclear compliance standards, disconnected data requests, and prolonged uncertainty about new product approval despite considerable capital investment and unclear future legal obligations.
EPA has opportunities to reduce these pressures. Codifying frequently referenced guidance through notice-and-comment rulemaking, aligning reporting obligations across programs, and engaging earlier with agencies like DOD and the U.S. Department of Commerce could provide the predictability and coordination manufacturers need to invest confidently in modernization. To the extent of trying “new ideas” or probing varied regulatory options, a pilot program could reward those who might be willing to volunteer if such program participation provided an interim safe harbor of sought-after certainty while emerging rules and definitions are further clarified. More information on the issues discussed at the hearing is available in our June 13, 2025, blog item.
LEGISLATIVE
Bipartisan VET PFAS Act Would Support Veterans Exposed To PFAS: Representatives Mike Lawler (R-NY) and Josh Riley (D-NY) introduced the VET PFAS Act (H.R. 3639) on May 19, 2025. According to Lawler’s May 29, 2025, press release, the bipartisan legislation would ensure veterans and their families exposed to PFAS at military installations receive the health care and disability benefits they have earned through the Department of Veterans Affairs (VA). The bill would:
Designate PFAS exposure as a service-connected condition for affected veterans;
Require the VA to provide health care and benefits for medical conditions associated with PFAS exposure; and
Ensure military families have access to the care and support they need.
Bipartisan Plant Biostimulant Act Would Advance Agricultural Innovation: On May 22, 2025, Senators Roger Marshall, M.D. (R-KS) and Alex Padilla (D-CA) introduced the Plant Biostimulant Act (S. 1907) to establish a standardized process for approving the commercial use of plant biostimulants as alternatives to synthetic pesticides and fertilizers. Marshall’s May 30, 2025, press release states that plant biostimulants “have demonstrated potential in advancing sustainable practices, including carbon sequestration and water quality enhancement.” According to the press release, the bill would also support research into the benefits of these technologies for soil health.
Bipartisan Bill Would Streamline FDA Review Of Nonprescription Sunscreens: On June 3, 2025, the Co-Chairs of the Congressional Skin Cancer Caucus, Representatives John Joyce, M.D. (R-PA), Debbie Dingell (D-MI), Dave Joyce (R-OH), and Deborah Ross (D-NC), introduced the Supporting Accessible, Flexible, and Effective (SAFE) Sunscreen Standards Act (H.R. 3686) to streamline the FDA review process of the effectiveness and safety of new ingredients for nonprescription sunscreens. According to Dave Joyce’s June 4, 2025, press release, the bill would:
Improve regulatory standards:
Directs FDA to establish clearer, more flexible standards for evaluating sunscreen ingredients;
Allows the use of real-world evidence, observational studies, and nontraditional scientific data to determine safety and effectiveness; and
Incorporates non-animal testing alternatives to align with modern research practices and ethical standards;
Requires FDA to update its final administrative order on pending sunscreen ingredients to:
Consider historical data on ingredients already used safely in the United States;
Reinforce that sunscreen is a proven cancer prevention tool; and
Use the new evidence and testing standards established in the bill; and
Increase transparency and reporting by requiring the Secretary of Health and Human Services to submit annual reports to Congress detailing:
Progress on implementing new standards;
How many applications were reviewed under the new process; and
FDA’s use of non-animal testing methods.
Bipartisan Legislation Would “Deliver Justice For PFAS-Impacted Families”: On June 5, 2025, Representatives Brian Fitzpatrick (R-PA) and Kristen McDonald Rivet (D-MI), Co-Chairs of the Congressional PFAS Task Force, introduced bipartisan legislation (H.R. 3761) to ensure greater transparency and accountability from DOD for communities impacted by widespread PFAS contamination. According to Fitzpatrick’s June 5, 2025, press release, the bill would establish a new high-level position at the Pentagon — Coordinator for PFAS-Impacted Defense Engagement — “to serve as a direct advocate for affected families, improve transparency, drive remediation, and ensure the government delivers answers, not delays.” The PFAS coordinator would be responsible for:
Engaging directly with affected communities to address concerns, ensure accountability, and provide updates on remediation efforts;
Streamlining communication between local stakeholders, advocacy organizations, and federal agencies; and
Driving progress on cleanup efforts with transparency and urgency.
MISCELLANEOUS
Petitions Filed To Add Chemicals To List Of Chemical Substances Subject To Superfund Excise Tax: On May 21, 2025, the Internal Revenue Service (IRS) announced that petitions have been filed to add the following chemicals to the list of taxable substances:
Ethylene propylene diene (EPDM) rubber (90 Fed. Reg. 21825): Petition filed by Exxon Mobil Corporation, an exporter of EPDM rubber;
Neo decanoic acid (90 Fed. Reg. 21824): Petition filed by Exxon Mobil Corporation, an exporter of neo decanoic acid;
Nonene (90 Fed. Reg. 21826): Petition filed by Exxon Mobil Corporation, an exporter of nonene;
Tridecyl alcohol (90 Fed. Reg. 21824): Petition filed by Exxon Mobil Corporation, an exporter of tridecyl alcohol; and
Tri-isononyl tri-mellitate (90 Fed. Reg. 21827): Petition filed by Exxon Mobil Corporation, an exporter of tri-isononyl tri-mellitate.
Comments on the petitions are due July 21, 2025.
Minnesota Extends Public Comment Period On Proposed PFAS Reporting Rule As Entities Voice Concerns About Compliance With Deadlines And Due Diligence Standards: On May 22, 2025, the Minnesota Pollution Control Agency (MPCA) held a public hearing on its “Proposed Permanent Rules Relating to PFAS in Products; Reporting and Fees” (proposed rule). Administrative Law Judge (ALJ) Jim Mortenson facilitated the hearing, which had more than 100 participants in attendance. MPCA has made available online the PowerPoint document used for the hearing presentation, the hearing exhibits, and a transcript of the hearing. The pre-hearing public comment period for the proposed rule closed on May 21, 2025. Under Minnesota administrative procedure, comments must be accepted for five days following a hearing on a proposed rule, and the overseeing ALJ may extend the comment period by no more than 20 days. Following the close of comments and a brief rebuttal period, the presiding ALJ will issue a report on the proposed rule within 30 days, unless an extension is granted. The post-hearing comment period for the proposed rule has been extended until 4:30 p.m. (CDT) on June 23, 2025. A rebuttal period of five business days, lasting from the close of the public comment period until 4:30 p.m. (CDT) on June 30, 2025, will follow. Persons may respond to public comments during this rebuttal period, but they may not submit new comments. Any person who wishes to comment on the rule or provide rebuttal may do so via e-comments, mail, or fax. MPCA will not accept comments submitted via e-mail. Comments must be received by MPCA by the end of the respective periods, so persons planning to submit comments or rebuttals via mail should ensure comments are sent with enough time to reach MPCA by the cutoff. More information on the public hearing is available in our May 29, 2025, memorandum.
President Signs EO To Restore Gold Standard For Science, Calls For Reevaluation Of Biden Administration’s Scientific Integrity Policies: On May 27, 2025, President Trump signed an EO on “Restoring Gold Standard Science.” 90 Fed. Reg. 22601. The EO states that the Trump Administration “is committed to restoring a gold standard for science to ensure that federally funded research is transparent, rigorous, and impactful, and that Federal decisions are informed by the most credible, reliable, and impartial scientific evidence available.” The EO restores the scientific integrity policies of the first Trump Administration and “ensures that agencies practice data transparency, acknowledge relevant scientific uncertainties, are transparent about the assumptions and likelihood of scenarios used, approach scientific findings objectively, and communicate scientific data accurately.” The EO directs the Director of the White House Office of Science and Technology Policy (OSTP), in consultation with the heads of relevant agencies, to issue guidance within 30 days for agencies on implementing “Gold Standard Science” in the conduct and management of their respective scientific activities. The EO defines Gold Standard Science as science conducted in a manner that is reproducible; transparent; communicative of error and uncertainty; collaborative and interdisciplinary; skeptical of its findings and assumptions; structured for falsifiability of hypotheses; subject to unbiased peer review; accepting of negative results as positive outcomes; and without conflicts of interest. Once OSTP publishes the guidance, the EO directs each agency head to update promptly applicable agency policies governing the production and use of scientific information, including scientific integrity policies, to implement the OSTP Director’s guidance. Within 60 days of the publication of OSTP’s guidance, agency heads must report to the OSTP Director on the actions taken to implement Gold Standard Science at their agency. More information on restoring the Gold Standard for Science is available in our June 5, 2025, memorandum.
EPA Publishes FY 2026 Budget In Brief: On May 30, 2025, EPA published its FY 2026 Budget in Brief. President Trump requested $4.16 billion for EPA for fiscal year (FY) 2026, a 54 percent decrease from the FY 2025 enacted budget level. According to EPA, the budget request supports 12,856 full-time equivalents (FTE), a decrease of 1,274 FTEs from the 2025 level, aligning with the President’s goal of streamlining the federal workforce. EPA states that it “is focused on a back-to-basics approach that will lower the cost of living, remove unnecessary barriers for business and industry, empower states, and return the Agency to administering core statutory obligations as Congress intended.” EPA notes that it is currently developing the FY 2026-2030 EPA Strategic Plan and states that the FY 2026 Budget will advance the EPA Administrator’s five strategic pillars: Clean Air, Land, and Water for Every American; Restore American Energy Dominance; Engage in Permitting Reform, Cooperative Federalism, and Cross-Agency Partnership; Develop Artificial Intelligence (AI) Capabilities; and Protect American Auto Jobs.
NTP Updates Report On Carcinogens Handbook On Methods For Conducting Cancer Hazard Evaluations: On June 2, 2025, the National Toxicology Program (NTP) announced the availability of The Report on Carcinogens Handbook on Methods Conducting Cancer Hazard Evaluations. An update to the 2015 version, it provides methods for conducting a robust and transparent evaluation to determine whether a substance is a cancer hazard. The topics covered include: developing and planning the evaluation framework; human exposure data evaluation; human cancer studies evaluation; experimental animal cancer studies evaluation; disposition and toxicokinetic data evaluation; mechanistic data evaluation; and evidence integration and cancer hazard conclusion.
AMS Conducting Referendum To Determine Whether To Continue Regulations Regarding National Paper And Paper-Based Packaging Research And Promotion Program: On June 3, 2025, the U.S. Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) published a notice of referendum on the Paper and Paper-Based Packaging Promotion, Research and Information Order. 90 Fed. Reg. 23421. This document directs that a referendum be conducted among eligible domestic manufacturers and importers of paper and paper-based packaging to determine whether they favor continuance of AMS’s regulations regarding a national paper and paper-based packaging research and promotion program. AMS also announced an immediate moratorium on the collection of assessments under the program. The referendum will be conducted by express mail and electronic ballot from July 14, 2025, through July 25, 2025. Ballots delivered to AMS via express mail or electronic ballot must show proof of delivery by no later than 11:59 p.m. (EDT) on July 25, 2025. Eligible persons will receive a ballot through mail and may cast a ballot through express mail or electronic ballot. Each person who is an eligible domestic manufacturer or importer at the time of the referendum and during the representative period from January 1, 2024, through December 31, 2024, shall be entitled to cast a ballot in the referendum.
WDOE Proposes To Regulate PFAS In Certain Consumer Products: The Washington Department of Ecology (WDOE) issued a proposed rule on June 4, 2025, that would regulate PFAS in certain consumer products. Beginning January 1, 2027, the proposed rule would prohibit the intentional use of PFAS in:
Apparel and accessories;
Automotive washes; and
Cleaning products.
Under the proposed rule, manufacturers would be required to report by January 31, 2027, intentionally added PFAS in the following products manufactured on or after January 1, 2026:
Apparel for extreme and extended use;
Footwear;
Gear for recreation and travel;
Automotive waxes;
Cookware and kitchen supplies;
Firefighting personal protective equipment (PPE);
Floor waxes and polishes;
Hard surface sealers; and
Ski waxes.
Annual reports would be due thereafter. WDOE will hold online hearings on July 9 and July 10, 2025. Comments on the following draft documents are due July 20, 2025:
Proposed rule: Includes draft restrictions and reporting requirements on intentionally added PFAS in 12 product categories. This rulemaking focuses on requirements related to PFAS in 12 new product categories;
Preliminary Regulatory Analyses: Explains the potential costs and benefits of the proposed rule; and
Draft State Environmental Policy Act (SEPA) Determination of Non-Significance and Environmental Checklist: Describes potential environmental benefits of the proposed rule.
WDOE will review comments, consider revisions to the proposed rule and other rulemaking documents, and respond to comments. WDOE states that it expects to decide on rule adoption in November 2025.
ACGIH Updates Documentation; Second Comment Period Will Begin July 1, 2025: The American Conference of Governmental Industrial Hygienists (ACGIH®) announced on June 12, 2025, that the first half of the Threshold Limit Value (TLV®) Development Process for 2025 has ended. Updated documentation is now available on ACGIH’s website through Data Hub and for purchase as PDFs in ACGIH’s Publications Store. ACGIH has posted the updated list of Notices of Intended Changes (NIC) and adopted substances. ACGIH notes that the second comment period will open July 1, 2025. ACGIH encourages further comment for the second half of the year. Comments are due September 30, 2025, with ratification occurring in November 2025, and updates in December 2025.
CPSC Publishes RFI On Reducing Regulatory Burdens: The U.S. Consumer Product Safety Commission (CPSC) published an RFI on June 12, 2025, seeking public comment on opportunities for CPSC to reduce burdens and costs of its existing rules, regulations, or practices without impacting safety. 90 Fed. Reg. 24791. According to CPSC, “[r]egulations and other practices that do not reasonably advance safety, but instead promote unscientific ideological agendas, create unnecessary burdens and costs, restrict consumer choice, or reduce competition, entrepreneurship, and innovation — and thereby restrain the American economy — should generally be eliminated or modified.” Comments are due August 11, 2025.
President’s FY 2026 Budget Requests Would Eliminate CSB, Reorganize CPSC: President Trump’s FY 2026 budget request for the Chemical Safety and Hazard Investigation Board (CSB) states that the President’s budget proposes to eliminate funding for CSB as part of the Trump Administration’s plans “to move the Nation towards fiscal responsibility and to redefine the proper role of the Federal Government.” The President’s budget request proposes $0 for CSB in FY 2026 with the expectation that CSB begin closing down during FY 2025. CSB’s emergency fund of $844,145 will be appropriated to cover costs associated with closing down the agency.
President Trump’s FY 2026 budget request for CPSC proposes to reorganize and transfer the functions of CPSC to the U.S. Department of Health and Human Services (HHS) Office of the Secretary as the Assistant Secretary for Consumer Product Safety (ASCPS). The budget request states that “[u]ntil the enactment of authorizing legislation to reorganize, the CPSC will continue to carry out its mission to protect the public from unreasonable risks of injury from consumer products as a standalone agency.” Under the budget request, the ASCPS would receive $135 million, $15.975 million below the FY 2025 enacted budget, to support 459 FTEs and operational costs, a reduction of 75 FTEs from the FY 2025 enacted budget. More information is available in our June 5, 2025, blog item.
God Only Knows: California Moves to Ban Hemp Products
With the passing of Brian Wilson, it seems like an appropriate time to debut The Beach Boys to Budding Trends, and the governor of California’s proposed ban of hemp products reminds me of one of Brian’s great lyrics:
If you should ever leave meThough life would still go on believe meThe world could show nothing to me
What’s Going On?
As expected by many, Gov. Gavin Newsom’s administration proposed a permanent ban on many of the hemp products available in the state, as reported in SFGate (emphasis added):
The California Department of Public Health proposed the ban Friday, which would make a controversial earlier emergency ban permanent, according to a CDPH document shared with SFGATE. It’s now in a 45-day comment period, with a public hearing planned next month.
Gov. Gavin Newsom has spearheaded a ban on these hemp THC products, saying they are accessible to minors and pose a public health risk because they do not face the same safety standards as state-regulated marijuana products do. Newsom pushed for last year’s emergency THC ban and extended it in March. It is now set to expire in September.
Making the ban permanent will have a major adverse economic impact on the state, according to the analysis released Friday. The CDPH estimates that it will cause a $602 million decreasein revenue for California businesses for the first 12 months and a $3.14 billion decrease over five years. The ban will also cost 18,478 jobs over five years, force 115 businesses to close, and reduce state sales tax revenue by $192 million, according to CDPH’s estimate.
The analysis found that small, independent retailers like corner stores and grocery stores would be especially impacted over the first five years of the ban, with $1.9 billion in lost revenue and 5,567 lost jobs.
Friday’s proposal to permanently ban hemp THC comes after years of complaints from California’s licensed marijuana industry, which has claimed that it faces unfair competition from unregulated hemp companies. Marijuana companies face sky-high regulatory costs, especially in California, and can only sell their products through state-licensed retailers. Hemp companies, on the other hand, face almost no regulations and have historically been able to sell their intoxicating drugs almost anywhere, including liquor stores, grocery stores and online.
This disparity between the two industries has created pressure on governors like Newsom to protect their state-regulated cannabis companies. In California, these businesses are already increasingly failing under the weight of the high taxes and expensive regulations overseen by Newsom. Other states with robust state-licensed marijuana markets have also restricted hemp THC, including Oregon and Washington.
Licensed cannabis companies would gain $69.8 million and 232 jobs over the first five years of the proposed ban, according to the CDPH analysis. The department said “these numbers are comparatively low to retail sales lost in other sectors” because demand for hemp THC drinks is minimal at state-licensed stores.
The department also said illicit sales will probably fill the void if hemp THC products are permanently banned. “Out-of-state businesses and the illegal market will supply the California THC hemp market,” the report said.
Why Is This a Problem?
I have just been in the middle of knife fights in the legislative halls of Alabama and Mississippi where hemp products were under attack. I’m currently working on the next federal Farm Bill and what the hemp language ultimately looks like. And just today I read of similar efforts in Delaware. So, I’ll admit this is an issue that has been on my mind for a long time.
I completely understand why state-regulated marijuana operators are opposed to often unregulated hemp operators being able to conduct business without the onerous burden of regulations and taxation. I also believe that there are ways to even the playing field without prohibiting consumable hemp products entirely.
Are you worried about minors obtaining product? Put laws in place that prohibit access to minors and spend the time and money enforcing those laws. The money can come from fees paid by hemp manufacturers and retailers in the form of licensing/permitting fees and taxes on hemp.
Worried about the safety and potency of products? Put extensive rules in place that govern testing requirements and potency caps, with the latter possibly tailored to where the products are sold. Perhaps grocery stores and gas stations/convenience stores would be limited to lower THC products, whereas specialty hemp stores would be able to sell different products with higher THC levels.
Worried about labeling and packaging? Put extensive rules in place that ensure packages are child resistant and labels clearly explain (with QR codes to COAs) what is in the product and how it was tested to ensure that the package contains what it says it does.
Or – and I suspect this is the motivation for many – are you worried that regulated marijuana operators are at a disadvantage as compared to hemp operators facing far less regulation? Then put them on a more level playing field. Impose similar taxes and regulations so that responsible marijuana operators are not punished for following the rules while hemp companies operate without government oversight. Marijuana operators shouldn’t be able to bully hemp operators out of business simply because of greed, but hemp operators shouldn’t get a free pass either.
Conclusion
Maybe God only knows why the government of California is making the decision to ban its robust hemp industry rather than seeking ways to reform it so that it addresses the stated (albeit likely not entirely complete) concerns of the hemp program’s critics. But this isn’t a Beach Boys album; this is real life and real governing with real implications to operators and consumers. The government has a chance to dig into this issue and make hard choices that can make California a better market for the cannabis plant generally and all of those people who have come to rely on it through the years. I won’t pretend that this process will be easy, and certainly not as easy as simply banning an entire class of products. That’s the easy way out. Maybe I’m just California Dreamin’, but Wouldn’t It Be Nice if the people of California were treated better by their government?
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Trial Court Strikes Down California’s Prop 65 Acrylamide Warning Requirements
A Federal District Court in California has ruled that Proposition 65 warning requirements for dietary acrylamide are unconstitutional. The California Chamber of Commerce (“CalChamber”) sued five years ago challenging the statewide requirement under Proposition 65 for warning labels on foods containing acrylamide. (California Chamber of Commerce v. Bonta, No. 2:19-cv-02019-DJC-JDP.) This ruling is a major victory for CalChamber and the latest chapter in its long battle with the California Attorney General and private enforcer Council for Education and Research on Toxics (“CERT”) over whether a warning can be required by the State in light of the disputed science around acrylamide.
What is Proposition 65?
Prop 65, also known as the Safe Drinking Water and Toxic Enforcement Act, requires businesses that sell products into California to provide warnings about significant exposures to chemicals known to cause cancer, birth defects, or reproductive harm. These substances can be present in consumer goods, food and beverages, residential environments, workplaces, or the environment.
What is Acrylamide?
Acrylamide is a substance that forms through a natural chemical reaction in certain plant-based foods during high-temperature cooking and can be found in foods like potato chips, bread, grilled vegetables, nuts, crackers, and olives. Although studies exposing laboratory rats and mice to high levels of acrylamide have been shown to produce cancer, other studies have found no consistent evidence that dietary acrylamide increases the risk of cancer in humans.[1]
The Original Warning
Prior to the initiation of the CalChamber lawsuit, if a product contained acrylamide, companies were required to provide what is now referred to as the “Original Warning”:
WARNING: Consuming this product can expose you to chemicals including acrylamide, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov/food.
In 2019, CalChamber brought suit alleging that forcing businesses to provide warnings stating that acrylamide in food is known to cause cancer violates its members’ First Amendment rights because the scientific evidence on acrylamide’s carcinogenicity is in dispute. In 2020, CalChamber sought a preliminary injunction to stop the enforcement of this warning obligation. The district court granted the injunction in March 2021, noting that the scientific debate over acrylamide’s cancer risk remains unresolved.
The Alternative Warning & New Warnings for Acrylamide
While the CalChamber litigation was pending, the California Office of Environmental Health Hazard Assessment (OEHHA) adopted an “Alternative Warning” for acrylamide, which would allow companies to obtain safe harbor protection with the following language beginning January 1, 2023:
Consuming this product can expose you to acrylamide, a probable human carcinogen formed in some foods during cooking or processing at high temperatures. Many factors affect your cancer risk, including the frequency and amount of the chemical consumed. For more information including ways to reduce your exposure, see www.P65Warnings.ca.gov/acrylamide.
CERT and the California Attorney General argued that the Alternative Warning mooted the CalChamber litigation, while CalChamber argued that the new regulation was still misleading based on the conflicting evidence regarding acrylamide’s effects.
In November 2023, OEHHA adopted additional alternative warning language for acrylamide (referred to as the “New Warning”) effective January 1, 2025, which allowed businesses to select amongst several qualifying statements to be included in their Prop 65 warnings:
The International Agency for Research on Cancer has found that acrylamide is probably carcinogenic to humans.
The United States Environmental Protection Agency has found that acrylamide is likely to be carcinogenic to humans.
The United States National Toxicology Program has found that acrylamide is reasonably anticipated to cause cancer in humans.
Acrylamide has been found to cause cancer in laboratory animals. Many factors affect your cancer risk, including the frequency and amount of the chemical consumed.
For more information including ways to reduce your exposure, see www.P65Warnings.ca.gov/acrylamide.
Cal. Code Regs. tit. 27, § 25607.2(c)(2).
What was the Court’s Ruling on Summary Judgment?
CalChamber continued to pursue its case even after the New Warning was adopted, arguing that none of the safe harbor warnings—the Original, Alternative, or New Warning—meet constitutional standards because they compel a message that remains scientifically controversial. After oral argument on February 12, 2025, the district court granted summary judgement in favor of CalChamber, holding that the Prop 65 warning requirement for dietary acrylamide is controversial due to the lack of scientific consensus and unnecessarily burdens businesses by compelling them to convey disputed scientific information.
First applying the Zauderer[2] test, the district court found that the warning was neither uncontroversial nor purely factual because there is no scientific consensus that dietary acrylamide poses a human cancer risk. (Cal. Chamber of Commerce v. Bonta, No. 2:19-cv-02019-DJC-JDP, at 18:13-16 (E.D. Cal. 2024)) The district court acknowledged that, while some scientific authorities classify acrylamide as a likely carcinogen, “authorities such as the FDA and the National Cancer Institute have questioned whether there is sufficient proof that dietary acrylamide is a cancer risk to humans.” (Id. at 22:3-6.) Although the law does not require complete consensus among the scientific community before a warning may be required, the district court found that the “New Warning” is “not purely factual and uncontroversial.” (Id. at 15:16-20.)
The district court next applied the Central Hudson[3] test, finding that the California Attorney General failed to show that the “New Warning” directly advanced the government’s interest and was not more extensive than necessary to achieve that interest. (Id. at 26:7-9.) The district court pointed out that there were less burdensome alternatives available for the State to achieve its objectives, such as posting information on the Internet or conducting advertising campaigns educating consumers. (Id. at 26: 14-22.)
Ultimately, the district court concluded that the Prop 65 safe harbor warning requirement for dietary acrylamide violates the First Amendment because it “burdens the free speech of businesses” and forces businesses to communicate a particularly controversial and disputable message about the carcinogenic risk associated with dietary acrylamide. (Id. at 26:14-16.) As a result, the district court issued a permanent injunction enjoining both the California Attorney General and all private enforcers from enforcing the acrylamide warning requirements. The California Attorney General filed a notice of appeal on June 2, 2025. With the appeal now pending, it is clear that this case is far from over and there is more to come.
FOOTNOTES
[1] See Acrylamide and Cancer Risk – NCI and Acrylamide | FDA
[2] Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio, 471 U.S. 626, 651 (1985).
[3] Central Hudson Gas & Electric Corp. v. Public Service Commission of New York, 447 U.S. 557 (1980).
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FDA Reimagined: Faster, Friendlier, and Focused on Cures
On June 10, 2025, the Commissioner of the FDA, Dr. Martin Makary, and Dr. Vinayak Prasad, the Director of the FDA’s Center for Biologics Evaluation and Research, published an article in JAMA discussing the “Priorities for a New FDA.” It is their view that in the past, the FDA has been reactionary, and that going forward, the FDA will focus on being proactive by rapidly allowing new products to be brought to market if they have “transformational potential.”
Going forward, the FDA is going to prioritize:
Increasing the speed at which research can be done by minimizing administrative burdens and becoming a “user-friendly FDA that partners with industry…”;
Implementing generative AI technology at the FDA to assist with application review, and the use of AI-based computational modeling to reduce the need for animal testing;
Harnessing large amounts of available data to accelerate research into the causes of disease, and for the post-approval monitoring of new products;
Using the FDAs power to address the cost of drug treatment in the United States; and,
Refocusing the FDA on food and its potential role as the root cause of chronic disease in the United States.
Dr. Makary and Dr. Prasad state that “…the FDA will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children, and common-sense approaches to rebuild the public trust. The FDA and our great medical profession should unite to consider fresh new approaches to the evolving health topics facing the US today.”
FDA Reportedly Set to Define UPFs
Yesterday, the New York Times reported that the FDA, in collaboration with USDA and other government agencies, plans to establish a new definition of “ultraprocessed foods” (UPFs) that will be released over the next “coming months.” The article reports that FDA will seek public comment on the definition, but it is not clear as to the regulatory pathway FDA will take in proposing a definition (e.g., rulemaking or guidance).
The article comes the same day as FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, director of FDA’s Center for Biologics Evaluation and Research (CBER), published “Priorities for a New FDA,” indicating that FDA has “begun work on defining ultraprocessed foods.” However, the report does not offer any timeline for agency action.
Per the New York Times article’s quotes attributed to Dr. Makary, FDA does not seek to ban ultraprocessed foods, but rather to define them “so that markets can compete based on health.” Dr. Makary predicts that the new UPF definition will encourage food manufacturers to entice customers by touting their food products as “non-ultraprocessed.”
FDA’s reported plans for a new UPF definition are not surprising given that the Make America Healthy Again (MAHA) Commission recently acknowledged the absence of a “single, universally accepted definition of UPFs” in its MAHA Report.
A new UPF definition could have a broad impact on federal and state regulation. For example, it could restrict foods covered under the Supplemental Nutrition Assistance Program (SNAP) and encourage states to harmonize the patchwork of UPF definitions found in state laws, proposed and passed.
FDA Releases Educational Materials on the NDIN Process
Yesterday, the U.S. Food and Drug Administration (FDA) unveiled two educational videos and a supplemental fact sheet to help the dietary supplement industry with the New Dietary Ingredient Notification (NDIN) review process. These educational materials are the latest release among several resources the FDA has put forth since the 1997 Final Rule: Premarket Notification for a New Dietary Ingredient. The full list of resources for the NDIN process can be found here.
The NDIN review process follows the Federal Food, Drug, and Cosmetic Act (the FD&C Act) requirement that manufacturers and distributors who wish to market dietary supplements that contain “new dietary ingredients” notify the FDA about these ingredients (subject to a narrow exception).
The new supplemental fact sheet lists 5 commonly observed issues FDA sees manufacturers and distributors make during the NDIN submission process. FDA hopes highlighting these issues will make it easier for manufacturers and distributors to successfully file an NDIN and avoid delays or negative responses that often follow submission issues.
The new educational videos titled, “Important Aspects of the NDIN Process” and “Correspondence Between FDA and the Notifier,” work together to provide an overview of the entire NDIN process. The first video, “Important Aspects of the NDIN Process,” walks through what an NDIN should and should not include, and common mistakes made during the NDIN submission process. The second video, “Correspondence Between FDA and the Notifier,” explains what the notifier can expect following the submission of an NDIN.
FTC and DOJ Announce Listening Sessions on Lowering American’s Drug Prices
On April 15, 2025, President Donald Trump issued Executive Order No. 14273, “Lowering Drug Prices by Once Again Putting Americans First, ” which outlines a series of targeted actions to lower prescription drug costs and improve access for Americans by optimizing federal health care programs, intellectual property protections, and safety regulations. Key directives include enhancing transparency and effectiveness in the Medicare Drug Price Negotiation Program, stabilizing and reducing Medicare Part D premiums, and accelerating approval of generics and biosimilars. Additional measures include streamlining drug importation, discouraging costly shifts in drug administration, increasing transparency in pharmacy benefit manager fees, and combating anti-competitive practices among drug manufacturers.
On June 11, 2025, the Federal Trade Commission and Justice Department’s Antitrust Division announced that they will jointly host a series of listening sessions to discuss the implementation of Executive Order No. 14273. The sessions will focus on improving the affordability of prescription drugs by increasing generic and biosimilar availability and reducing anti-competitive practices and regulatory barriers. FTC Chairman Andrew N. Ferguson and Assistant Attorney General Gail Slate will direct the sessions, which will feature remarks by both practitioners and scholars. Ultimately, these sessions will inform the joint report contemplated by Executive Order No. 14273.
The listening sessions are scheduled for the following dates:
Monday, June 30 at 2 pm ET – Anticompetitive Conduct by Pharmaceutical Companies Impeding Generic or Biosimilar Competition
Thursday, July 24 at 2 pm ET – Formulary and Benefit Practices and Regulatory Abuse Impacting Drug Competition
Monday, August 4 at 2 pm ET – Turning Insights into Action to Reduce Drug Prices
Defra Calls for Comments on Indicative Lists for LC-PFCAs, Their Salts, and Related Compounds
On June 2, 2025, the United Kingdom (UK) Department for Environment, Food & Rural Affairs (Defra) requested comment on a draft indicative list for long-chain perfluorocarboxylic acids (LC-PFCA), their salts, and related compounds. According to Defra, at the 20th meeting of the Persistent Organic Pollutants (POP) Review Committee of the Stockholm Convention on POPs, the Committee recommended listing LC-PFCAs, their salts, and related compounds in Annex A of the Convention, allowing for specific exemptions. Defra notes that the listing extends to compounds classified as substances capable of degrading or transforming into LC-PFCAs. Because of the complexity of identifying and effectively communicating the wide variety of substances that can break down or convert into perfluorooctanoic acid (PFOA) or LC-PFCAs, the Committee established an intersessional working group to develop a draft indicative list of long-chain PFCAs, their salts, and related compounds. Defra states that the draft indicative list for LC-PFCAs will complement existing registers, covering the listings of PFOA, its salts, and PFOA-related compounds, as well as perfluorohexanesulfonic acid (PFHxS), its salts, and PFHxS-related compounds. The Committee seeks additional information and feedback on the indicative lists. Comments are due June 30, 2025.
Justice Rushed Is Justice Denied: Why Alabama’s Attorney General Can Show Wisdom Rather Than Power on Hemp
One of my favorite quotes from Justice Potter Stewart (naturally, a Supreme Court justice writing about watching pornography is my favorite) is “[f]airness is what justice really is.” The Alabama attorney general has an opportunity to demonstrate fairness and put wisdom before power. Will he?
We’ve written extensively about Alabama’s new law substantially curbing the sale of most forms of hemp. From the Alabama Political Reporter:
After Gov. Kay Ivey signed House Bill 445 — the bill setting major restrictions on Alabama’s hemp and CBD industry — into law in May, confusion arose over exactly when the bill’s provisions, specifically its ban on the sale and possession of smokable hemp products, would go into effect.
While the legislation’s language stipulates that it “shall become effective on July 1, 2025,” several provisions regarding the licensure of consumable hemp manufacturers, wholesalers and retailers have an effective date of Jan. 1, 2026.
However, according to reporting from WSFA 12 News, the Alabama Attorney General’s Office has confirmed that the smokable hemp ban will indeed go into effect in July.
“The criminal prohibition on the sale or possession of hemp products specifically excluded from the definition of ‘consumable hemp product’ goes into effect July 1, 2025,” a spokesperson for AG Steve Marshall’s office told WSFA on Tuesday.
This means that smokable hemp products — defined in the bill as “any plant product or raw hemp material that is marketed to consumers as hemp cigarettes, hemp cigars, hemp joints, hemp buds, hemp flowers, hemp leaves, ground hemp flowers, or any variation of these terms to include any product that contains a cannabinoid, whether psychoactive or not” — will indeed become illegal for sale or possession in Alabama starting next month.
The AG’s spokesperson also noted that selling or possessing any such product in Alabama after July 1 “could subject an individual to prosecution for a Class C felony” punishable by a maximum prison sentence of 10 years and up to a $15,000 fine.
It is worth noting that, in contrast, an individual charged with “personal use” marijuana possession in Alabama only faces a Class A misdemeanor with a much lighter maximum sentence of 1 year in prison and a $6,000 fine.
I’ll leave it to the lawyers and courts who will almost certainly be hearing this case in short order to decide whether this is good law, but it strikes me as an unnecessary policy choice that will lead to more bad consequences than good.
Regardless of whether you agree with it, the Alabama Legislature made a choice to substantially limit the availability of hemp products in Alabama. It will soon be decided whether that choice was legal, but in the meantime it seems both unnecessarily punitive to operators and shortsighted to threaten felony charges on July 1 for operators and consumers engaged in an activity that was legal a month ago.
Citizens and businesses should be able to rely on laws to at least the extent that they shouldn’t have to worry about immediately closing their businesses and finding new access to therapies at the drop of a hat. I have been on the phone this week with people expressing hopelessness and despair about their inability to comply with the new law on such short notice (to say little of the fact that possessing hemp is now a felony while possessing marijuana is a misdemeanor).
Add to that the ABC is overwhelmed dealing with the implementation of the new hemp laws and the new vape laws. Put simply, the regulators understandably don’t yet know how to enforce these new laws.
I encourage the attorney general to reconsider and instruct law enforcement to stand down on enforcing the hemp law until January 1 so that businesses can make proper arrangements for compliance and regulators can implement formal rulemaking.
To do otherwise would be to unnecessarily punish hemp operators and motivate formerly legal operators to simply move to an unregulated market to get rid of their inventory. I assure you they have no intention of simply destroying it in the next few weeks.
This is a chance to do right by all stakeholders. Let’s take it.
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FDA Ratchets Enforcement on Social Media Promotion in New Warning Letter
This week, the U.S. Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) posted a warning letter (the “Letter”)[1], issued on May 29, 2025, to Sprout Pharmaceuticals, Inc. (“Sprout”) and its CEO, Cindy Eckert (“Eckert”), regarding a social media post promoting ADDYI® (flibanserin) (“Addyi”). According to FDA, the now-flagged Instagram post, shared by Eckert, touted Addyi’s benefits but left out crucial safety information and important details for the indicated population. There is a lot to unpack with this Letter and FDA’s manner of issuance, but as previewed in our prior blog posts this year, we believe this to be yet another example of FDA’s enhanced focus on drug advertising and promotion. Expect to see more warning letters—especially via social media advertising and promotion, actions directed at executives or personal social media accounts, and other creative ways the agency can push its mandate—in lieu of written regulation—to police the pharmaceutical industry.
Promotional Content
Addyi is the first FDA-approved medication for premenopausal women struggling with acquired, generalized hypoactive sexual desire disorder (HSDD). However, its use is highly specific—including a limitation of use—and comes with serious safety warnings, including a boxed warning for severe low blood pressure and fainting, especially when combined with alcohol or certain medications.
The Instagram post at the heart of the Letter (the “Post”) was shared on Eckert’s personal account, and included both content from a People Magazine article (the “Article”) and Eckert’s commentary about the Article. FDA made it a point to clarify that it considers a screenshot and user-generated text as one “post,” which is both important for contextualizing this Letter and for understanding how FDA thinks about these increasingly common types of social media posts. FDA found that the Post underscored Addyi’s benefits and big-picture messaging (e.g., “the sex pill for women”) but skipped over critical risks and omitted limitation of use language that Addyi isn’t approved for postmenopausal women, men, or to boost sexual performance in general. FDA’s principal concern, though, was doing this via a high-profile social media platform.
In short, FDA determined that the Post promoted Addyi in broad strokes for women’s sexual health, left out required safety and usage details, and created the impression that the product is safe and effective for a broader group than what FDA has actually approved.
Prior Warning to Sprout
This isn’t FDA’s first warning to Sprout; a previous warning letter in 2020[2] focused on a radio ad for Addyi that, in FDA’s eyes, touted Addyi’s benefits for women affected by HSDD but skipped over many of the drug’s risks and key limitations. For instance, the FDA found that the advertisement only briefly mentioned low blood pressure and fainting, but didn’t explain what the FDA views as bigger risks—like how drinking alcohol close in time to taking Addyi makes these dangers much worse. Also, according to the FDA, the ad left out the fact that certain prescription meds or liver problems can seriously increase the risk, and didn’t mention some other risks entirely. In short, the FDA viewed the presentation of information to be false and misleading with respect to risk and scope of Addyi’s approved uses.
FDA called out nearly identical issues in this year’s Letter, providing even more reason for FDA to be concerned, and suggesting that FDA feels the company hasn’t learned from past missteps.
Takeaways
Risk Presentation and Social Media Platforms
Failure to present risk information has historically been, and remains, low-hanging fruit for FDA enforcement. As we covered towards the end of 2024,[3] social media is a platform for promotional content that is of growing concern for the FDA. All told, it is unsurprising that an Instagram post promoting an FDA-regulated product, but providing no risk information, was the subject of FDA scrutiny. However, there is more nuance here than meets the eye.
The Post from Eckert’s personal account includes a screenshot of the Article about Addyi, which makes some of the claims that the FDA takes issue with, including “the sex pill for women” and “Addyi is the first FDA-approved treatment for women’s sexual dysfunction.” The Post also includes Eckert’s commentary to the Article that makes an additional claim that FDA takes issue with: “[t]he first articles on @addyi a decade ago questioned the women struggling, told them it was normal, debated how many more satisfying sexual events were enough for them to deserve a pill…” Of course, there are two forms of content at issue here: the Article and Eckert’s own commentary, but the FDA views them as one. FDA makes this clear in a footnote, but the concept is historically well-understood among advertising and promotional committees. In short, reposting/endorsing/liking third-party communications about a product, and in some cases (like here) providing commentary about the product and the reposted content, will be viewed as one communication by FDA, so explicit and implied claims related thereto should be considered.
In examining the Post and FDA’s analysis, a few major points stand out regarding risk and omission of material information.
Fair Balance
The Post, on its surface, is clearly well-intentioned—aimed at breaking the stigma around HSDD and encouraging open conversation about an often-overlooked issue. The Post, particularly through Eckert’s commentary, spotlights the value of personal storytelling from women living with HSDD, and praises the efforts of the couple highlighted in the Article. However, under FDA regulations, any communication that mentions a drug by name (in this case, Addyi) and makes reference to its use (sexual dysfunction), either explicitly (such as “sex pill for women”) or implicitly (for example, by discussing how the product affected a couple’s marriage), triggers specific promotional requirements. In particular, FDA rules require a fair balance between information about the drug’s benefits and its risks.
In this instance, the FDA noted a complete absence of fair balance. The post fails to mention any of Addyi’s safety risks or provide the full FDA-approved indications. This omission is especially concerning to the FDA, given that Addyi carries a boxed warning for risks such as severe hypotension and loss of consciousness, particularly when used with alcohol. The Letter specifically called out the lack of this critical safety information. Had Addyi not been a boxed warning product, the absence of safety information might have resulted in a less severe FDA response if there had at least been a brief mention or link to the product’s safety profile.
Limitations of Use
FDA highlights that according to the indications of usage section of the FDA-approved product labeling (“PI”), Addyi is indicated for the “treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire that causes marked distress or interpersonal difficulty,” and is not due to: (1) a co-existing medical or psychiatric condition; (2) problems within the relationship; or (3) the effects of a medication or other drug substance. Further, FDA noted that Addyi is not indicated for postmenopausal women, men, or to enhance sexual performance.
There are two key omissions noted by the FDA with respect to the PI. First, according to the FDA, the post failed to disclose Addyi’s limitations of use. Second, and perhaps more subtle, is that, in FDA’s eyes, the broad claim “sex pill for women” suggests that Addyi enhances sexual performance and may be used by “women” in general, as opposed to premenopausal women, as indicated in the PI. FDA’s concern stems from the same principle discussed earlier: once a drug and its use are mentioned, promotional rules apply, requiring that the content accurately present the drug’s approved indications and not mislead consumers. In this instance, the FDA may believe the post creates the impression that Addyi is suitable for all women seeking sexual enhancement, regardless of age or underlying conditions, when in reality, its approval is limited to a specific patient population.
Ultimately, this case serves as a cautionary example: even content intended to reduce stigma or advocate for patients on social media is subject to FDA rules on drug promotion. Any mention of a prescription product’s name, plus its use or benefits, requires the communicator to provide balanced disclosure of safety risks and approved indications.
Julian Klein, a summer associate in the firm’s New York office, contributed to this article.
FOOTNOTES
[1] Warning Letter available here: Sprout Pharmaceuticals, Inc. – 709942 – 05/29/2025 | FDA
[2] 2020 Warning Letter available here: Sprout Pharmaceuticals, Inc – 610569 – 08/31/2020 | FDA
[3] 2024 article available here: Key Takeaways From FDA’s Latest Social Media Warnings – Law360
HHS Announces Release of MAHA Report
On May 22, 2025, the U.S. Department of Health and Human Services (HHS) announced the release of a new federal report, Making Our Children Healthy Again (MAHA Assessment) issued by the Make America Healthy Again (MAHA) Commission. The MAHA Commission was established by Executive Order (EO) 14212 to:
(a) study the scope of the childhood chronic disease crisis and any potential contributing causes, including the American diet, absorption of toxic material, medical treatments, lifestyle, environmental factors, Government policies, food production techniques, electromagnetic radiation, and corporate influence or cronyism;
(b) advise and assist the President on informing the American people regarding the childhood chronic disease crisis, using transparent and clear facts; and
(c) provide to the President Government-wide recommendations on policy and strategy related to addressing the identified contributing causes of and ending the childhood chronic disease crisis.
The MAHA Commission was required to submit to the President, within 100 days of the EO’s release on February 13, 2025, this MAHA Assessment. Within 180 days of the date of the EO, or by August 12, 2025, the MAHA Commission is required to submit to the President a “Make Our Children Healthy Again Strategy” based on the findings from the MAHA Assessment.
According to HHS, the MAHA Assessment identifies key drivers behind childhood chronic diseases, including poor diet, accumulation of environmental toxins (such as pesticide exposure), insufficient physical activity, chronic stress, and overmedicalization.
Among other things, the MAHA Assessment examines pesticide use in agriculture and the perceived negative impacts it has on children. It calls for more research and potential shifts in food and farming policies to improve children’s health.
The MAHA Assessment includes a subsection entitled “Why Children Are Uniquely Vulnerable to Environmental Chemicals,” where pesticides are mentioned several times. The MAHA Assessment states that children are at heightened risk when exposed to environmental chemicals, including pesticides. The MAHA Assessment states the following as key factors:
Sensitive Developmental Windows: Even minor exposures during critical periods — in utero, infancy, early childhood, and adolescence — can result in developmental delays or permanent harm.
Developing Immune Systems: Young children have maturing immune systems, making them susceptible to chemical exposures that can disrupt lifelong immune development.
Detoxification Challenges: Babies struggle to detoxify chemicals as effectively as adults, allowing chemicals to accumulate in their smaller bodies.
Accelerated Brain Development: Early childhood is marked by rapid brain development, with up to one million new neural connections forming every second. Toxic exposures during this time can derail neurodevelopment, leading to lifelong learning disabilities and behavioral disorders.
Endocrine Disruption: Multiple developmental stages, from fetal growth to onset of puberty, are regulated via exquisitely sensitive hormonal signaling that can be disrupted by endocrine-disrupting chemicals, impacting growth trajectories and outcomes from conception through early adulthood.
Adolescent Brain Remodeling: The brain undergoes a second phase of remodeling during adolescence, particularly in regions responsible for impulse control and emotion. Neurotoxic substances — such as solvents and heavy metals — can have lasting effects that extend well beyond the teenage years.
With regard to how children are exposed to hazardous substances in different ways, the MAHA Assessment states several factors including:
Breastmilk: The MAHA Assessment states: “Virtually every breastmilk sample … tested in America contains some level of persistent organic pollutants (POPs), including pesticides, microplastics, and dioxins”;
Household Dust: Infants and toddlers ingest more household dust than adults, and according to the MAHA Assessment, much of household dust “contains detectable levels of lead, flame retardants, and pesticide residues”;
Home Environment: The MAHA Assessment cites to a 2009 American Healthy Homes Survey, a collaborative effort by the U.S. Environmental Protection Agency (EPA) and the U.S. Department of Housing and Urban Development (HUD), for demonstrating “the widespread presence of pesticides in U.S. homes, with almost 90% showing measurable levels of at least one insecticide on floors”; and
Food: The MAHA Assessment states: “More than eight billion pounds of pesticides are used each year in the food systems, around the world, with the U.S. accounting for roughly 11%, or more than one billion pounds.”
The MAHA Assessment states some epidemiological and clinical studies raised concern about possible links between pesticides, herbicides, and insecticides and adverse health outcomes in children. It specifically notes that glyphosate may have a wide range of possible health effects, ranging from reproductive and developmental disorders to cancer, liver inflammation, and metabolic disturbances. Atrazine is also specifically mentioned as causing endocrine disruptions and birth defects. The MAHA Assessment notes that federal government reviews of epidemiologic data for the most common herbicide did not establish a direct link between correct use of the herbicide and adverse health outcomes. In addition, the MAHA Assessment acknowledges that “more recent data from the USDA’s Pesticide Data Program found that 99% of food samples tested in 2023 were compliant with EPA’s safety limit.” HHS states that an updated health assessment by the federal government on common herbicides is expected in 2026.
Commentary
The MAHA Assessment specifically names pesticides chlorpyrifos, atrazine, and glyphosate as examples presenting notable risks from modern agricultural production methods. The MAHA Assessment highlights many of the problems said to be associated with modern food production as a system — processed food ingredients, nutrition, and typical farming practices. The references to pesticides are generally grouped with other categories or substances, including heavy metals, per- and polyfluoroalkyl substances (PFAS), fluoride, and phthalates. The MAHA Assessment acknowledges that EPA has a “robust risk-based approach that considers hazard and exposure for assessing the risks of chemicals, including pesticides, to human health and the environment.”
Throughout the MAHA Assessment, there are footnotes citing studies in an effort to raise concerns about the dangers of the modern food production system, yet the established data about pesticide residues are found to be compliant with the requirements of the Food Quality Protection Act (FQPA). When discussing EPA’s “robust risk-based approach,” the MAHA Assessment does not explicitly note that pesticide residues in food have been found to have a “reasonable certainty of no harm” based on EPA’s robust review of a comprehensive data set. There is no mention of the safety standard in FQPA that there is a “reasonable certainty of no harm” from pesticide residues — perhaps since such notes might sound contrary to the MAHA Assessment’s tone that the food supply and its components are causing widespread harm to the consuming public. Separately, it is curious that in any cross-agency review process, EPA did not insist on such an explanatory note.
It also is interesting to note that in the MAHA Assessment’s “Next Steps” section, where the MAHA Commission sets forth research initiative recommendations that are underway or will begin in the near future, there are no specific recommendations for EPA. There is, however, a recommendation to “fund independent studies evaluating the health impact of self-affirmed GRAS [Generally Recognized As Safe] food ingredients, prioritizing risks to children and informing transparent FDA [U.S. Food and Drug Administration] rulemaking.”
As noted above, the MAHA Commission has until August 12, 2025, to submit the Make Our Children Healthy Again Strategy, based on the findings noted in the MAHA Assessment. While Administrator’s Zeldin’s press release regarding the MAHA Assessment did not respond to or address any statements in the MAHA Assessment regarding pesticide exposures, it will be important to see what recommendations are forthcoming in the Strategy as they relate to pesticides and food.
Cloud Control: Alabama’s Newest Nicotine Regulation That’s Just Too “Juicy” to Ignore
On May 14, Alabama Gov. Kay Ivey signed Alabama HB8 into law. Effective June 1, HB8 introduced sweeping changes that will reshape how nicotine products are sold, marketed, and regulated in Alabama. You heard that right, nicotine — not cannabis. While the subject of HB8 is a little out of our typical green wheelhouse, this coverage is backed by popular demand and it implicates many issues facing the cannabis industry in Congress, state houses, and courthouses across the country.
While the bill’s primary focus is public health — specifically, curbing youth vaping — its impact on businesses and consumers will be significant. In this post, we break down the key provisions of HB8 and explore what they mean for retailers, manufacturers, and vape enthusiasts.
Grab a spot on the couch, pop some popcorn (the snack, not the lung condition), and let’s unpack this thing.
Youth Access & Possession Restrictions
With limited exceptions, individuals under the age of 21 are prohibited from using or possessing nicotine products. The use of fake identification by anyone under the age of 21 to purchase nicotine products is also prohibited, and the punishment for attempts to do so increase with each violation.
Specialty Retailers
The law creates a new category of regulated business: the “specialty store.” Specialty retailers must prohibit anyone under the age of 21 from entering the premises by utilizing third-party age verification technology. To legally operate as a specialty retailer of electronic nicotine delivery systems (ENDS), one must pay a $1,000 annual licensing fee per location and a $50 application fee per location. Notably, HB8 restricts the sale of all non-federally authorized nicotine products to these specialty stores only. Practically speaking, this means that all but 34 products, including a swath of popular flavored nicotine products, are restricted to specialty stores.
Sales Restrictions
HB8 bans the sale of nicotine products through vending machines and prohibits self-service displays outside of specialty retailers. Synthetic nicotine products are illegal without federal authorization. All liquid nicotine containers intended for use in ENDS must be sold in child-resistant packaging. Additionally, all nicotine retailers must post clear signage about the legal age requirement and health risks, with specialty retailers of alternative nicotine products, e-liquids, and ENDS required to display additional warnings.
American Made or Federally Authorized
Beginning October 1, 2025, no e-liquid, ENDS, or alternative nicotine product may be added to Alabama’s publicly available ENDS Directory unless it is either (1) made, packaged, and labeled in the United States or (2) has received federal authorization.
Search, Seizure & Forfeiture Provisions
Unauthorized nicotine products, along with any fixtures, equipment, materials, or property associated with their sale or use, may be subject to search, seizure, and forfeiture or destruction.
Advertising & Marketing Restrictions
HB8 severely limits how nicotine products may be marketed. Claims by retailers or manufacturers that products help with tobacco cessation or are safer alternatives to cigarettes are prohibited unless explicitly authorized by the FDA. Retailers and manufacturers must limit billboard advertisements to references to tobacco, menthol, or mint flavors. They may not advertise on any billboard within 1,000 feet of schools and playgrounds and are prohibited from referencing candy, desserts, brand-name sweets, or other flavors or imagery likely to appeal to minors, such as cartoon or video game characters.
Specialty retailers and manufacturers may not advertise in or sponsor youth-oriented events or publications, and the law further prohibits them from offering scholarships or sponsorships in connection with nicotine products.
Specialty retailers may not use flashing lights or additional signage, apart from signage displaying the business’s trade name, indicating they sell ENDS, alternative nicotine products, or e-liquids.
Public Education & Prevention Measures
The Alabama State Board of Education must establish a model K–12 policy for vape education and prevention, which (at a minimum) each local school board must adopt by November 1, 2025.
Fees for Manufacturers & Certification, Documentation & Notification Requirements
Manufacturers of e-liquids and alternative nicotine products are subject to a $2,000 initial registration fee and a $500 annual renewal fee to continue operating in Alabama.
Manufacturers of e-liquids and alternative nicotine products are required to submit certifications under penalty of perjury disclosing the nicotine source, manufacturing location, and federal regulatory status of their products. They must also provide supporting documentation and product information, and they have a continuing obligation to notify the state of material changes.
Oversight, Enforcement & Advisory Boards
The Alcoholic Beverage Control (ABC) Board is designated as the primary enforcement authority. It has the power to impose fines, revoke permits, and adjudicate contested applications and enforcement actions. Additionally, HB8 establishes an advisory board composed of representatives from various parts of the state government, as well as the executive director of a nonprofit organization (Children First) tasked with monitoring the implementation of HB8.
Allocation of Funds
HB8 creates the Vaping Licensing and Enforcement Fund, and money collected pursuant to HB8, with limited exceptions, will be distributed as follows: 40% to licensing and compliance efforts, 20% to the Public Safety Fund for enforcement, 20% to the State Board of Education for awareness and prevention programming, and 20% to the Unified Judicial System for education, prevention, and substance abuse initiatives.
Proponents see HB8 as a clear, bipartisan victory for youth safety. Those opposed might say the bill introduces restrictions that will negatively affect small businesses and create a larger underground market for minors.
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