• The Non-GMO Project has introduced a logo that would highlight foods that do not contain “ultra-processed” ingredients, called “Non-UPF Verified.”  The program was created by the Non-GMO Project’s newly established Food Integrity Collective.  The founder and CEO of the Non-GMO Project and the Food Integrity Collective, Megan Westgate, alleged that “[t]he Standard American Diet has become one of the leading risk factors for death worldwide, yet navigating today’s food landscape can feel like an impossible task.”
  • The new certification will complement the Butterfly seal, intended to help consumers choose foods that the Non-GMO Project believes promote food that is not ultra-processed.  According to the organization, “Non-UPF Verified” will set clear standards and encourage food manufacturers to offer more minimally processed options, based on an “8-Petal Framework for Food Integrity.”
  • The term “ultra-processed food” is not formally defined, which raises questions as to how the certification program defines the term and whether the logo will be meaningful.  For example, the National Institute of Health (NIH) defined “ultra-processed foods” in 2019 as foods that modify the nutritional content of their ingredients to boost their profitability, convenience, and shelf life. However, other definitions vary and there is no consensus.
  • The new certification program will launch its pilot phase in Spring 2025 and food manufacturers interested in the certification can learn more at: www.nonultraprocessed.org.
  • Last month, Representatives Steven Womack (Arkansas) and Tracey Mann (Kansas) introduced a bill which, if passed, would prevent USDA from finalizing, implementing, administering, or enforcing the proposed rule “Salmonella Framework for Raw Poultry Products.” 89 Fed. Reg. 64678 (Aug. 7, 2024).
  • Under the proposed rule, raw poultry containing 10 or more colony forming units (CFU) of any Salmonella and any detectable level of Salmonella serotypes of public health significance would be considered adulterated under the Poultry Products Inspection Act. If the standard is finalized, it would also be accompanied by routine USDA sampling and verification testing for Salmonella. The proposal would also require that poultry slaughter establishments develop and implement written procedures to prevent contamination by enteric pathogens throughout the entire slaughter and dressing operations and maintain records documenting those procedures.
  • The bill was introduced the same week that the Government Accountability Office (GAO) issued a report noting that USDA’s Food Safety and Inspection Service (FSIS) had paused work on several microbial adulterant standards to work on the Salmonella framework and recommending that the agency develop a plan to prioritize its proposals and determine which standards are needed.
  • On February 3, 2025, Senator Cory Booker and Representative Rosa DeLauro introduced a bill to provide FDA the authority to collect microbial samples at feed lots during foodborne illness outbreaks or when there is a public health need.
  • The bill is a response to the recent spread of H5N1 (bird flu), as well as persistent foodborne illness risks. According to Rep. DeLauro, the bill, titled the Expanded Food Safety Investigation Act, will “ensure FDA has the power to investigate corporate agribusinesses, respond effectively to public health threats, and protect American consumers.”
  • The goal of the bill, which is endorsed by several non-governmental organizations, is to allow FDA to enter feed lots, which have been linked to outbreaks involving fresh produce due to water runoff adjacent to irrigation canals causing contamination of crops.
  • The full text of the bill is not yet available. Keller and Heckman will continue to monitor the bill, along with other food safety legislation.
  • On January 31, 2025, President Trump signed an executive order titled “Unleashing Prosperity Through Deregulation.”  This order mandates that federal agencies identify at least 10 existing rules, regulations, or guidance documents to repeal whenever they seek to introduce a new rule or regulation.  Additionally, the order stipulates that the Director of the Office of Management and Budget (OMB) will ensure standardized measurement and estimation of regulatory costs.  For fiscal year 2025, the total incremental cost of all new regulations must be significantly less than zero, accounting for offsets from the elimination of costs associated with the ten repealed regulations.
  • The executive order criticizes the costs of regulation, stating that overregulation discourages entrepreneurship, consumer choices, individual liberty, and harms small businesses.  It references Executive Order 13771 which President Trump signed during his first term in which he required agencies to eliminate two regulations for each new regulation issued—a policy rescinded by former President Biden on his first day in office.  The order notes that the Trump Administration had previously eliminated five and a half regulations for every new regulation issued.
  • The order also directs the Director of the OMB to provide agency heads with guidance on implementing the order, including standardizing methods for determining costs.  Furthermore, it revokes OMB Circular No. A-4 (“Regulatory Analysis”) and reinstates the Memorandum of Agreement (MOA) between the Department of Treasury and the OMB from April 11, 2018, regarding the review of tax regulations under Executive Order 12866.
    • OMB Circular No. A-4 provided guidance to federal agencies on developing regulatory analysis, including assessing costs and benefits of regulatory actions.  The revocation of this circular aims to streamline the regulatory process and reduce perceived burdens on businesses.
    • The MOA between the Department of Treasury and the OMB established a framework for reviewing tax regulations, ensuring economic analysis while maintaining timely tax guidance.  Executive Order 12866, signed in 1993, set principles for regulatory planning and review, emphasizing the need for cost-benefit analysis and coordination among federal agencies.
  • This new executive order represents a significant shift in regulatory policy.  Keller and Heckman will continue to monitor any new executive orders issued by the new administration that affect the federal government, particularly those related to the administrative state and regulated industries.
  • Earlier this month, FDA released a summary of a strategy intended to prevent human norovirus and hepatitis A virus (HAV) outbreaks associated with fresh and raw berries. Both norovirus and HAV are types of enteric virus (effecting the gastroenteric system) which have been linked to imported fresh and frozen berries; domestically grown berries have not been linked to an outbreak of these viruses for 35 years.
  • Among the information consulted in developing the plan were the results of 1,558 samples of frozen strawberries, raspberries, and blackberries from November 2018 to September 2023, which showed HAV in 8 samples and norovirus in 10 samples.
  • The pillars of the plan are (1) promoting high compliance rates with FDA’s food safety requirements, (2) encouraging the berry industry to consistently apply pre- and post- harvest sanitation practices, including conducting root cause analysis when failures occur, (3) broadening knowledge regarding the viability, persistence, detection, and mitigation of viruses in fresh and frozen berries, pre- and post-harvest environments, and agricultural water sources, and (4) incentivizing the use of immunization to promote worker health.
  • FDA currently plans to hold a webinar on February 20, 2025, to provide an overview on the updated definition of the nutrient content claim “healthy.”
  • As we discussed on this blog, in December 2024, FDA published a final rule updating the requirements to use the implied nutrient content claim “healthy” on human foods. To make a “healthy” claim, a product must:
    • Contain a certain amount of food from at least one of the food groups or subgroups recommended by the Dietary Guidelines for Americans; and
    • Meet specific limits for added sugars, saturated fat, and sodium.
  • Registration is required to attend the webinar, which is free and open through the day of the webinar. During the webinar, FDA will discuss pre-submitted questions, which must be submitted through the registration page by January 31, 2025.
  • Keller and Heckman will continue to provide updates related to the “healthy” final rule.
  • On January 20, 2025, President Donald Trump signed a memorandum titled, “Regulatory Freeze Pending Review,” imposing a regulatory freeze on all federal agencies.
  • The key points of the regulatory freeze are as follows:
    • Do not Propose or Issue Any New Rules: Agencies cannot propose or issue any new rules in any manner, including sending them to the Office of the Federal Register (OFR), until they are reviewed and approved by a department or agency head appointed by the President.
    • Automatically Withdrawing Unpublished Rules: Any rules that have been sent to the OFR but have not yet been published must be immediately withdrawn to be reviewed by a department head or agency head appointed by the President.
    • Delay Effective Date of Already Published Rules: For rules that have been published but have not yet taken effect, agencies are to consider postponing their effective date for 60 days to review any questions of fact, law, or policy.  During this period, agencies may open a comment period for public input and consider further delaying the rules if necessary.
  • The freeze applies not only to rules but also to any substantive agency action, including Advanced Notices of Proposed Rulemaking (ANPR), Notice of Proposed Rulemaking, notices of inquiry, and any agency statement of general applicability that sets forth a policy on any regulatory or technical issue.
  • This freeze will impact all recently proposed rules by requiring them to undergo a review process, which may lead to the rules being withdrawn, modified, or delayed in implementation.  The following recently proposed rules or finalized but not yet effective rules issued by FDA include:
  • Alongside the regulatory freeze, President Trump has directed federal agencies to temporarily stop all public communications.  This includes press releases, social media updates, and other public statements.  The pause is in effect through February 1.
  • Keller and Heckman will continue to closely monitor any changes made to pre-existing proposed or finalized rules and any new executive orders or rules promulgated by the new administration.
  • On January 22, 2025, the Association of American Feed Control Officials (AAFCO) membership approved a proposal from Kansas State University’s Olathe Innovation Campus (Olathe) to provide the scientific review for a new animal food ingredient submission pathway.  The new pathway replaces AAFCO’s former Ingredient Definition Request process that ended due to the expiration of AAFCO’s Memorandum of Understanding with the U.S. Food and Drug Administration (FDA).
  • The new ingredient approval pathway will include a scientific review panel comprised of subject matter experts from US universities and independent consultants that have diverse experience in various processes, animal nutrition, and target animal species.  The expert panel will evaluate potential ingredient submissions from industry and provide recommendations back to AAFCO membership for final approval.  Approved ingredients will then be included in AAFCO’s Official Publication.
  • According to AAFCO, the new pathway is intended to complement FDA’s current GRAS Notice program and to provide the feed industry with another option to “bring new and innovative products to market.”  The format of the submission will be similar to a GRAS Notice and there will be a three tier fee schedule associated with the review dependent on the complexity of the submission. AFFCO anticipates having the program in place by May 2025.
  • Keller and Heckman LLP will continue to monitor and communicate on any developments.
  • On January 7, 2025, the U.S. Court of Appeals for the Fourth Circuit upheld Virginia Senate Bill (SB) 903, which was signed into law in 2023 and regulates the sale of hemp products based on their total tetrahydrocannabinol (THC) concentration, regardless of whether the THC is delta-9 (the psychoactive component of marijuana) or delta 8, any other form of THC.
  • Following the passage of the 2018 Farm Bill, “hemp” is excluded from the definition of marijuana, which is listed under the Controlled Substances Act (CSA).  Hemp is defined in the 2018 Farm Bill as any part of the cannabis plant, including derivatives, that do not have more than 0.3% delta-9 THC. Thus, under the CSA, hemp products containing 0.3% or less delta-9 THC are not subject to penalties even if they contain higher levels of other forms of THC such as delta-8 THC, which is also psychoactive.
  • Responding to concerns about the absence of regulation of these other forms of THC and reports of adverse events with delta-8 THC in children, Virginia passed SB 903 which prohibited the retail sale of hemp products containing a total THC concentration greater than 0.3% and prohibiting hemp processors from selling hemp to a person the processor knows or has reason to know will use those products in a way that violates the total THC limit.
  • Plaintiffs brought suit and alleged that the Virginia law was (1) preempted by the 2018 Farm Bill and (2) violated the Dormant Commerce clause. On these issues, the 4th Circuit upheld the lower court’s decision and held that the Virginia law was not preempted and did not violate the dormant commerce clause.
  • Regarding preemption, while the court recognized that the statutory notes indicated that the 2018 Farm Bill does not prohibit interstate commercial distribution of hemp, it held that law “says nothing about the ability of states to regulate the sale of hemp products within their borders.” Indeed, with respect to production, the 2018 Farm Bill was explicit in allowing States to regulate the production of hemp in a more stringent manner.  The Court also held that field preemption did not apply and that in fact the 2018 Farm Bill had expressly carved out a substantial role for state regulation. Finally, the Court rejected the Plaintiff’s argument that the Farm Bill had intended to create a national hemp market or that the Virginia law conflicted or created an obstacle to the purpose of the 2018 Farm Bill.
  • Regarding the dormant commerce clause, the Court held that there was no discrimination between in and out of state economic interests (the law applied equally to in and out of state actors) and that it also did not unjustifiability burden the flow of interstate commerce as would otherwise be required to find a dormant commerce clause violation.
  • On January 17, 2025, the Alcohol and Tobacco Tax and Trade Bureau (TTB) proposed two rules that would require nutrition and food allergen labeling on alcoholic beverages, including wines, distilled spirits, and malt beverages. The proposed rules are in response to the Department of the Treasury’s February 2022 report on Competition in the Markets for Beer, Wine, and Spirits, which recommended TTB revive or initiate such rulemaking.
  • The proposed Alcohol Facts Statements in the Labeling of Wines, Distilled Spirits, and Malt Beverages would require disclosure of per-serving alcohol, calorie, and nutrient content information in an “Alcohol Facts” statement on all TTB-regulated alcoholic beverage labels. Specifically, the Alcohol Facts statement would be required to include:
    • The serving size of the product;
    • The number of servings per container;
    • Alcohol content as a percentage of alcohol by volume;
    • The mount of pure ethyl alcohol per serving in fluid ounces;
    • The number of calories per serving; and
    • The amount of carbohydrates, fat, and protein per serving.
  • The amount of sugars may be optionally declared in the Alcohol Facts statement. The statement must be presented in a panel or linear format. An example of each format is below:
  • The proposed Major Food Allergen Labeling for Wines, Distilled Spirits, and Malt Beverages would require labeling disclosures of all major food allergens used in the production of TTB-regulated alcoholic beverages. The declaration must consist of the words “Contains Major Food Allergen(s)” followed by a colon and the name of the food source from which each major food allergen is derived. Processing aids may include the parenthetical explanation “(processing aid)” following the name of the allergen. If major food allergens used in the production of distilled spirits have been completely distilled such that no protein remains, the declaration is not required.
  • TTB is accepting comments on both proposed rules until April 17, 2025, at regulations.gov. Comments on the nutrition labeling rule should be filed in Docket No. TTB-2025-0002, and comments on the allergen rule should be filed in Docket No. TTB-2025-0003. Keller and Heckman would be happy to help prepare comments and will continue to monitor TTB’s proposed labeling rules.