On March 24, 2025 Governor Patrick Morrisey of West Virginia signed into law H.B. 2354 which will impose a ban on the use of specified food additives, including seven food dyes, in food, drink, confectionery, or condiment products in the state. In passing this law, West Virginia became the first state
Continue Reading West Virginia Passes Law Prohibiting the Use of Seven Food Dye Ingredients
Executive Order on Deregulatory Initiative: What it Means for Food, Cosmetic, Drug, and Device Stakeholders
On February 19, 2025, President Trump issued an Executive Order titled “Ensuring Lawful Governance and Implementing the President’s ‘Department of Government Efficiency’ Deregulatory Initiative” (the EO). The stated purpose of the EO is to advance the Administration’s policies of focusing executive enforcement actions on regulations “squarely authorized by federal statute” and deconstructing the administrative state in order to achieve the stated goal of “[e]nding Federal overreach and restoring the constitutional separation of powers.” The EO appears to present opportunities for FDA-regulated stakeholders to identify certain regulations, guidance, and enforcement actions for recission or termination. Likewise, certain stakeholders may face changes in the competitive balance with competitors if the EO causes FDA to stop enforcing regulations that currently prohibit the marketing of certain products.
Key Provisions of the EO
In order to effectuate the stated policy, the EO provides for 1) the rescission of existing regulations across federal agencies, 2) the de-prioritization and termination of certain ongoing enforcement actions, and 3) the review of new regulations by members of the Department of Government Efficiency (DOGE) and the Administrator of the Office of Information and Regulatory Affairs (OIRA):
- “Rescinding Unlawful Regulations and Regulations That Undermine the National Interest”: The EO directs agency heads, in coordination with their DOGE team lead and the Office of Management and Budget (OMB) Director, to, within the next 60 days, review all agency regulations and identify regulations deemed to be 1) unconstitutional, 2) unlawful, 3) based on “anything other than the best reading of the underlying statutory authority or prohibition,” 4) implicating “matters of social, political, or economic significance that are not authorized by clear statutory authority,” 5) excessively costly, 6) “harmful to the national interest,” or 7) overly burdensome for small businesses or entrepreneurs. Notably, and consistent with the Administration’s other recent deregulatory actions, the EO defines “regulations” to include guidance documents. The EO states that the Administrator of OIRA, in consultation with agency heads, will then develop a Unified Regulatory Agenda to rescind or modify the identified regulations. Pursuant to this mandate, FDA will likely be expected to conduct a broad review of its regulations and guidance documents over the next 60 days and identify items that may merit rescission.
- “Enforcement Discretion to Ensure Lawful Governance”: The EO grants agency heads discretion to “preserve their limited enforcement resources” by 1) de-prioritizing enforcement of regulations that are “based on anything other than the best reading of a statute” or “that go beyond the powers vested in the Federal Government by the Constitution”; and 2) to terminate ongoing regulatory enforcement proceedings which “do not comply with the Constitution, laws, or Administration policy.” This, in turn, could pose significant implications for both future and ongoing FDA enforcement actions. Under the EO, even long-standing precedents that provide the foundation for FDA’s enforcement activities could be scrutinized if the Administration considers them to be not based on the current “best” reading of a statute. In practical terms, this could lead to the truncation or effective deletion of certain long-standing regulatory requirements across all product areas regulated by FDA.
- “Promulgation of New Regulations”: The EO requires that agency heads consult with their DOGE Team Leads and the Administrator of OIRA on potential new regulations as soon as practicable and instructs DOGE Team Leads and OIRA to evaluate potential new regulations against certain criteria outlined in the EO.
FDA Issues Draft Guidance on the Labeling of Plant-Based Foods
On January 6, 2025, the U.S. Food and Drug Administration (FDA) issued its Draft Guidance on the Labeling of Plant-Based Alternatives to Animal-Derived Foods. The draft guidance outlines FDA’s recommendations for naming plant-based egg, seafood, poultry, meat, and dairy products (other than milk[1]) in compliance with FDA’s naming requirements for non-standardized foods. The draft guidance expressly “excludes animal proteins produced by microflora,” such as those produced using precision fermentation. Interested stakeholders should provide comments on the draft guidance by May 7, 2025, after which point FDA will begin work on the final guidance.
I. FDA’s Naming Requirements for Non-Standardized Foods
The Federal Food, Drug, and Cosmetic Act (FDCA) and FDA’s implementing regulations require that the labels of non-standardized foods (i.e., foods for which FDA has not issued a standard of identity) bear the common or usual name of the food or, if there is no such name, an accurate description of the food or a fanciful name commonly used by the public.[2] The draft guidance notes that while many plant-based alternatives are foods for which no common or usual name has been established, manufacturers should look to FDA’s general principles for identifying common or usual names when selecting names for these foods.[3] For example, appropriate names should describe the basic nature of the food, should be uniform among identical or similar products, and should adequately distinguish between classes or subclasses of a product. Against this backdrop, the draft guidance provides specific recommendations for naming plant-based alternatives.
II. FDA’s Recommendations
The draft guidance’s primary recommendation—and one that could pose implications for many currently-marketed plant-based products—is that the statement of identity for plant-based alternatives should identify the specific plant source(s) from which the food is derived (e.g., “soy chicken,” “black bean mushroom veggie patties,” “chickpea and lentil-based fish sticks”). The draft guidance notes that, while general terms like “plant-based” can help convey that a product is not animal-derived, such terms do not, by themselves, adequately distinguish a food from other plant-based alternatives and therefore do not provide consumers with sufficient information to make purchasing decisions. Thus, while terms like “plant-based” can be used as part of a product’s name, the draft guidance recommends that such terms be accompanied by language that identifies the specific plant source(s) in the product (e.g., using “plant-based soy-bacon” instead of just “plant-based bacon”).Continue Reading FDA Issues Draft Guidance on the Labeling of Plant-Based Foods
FDA Seeks Public Input on Process for Human Food Export Certification Lists
On November 8, 2024, the Food and Drug Administration (FDA) issued a notice of request for information (RFI) regarding the agency’s current approach to providing export certification in the form of lists (export lists) for human food products. The RFI seeks to learn more about U.S. exporters’ experiences and the challenges they face related to meeting export listing requirements of other countries and FDA’s certification processes for export lists. FDA will use this information to inform the continuing development of its export list program for human foods.
Background
Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply a “certification” for products FDA regulates. In many cases, a foreign government may be seeking official assurance that the product can be marketed in the U.S. or otherwise meets specific U.S. requirements. A foreign government also may require export certification as part of the process to register or import a product into that country. For the importation of certain products, some countries require export certification in the form of inclusion on a list of establishments that the competent authority in the exporting country has certified as complying with applicable food safety requirements.
Under FDA’s Export Certification Program for FDA-regulated human food products, the agency provides an “export certification” in the form of an export certificate or export list.[1] FDA’s export certification provides the agency’s official attestation concerning a product’s regulatory status, based upon available information at the time FDA issues the certification. In addition, as of August 2024, FDA has established export lists that cover 19 categories of food products for Chile, China, the European Union, Saudi Arabia, Taiwan, and the United Kingdom.
FDA is authorized under section 801(e)(4)(B) of the FD&C Act to charge a fee of up to $175 for each written export certification that the agency issues within 20 days of receipt of the request for certification. The agency does not currently charge fees for food export lists, but is considering implementing fees to offset the associated operational costs.Continue Reading FDA Seeks Public Input on Process for Human Food Export Certification Lists
FDA Issues Draft Guidance on New Voluntary Targets for Sodium Reduction in Foods
August 21, 2024, Covington Alert
On August 15, 2024, the Food and Drug Administration’s (FDA’s) Center for Food Safety and Nutrition (CFSAN) took another important step in its sodium reduction efforts by issuing a Draft Guidance that contains new voluntary targets for sodium reduction in foods. The Draft Guidance builds on FDA’s October 2021 Final Guidance on Voluntary Sodium Reduction Goals, which established short-term voluntary targets for reducing sodium in commercially processed, packaged and prepared food. The Draft Guidance proposes new three-year sodium reduction targets for 16 overarching food categories and 163 subcategories that are commercially processed and packaged, or prepared in food service establishments such as restaurants.
Background
Average sodium intake in the United States is currently almost 50% more than the recommended limit.[1] To help reduce sodium across the food supply, FDA has taken an iterative, step-wise approach that includes establishing voluntary sodium targets for industry, monitoring and evaluating progress, and engaging with stakeholders.
FDA’s sodium reduction efforts began in 2016, when it released draft guidance on the agency’s short-term and long-term goals for sodium reduction in a variety of commercially processed, packaged, or prepared foods. FDA issued final guidance on this topic in October 2021 (Final Guidance), in which it set a goal of reducing average sodium intake from over 3,400 mg/day to 3,000 mg/day. As of 2022, about 40% of the targets set for foods in the Final Guidance had been reached.[2] FDA has deemed the Final Guidance “Phase I” of its sodium reduction efforts.Continue Reading FDA Issues Draft Guidance on New Voluntary Targets for Sodium Reduction in Foods
FDA Issues Final Guidance on Demonstrating Effectiveness of Anthelmintics in Dogs
June 27, 2024, Covington Alert
On June 25, 2024, the Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) announced that it has finalized Guidance for Industry (GFI) #276, Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs (Final Guidance). The Final Guidance replaces CVM’s draft guidance issued in November 2022. While CVM’s core recommendations remain the same, the Final Guidance clarifies the discussion and recommendations related to geographic locations from which Dirofilaria immitis (D. immitis) larvae used in trials should be sourced, laboratory dose confirmation studies, and field effectiveness studies for products intended to prevent heartworm disease. CVM’s stated overarching goal in making the revisions is to better align GFI #276 with current technology and veterinary epidemiology, including available diagnostic methodology. Drug sponsors who deviate from these recommendations are encouraged to discuss the deviations with CVM.
Background
On May 24, 2018, FDA published a Federal Register Notice requesting public input on possible alternative approaches for evaluating the effectiveness of heartworm disease prevention products for dogs. On its webpage announcing the final guidance, FDA explained that it asked for public input because of reports of lack of effectiveness and certain limitations of the effectiveness studies conducted to support product approval. FDA’s then-current recommendation for demonstrating the effectiveness of a new animal drug intended to prevent heartworm disease was for sponsors to conduct two laboratory dose confirmation studies and one multi-site field effectiveness study under the principles of Good Clinical Practice. FDA specifically requested input on the population level effectiveness endpoint, exposure to infective D. immitis larvae in field studies, outcome assessment in field studies, and laboratory study designs.Continue Reading FDA Issues Final Guidance on Demonstrating Effectiveness of Anthelmintics in Dogs
FDA Announces Availability of Final Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 4)
On October 13, 2023, the Food and Drug Administration (FDA) announced that the guidance entitled “Prior Notice of Imported Food Questions and Answers (Edition 4): Guidance for Industry,” originally released as draft guidance on September 13, 2022, has been made final. FDA received no comments on the draft
Continue Reading FDA Announces Availability of Final Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 4)FDA Issues Draft Compliance Policy Guide for Major Food Allergen Labeling and Cross-Contact
On May 16, 2023, FDA released a draft compliance policy guide (“draft CPG”) for major food allergen labeling and cross-contact, which updates the 2005 CPG Sec 555.250 Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens. CPGs are intended to advise FDA staff, including investigators, of the agency’s strategy for assessing and enforcing industry compliance. The draft CPG contains FDA’s current policies on major food allergen labeling requirements, allergen cross-contact, voluntary allergen information (e.g., advisory label statements), thresholds, and regulatory actions. The draft CPG is more comprehensive than the 2005 CPG and is intended to create a uniform standard and minimize the possibility that individual FDA staff will follow differing regulatory approaches.
The draft CPG details the allergen labeling requirements of the Federal Food, Drug, and Cosmetic Act. We do not discuss those requirements here, but instead focus on the policies the draft CPG discusses that are not addressed, in detail, in other FDA allergen documents, such as the recent draft guidance, Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act.
I. Allergen Cross-Contact
Allergen cross-contact is the unintentional incorporation of a food allergen into a food that does not contain that allergen as an ingredient. The draft CPG notes that the likelihood an allergen will be present due to cross-contact can be impacted by factors such as the characteristics of the food, the distribution of the allergen within a food (homogeneous versus particulate), the type of manufacturing process, the equipment used, and the cleaning procedures applied (e.g., dry cleaning versus wet cleaning). While FDA acknowledges these factors, the agency states that cross-contact may occur due to practices such as the failure to clean shared equipment adequately or segregate allergens properly, improper rework addition, or improper production scheduling. The draft CPG does not explicitly acknowledge that even with adequate CGMPs, sanitation, and preventive controls, cross-contact can still occur.
The draft CPG also confirms FDA’s position that “[m]ajor food allergens unintentionally incorporated into a food are not to be declared in the ingredient list or the ‘Contains’ statement.”Continue Reading FDA Issues Draft Compliance Policy Guide for Major Food Allergen Labeling and Cross-Contact
FDA Plans to Redesign the Human Foods Program
On January 31, 2023, FDA Commissioner Robert M. Califf announced a proposed redesign of the human foods program at FDA. The proposal follows the findings and recommendations of a Reagan-Udall Foundation expert panel that Dr. Califf had charged with evaluating the agency’s existing human foods program. Commissioner Califf called the
Continue Reading FDA Plans to Redesign the Human Foods ProgramExpanded Conditional Approval Draft Guidance Issued
On September 26, the U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) issued a draft guidance explaining the criteria it plans to apply when granting “expanded conditional approval” to new animal drugs not intended for minor uses or minor species that address a serious or life-threatening disease
Continue Reading Expanded Conditional Approval Draft Guidance Issued