Food and Drug Law

Over the last week or so there have been several developments from the Trump Administration and Congress affecting the food industry. We outline several of those developments below and identify key ways industry stakeholders can engage.

Click here to read the full alert on cov.com.

Continue Reading In Case You Missed It: Recent Food-Related Developments from the Trump Administration and Congress

Yesterday, Texas governor Greg Abbott signed into law S.B. 25, which requires food products containing any of 40+ specified ingredients to bear a warning label. This follows Texas’s enactment of S.B. 314 in late May, which prohibits Texas school districts and open-enrollment charter schools from providing free or reduced-price meals that contain any of 17+ specified ingredients. As of the date of this writing, Louisiana S.B. 14, which would impose (1) disclosure requirements for any food product sold in the state that contains specified ingredients, and (2) a ban on the use of certain ingredients in school meals, is sitting on the governor’s desk. It will become law if he signs it or takes no action by June 25. These actions are part of a larger trend of increased scrutiny of food and color additives, as we previously reported and which is a significant feature of the Make America Healthy Again (“MAHA”) Commission’s Assessment released on May 22, 2025.

Texas S.B. 25

S.B. 25 requires human food products containing any of 40+ specified ingredients to bear the following warning label: “WARNING: This product contains an ingredient that is not recommended for human consumption by the appropriate authority in Australia, Canada, the European Union, or the United Kingdom.” Violators may be subject to a fine not to exceed $50,000 per day for each distinct food product in violation of the requirement.

The ingredients subject to the warning label requirement are the FD&C colors (i.e., Blue Dye No. 1, Red Dye No. 40, etc.) and numerous other ingredients including bleached flour, bromated flour, azodicarbonamide, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), potassium bromate, and propylparaben. Although the sweeteners aspartame, sucralose, acesulfame potassium (as well as high fructose corn syrup) were listed in earlier drafts of the bill, they are not included in the bill ultimately signed into law. 

The warning requirement will apply only to food product labels “developed or copyrighted on or after January 1, 2027.” Thus, it appears that food labels in use or even just copyrighted before that date could continue to be used for extended periods of time beyond that date.

Continue Reading Texas Also Enacts Bans on Certain Ingredients in School Meals; Similar Louisiana Bill Progresses

On April 15, President Trump issued an Executive Order titled “Lowering Drug Prices By Once Again Putting Americans First” and an accompanying “Fact Sheet: President Donald J. Trump Announces Actions to Lower Prescription Drug Prices.”  The President directs a wide range of drug pricing actions, including…

Continue Reading Covington recently issued several client alerts regarding the Trump Administration’s actions related to drug pricing.

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

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):

  1. “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.
  2. “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. 
  3. “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.
Continue Reading Executive Order on Deregulatory Initiative: What it Means for Food, Cosmetic, Drug, and Device Stakeholders

On 23 January 2025, we hosted the 2025 edition of the Covington European Life Sciences Symposium. The Symposium brought together colleagues from London, Brussels, Frankfurt and Dublin with our industry connections to explore the evolving challenges and opportunities facing the European life sciences sector.

Throughout the day our speakers shared their perspectives on a range of legal, regulatory, and business trends, including the evolving regulatory frameworks in the EU and UK; information exchange in ongoing collaboration; investigations and whistleblowing; key ESG topics, and the complexity of options to acquire in pharma deals.

We have set out some of the discussion from the sessions below.

European Life Sciences – The Changing Landscape for Pharma and Biotech

Grant Castle, Head of Covington’s European Life Sciences Regulatory Practice, Peter Bogaert, Marie Doyle-Rossie and Anna Wawrzyniak kicked off with a discussion about the Changing Landscape for Pharma and Biotech.

The UK and EU both aim to deliver access to innovative and transformative medicines and foster international competitiveness in the life sciences industry. Despite the practical challenges faced by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in recent years, it has emerged as an ambitious regulator and is establishing innovative regulatory frameworks, including an international reliance scheme (see our update here), point of care manufacturing regulations, and the relaunch of the Innovative Licensing and Access Pathway (ILAP).

The EU is also pursuing a wave of legislative reform, including wide ranging revisions to the EU’s pharmaceutical legislation, the EU’s supplementary protection certificates (SPC) rules, and proposals for a compulsory licensing scheme.

There can sometimes be a tension between the UK’s and EU’s aims and the practical impacts of regulatory reform, especially in the early stages of implementation.

Continue Reading The Covington European Life Sciences Symposium 2025

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

The European Union has just published a new (recast) Urban Wastewater Treatment Directive (“UWWTD”) in the EU’s official journal.  The UWWTD imposes important new Extended Producer Responsibility (“EPR”) obligations that will have a significant financial and administrative impact on companies marketing human medicines and cosmetic products in the EU.  Member States must implement the new UWWTD by July 31, 2027 and must apply the new EPR obligations to in‑scope companies by December 31, 2028. 

In a previous blog, we discussed the new EPR obligations in detail.  In this blog, we outline the key financial provisions of the EPR obligations and raise different questions concerning Member States’ discretion when transposing the EPR obligations into their national laws.

Extended Producer Responsibility under the UWWTD

The UWWTD requires Member States to ensure the treatment of urban wastewaters to remove micropollutants (so‑called fourth stage, or “quaternary” treatment).  Article 9 of the Directive also requires Member States to ensure that producers that market products listed in Annex III (i.e., human medicinal products and cosmetic products) have EPR obligations and pay, via producer responsibility organizations (“PROs”), for the costs of the quaternary treatment of urban wastewater, for data collection, and for other costs required to exercise their EPR. 

Specifically, Article 9 requires that producers subject to EPR obligations must cover:

  • At least 80% of the costs associated with quaternary treatment of wastewater to remove micropollutants.  This includes both capital investments for building or expanding urban wastewater treatment facilities and operational expenses for the treatment facilities.
  • 100% of the costs for gathering data on the products they place on the market.
  • 100% of other costs (e.g., administrative) required to exercise their EPR.

As noted above, Annex III currently lists human medicines and cosmetics as the product groups covered by the EPR obligations.  However, the UWWTD requires the Commission to assess the possible expansion of that list and to make the related legislative proposals by December 31, 2033.

National Implementation: Some Questions

The EPR obligations of the UWWTD will only apply to producers once Member States implement them into their national laws.  The Directive requires Member States to adopt their national implementing laws by July 31, 2027 and to apply the EPR obligations not later than December 31, 2028.  Member States may choose to apply the EPR obligations earlier.

The UWWTD leaves Member States with some discretion as to how they implement the EPR obligations, and also allows Member States to impose stricter and broader requirements.  Recital 3 of the Directive makes this clear, as it states that “[i]n line with Article 193 of the [TFEU] Member States can go beyond the minimum requirements set out in this Directive.  Member States could consider for instance […] imposing additional requirements for, or broadening the spectrum of the application of, their national extended producer responsibility systems.” 

Continue Reading The EPR Obligations of the New Urban Wastewater Treatment Directive Key Questions and Next Steps for Member States
EU justice
European Union Law Scales of Justice

In a precedent decision, on 13 November 2024, the EU General Court annulled significant parts of a Commission Regulation, which sought to restrict or place under scrutiny the addition of certain botanicals containing hydroxyanthracene derivatives (“HADs”) to foods.  The Court held that the Commission had exceeded its powers by seeking to regulate botanical “preparations.”  Moreover, the Commission, in relying on the scientific opinion of the European Food Safety Authority (“EFSA”), had failed to demonstrate that the relevant substances would be ingested in amounts greatly exceeding those consumed from a normal diet or otherwise represented a potential risk to consumers. 

1. Background

Regulation (EC) 1925/2006 governs the addition of vitamins and minerals and of certain other substances to food (the “Fortification Regulation”).  Article 8 permits the Commission on its own initiative, or on the basis of information provided by Member States, to prohibit, restrict or place under scrutiny “substances” and “ingredients containing a substance”, which are “added to foods or used in the manufacture of foods under conditions that would result in the ingestion of amounts of this substance greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet and/or would otherwise represent a potential risk to consumers.”

In 2016, the Commission, relying on Article 8, requested EFSA to provide a scientific opinion on the safety of HADs and preparations containing HADs.  In November 2017, EFSA adopted its scientific opinion “Safety of hydroxyanthracene derivatives for use in foods” (“the EFSA Opinion”) in which it concluded as follows:

Continue Reading EU Court Overturns EU-wide Botanical Food Ban

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