Photo of Cory Trio

Cory Trio

Cory Trio is an associate in the firm’s Washington, DC office where he is a member of the Food, Drug, and Device Practice Group. Cory helps food, dietary supplement, OTC drug, and consumer product clients navigate a broad range of U.S. regulatory requirements. He has wide-ranging expertise on FDA and USDA food safety and manufacturing requirements, including FDA’s Food Safety Modernization Act (FSMA) regulations. He regularly advises clients on the development and implementation of food safety and quality programs and in responding to regulatory inspections, product recalls, and quality events. Cory also counsels clients on product labeling and claim substantiation issues, helping clients advance their marketing goals while mitigating regulatory and litigation risks.

Cory counsels OTC drug manufacturers on product development, labeling, and manufacturing issues, with a particular focus on helping clients navigate the CARES Act OTC monograph reforms. He also advises clients across product categories on FDA’s import and export requirements.

Contact:Read more about Cory TrioEmail

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 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

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

Drug manufacturers have responded to the COVID-19 pandemic by adopting measures to ensure continuity in their operations—continuity that is vital to safeguarding the global drug supply. In doing so, some have faced unprecedented challenges with regard to ensuring the health of their employees, preventing COVID-19 transmission at their facilities, and

…
Continue Reading FDA Releases Guidance on Resuming Normal Drug and Biologics Manufacturing Operations During COVID-19