Photo of Maile Hermida

Partner, Washington, D.C.

Maile Gradison Hermida represents all segments of the food industry and their trade associations. She has a keen understanding of the issues affecting the industry, from product development through production, distribution, and retail sale. Her core practice involves helping companies ensure they are in compliance with regulations from federal agencies such as the Food and Drug Administration (FDA) and U.S. Department of Agriculture. Maile also provides strategic advice on public policy issues, frequently involving agency rulemakings.

Maile has considerable experience with the FDA Food Safety Modernization Act (FSMA), having worked with numerous companies and trade associations on all aspects of the law since the day it was signed. She translates her in-depth knowledge of FSMA into practical solutions for companies working on implementation strategies. She also is a Preventive Controls Qualified Individual (PCQI), as well as a Food Safety Preventive Controls Alliance Lead Instructor for the PCQI training.

Additionally, Maile assists companies with matters involving regulatory enforcement. She helps clients navigate product recalls; government inspections; and other enforcement actions, such as Warning Letters and import detentions. Maile also advises clients on the development of label and advertising claims, as well as labeling requirements for foods and dietary supplements.

Maile is a frequent speaker and contributor to industry publications. Prior to joining Hogan Lovells, she served as a judicial clerk to the Honorable Charles F. Lettow of the U.S. Court of Federal Claims. Maile graduated with high honors from The George Washington University Law School, where she served as executive editor of The George Washington Law Review.

The U.S. Food and Drug Administration (FDA) recently announced that routine inspections of small businesses to verify compliance with the FDA Food Safety Modernization Act’s (FSMA) Intentional Adulteration (IA) rule will begin in March 2021. The IA rule requires food facilities covered by the rule to develop and implement a food defense plan that identifies

The U.S. Food and Drug Administration (FDA) recently released its “Blueprint for the Future” (Blueprint) as part of the New Era of Smarter Food Safety initiative. Launched in April 2019, this effort seeks to build upon FDA’s work implementing the FDA Food Safety Modernization Act (FSMA) by establishing a new approach to food safety that

Dr. Stephen M. Hahn, the Commissioner of Food and Drugs for the Food and Drug Administration (FDA) issued a statement on July 10, 2020, describing the agency’s intentions and approach to resuming domestic inspections in light of the COVID-19 pandemic. After temporarily suspending inspections in March 2020, FDA is working toward restarting on-site inspections during

The U.S. Food and Drug Administration (FDA) recently provided an update from FDA Commissioner Stephen Hahn M.D. and Deputy Commissioner for Food Policy and Response Frank Yiannas on the forthcoming New Era of Smarter Food Safety Blueprint (Blueprint), which will outline the agency’s strategy to create “a more digital, traceable, and safer food system” over

On May 27, 2020, the U.S. Food and Drug Administration (FDA) issued new guidance for human food establishments on voluntarily reporting to FDA temporary closures or significantly reduced production due to the COVID-19 public health emergency. The agency’s guidance document is entitled “Reporting a Temporary Closure or Significantly Reduced Production by a Human Food Establishment

The U.S. Food and Drug Administration (FDA) recently provided an update regarding its plans for conducting routine surveillance inspections of domestic and foreign facilities during the COVID-19 pandemic. FDA announced in March that it would temporarily postpone foreign and domestic inspections, with the exception of certain “mission-critical” inspections, as identified on a case-by-case basis. In

On April 21, 2020, Chipotle Mexican Grill, Inc. (Chipotle) and the U.S. Department of Justice (DOJ) entered into a three-year deferred prosecution agreement (DPA) in connection with norovirus and Clostridium perfringens outbreaks that occurred between August 2015 and July 2018. Chipotle agreed to pay $25 million in criminal fines and implement a number of systematic

Yesterday, the U.S. Food and Drug Administration (FDA) posted on its website a conversation with FDA Deputy Commissioner for Food and Policy Response Frank Yiannas that addresses common questions concerning food availability and food safety during the COVID-19 pandemic. Consistent with prior statements from FDA, Deputy Commissioner Yiannas reiterates that currently there are no food

The U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) recently updated their respective questions and answers guidance to address questions or update their recommendations concerning food safety and COVID-19. FDA has supplemented its questions and answers guidance on topics regarding the food supply, social distancing, and responding to a worker who

This post summarizes the U.S. Food and Drug Administration (FDA) Compliance Program Guidance Manual (CPGM) for food facilities subject to preventive controls and sanitary human food operation requirements. As an overview, FDA’s “Compliance Programs” provide instructions to FDA personnel for conducting activities to evaluate industry compliance with the Federal Food, Drug, and Cosmetic Act (FFDCA)