Maile Gradison

She has considerable experience with the Food and Drug Administration (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 frequently presents trainings related to FSMA compliance and preparedness. Reflecting her deep involvement with all things FSMA, Maile is a Food Safety Preventive Controls Alliance (FSPCA) Lead Instructor for the Preventive Controls for Human Food training and an FSPCA Trainer of Trainers and Lead Instructor for the Foreign Supplier Verification Programs (FSVP) training.

Maile is known for helping companies become and remain compliant with regulations overseen by federal agencies such as the FDA and U.S. Department of Agriculture (USDA). She helps companies navigate tough situations involving product recalls, government inspections, and other enforcement actions such as Warning Letters and import detentions.

Maile also provides clients with advice on public policy issues and strategies for affecting regulatory change. She has vast experience advocating to FDA, including preparing comments on agency rulemakings.

Additionally, Maile helps clients with food labeling requirements and development of label and advertising claims.

Maile is a frequent speaker and contributor to industry publications. Prior to joining us, 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.