The Food and Drug Administration (FDA) recently issued a Constituent Update addressing how food industry associations can involve the agency in developing their own guidance documents. Today’s post provides an overview of the 5-step process FDA outlines to involve the agency in the development of industry association regulatory guidance documents. FDA explains that following these steps may increase the likelihood FDA will be involved in the guidance process by providing technical advice, linking to the final document for informational purposes, and/or incorporating industry guidelines into its own guidance. These recommendations should be of interest to industry associations that are contemplating developing compliance guidelines for their members, so that they can take advantage of the collaboration being offered by FDA.

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Photo of Maile Hermida 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…

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.

Photo of Samantha Dietle Samantha Dietle

Senior Associate, Washington, D.C.

Sam Dietle provides practical legal solutions and regulatory guidance to all segments of the food industry, including manufacturers, restaurants, retailers, animal producers and processors, and their trade associations.

She advises clients on federal and state regulatory issues that arise…

Senior Associate, Washington, D.C.

Sam Dietle provides practical legal solutions and regulatory guidance to all segments of the food industry, including manufacturers, restaurants, retailers, animal producers and processors, and their trade associations.

She advises clients on federal and state regulatory issues that arise throughout the entire food supply chain, including labeling and advertising compliance and claim substantiation issues, enforcement actions by the Food and Drug Administration (FDA) and United States Department of Agriculture (USDA), litigation support, and drafting comments on proposed regulations and agency guidance. Sam also counsels clients in consumer products industries on compliance with Consumer Product Safety Commission (CSPC) requirements.

Prior to joining Hogan Lovells, Sam advised food packaging companies on FDA premarket requirements and regulatory compliance matters. Sam also worked with electronic cigarette companies as FDA began to regulate this industry. While in law school, she served as a judicial intern in the U.S. Court of Federal Claims, working on vaccine injury claims cases.