There have been several recent developments regarding implementation by the Food and Drug Administration (FDA) of the FDA Food Safety Modernization Act (FSMA) that should be of interest to the food industry. In this post, we summarize the following topics:

  • Regarding imports:
    • FDA’s recognition of Australia’s food safety system as comparable to the United States, which allows for modified Foreign Supplier Verification Programs (FSVP) requirements of certain foods imported from Australia;
    • Information from FDA to importers about key things they need to know about compliance with the FSVP rule and what to expect during upcoming inspections;
    • Launch of a website where organizations can apply for recognition as a third-party accreditation body.
  • Information from FDA on the agency’s implementation of the Sanitary Transportation of Human and Animal Food (Sanitary Food Transportation) rule;
  • FDA’s plans to extend the compliance dates for the agricultural water requirements of the Produce Safety regulation; and
  • Inflation-adjusted values applicable to several very small business-related definitions used in the FSMA rules.

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Photo of Joe Levitt Joe Levitt

Partner, Washington, DC

As the FDA’s former top food regulator, Joe Levitt brings a true insider’s knowledge to helping food industry clients deal effectively with the FDA. Whether influencing policy making or confronting a threatened compliance action, Joe’s 25 years of FDA experience puts clients in the best position to succeed.  In the private sector, Joe was on the ground floor when Congress developed the landmark FDA Food Safety Modernization Act (FSMA). Joe was also a leading voice for the food industry when the FDA developed regulations that all food companies must now follow. No one can help navigate the labyrinth of FDA’s FSMA regulations better than Joe and his team, and no one can better put your company in the driver’s seat when the FDA inspector knocks on your door for your first FSMA inspection.

Joe adeptly handles high visibility recalls and compliance actions. If a company finds itself in trouble with the FDA, they need someone with a deep insider’s understanding of what works and what doesn’t. Joe knows what the agency expects in the compliance arena, and the bar clients will be expected to meet. He can communicate his client’s position calmly and effectively to the FDA so the matter gets put behind them. His record of “helping startups and multinational companies… survive Food and Drug Administration investigations and avoid import bans that could shutter the companies,” led to Joe being named a Law360 Food & Beverage MVP (2016).

Joe is among the most decorated officials in FDA history, with his achievements being recognized by multiple U.S. presidents, cabinet secretaries, and FDA Commissioners. He maintains close working relationships with senior FDA officials and has served as the Board Chair of the FDA Alumni Association.

Photo of Maile Hermida Maile Hermida

Partner, Washington, DC

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 Elizabeth Fawell Elizabeth Fawell

Counsel, Washington, DC

Elizabeth Fawell navigates the detailed, and often complex, regulatory issues confronting food companies and helps them understand both the rules and various risks involved so that they can make informed business decisions. Elizabeth works with every segment of the food industry, including manufacturers, distributors, retailers, restaurants, and food service operators; and their trade associations.  Elizabeth’s work on behalf of food industry clients with the Food Safety Modernization Act (FSMA) since its inception and her understanding of Hazard Analysis Critical Control Point (HACCP) systems provides her with the experience and perspective needed as she counsels clients on how to comply with new requirements under the law. Elizabeth is a Preventive Controls Qualified Individual (PCQI) and has completed the FSPCA PCQI training.

Elizabeth knows how laws, regulations, and guidance documents are developed, interpreted, and enforced. Her extensive knowledge enables clients to prevent and respond to enforcement actions such as Warning Letters, Import Alerts, and agency investigations. She helps clients in determining whether an RFR is necessary and whether a recall is warranted. If so, she helps manage the recall to minimize business impacts. Elizabeth provides real-time advice during factory inspections, helps clients prepare 483 responses, and drafts inspection manuals. She also assists clients in lawfully and creatively promoting their products; such as the development of labels, claims, and website and promotional campaigns. Elizabeth also supports clients in advertising disputes and with responses to FTC and Attorney General investigations.

Elizabeth helps clients stay informed of and ahead of public policy issues and develops strategies for effective advocacy before regulators. She also counsels clients on compliance with Consumer Product Safety Commission (CPSC) safety standards, testing and certification requirements, and reporting obligations.

Elizabeth is a member of the Food and Dietary Supplements Committee of the Food and Drug Law Institute.

Photo of Leigh Barcham Leigh Barcham

Associate, Washington, DC

Leigh Barcham provides business-oriented legal and policy solutions to food and agriculture companies and trade associations. She advises clients on state and federal regulatory issues that may arise throughout the entire food production line from farm to table. Leigh also guides clients in consumer products industries as they navigate federal advertising laws and regulations.
When she joined Hogan Lovells, Leigh brought with her more than five years of public policy experience. A part-time student by night and a law clerk by day, Leigh worked throughout law school at a firm in Washington, D.C., focusing on legislation and federal regulation affecting the energy industry. Before law school she served as a policy analyst for international affairs and climate change at the White House Council on Environmental Quality.

Samantha Dietle

Associate, Washington, DC

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.