October 25 – 27
Hogan Lovells Office, Beijing, China

The new Preventive Controls for Human Food regulation issued by the U.S. Food and Drug Administration (FDA) under the FDA Food Safety Modernization Act (FSMA) is the most significant change to food regulation since the 1930s.  FDA has started conducting inspections for compliance with the rule, both domestically and internationally.

The rule requires that key food safety management activities must be completed by a “preventive controls qualified individual” who has “successfully completed training in the development and application of risk-based preventive controls.”  This requirement typically applies even if a company is located outside of the U.S., so long as it manufactures food for U.S. consumption.

Hogan Lovells attorneys Maile Hermida (Partner) and Xin Tao (Associate), both Food Safety Preventive Controls Alliance (FSPCA) lead instructors for this regulation, will present the  training program developed by the FSPCA.  This is the “standardized curriculum” recognized by FDA.  Successfully completing this course is one way to meet the requirement to become “preventive controls qualified individual.”

For more information and to register, click here.

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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 Xin Tao Xin Tao

Senior Associate, Washington, DC

With a working knowledge of regulatory requirements and a strong understanding of life science, Xin Tao works closely with clients in the food and drug industry to navigate the evolving federal and state regulatory environments and develop innovative regulatory strategies to commercialize products made with emerging technologies.  Xin’s background in life science (biochemistry and biophysics) assists him in his science-based food and drug law practices. Xin advises clients on food and drug law with a particular focus on novel food and dietary ingredients, biotechnology, FDA cGMP compliance, ingredient labeling, and California’s Proposition 65.  Xin’s unique ability in understanding and interpreting the complex scientific issues as they relate to the governing regulatory requirements helps clients with all phases of the product development, manufacturing, and marketing.  He is also increasingly expanding his expertise of USDA’s organic regulatory regime as it pertains to his clients.

Xin has helped numerous food, dietary supplement, and pharmaceutical companies evaluate the need for marketing approval from the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA). He also pursues clearance or pre-market approval (e.g., food additive petition, GRAS notice, NDI notification) when necessary and responds to FDA enforcement activities including Warning Letters and Import Alerts. Xin has advised numerous companies on issues relating to the advertising and promoting of products including the Federal Trade Commission (FTC)’s claim substantiation standards . Xin also has vast experience with FDA and USDA due diligence investigations for companies subject to takeover or merger activity.

Xin is very actively involved in a number of organizations that serve Chinese legal and life science professionals in the Washington region, including the Sino-American Pharmaceutical Professionals Association and Washington DC Chinese Legal Association.  Xin is a frequent speaker and contributor to industry publications both in the U.S. and China.  He is adept at assisting both Chinese food and drug companies doing business in the U.S. and U.S. clients doing business in China.

During law school, Xin worked as a regulatory food scientist and also served as an executive editor of the Georgetown Environmental Law Review.