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FDA Announces Public Meetings and Requests Comments on Agricultural Biotechnology Education and Outreach Initiative

Date: 16 October 2017
U.S. Food, Drugs, Medical Devices and Cosmetics (FDA) Alert
By: Michael H. Hinckle, Snehal Trivedi, Michael D. Bryan

On October 13, 2017, the U.S. Food and Drug Administration (the “FDA”) announced in the Federal Register a notice of two upcoming public meetings and request for comments related to the initial phase of the Agency’s Agricultural Biotechnology Education and Outreach Initiative (the “Initiative”). [1] Stakeholders, including agriculture and food companies, food service management companies, industry trade groups, and related health care entities, should consider utilizing these engagement opportunities to inform the development of the Initiative’s education and outreach goals, messaging, and strategies.

FDA will hold the two public meetings — on November 7, 2017, in Charlotte, North Carolina and on November 14, 2017, in San Francisco, California, and will accept comments electronically or in writing through November 17, 2017.

The Initiative is the result of a $3 million appropriation under the Consolidated Appropriations Act of 2017 (Pub. L. 115-31), which requires the FDA, in coordination with the U.S. Department of Agriculture (the “USDA”), to develop science-based consumer education and outreach information on the environmental, nutritional, food safety, economic, and humanitarian impacts of agricultural biotechnology on the nation’s food and animal feed supply.

The FDA encourages comments to address the following questions: 
        1. What are the specific topics, questions, or other information that consumers would find most useful, and why? 
        2. Currently, how and from where do consumers most often receive information on this subject? 
        3. How can the FDA (in coordination with the USDA) best reach consumers with science-based educational information on this subject?

K&L Gates’ FDA capabilities allow us to provide multidisciplinary, global, regulatory, and transactional advice to help clients navigate FDA matters throughout the life cycle of their products. Given our substantive experience in and knowledge of FDA-regulated industries, we are well positioned to facilitate stakeholder engagement with the FDA. We will continue to monitor and provide updates of further developments in this area.

Notes:

[1] 82 Fed. Reg. 47750 (Oct. 13, 2017).

Michael H. Hinckle
Michael H. Hinckle
Research Triangle Park

This publication/newsletter is for informational purposes and does not contain or convey legal advice. The information herein should not be used or relied upon in regard to any particular facts or circumstances without first consulting a lawyer. Any views expressed herein are those of the author(s) and not necessarily those of the law firm's clients.

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