July 22, 2019

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FDA Promotes Programs for Safe Use of Biotechnology

Drs. Susan Mayne, head of the Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition (CFSAN), and Dennis Keefe (head of CFSAN’s Office of Food Additive Safety) published a post on the FDA Voices blog on March 21 discussing FDA’s  Voluntary Plant Biotechnology Consultation Program (the Consultation Program) and the Plant and Animal Biotechnology Action Plan. Under the Consultation Program, which has been in existence since 1995 and has conducted 184 consultations, companies are encouraged to provide FDA with information on the biotechnology so that FDA can provide individualized guidance on the data needed to address potential issues arising out of the biotechnology.  The company then presents the data to FDA and they work together to address any residual issues.  At the conclusion of the review, FDA provides the company a letter and posts relevant information about the review on its website.  More details on the Consultation Program can be found in FDA’s Statement of Policy.

On October 30, 2018, FDA announced its new Plant and Animal Biotechnology Innovation Action Plan.  As outlined in the Daily Intake Blog at the time, “the priorities are intended to ensure the safety of plant and animal biotechnology products, foster continued public confidence in FDA’s regulation of these products, and avoid unnecessary barriers to future innovation consistent with FDA’s mission to protect and promote the public health”.   See our blog post or FDA’s landing page for more.

On March 21, FDA’s Center for Veterinary Medicine (CVM) announced a webinar on the topic of “Genome Editing in Animals” scheduled for April 25. This webinar, originally scheduled for December 3, and long linked to the Plant and Animal Biotechnology Innovation Action Plan, “will be focused on information for those using genome editing to develop animals with genomic alterations. In the future, CVM intends to provide opportunities for other stakeholders, such as animal producers and farmers, who may be interested in raising genome-edited animals”.  The webinar is open to the public, but advance registration is required.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...