On May 3, 2018, the U.S. Department of Agriculture (USDA) Agricultural Marketing Service (AMS) published its long-awaited proposed rule implementing the National Bioengineered Food Disclosure Standard, which directs USDA to establish a federal mandatory disclosure regime for “bioengineered food” and “food that may be bioengineered.” The rule, when finalized, could cover a broad scope of products, including fruits and vegetables, dairy products, processed foods and beverages and dietary supplements as well as ingredients within these products.

Despite its potential broad impact and delay in release, the proposal falls short in offering clarity with respect to several key issues, including the scope of coverage, applicability to new and emerging technologies such as genome editing, and procedures for demonstrating compliance. This Sidley Update is an outline of key issues that warrant stakeholder attention.

On May 18, Sidley hosted a webinar to provide an in-depth discussion of these and other critical issues relating to the rulemaking, including:

Which foods are covered / not covered
Technical definition of “Bioengineering” and determination of whether a food is bioengineered
Exemptions
Disclosure options
Compliance & enforcement

Our integrated, knowledgeable FDA food team has represented many of the major food manufacturers and distributors over the past 20 years and is focused on a broad range of emerging legal issues for global food companies. If you are interested in viewing the webinar or obtaining materials, please contact (mlimongello@sidley.com).

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Ranked in Chambers Life Sciences","Target":"_self","CssClass":"","Language":"","Children":null},"TemplateID":"45ca2f0b-2ecf-46b6-bfe6-5c8127987b21"},{"ID":"bf0734cf-0b21-4f47-a20b-15df3575aee2","ContentType":"Sidley Updates","DisplayDate":"Spring 2018","Title":"Securities Class Actions in the Life Sciences Sector","ShortTitle":"","Summary":"

Sidley is pleased to present its annual year-in-review addressing developments in securities class actions brought against life sciences companies in 2017.

In this publication, we provide an overview and analysis of trends in decisions involving life sciences companies with products at two distinct stages of development—pre- and post-FDA approval. We also summarize each of the reported federal decisions in this area and catalog the new securities class action complaints filed against life sciences companies in 2017.

Click here to view a two-page summary.

Click here to download the PDF.

Click here to order hard copies. Limited supply available.

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Sidley in Silicon Valley: Life Sciences