On July 22, 2020, the U.S. Food and Drug Administration (FDA) submitted draft enforcement guidance for cannabidiol (CBD) industry for review by the White House’s Office of Management and Budget (OMB). The draft guidance is not yet available. No date or proposed deadline for producing a final policy, but this submission indicates that the FDA is making some progress towards long-awaited guidelines for the industry. Continue Reading Industry Insights: FDA Submits CBD Enforcement Policy to OMB
On July 22, Perkins Coie Partner Larry Reichman and Associate Tommy Tobin presented a CLE program entitled “Food and COVID-19: Regulatory Approaches to Secure the Food System During the Coronavirus Pandemic” to the Practising Law Institute (PLI). This One-Hour Briefing covered topics ranging from food safety to securing food work environments. The program emphasized the substantial challenges facing food supply chains, especially given disruptions to foodservice operations and changing consumer demand. During the COVID-19 public health emergency, many state and federal regulators have adopted temporary changes to adapt to extraordinary conditions. The presenters explored what these changes were and whether certain changes might continue after the emergency period.
The On-Demand recording of the PLI program may be accessed here: https://www.pli.edu/programs/food-and-covid-19-regulatory-approaches
In 2011, Perkins Coie’s winning defense in Turek v. General Mills led to the first published federal appellate decision on the scope of the preemption defense under the Nutrition Labeling and Education Act (NLEA). Subsequently, the preemption defense remains strong under the NLEA and other aspects of the federal Food Drug & Cosmetics Act (FDCA), including in cases involving supplements. See Dachauer v. NBTY, Inc. 913 F.3d 844 (9th Cir. 2019). That trend continues. On May 11, 2020, the Second Circuit held that the preemption defense extends to cosmetic products regulated under the FDCA as well.
California courts remain a top forum for food litigation matters. So many matters are heard in the Northern District of California that it has gained a reputation as the “Food Court.” Now, the California Supreme Court has held that two of the state’s most widely used consumer protection statutes must be tried by a judge rather than a jury.
California’s False Advertising Law (“FAL”), codified at Cal. Bus. & Prof. Code § 17500 et seq., and the Unfair Competition Law (“UCL”), codified at Cal. Bus. & Prof. Code § 17200, et seq., represent two of the most common vehicles for plaintiffs to bring suits alleging false product claims or purported misrepresentations on food labels. Continue Reading Notable Ruling: No Jury for False Advertising and UCL Suits, California Supreme Court Rules
Consumers’ response to COVID-19 has led to increased demand for personal protective equipment and other much-needed supplies to aid consumers and healthcare professionals in the fight against the disease. Alcohol-based hand sanitizer is one such product, with the U.S. Centers for Disease Control and Prevention recommending hand sanitizers when soap and water are not available. The FDA has issued recent guidance intended to provide “flexibility” for manufacturers and increase the supply of alcohol-based hand sanitizer in the marketplace.
Spurred on by the FDA’s guidance and similar guidance from other agencies, many manufacturers, such as fragrance companies and distilleries, are already pivoting production lines to make hand sanitizers or its component parts. Yet, alcohol-based hand sanitizers are over-the-counter drugs regulated by FDA. As manufacturers prepare to temporarily repurpose existing manufacturing facilities to enter the hand sanitizer market, they should keep several considerations in mind and maintain compliance with the FDA guidance documents. Read more here.
With 61 new filings in the first three months of 2020, 2020 is on-track with 2019 to be a big year in food and beverage litigation. About a third of new cases allege defendants misleadingly claim their product contains vanilla, while the remainder of cases are an even mix between cases alleging misleading health misrepresentations, natural claims, false-fact, and Proposition 65.
Vanilla. We wrote about the uptick in “vanilla” cases in our 2019 Food Litigation Year in Review, and the early numbers from 2020 confirm this remains a popular area for plaintiffs. There were 21 new “vanilla” cases filed in 2020 out of 61 total cases. All but one of these cases was filed in New York federal courts by the same group of plaintiffs’ counsel—Sheehan & Associates and Reese LLP. The complaints allege that “vanilla” claims on a wide variety of products (from milk to herbal tea) are false because the products derive their vanilla flavor in part from vanilla flavoring, rather than vanilla beans or vanilla extract. Vanilla flavoring, plaintiffs allege, contains non-vanilla flavors that reasonable consumer do not expect in products labeled vanilla. Continue Reading PC Food Litigation Index: Q1 2020
On March 3, 2020, CLE International held the second day of Food Law: Navigating the Intersection Between Regulation of Litigation. Now in its fifth year, the conference convenes individuals from the plaintiffs’ bar, academia, industry, and large law firms.
Perkins Coie’s David T. Biderman presented alongside attorneys from the plaintiff and defense bar on the panel “The Reasonable Consumer: An Interactive Debate.” Panelists discussed recent trends in reasonable consumer decisions from the Second and Ninth Circuits and how these developments may affect the reasonable consumer doctrine moving forward.
On March 2, 2020, CLE International held the first day of Food Law: Navigating the Intersection Between Regulation of Litigation. Now in its fifth year, the conference convenes individuals from the plaintiffs’ bar, academia, industry, and large law firms.
Today’s presentations included discussions of litigation case studies and regulatory issues facing food companies in today’s marketplace. For example, in-house counsel detailed their perspectives on the FDA’s standards of identity, the agency’s definition of “healthy,” and other regulatory developments in the context of advances of food and nutritional science. Specifically, general counsel for several food companies discussed issues with compliance with regulations finalized decades ago and ongoing efforts to update regulations using citizen petitions and other means to adapt to changes in food technology. Other panels focused on advocacy strategies of non-governmental organizations through both regulation and litigation. Panelists from the Animal Legal Defense Fund and other public interest organizations discussed allegations of “humane-washing,” and an increase in lawsuits targeting animal welfare claims on consumer packaged goods (CPG) labeling.
Perkins Coie is pleased to present its fourth annual Food Litigation Year in Review 2019, offering a summary of the past year’s key litigation outcomes, regulatory developments, and filing data. Using metrics from our proprietary database, developed by our food litigation team in order to track and understand trends in this area, 2019’s Year in Review again reports an increase in class action litigation, with a record-breaking 173 new lawsuits filed. The upward filing trends in the class action landscape are mirrored in other industries and in the prosecution of related claims: putative class actions against the pet food and dietary supplement industries were on the rise in 2019, as were Proposition 65 warning notices. Continue Reading Food Litigation Year in Review 2019
California’s Office of Environmental Health Hazard Assessment (OEHHA) issued finalized amendments on January 14, 2020, to its regulations that will become effective on April 1, 2020. Per OEHHA in its Final Statement of Reasons, the amendments “clarify how intermediate parties in the chain of distribution can satisfy their obligation to provide a warning” under Proposition 65. OEHHA also revised the level of knowledge required to trigger warning obligations for retail sellers.