The Food & Drug Law Institute (FDLI) started its annual conference on October 6, 2020. The conference set out to explore advanced topics in Food & Drug Law. In this blog series, Perkins Coie reports on the three-day conference and meaningful takeaways for food litigation. Continue Reading View from the FDLI Annual Conference – Day One
A recent putative class action regarding edible cannabidiol (CBD) products reminds potential plaintiffs of the importance of pleading with particularity.
On behalf of a putative class of consumers, a purchaser alleged that Bhang Medicinal Chocolates contained a smaller quantity of CBD than the product advertised. Plaintiff asserted that he had independent lab testing to support this claim. On this basis, the purchaser alleged violations of California’s Unfair Competition Law (“UCL”), False Advertising Law (“FAL”), and Consumer Legal Remedies Act (“CLRA”), and he also lodged claims of breach of express warranty, fraud, and negligent misrepresentation. Read the full article on our sister blog Cannabis Legal Highlights the 411 on 420.
A new rule from the U.S. Drug Enforcement Agency (DEA) has caused considerable concern within the cannabidiol (CBD) industry. The rule relates to the distinction made in the 2018 Farm Bill that removed certain cannabis products, such as industrial hemp and those containing hemp-derived CBD, with levels of THC not exceeding 0.3% by weight from the federal controlled substances list. THC is the psychoactive substances most associated with a marijuana “high.” DEA’s interim final rule appears straightforward at first glance: cannabis products containing more than 0.3% by weight are subject to DEA enforcement as controlled substances. The rule appears to mean, however, that THC levels can never exceed 0.3% at any point during the product’s manufacturing process, even if the final product offered for sale had THC at appropriate levels. Continue Reading New DEA Rule May Threaten CBD Manufacturing
On July 28, 2020, the U.S. Securities and Exchange Commission (SEC) accused six individuals and their companies with securities fraud in connection with two cannabis-related businesses in California that raised $25 million in an unregistered securities offering. The SEC’s complaint was filed in the Central District of California and seeks permanent injunctions, disgorgement of ill-gotten gains plus prejudgment interest, and civil penalties. Read the full article on our sister blog White Collar Briefly.
California’s Attorney General (AG) releases annual summaries of Proposition 65 settlements. This settlement data provides important insight into Proposition 65 litigation trends. Here are some of the most important takeaways from the 2018 data.
First, the average settlement amount was $42,424.52. According to the state AG’s report, there were 829 settlements in calendar year 2018. Many of these settlements also entailed injunctive relief, such as the addition of new labeling or reformulation of the products. Continue Reading Proposition 65 Settlements: Lessons from 2018 Data
Welcome to the first in a multipart series of posts regarding California’s Proposition 65 (Prop. 65). This piece introduces readers to the law and its requirements. Future posts will dive deeper into analysis and trends regarding Prop. 65 litigation. Continue Reading An Introduction to California’s Proposition 65: What is Proposition 65?
The Second Quarter of 2020 has demonstrated increased filings in the food litigation space. Amidst reduced court operations and a significant decrease to general commercial litigation filings attributable to the COVID-19 public health emergency, the number of food litigation cases filed so far this are substantially higher than this point last year. As of June 2020, more than 100 food litigation matters have been filed so far this year.
One of the surprising trends emerging in the second half of 2019 was the increase in filings in New York. Traditionally, California has been the most common destination for food litigation filings. At the end of 2019, New York courts saw more cases filed, and this trend has continued into 2020. More than 50 food litigation, or approximately half, of all food litigation matters filed year-to-date June 2020 were filed in New York courts. Continue Reading PC Food Litigation Index: Q2 2020
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.