On November 12, President Biden announced his intention to nominate Dr. Robert Califf as Commissioner of the U.S. Food and Drug Administration (“FDA”). Dr. Califf, a cardiologist, previously served as FDA Commissioner in the Obama Administration between February 2016 and January 2017. Califf is currently a professor of medicine at Duke.
The FDA has been
Earlier this month, the FDA released a seven-page plan to accelerate its research into the safety of cannabis-derived products. The plan follows two reports to Congress last year (which the Perkins Coie Cannabis Industry Group has previously written about here and here) on the safety and labeling of products containing cannabidiol (CBD) and a public statement from outgoing FDA leadership in early 2021 seeking better data for a better understanding of CBD safety. For those in the industry hoping that this latest FDA announcement is the agency’s long-awaited CBD enforcement guidance, the wait continues. Instead, the FDA recognizes that “the growth of the [cannabis-derived product] market continues to outpace the growth in the science and our understanding of the public health implications of these products.”
Before issuing new rulemaking and guidance, the FDA’s new data acceleration plan notes that the agency “needs a better understanding of the quality and safety systems that are currently in place across the overall supply chain from origin, manufacturing, and distribution to consumer usage” with regard to products derived from cannabis. According to the agency, the market for these products is “fragmented and dynamic” “with hundreds of small manufacturers selling products online,” and is “rife with potential quality and safety concerns.”
Continue Reading FDA Releases Plan to Obtain Data Regarding Cannabis-Derived Product Usage & Safety
Earlier this month, California legislators passed a law, AB 45, aimed at providing guardrails for an expanded consumer marketplace for products containing hemp and hemp-derived cannabidiol (CBD) in California. Given that the bill will take effect immediately following Governor Newsom’s signature, cannabis businesses, and businesses looking to add hemp to their products, should take note of the new law. With the new law’s passage, many hemp-derived CBD products will be able to enter the market legally in California. Here are five key takeaways from AB 45 for the cannabis industry.
Continue Reading Five Takeaways From California’s New State Industrial Hemp Bill
Today, the U.S. Federal Trade Commission (FTC) announced a settlement in its most recent law enforcement action in its ongoing efforts to monitor the marketplace regarding misleading cannabidiol (CBD) product claims. The action targets Kushly Industries LLC (Kushly) and the company’s sole officer for allegedly making false or unsupported health benefit claims about Kushly’s CBD product.
Continue Reading FTC Continues Crackdown on Unsupported CBD Marketing
On March 22, 2021, the U.S. Food and Drug Administration (FDA) released two warning letters to U.S. companies selling products containing cannabidiol (CBD). These warning letters highlight the FDA’s continuing vigilance on marketing of products containing CBD. Without having undergone rigorous testing and FDA review and approval, it remains a violation of the Federal Food Drug and Cosmetics Act (FD&C Act) to sell products containing CBD that make specific health claims related to the treatment or prevention of disease or other conditions or the function or structure of the body. This includes claims on a product’s label and applies to any marketing material in any form.
In these letters, the FDA highlights that “a nonprescription drug product containing CBD cannot be legally marketed without an approved new drug application, regardless of whether the CBD is represented on the labeling as an active ingredient or an inactive ingredient.” In other words, a drug manufacturer cannot add CBD to a non-prescription over-the-counter (OTC) pain cream, even if CBD is listed as in “inactive ingredient.”
Continue Reading CBD Regulation: Recent FDA Enforcement Casts a Wider Net Over CBD Products
California was an early state to legalize marijuana for recreational use, but the state has been slower to regulate hemp-derived products such as cannabidiol (“CBD”).
Continue Reading California Bill Offers Insights into Future of CBD Regulation
Perkins Coie is pleased to announce that its fifth annual Food Litigation Year in Review, in coordination with the expansion of the firm’s practice, has been broadened and renamed the Food & Consumer Packaged Goods Litigation Year in Review. With this rebranding, we have featured a section on the latest cannabis litigation trends.
Continue Reading Food & Consumer Packaged Goods Litigation Year in Review 2020
Perkins Coie is proud to announce the launch of “Cannabis Law: A Primer on Federal and State Law Regarding Marijuana, Hemp, and CBD,” published by the American Bar Association, authored by various Perkins Coie Cannabis Law attorneys, and edited by Barak Cohen, chair of our Cannabis Law industry group, and Michael Bleicher. Until
Two recent actions from the Biden Administration may have immediate consequences for the cannabis industry. First, a new Executive Order signed by President Biden reversed prior policy requiring federal agencies to submit guidance documents to the White House for review. Second, the Biden Administration distributed a memorandum to federal agencies asking them to postpone any rules published in the Federal Register for 60 days.
Continue Reading Looking Ahead: Cannabis Policy Update January 2021
Though it appeared the smoke might blow in a more favorable direction, the hopes of marijuana-adjacent businesses using the Bankruptcy Code were snuffed out once again by the Bankruptcy Court in Colorado. The Controlled Substances Act (the CSA) makes it illegal to rent, lease, or make available for use or profit from a location for the manufacture, storing, or distribution of controlled substances. Federal law generally imposes criminal liability for aiding and abetting the unauthorized manufacture, distribution, or dispensing of marijuana, which is a Schedule 1 controlled substance. A number of courts have ruled that businesses whose operations constitute federal crimes cannot take advantage of the federal bankruptcy system.[1] Bankruptcy courts have even dismissed cases where the debtor does not operate a cannabis business, but operates ancillary businesses such as the manufacture or sale of equipment that may be used to cultivate marijuana (discussed below), or leasing real estate to marijuana growers.
Continue Reading Another Blow to Bankruptcy Relief for Marijuana-Adjacent Debtors