Cannabidiol (CBD)

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California enacted statute AB 45 in October 2021, authorizing the use of hemp and hemp-derived cannabidiol (CBD) in food, beverages, dietary supplements, and cosmetics at the state level. Now, state regulators have proposed new regulations to govern the state’s hemp-derived CBD market. Comments on the proposed regulations are due by May 31, 2022.

California’s proposed regulations primarily address new registration requirements for in-state industrial hemp manufacturers and out-of-state industrial hemp extract manufacturers. In-state manufacturers of extract, human foods (including beverages and dietary supplements), cosmetics and processed pet food products containing industrial hemp will need the appropriate registration for their respective products. Manufactures may be required to hold multiple registrations for each type of product manufactured if the proposed rule is adopted.…

Continue Reading California Proposes New CBD Regulations & Registration Requirements

Earlier today, May 4, 2022, the FDA issued warning letters to five companies selling products that contain delta-8 tetrahydrocannabinol (Delta-8 THC). Several of the companies also manufactured products containing hemp-derived cannabidiol (CBD). Significantly, today’s actions represent the first time the FDA has issued warning letters for products containing Delta-8 THC. According to the agency, “Delta-8 THC has psychoactive and intoxicating effects and may be dangerous to consumers,” and the FDA has received reports of adverse events after individuals consumed products containing Delta-8 THC.

Delta-8 THC is one of many cannabinoids produced in the cannabis plant, and it can have psychoactive and intoxicating effects. Products containing Delta-8 are available in numerous forms, such as edibles, extracts, and tinctures. Today’s five warning letters allege the companies violated federal law in the marketing of unapproved Delta-8 THC products as treatments for various medical conditions or for therapeutic use. The letters further claimed violations regarding drug misbranding and the addition of Delta-8 THC in food, such as gummies, chocolate, caramels, and chewing gum.…

Continue Reading FDA Issues New Warning Letters For Delta-8 and CBD Products

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

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…