Food and Drug Administration (FDA)

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

Most Americans are familiar with the term “THC” at this point. What they might not yet appreciate is that common nomenclature is actually referring to Delta-9-tetrahydrocannabinol or “Delta-9” THC. That’s the scientific terminology for the molecule in marijuana that’s well-known for its psychoactive properties—i.e., what causes a “high.” Delta-9 is a cannabinoid and there are hundreds of different cannabinoids within any given cannabis plant.
Continue Reading Delta-8: A New Low in Highs

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

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

Since the legalization of marijuana in a growing number of states and of hemp-derived CBD at the federal level, lawmakers have been hard pressed to keep pace with the explosive growth of the industry.  However, with a number of potential sources for regulatory developments in both industries on the horizon, 2021 could be the year for greater legalization and regulatory clarity for marketing these products.
Continue Reading Cannabis and CBD Marketing Developments in 2021

On December 22, 2020, the U.S. Food and Drug Administration (FDA) issued five warning letters to companies selling products containing cannabidiol (CBD). In a statement, the FDA’s Amy Abernethy, principal deputy commissioner, explained that the agency remains “focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety,” and that the agency “will continue to monitor and take action, as needed, against companies that unlawfully market their products—prioritizing those that pose the greatest risk of harm to the public.”
Continue Reading FDA Issues 5 Warning Letters Targeting Unsupported CBD Health Claims

On October 27, 2020, the New York State Department of Health issued proposed regulations regarding cannabinoid hemp products. These proposed regulations (available here) are open for public commentary until January 11, 2021. They would change how products containing hemp-derived cannabinoids, including cannabidiol (CBD), are manufactured and sold in New York State. While the industry continues to await federal guidance from the FDA, these proposed regulations offer a glimpse into what actions the federal government might take with regard to CBD.
Continue Reading New York State Proposes New Cannabinoid Product Regulations