Food and Drug Administration (FDA)

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

A recent Trademark Trial and Appeal Board decision confirmed that, for now and the foreseeable future, companies selling CBD-infused products intended for consumption, including CBD derived from hemp, will not be able to obtain a federal trademark registration covering such use.

The Lanham Act, the federal statute that regulates federal registration of trademarks, requires use of a trademark in commerce to qualify for federal registration. Accordingly, the United States Patent and Trademark Office (USPTO) will refuse registration of a trademark that is not in lawful use in commerce. Currently, the Food & Drug Administration (FDA) has interpreted the Food, Drug, and Cosmetics Act (FDCA) to prohibit the use of CBD in products intended for consumption. As a result, federal trademark registration for various goods that contain CBD, including dietary supplements, foods, and beverages, will be refused registration by the USPTO as unlawful under the FDCA.
Continue Reading Consumable CBD: No Federal Trademark Registration

As part of its ongoing efforts to address “unanswered questions about the science, safety, and quality of products” containing cannabidiol (CBD) and other cannabinoids, the U.S. Food and Drug Administration (FDA) has announced a multi-disciplinary conference to be held on November 19, 2020.  Hosted by the FDA’s Office of Women’s Health, the public meeting will discuss potential biological and psychosocial differences in use and responses to CBD and other cannabinoids.
Continue Reading FDA Announces Scientific Conference on Sex, Gender, & Cannabinoids