Food and Drug Administration (FDA)

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

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.
Continue Reading Putative CBD Chocolate Class Action Dismissed: Allegations Must Be Plead with Particularity

Amid sustained legislative pressure for regulatory guidance and the FDA’s recent submission of draft enforcement guidance regarding cannabidiol (CBD) to the White House, signs from the FDA indicate increased momentum towards a federal pathway for the CBD market. This momentum from the FDA is affected by the approach to CBD taken by the U.S. Drug Enforcement Administration (DEA). While the industry awaits the FDA’s forthcoming guidance policy on CBD enforcement, the FDA’s approach articulated in two recent guidance documents contains important signals.
Continue Reading FDA Guidance Offers Clues Regarding Future Federal CBD Policy

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

Yesterday, the FDA belatedly released a report in its progress towards CBD enforcement, as required by Congress.

Although the report repeats the FDA’s concerns regarding CBD safety, and fails to offer a useful timeline for a reasonable regulatory pathway for the CBD market, it also affirms a desire for a nuanced “risk-based” approach to CBD

Perkins Coie’s Food Litigation 2019 Year in Review assessed key legal issues facing the food and beverage industry. Among these topics was cannabis, and especially hemp-derived CBD, in food and beverage products. The 2018 Farm Bill ushered in a new era for cannabis and cannabidiol (CBD). Following the law’s passage, products containing CBD have continued

On the heels of the U.S. Food and Drug Administration’s (FDA) recent declarations regarding the safety of products containing cannabidiol (CBD), several companies have been hit with class action lawsuits alleging that that the company’s CBD-containing products are mislabeled and falsely advertised in violation of state law. Further class action litigation is expected given the

On July 31, Dr. Scott Gottlieb, the outgoing FDA commissioner, published an editorial in which he proposed how the FDA could expedite approval of food and beverage products that contain cannabidiol (CBD).

In the full article on PerkinsCoie.com, we review Dr. Gottlieb’s proposal which highlights areas of concern for business involved in the CBD