Governor Gavin Newsome recently signed California Assembly Bill 45 (AB 45) into law, which, among other things, allows hemp-derived cannabidiol (CBD) to be included in any food, beverages, and dietary supplements sold in California. This is not only a break from California’s prior position prohibiting CBD from being included in such products even as the State began to tax and regulate its cannabis industry, but it is also in stark contrast with the U.S. Food and Drug Administration’s (FDA’s) current position on the issue. Continue Reading California Passes CBD Law That Conflicts With FDA Guidance

On December 22, 2020, we blogged about the omnibus 2021 Consolidated Appropriations Act passed by Congress, which included legislation extending the applicability of the Prevent All Cigarette Trafficking (“PACT”) Act to electronic nicotine delivery systems or “ENDS.”  The legislation, called the ‘‘Preventing Online Sales of E-Cigarettes to Children Act,’’ sweeps ENDS into the PACT Act by amending the PACT Act’s definition of a cigarette to include electronic nicotine delivery systems, thereby subjecting remote sales of these products to various requirements and restrictions.  Another important feature of this new law is that the defined term “ENDS” in this new legislation actually covers more than electronic nicotine delivery systems. Continue Reading THC, CBD and other Non-tobacco Vaping Product Sellers Should Take Note of New PACT Act Provisions

Relying on the regulatory and legal uncertainty surrounding cannabidiol (CBD), Food and Drug Administration statements and state laws, several class actions have been filed since late 2019 against companies selling CBD products, a number of which have been filed in California federal courts. In at least two cases, courts have adopted defendants’ requests to delay the cases while the FDA continues to study CBD and how it should be federally regulated. These cases could represent a developing “wait and see” approach by federal courts dealing with CBD class action lawsuits. Continue Reading Federal Courts May Be Trending Toward Delaying CBD Consumer Class Action Lawsuits

In recent weeks the U.S. Food and Drug Administration and the Federal Trade Commission have teamed up to prevent companies from advertising and selling products that claim to treat COVID-19. The agencies have specifically targeted companies selling cannabidiol (CBD) products such as Nova Botanix LTD, CBD Online Store, Indigo Naturals, and Native Roots Hemp. Continue Reading FDA and FTC Target CBD Companies Over COVID-19 Claims

The U.S. Food and Drug Administration continues to be concerned about the proliferation of products containing CBD that are marketed for therapeutic or medical uses that have not been approved by the FDA.  On Tuesday, July 23, 2019, FDA issued a press release announcing it has issued a warning letter to Curaleaf Inc., of Wakefield, Massachusetts, alleging the company illegally sold unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases. Continue Reading U.S. Food and Drug Administration Expresses Concerns About Therapeutically Marketed CBD Products

The term tetrahydrocannabinol (THC) is most often associated with the delta-9 THC cannabinoid, which is one of over 100 cannabinoids found in both high-THC marijuana and low-THC hemp. Delta-9 THC is also the cannabinoid most often responsible for getting cannabis users “high” and is the cannabinoid that has been explicitly prohibited by the federal Controlled Substances Act (CSA). Continue Reading Delta-8’s 2018 Farm Bill Honeymoon May Be Slowly Coming to an End

Smokable hemp is one of the fastest growing submarkets of the hemp industry, but hemp growers and manufacturers in Texas may not be able to take advantage. A pair of cases in Texas district and appellate courts are trying to make sure that’s not the case. Continue Reading Texas Courts Hear Oral Arguments Regarding State’s Smokable Hemp Ban

In November 2019, we reported that the United States Department of Agriculture (USDA) issued an interim final rule establishing a domestic hemp production program that was intended to go into effect for two years before being replaced by a final rule. On January 19, 2021, USDA published that final rule after considering nearly 5,900 public comments and incorporating lessons learned from the 2020 growing season. While the final rule focuses on industrial hemp production, not processed hemp products (such as CBD derived from hemp), it may be particularly important to those who wish to exercise due diligence on their agricultural supply chains. It will be effective March 22, 2021, unless the new Administration changes the timeline. Continue Reading USDA Finalizes Rule to Establish Domestic Hemp Production Program

In early April, Virginia Governor Ralph Northam signed Senate Bill 918, approving industrial hemp extract, such as cannabidiol (“CBD”), as a food, subjecting it to applicable laws and regulations.  The bill defines “food” as “any article that is intended for human consumption. . . [and] does not mean drugs as defined in [Va. Code] § 54.1-3401.” The bill establishes requirements for the production and manufacture of hemp extracts and authorizes the Virginia Board of Agriculture and Services to adopt regulations regarding contaminant tolerances, labeling, and batch testing. Continue Reading Virginia becomes the most recent state to regulate hemp extracts as food

Last week, the United States Department of Agriculture (USDA) issued its interim final rule on the establishment of a domestic hemp production program.  It is intended to be effective for two years and then be replaced with a final rule.  The rule outlines provisions for USDA to approve plans submitted by States and Native American tribes for the US domestic production of hemp. Continue Reading USDA Issues Interim Final Rule on Hemp