Delta-8 Products Targeted by CT AG for Safety Concerns

Seth Goldberg
Seth A. Goldberg

I have previously written about lawsuits filed against manufacturers and sellers of hemp-synthesized intoxicants (HSI), such as Delta-8 THC, by the Attorneys General of California and Nebraska, as well as warning letters issued by the FDA, to stop the marketing and sale of HSIs.  Add to those, recent enforcement actions by the Attorney General of Connecticut against seven HSI manufacturers/sellers, which claim they have violated the CT’s unfair competition laws by marketing and selling unregulated cannabis products. 

The key point of all of the above actions is the unregulated nature of HSIs, which creates public safety concerns.  As the CT AG explained:  “Cannabis is legal for adults in Connecticut, but it’s not a free-for-all—retailers must be licensed and legal cannabis products must comply with strict safety standards. . . None of these products have been subject to Connecticut’s rigorous testing standards or contain appropriate warnings. Some are sold in dangerous and misleading packaging designed to appeal to children. These products are designed to deceive consumers into believing they are safe, tested, and regulated—that is false. ” 

HSIs can be just as intoxicating, if not more so, than cannabis products regulated under a state’s medical or adult-use cannabis laws and regulations.  However, in many states HSIs are not regulated and thus may not have undergone safety testing or be accurately labeled, posing health and safety risks to consumers.   While, as I have previously written, the cannabis and hemp industries may debate whether the 2018 Farm Bill legalized HSIs, there should not be any real debate about the need for product safety or the right of states to protect their citizen consumers.  

Cannabis Beverage Companies Need to be Aware of PFAS in Local Water Supplies

Ethan Feldman

Imagine that a cannabis beverage manufacturer’s plant draws water from a public watershed that is contaminated with a synthetic chemical or chemicals that are classified as probable human carcinogens.  Unbeknownst to the manufacturer, the advertising and labeling for their beverage products include a marketing campaign focused around the phrases “organic” or “all natural.”  This scenario is more than a hypothetical.  Synthetic compounds known as per- and polyfluoroalkyl substances (PFAS) are found in public water supplies across the United States.  There are about 15,000 different chemical compounds that fall under the PFAS umbrella.  The International Agency for Research on Cancer (IARC) has classified certain of these chemicals carcinogenic, as well as possibly carcinogenic to humans.

PFAS are commonly known as ‘forever chemicals’ because of the time it takes for them to degrade.  Not only have PFAS been linked to cancer, but also to immunodeficiencies, reproductive harm, and developmental defects in children.

According to the Centers for Disease Control, exposure to PFAS can occur from eating food packaged in PFAS-containing material, eating food grown or raised near places that used or made PFAS, but, most significantly, from drinking water.  Here is a link to PFAS contamination sites in the United State as of November 28, 2023, and it is estimated that drinking water for 26 million U.S. citizens may be contaminated with PFAS.

PFAS litigation is on the rise.  The past few years have seen many lawsuits filed by attorneys general and private citizens against PFAS manufacturers stemming from public water supply contamination.  Additionally, over the past few years, the Environmental Protection Agency (EPA) has worked to establish uniform permissible PFAS levels as it pertains to public water supplies.

In 2018, the cannabis beverage market was valued at over $900 million, and is projected to grow by 17% until 2033.  The emulsification process used to create cannabis infused beverages involves creating water-soluble cannabinoids that are then mixed into water-based solutions, and the final product can appear in the form of a soda, sparkling water, or juice, to name a few.

The EPA, state and local governments, and plaintiffs’ attorneys are keeping a close eye on the evolution of PFAS, and additional litigation is almost certain.  The scenario presented above may potentially lead to not only personal injury claims, but also presents a classic situation on which consumer fraud class actions are based.

Cannabis beverage manufacturers must be vigilant in complying with not only state regulations pertaining to cannabis manufacturing, but also must be mindful to appropriately handle PFAS contaminated water the company uses to manufacture cannabis beverages.

FDA Warning Letter Targets Delta-8 THC

Seth Goldberg
Seth A. Goldberg

On December 5, 2023, FDA issued a warning letter to a manufacturer (Hemp XR) of food products, such as gummies, cookies, etc., that contain delta-8 THC.  The warning letter notes that delta-8 THC has not been generally recognized  as safe (GRAS) for use in food, and has not received pre-market approval to be used as a food ingredient, which requires data demonstrating safety.  As a result, FDA warns that the interstate marketing of the food products at issue violates the Food, Drugs and Cosmetics Act.  The warning letter makes similar assertions with respect to the manufacturer’s food products containing CBD. 

FDA notes that its concerns with respect to delta-8 THC include:  “1) Delta-8 THC products have not been evaluated or approved by FDA for safe use and may be marketed in ways that put the public health at risk; 2) FDA has received adverse event reports involving Delta-8 THC containing products; 3) Delta-8 THC has psychoactive and intoxicating effects; 4) FDA is concerned about the processes used to create the concentrations of Delta-8 THC claimed in the marketplace; and 5) FDA is concerned about Delta-8 THC products that may be consumed by children, as some packaging and labeling may appeal to children.”

As I have previously written, manufacturers of products containing delta-8 THC are exploiting an ambiguity in the definition of hemp under the 2018 Farm Bill that they assert legalized chemical substances converted from hemp cannabinoids through chemical processes on the notion that such substances were “derived” from hemp.      

Another Lawsuit Challenging State Regulation of Hemp Synthesized Intoxicants

Seth Goldberg
Seth A. Goldberg

Another lawsuit challenging state regulations that attempt to curb the use of hemp-synthesized intoxicants (HSI) in consumer products was commenced last week.

In a complaint filed in federal court in Alaska on November 2, 2023, AK Industrial Hemp Assoc. et al. v. Alaska Department of Natural Resources, et al, the plaintiffs challenge the constitutionality of Alaska regulations that prohibit the sale in Alakska of hemp products for human consumption that contain delta-9 THC or synthetic cannabidiol.

There are now more than half a dozen lawsuits challenging state regulations that target HSIs, which further demonstrates the need for Congress to make clarifying changes to the definition of hemp in the 2023/24 Farm Bill to correct the loophole that has resulted in the proliferation of these intoxicating and potentially unsafe substances.

On November 17 at 12:00 eastern, Duane Morris will be hosting a webinar about the “loophole” in the definition of hemp in the 2018 Farm Bill that has led to the proliferation of HSIs, including the science behind HSIs; litigation challenging state regulation of HSIs; and the 2023/24 Farm Bill and HSI policy. 

Why Hemp-Synthesized Intoxicants Need Uniform Regs

Dylan Anderson and Seth Goldberg authored the Law360 article “Why Hemp-Synthesized Intoxicants Need Uniform Regs.”

They write, “The next time you find yourself at a gas station loading up for a road trip on your snack or energy drink of choice, you may notice a surprising offering at the counter: products made from cannabis that have an intoxicating effect, but that are not governed under a state’s recreational or medical marijuana laws and regulations.” Read the full article.

Virginia’s Restriction of Hemp Synthesized Intoxicants Upheld by Federal Court

Seth Goldberg
Seth A. Goldberg

On October 30, 2023, in Northern Virginia Hemp and Agriculture LLC, et al., v. The Commonwealth of Virginia, the U.S. District Court for the Eastern District of Virginia  refused to enjoin a Virginia statute, SB 903, aimed at curbing the production and distribution of products containing intoxicating chemical compounds derived from federally lawful hemp (“Hemp Synthesized Intoxicants” or “HSIs”).  SB 903 imposes upon hemp products,  including edibles and smokables, industrial hemp extracts, and any other consumable substance, a limit of no greater than .3% total THC concentration and no more than two milligrams of total THC per package or amount of cannabidiol that is no less than 25 times greater than the amount of total THC per package.

This restriction, referred to as a “Total THC Standard,” is intended to prevent the sale to consumers of ingestible, smokable, and otherwise consumable products that contain intoxicants derived from federally lawful hemp that are the functional equivalent of the delta-9 THC in federally unlawful marijuana. Such products have proliferated since the 2018 Farm Bill because chemical processes can be used to convert the chemicals in hemp into intoxicating compounds like delta-8 THC.

The Court in No. VA Hemp determined that the plaintiffs were unlikely to succeed on the merits of their claims because, among other things, the 2018 Farm Bill did not preempt states from regulating hemp products sold in their states.

 

 

AG Consumer Protection Lawsuits Target Delta-8 and Perceived “Loophole” in 2018 Farm Bill

Seth Goldberg
Seth A. Goldberg

The Nebraska Attorney General and the California Attorney General have filed lawsuits recently under their states’ consumer protection statutes targeting the manufacturers of hemp products containing Delta-8 THC, noting the health and safety risk to consumers of these products.  Such products, known as “hemp synthesized intoxicants” or “HSIs” are often just as intoxicating as the Delta-9 THC in state-legal adult-use and medical marijuana, but may not be subject to the same types of licensure, testing, and packaging/labeling requirements imposed under state cannabis programs. 

As I have previously written, the manufacture and distribution of HSIs appears to be the result of a perceived loophole in the 2018 Farm Bill’s legalization of hemp and its “derivatives, extracts, cannabinoids, isomers.”  Proponents of HSIs assert that, in defining hemp in the 2018 Farm Bill, Congress did not prohibit the chemicals in hemp from being converted into psychoactive compounds.

Opponents of HSIs argue that hemp was legalized as an agricultural commodity, and the 2018 Farm Bill was focused on the production (cultivation) of hemp, not consumer finished products that could be manufactured using its constituents.  They posit that Congress did not intend for the chemicals in hemp to be converted into a host of compounds just as intoxicating as Delta-9 THC. 

State AG consumer protection lawsuits against manufacturers of products containing HSIs are an attempt to curb their proliferation.  Congress may address the perceived loophole that is being exploited to manufacturer HSIs in the forthcoming Farm Bill. 

 

Did Congress Intend to Legalize Intoxicating Hemp Products in the 2018 Farm Bill?

Seth Goldberg
Seth A. Goldberg

The 2018 Farm Bill legalized “Hemp,” defining it as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.”  The .3% delta-9 THC threshold  distinguishes hemp from marijuana, which remains a federally unlawful Schedule I controlled substance, based on the psychoactive effect of delta-9 THC.

Today, consumers can walk into convenience stores, gas stations, and the like, or shop online, and purchase an array of cannabis products that have the same psychoactive effects as delta-9 THC in federally unlawful Marijuana, i.e., delta-9 THC at greater than .3% on a dry weight basis, but, because they were manufactured using “derivatives, extracts, cannabinoids, isomers” found in Hemp, their manufacturers claim they are legal.   These products, which contain delta-8 THC, delta-10 THC, and other chemical compounds, are the result of chemical processes that convert the Hemp “derivatives, extracts, cannabinoids, isomers” into compounds that are the functional equivalent of the delta-9 THC in federally unlawful Marijuana.

Manufacturers of delta-8 products believe the 2018 Farm Bill does not prohibit the conversion of the “derivatives, extracts, cannabinoids, isomers” in Hemp into an intoxicating compound, which begs the question: did Congress really intend to legalize intoxicating compounds created from Hemp “derivatives, extracts, cannabinoids, isomers”  that are functionally equivalent to the delta-9 THC in federally unlawful Marijuana?  It would seem that the .3% delta-9 THC distinction between Hemp and Marijuana is about psychoactive effect, not about a particular chemical.

California AG Targets Online Sales of Hemp Synthesized Delta-9 Inhalable Products

Seth Goldberg
Seth A. Goldberg

On September 11, 2023, the California Attorney General’s Office filed a Complaint against a handful of manufacturers of “inhalable hemp products” because they contained hemp-synthesized Delta-9 THC and beta-Myrcene.   The Complaint alleges that the sales of such inhalable hemp products violates California’s Proposition 65 and California’s Unfair Competition statutes.   Although under California’s AB 45 hemp and cannabinoids, extracts, or derivatives of hemp are permitted to be included in food and beverages , dietary supplements, cosmetics, processed pet food, AB 45 explicitly prohibits the sale of inhalable hemp products in California.  Likewise, Prop 65 identifies Delta-9 THC and beta-Myrcene as chemicals known to cause developmental harm, and are thus required to be labeled accordingly; Defendants products were not so labeled.  Importantly, none of the Defendants are California residents, and all of the products at-issue appear to have been purchased online and delivered from outside California.  Thus, this action should send a strong message to hemp synthesized D-9 manufacturers selling inhalable products into California.

© 2009- Duane Morris LLP. Duane Morris is a registered service mark of Duane Morris LLP.

The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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