Arkansas was among the states with a developing hemp market. In 2019, Arkansas passed Act 504 to decouple hemp from marijuana and include a broad definition that encompassed hemp and its derivatives. But on April 11, 2023, Act 629 (“the Act”) was enacted, which narrowed the definition of hemp, recriminalized its possession, and restricted manufacturing, transportation, and sale of popular hemp-derived cannabinoid products. On July 31, 2023, plaintiffs sued the state of Arkansas and several government officials to enjoin enforcement of the Act.
Plaintiffs alleged that the Act excluded hemp derived-cannabinoid products from the state’s definition of marijuana but narrowed the definition of hemp by recriminalizing all hemp products “produced as a result of a synthetic chemical process,” including Delta-8 and Delta-9 THC. But there is no synthetic distinction permitted under the Farm Bill of 2018. In this sense, the Act is in direct conflict with the DEA’s determinations that Delta-8 and other cannabinoid products with no more than 0.3 percent Delta-9 THC are considered hemp and not a controlled substance under federal law.
Plaintiffs’ primary argument is that the Act’s provisions are preempted by federal law because they (1) attempt to revise federal law to reclassify certain hemp-derived cannabinoids as illegal controlled substances; (2) interfere with the free flow of interstate transportation and shipment of hemp products; and (3) impose a narrower definition of hemp than mandated by federal law in violation of the Supremacy Clause of the Constitution and in conflict with legal principles.
Further, the Act is a substantial burden on interstate commerce in violation of the Commerce Clause and infringes on plaintiffs’ constitutional rights, amounting to a regulatory taking under the Constitution because it entirely bans hemp products that contain any amount of THC. Plaintiffs argued that substantial investments in their businesses are based on the established regulatory scheme prior to the Act, along with the inventory. Accordingly, the Act infringes upon the investment expectations upon which Plaintiffs have built their livelihoods, in addition to taking their property without just compensation.
The trial court granted plaintiff’s motion for a preliminary injunction and rejected the state’s motion to dismiss on September 8, 2023. The court reasoned that the Act was preempted by federal law. Under the 2018 Farm Bill, “Arkansas can regulate hemp production and even ban it outright if it is so inclined.” But “changing definitions from a federal program, which it had already fully joined,” was not constitutionally valid. Also, the 2018 Farm Bill explicitly provides that “no State or Indian Tribe shall prohibit the transportation or shipping of hemp or hemp products.” Considering that Arkansas is criminalizing “hemp-derived products without an effective exemption for interstate commerce,” Act 629 is preempted by federal law. The court also stated that the Act contains terms that are vague and would confuse “even an exceptionally intelligent reader,” and the plaintiffs demonstrated irreparable harm in the form of a credible threat of criminal sanctions.
This decision marked an important precedent for the hemp market in the U.S. because, thanks to lobbying efforts by the recreational and medical marijuana industry, states are unconstitutionally regulating a hemp market that has been legalized and regulated under federal law. The court’s decision provides hemp business owners a reprieve to continue operations.
Maryland was the next state to experience litigation over cannabis, namely hemp and marijuana regulation enacted in 2023. On July 1, 2023, Maryland passed the Recreational Cannabis Act (“the RCA”), which legalized recreational marijuana only if purchased at a dispensary licensed by the state. But the RCA lumped marijuana and hemp together, even though the definition of hemp as established in the Farm Bill remained unchanged in the state. Further, the license system allowed only a few businesses to obtain a license and sell marijuana products, hemp products, or both.
Prior to enactment of the RCA, and similar to many other states, Maryland had no laws regulating the sale or distribution of hemp-derived Delta-9 THC products and relied solely on the definition under the 2018 Farm Bill. Under federal law, thousands of Maryland hemp businesses were selling hemp products that met the definition of “industrial hemp,” including the hemp plant and all its derivatives with a Delta-9 THC concentration of not more than 0.3 percent on a dry weight basis.
But the RCA prohibited the sale or distribution of previously lawful hemp derived products other than certain tinctures without first obtaining a license, a highly unlikely occurrence under the RCA. It also limited the amount of THC that may be contained in a product to no more than 0.5 mg of THC per serving unless the seller was licensed and complied with manufacturing standards, laboratory testing, packaging, and labeling requirements. Sales to individuals under twenty-one years of age were prohibited, and the product was required to be derived from naturally occurring, biologically active chemicals. The RCA allowed hemp-derived tinctures containing a ratio of CBD to THC of at least fifteen to one, and 2.5 mg or less of THC per serving or 100 mg per package. The RCA regulated consumable and inhalable intoxicating hemp products with other cannabis products, while exempting non-intoxicating products, such as CBD edibles, lotions, and tinctures.
Plaintiffs stated that the majority of their products that were previously lawful to distribute without a license could not meet the new standards for maximum mg of THC and were, therefore, subject to violations. To comply, plaintiffs would have to obtain a license, which they alleged was almost impossible due to the limited number of licenses and other restrictions such as social equity provisions and lottery requirements.
The plaintiffs’ primary argument was that the licensing factors were not related to public safety or health concerns, and that the social equity concerns were no reason for a state to grant monopolies. Even if they were, there was no relation between the factors in the Act defining social equity and the redress of past grievances. In addition, plaintiffs alleged that they were being deprived of income, particularly given the likelihood they would not be able to obtain a license under the statute. They further argued that consumers were deprived of buying hemp products from a store that does not sell marijuana; instead the RCA forced them to buy products in a store where the main focus is on “getting high.”
On October 12, 2023, the Maryland court granted plaintiffs’ preliminary injunction, finding that (1) the licensing scheme, as applied to hemp producers, is preempted by the 2018 Farm Bill; (2) the law creates a monopoly that “unfairly excludes many from their right to continue or enter the profession of their choosing;” (3) the law “does not survive an equal protection review under Article 24 of the Maryland Declaration of Rights;” and (4) prohibiting the sale of hemp products that were previously legally sold does not affect Defendants and, due to the balance of conveniences, the market may continue. As with Arkansas, this decision was a significant win for the hemp industry seeking to survive in a rapidly growing and changing market.
Similarly, in February 2022, Gwinnett County, Georgia law enforcement officers executed a search warrant at a warehouse owned by plaintiff and seized edible and nonedible products containing Delta-8 and Delta-10 THC for possession of a controlled substance with the intent to distribute. The state returned the nonedible products stating that those products were not controlled substances but maintained that edible products were controlled substances.
The Gwinnett County district attorney had taken the position that it was illegal to possess or sell products containing Delta-8 and Delta-10 THC, which in its opinion, were controlled substances because these products did not fall within an exclusion for “hemp products” within Schedule I of the Georgia Controlled Substances Act.
On June 23, 2022, plaintiff filed a lawsuit against the state arguing that the warrant authorizing the seizure of the items was not supported by probable cause because Georgia’s Schedule I expressly excluded THC when found in hemp or hemp products when containing less than 0.3 percent concentration of Delta-9 THC. The Court of Appeals’ November 2, 2023, decision held that Delta-8 and Delta-10 THC are not controlled substances because Schedule I expressly excluded hemp products and hemp from the Controlled Substances Act. The court gave emphasis to the statutory language, interpreting it to mean that there was no probable cause to issue the warrant and seize the products.
Finally, in Virginia, the law defined hemp and its products in accordance with the 2018 Farm Bill. Under the 2018 Farm Bill, hemp is determined solely by its concentration of Delta-9 THC; concentrations of any natural isomers like Delta-8 or Delta-10, or synthetic isomers like Delta-3, Delta-4 THC were not relevant to whether a product of the cannabis plant qualifies as hemp because the definition technically only includes Delta-9 THC.
This interpretation changed in Virginia with the passage of Act SB 903, which was signed into law on April 12, 2023. Act SB 903 used the Farm Bill definition of “industrial hemp,” but implemented a new standard for hemp products, industrial hemp extracts, and other derivatives. These products cannot have more than 0.3 percent of total THC to be legal. “Total THC” includes quantities of Delta-9 and all other isomers, including Delta-8. In other words, hemp products with 0.4 percent of Delta-8 THC but 0 percent Delta-9 THC would be illegal under the new law, although legal under the Farm Bill.
Moreover, Act SB 903 also made it illegal to sell industrial hemp to a manufacturer anywhere in the world that creates hemp products that do not comply with Virginia’s “total THC” standard. To understand more of the “total THC” standard, Act SB 903 stated that products must contain only Delta-9 THC, excluding all other isomers that were allowed before its passage, or contained no more than two milligrams of total THC per package or an amount of CBD that is no less than twenty-five times greater than the amount of total THC per package.
These changes created a drastic shift in the market. Plaintiffs filed a lawsuit against the state of Virginia under the argument that Act SB 903 contradicts the Supremacy Clause, because federal law is the supreme law of the land and the 2018 Farm Bill preempts state law. They argued that the Commonwealth does not have authority to redefine any part of the federal definition of hemp as it has done in SB 903, and that the law harms manufacturers, buyers, retailers, possessors and transporters in Virginia because the act is restricting free interstate commerce under the Commerce Clause.
Contrary to Arkansas, Maryland, and Georgia, on October 30, 2023, the Court for the Eastern District of Virginia rejected the plaintiff’s injunctive relief petition, holding that the 2018 Farm Bill relaxes the federal regulations concerning hemp, but it permits states to enact more stringent regulations of hemp production. The court stated that federal law preempts state laws that attempt to regulate the transportation or shipment through the state but does not preempt state regulations of other aspects of industrial hemp, such as the growth, production, sale, and use of industrial hemp and hemp products. According to the court, high doses of Delta-8 and adulterated products made children sick in Virginia and therefore there was a legitimate interest for the state to enforce Act SB 903.
With regards to the Commerce Clause, the court opined that there was no evidence on record that Act SB 903 seeks to advantage in-state firms or disadvantage out-of-state rivals. The court also held that plaintiffs could not show irreparable harm to grant injunctive relief because of the delay in filing the lawsuit. According to the court, because the act passed on February 7 of 2023 and plaintiffs waited until September 1 to file, there was evidence of the absence of irreparable harm.
In conclusion, the hemp industry has been fighting statutory developments in several states that have implemented statutory changes that are unconstitutional. The courts’ decisions are consistent in granting injunctive relief petitions on the basis that the new regulations tend to be unenforceable and are attempting to contradict constitutional rights and principles such as the Supremacy Clause and the Commerce Clause. We expect that, with these precedents, states will consider the hemp industry as a federal legal business that needs to be properly regulated, rather than arbitrarily regulated to favor only a few.
II. Agriculture
A. National Pork Producers Council v. Ross
Author: Nicole Cook
In May of 2023, the U.S. Supreme Court issued its much-anticipated decision in National Pork Producers Council v. Ross. The decision focused on challenges to California’s Proposition 12 (“Prop 12”), the Farm Animal Confinement Initiative, which was passed by California voters in 2018. As relevant here, Prop 12 forbids the in-state sale of whole pork meat that comes from breeding pigs (or their immediate offspring) that are “confined in a cruel manner.” Confinement is “cruel” if it prevents a pig from “lying down, standing up, fully extending [its] limbs, or turning around freely.” Before Prop 12’s adoption, proponents suggested the law would benefit animal welfare and consumer health while opponents claimed that existing farming practices protected animals better by, for example, preventing pig-on-pig aggression, and ensured consumer health by avoiding contamination. After Prop 12’s adoption, two organizations—the National Pork Producers Council and the American Farm Bureau Federation—filed a lawsuit on behalf of their members who raise and process pigs. They asserted that, because most of California’s eggs, veal, and pork products are imported from outside California, most of Prop 12’s compliance costs will be borne by out-of-state businesses, which violates the dormant Commerce Clause by impermissibly burdening interstate commerce.
The federal district court dismissed the case for failure to state a claim. The Ninth Circuit affirmed that decision and the two agricultural groups petitioned the U.S. Supreme Court for review, which the court granted. The Supreme Court affirmed the Ninth Circuit’s decision and held that, if state statutes do not purposefully discriminate against out-of-state economic interests, the dormant commerce clause does not prohibit their implementation, regardless of whether those laws have the practical effect of regulating commerce outside the State. As a result of the decision, all breeding swine farms will need Prop 12 certifications by January 1, 2024, in order for buyers and pork distributors to sell pork to the California market. Outside states selling eggs and veal to California must also be in compliance by January 1, 2024.
III. Environmental, Social, and Governance (“ESG”) in the Food & Agriculture Industry in the European Union
Author: Austin Pierce
Although environmental regulations in the EU have existed for some time, there have historically been various exceptions or other special treatment afforded to the production of food and related cultivation endeavors. There has been an increasing recognition of the prominent role that food and agriculture play in shaping the sustainability of society, both through environmental and social impacts. As such, several new regimes—both regulatory and extra regulatory—have been established in 2023 that incorporate or explicitly focus on the food and agriculture sector’s environmental and social profile.88 These include two significant regulatory developments in the European Union.
First, the European Sustainability Reporting Standards (the “ESRS”)—a principal component of the ESG disclosure regime under the EU’s Corporate Sustainability Reporting Directive (“CSRD”)—were adopted by the European Commission. CSRD requires businesses across industries that meet certain financial and/or employment thresholds to provide disclosures on a range of environmental, social, and governance (“ESG”) related topics. The ESRS provide detailed disclosure requirements for various topics, including climate change, biodiversity and ecosystems, and labor practices. The applicability of these requirements ultimately turns on whether they are material, based on a “double materiality” standard, looking not only at the degree to which the environmental/social matter in question impacts the company, but also at how the company impacts that environmental/social matter.
But the EU has also moved beyond disclosure requirements to impose substantive expectations on the environmental and social provenance of certain products. In particular, the EU Deforestation Regulation (“EUDR”) targets the production profile of several key agricultural commodities—cattle, cocoa, coffee, palm-oil, rubber, soya, and wood, as well as relevant products that contain or have been made (or fed) with such commodities.
The marketing or sale of such products in the EU is prohibited unless they are: (1) deforestation-free; (2) produced in accordance with relevant legislation of the country of production; and (3) covered by a due diligence statement to that effect. This ultimately implicates a variety of laws, including land use; environmental protection; forestry management; third-party rights; labor rights; human rights; indigenous rights (particularly the concept of free, prior, and informed consent); and various commercial laws on tax, anti-corruption, trade, and customs. The degree of due diligence required under the EUDR will depend on the relative risk profile of the country of production. Such risk profiles are to be established by the European Commission within eighteen months of the EUDR entering into force (therefore, by the end of 2024). Nevertheless, the degree of due diligence required in most cases is expected to be extensive, which may be quite complex for companies with far-reaching supply chains that may draw from a variety of different locales.
In the United States, efforts to address environmental and social matters in the food and agriculture sectors have relied more on incentive-based approaches, often folded into the approximately five-year “Farm Bill(s)” that significantly influence agricultural practice in the country. The current iteration of the Farm Bill, the Agriculture Improvement Act of 2018, expired in September 2023; but various programs are proposed for the new bill, including expanded technical and financial assistance for certain sustainability-related practices, such as precision agriculture technologies that can help to reduce fertilizer and water usage. But the ultimate contents of the new farm bill are uncertain, as it has continued to undergo intense scrutiny and negotiation in Congress despite the expiration of the prior version.
Meanwhile, there have been multiple developments from civil society as well. In September 2023, the Taskforce on Nature-related Financial Disclosures (“TNFD”) published final recommendations for organizations’ assessment, management, and disclosure on nature’s intersection with their businesses. TNFD seeks to provide similar structure for companies’ approach to natural capital as the Task Force on Climate-related Financial Disclosures (“TCFD”) has provided for climate. There are significant parallels between the two frameworks, though the TNFD is modified to fit the larger scope and variability associated with nature. TNFD has also produced a range of guidances, including draft guidance for several priority sectors that include food and agriculture, aquaculture, and forestry management.
Food and agriculture are a priority industry for Nature Action 100 (“NA100”), an investor group representing approximately $24 trillion in assets under management that is focused on engaging with public companies on the management of nature-related matters. NA100 announced eight key sectors for engagement earlier this year, including food, chemicals (particularly noting agricultural chemicals), food and beverage retail, and forestry and paper. A survey of investors also noted that, of these key sectors, the most common engagement targets were based in the food sector, with forestry and paper being the third most popular target sector.
Engagement may include requests for additional disclosures and information but may also translate into shareholder proposals or other strategies to elicit the desired information.
All together, these developments indicate a substantial increase in attention to the environmental and social performance of the food and agriculture sector from a variety of stakeholders, leveraging multiple areas of law and civil society to promote such stakeholders’ expectations.
IV. The U.S. Food and Drug Administration’s Final Food Traceability Rule
Author: Nicole Cook
The U.S. Food and Drug Administration (FDA) released its final rule on the traceability of high-risk foods (“the Rule”) on November 21, 2022. The Rule is one of the last remaining regulations to implement the Food Safety Modernization Act (FSMA). The Rule became effective January 20, 2023, and has a compliance date of January 20, 2026. The goal of the Rule is to improve the efficient recall of high-risk foods (e.g., leafy greens, fresh-cut produce, soft cheeses, fish) in the event of a foodborne illness outbreak by requiring certain data points to travel with foods from the farm level (or manufacturer or fishing vessel, depending on the food) to the retail level. The FDA anticipates that these data points will facilitate the tracking of listed foods from the marketplace back to the point of harvest (e.g., for fresh produce and aquaculture products), point of manufacturing (e.g., for soft cheeses and deli salads), or fishing vessel. Under the Rule, every entity along the supply chain is required to maintain records that will allow the FDA to follow the supply chain and ensure that other foods that may be similarly contaminated can be removed from the market in the event of a recall.
The Rule imposes record keeping requirements on certain foods that FDA considers high risk for foodborne illness outbreaks. Foods on that “traceability list” (listed foods) include leafy greens, fresh-cut produce, sprouts, soft cheeses, fish, shellfish, and deli salads. The FDA concluded that these and the other listed foods met criteria established by Congress to rate them as high-risk, including the history and severity of past foodborne illness outbreaks associated with the food, the health and economic impacts of such outbreaks, and the risk of the food being subject to microbiological or chemical contamination.
Under the Rule, parties handling listed foods at certain points along the supply chain (known as Critical Tracking Events) must record specific types of information (known as Key Data Elements). The Critical Tracking Events are limited to: (1) harvesting; (2) cooling (before initial packing); (3) initial packing; (4) shipping (only after initial packing; includes intracompany shipment); (5) receiving (only after initial packing phase; includes intracompany shipment); and (6) transformation (e.g., manufacturing/processing, commingling, repacking or relabeling, changing packaging or packing). The Key Data Elements vary depending on the type of Critical Tracking Event, but they include information such as geographic coordinates for the growing location.
A Traceability Lot Code must be assigned at the initial packing stage for fresh produce and with any transformation activity (e.g., repacking). Accordingly, a given listed food may have different Traceability Lot Codes as it moves through the supply chain. The Traceability Lot Code travels with the food and must be recorded at each subsequent Critical Tracking Event, along with any relevant Key Data Elements. Covered parties must also maintain and make available for FDA inspection a written traceability plan and records of compliance. The Rule does not apply to ingredient suppliers producing ingredients for manufacturers of listed processed foods. For example, the Rule does not apply to milk and rennet suppliers selling ingredients to a soft cheese manufacturer. The requirements under the Rule start with the soft cheese manufacturer.
Also, FDA has:
clarified in its comments that, if the listed food is described as being ‘fresh,’ the rule applies only to the fresh form. Listed foods include fresh herbs, for example. Dried herbs are not subject to the rule. The entity that processes fresh herbs into dried herbs must maintain receiving records for the fresh herbs but is not required to maintain records for its subsequent transformation and shipping activities. In addition, subsequent recipients of that food do not have to maintain traceability records under the rule.
In addition to accelerating FDA’s recall process for foods, it is hoped that the Rule will also benefit industry by limiting the scope of recalls (e.g., limiting the recall of a certain product produced by a single farm, rather than recalling all such product from the same growing region).
V. Consumer Consumables and Food
A. Chile: New Regulation for Labeling and Advertisement of Alcoholic Beverages – A Paradigm Change
Authors: Cristina Busquets and Ignacio Gillmore
Following the regulatory trends in the country during the past few years, in 2023, Chile enacted a regulation setting forth new labelling requirements and advertisement restrictions on alcoholic beverages. This new regulation could represent a major challenge for the alcoholic beverages industry, especially for foreign manufacturers because it entails relevant changes to the labelling requirements currently in force for these type of products in Chile.
In July 2023, Decree No. 98 of 2023 of the Ministry of Interior and Public Health (the “Regulation”) was published in the Chilean Official Gazette, as a regulation of Law No. 21,363 (the “Law”), which was published on August 6, 2021. The Regulation establishes new requirements and imposes new restrictions for the commercialization and advertising of alcoholic beverages in Chile, among other matters. Although enacted over two years ago, the Law has not yet entered into force in practice with regards to many of its provisions because, as expressly stated therein, it required the issuance of specific regulations to determine the characteristics and scope of its new obligations. After several months of discussion within the Government, finally, in July 2023, the Regulation was enacted.
In general terms, the Law requires any beverage with an alcoholic graduation equal to or higher than 0.5 degrees to include, in its container, box, or packaging, a visible warning regarding harmful consequences of consumption. The warning is required to include phrases regarding the risks of excessive alcohol consumption, along with graphic signs especially intended for those segments of greater risk, such as pregnant women, minors, and drivers. Additionally, the Law establishes that containers of these products must also include a graphic warning sign, either adhered or printed, showing a car, a pregnant woman, or the number eighteen, each one fully circled, or otherwise dictated by the correspondent regulations.
The Law also requires inclusion of warnings in any advertising communicated through written media, posters, or advertisement signs of any kind, be they physical or virtual, audiovisual advertising, and radio announcements. Additionally, manufacturers, producers, distributors, and importers of alcoholic beverages must provide on its containers or labels its energy content.
At the same time, the Law introduces several limitations to the advertising of alcoholic beverages:
- Advertising of alcoholic beverages on television is restricted to between 10:00 PM and 6:00 AM;
- Radio advertising, whether direct or indirect, is restricted to between 4:00 PM and 6:00 PM;
- Prohibition of any form of advertising of alcoholic beverages—whether commercial or non-commercial, direct or indirect—at sporting events, except for mega sporting events held in Chile;
- Prohibition to include, in any sports item massively distributed, as well as in promotional items linked to any kind of sports activity, the name, logo or images related to alcoholic beverages, including any sign or reference to their brands or products;
- Prohibition of any form of advertising of alcoholic beverages—whether commercial or non-commercial, direct, or indirect—in any product, publication or activity exclusively intended for minors. The Law also establishes a prohibition of selling these products by means of “commercial hooks” such as gifts, contests, games, or other child attracting elements; and
- Prohibition of developing propaganda that encourages the consumption of alcohol in public places, such as streets, squares, or beaches. But signs found on roads or highways that allow arriving at places of production of alcoholic beverages, such as vineyards, are excepted.
Importantly, the Regulation establishes the graphic characteristics of the warnings on harmful consumption that must be included in the packaging of alcoholic beverages, as well as the manner in which such warnings must be incorporated in the advertising of these products. It also regulates the manner in which the declaration of the calorie content of the products must be made. The Law sets forth that the entry into force of all the aforementioned obligations and restrictions shall be subject to the issuance of the corresponding regulation.
The Regulation requires warnings to be incorporated on a back face or label of the container or package, with a black or white background. The size of the warning may not cover less than fifteen percent of the surface of the back face or label of the respective container, box, or package. In the event that the container, carton, or package, as the case may be, does not have a back label, the value indicated above shall be considered with respect to the front label. But the complete warning shall not be less than 6.2 cm wide and 3.5 cm high, and each of the octagonal symbols shall not be less than 1.7 cm high and 1.7 cm wide. The complete warning shall not occupy more than thirty percent of the packaging. The producer or manufacturer in the case of national products, and the importer in the case of imported beverages, shall be responsible for affixing the warning. The Regulation includes the following graphic examples: