Delta-8 is NOT Legal.
The debate over Delta-8 THC’s legal status has divided the industry. Contrary to what we hear from the media, see in the stores, or learn from cannabis operators; and despite the incredible amount of Delta-8 THC products being sold across the country today, there is absolutely no grey area around the legality of Delta-8 THC. Delta-8 THC is NOT federally legal. Yet Delta-8 products are flooding the US market more and more every day, and the companies producing them continue to grow at exponential rates.
Delta-8 is Schedule 1.
Delta-8 is considered a Schedule 1 Controlled Substance by the US Drug Enforcement Administration (DEA) because it is known to cause psychoactive impairment to the consumer. Because these products cause intoxication, they require a regulatory structure in line with state medical and adult use marijuana programs. Despite the illegality, Delta-8 products have taken off as the newest way to get high. Since the distribution of Delta-8 products is not controlled, these products are being marketed and sold as if they were typical legal hemp products containing non-psychoactive cannabinoids, by licensed hemp companies and transported across state lines.
Delta-8 Puts Consumers at Risk
Unsuspecting consumers are being offered Delta-8 “shots” in their morning coffee at their local coffee shop while on their way to work, with no warning about the potential for impairment or how it might impact the ability to drive. Delta-8 gummies and vape cartridges are being sold in incredibly high doses to teenagers in vape shops and gas stations as if they are harmless hemp products that do not get you high. Not only are the consumers of these products being put at risk, so are the unwitting business owners that are carrying these products, without an understanding of their own liability for selling them.
Quality and Safety of Delta-8.
Because Delta-8 products are federally illegal, they do not fall within existing regulations for hemp products, which means they are not required to contain warning labels or advise to the consumer on the potential for impairment. It also means no one is monitoring the production of these products to assure only safe production practices are being used, or that the products being sold are of good quality. One needs only perform a quick Google search to recognize the quality issues with Delta-8 products: there are hemp companies proudly marketing themselves as “the Delta-8 manufacturers who do not use bleach to create our products’. This Op-Ed, I Stand Corrected: The Truth About Delta-8 THC, provides a deep dive into Delta-8 the quality and safety issues for those that are interested.
US Cannabis Laws Are Confusing.
Like so many things related to cannabis, the confusion around the legal status of Delta 8 exists due to the conflict between state and federal drug laws. Cannabis remains a Schedule 1 Controlled Substance at the federal level in the US. Due to this status, for the past decade, both hemp and marijuana operations have been required to be in compliance with state specific laws and regulations that vary greatly across the country. This means the cannabis industry (both hemp and marijuana) has paid very little attention to the existing federal laws, resulting in the former confusion around the legality of CBD products and the explosive and dangerous situation happening with Delta-8 products.
2018 Farm Bill.
Federal cannabis laws changed when hemp was fully legalized on Thursday, December 20th, 2018, when the Agriculture and Nutrition Improvement Act of 2018 (referred to as the 2018 Farm Bill) was signed into law. The passage of the Farm Bill created a new, and somewhat broad, definition of hemp:
“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 clear intent of Congress, including overwhelming, non-partisan committee support in the House and Senate, was to provide another crop for America’s farmers to add into their rotation, so long as the crop and the products derived from hemp harvests were not intoxicating. Cannabis that causes impairment and intoxication were already distinguished from hemp, via state legalized medical and adult use marijuana programs, when the Farm Bill passed. This leaves no confusion about the legality of products containing THC in amounts that can cause intoxication.
FDA Oversight of Delta-8.
Upon passage of the 2018 Farm Bill, confusion ensued because the passage did NOT impact or negate the existing laws and regulatory authority granted to other federal agencies as they relate to hemp and products derived from hemp. Initially this confusion arose around the legality of CBD. The industry has now moved on to a different question: the legality of Delta-8.
Congress explicitly preserved FDA’s authority to regulate products containing cannabis or cannabis derived compounds under the Food, Drug, and Cosmetics Act (FD&C), as well as Section 351 of the Public Health Service Act of 1944 (PHSA). Both of these Acts grant federal authority to FDA to oversee the safety of all food, drugs, medical devices, and cosmetics and to take legal action to stop the interstate commerce of products which involve a health or safety risk. They also prohibit adding the active ingredient of a drug into any food or beverage (including those for animals) intended for interstate commerce and prohibits those products from being marketed as dietary supplements. Further, FD&C Section 301 (II) defines active ingredients as ingredients used in previously approved drugs, as well as ingredients used in drugs that have undergone substantial clinical investigations. CBD is the active ingredient in the FDA approved medication Epidiolex. THC is the active ingredient in the FDA approved medications Marinol and Syndros, while Sativex contains both THC and CBD. Epidiolex has recently been de-scheduled from Schedule V of the DEA’s Controlled Substance List.
As such, FDA concluded that adding THC or CBD into any food or beverage product (including animal food) intended for interstate commerce or marketing products containing CBD or THC as a dietary supplement are prohibited. All of this confusion eventually prompted the release of a formal statement from the FDA Commissioner to clarify the situation:
“we [FDA] treat products containing cannabis or cannabis-derived compounds as we do any other FDA-regulated products — meaning they’re subject to the same authorities and requirements as FDA-regulated products containing any other substance. This is true regardless of the source of the substance, including whether the substance is derived from a plant that is classified as hemp under the Agriculture Improvement Act”.
It is clear from the statement above that Delta-8, as a cannabis derived compound, regardless of whether that compound it is derived from hemp or marijuana, falls under FDA oversight.
Legality of Cannabinoids Under the Farm Bill.
According to FDA, the cannabis plant, (both hemp and marijuana) are made up of biologically active chemical compounds, called cannabinoids. The most commonly known cannabinoids are tetrahydrocannabinol (THC) and cannabidiol (CBD). Even though the Farm Bill federally legalized hemp and removed it from the Controlled Substances List, the individual cannabinoids that make up the cannabis plant, still remain Schedule 1.
Tetrahydrocannabinol, or THC, is a psychoactive cannabinoid, which causes impairment. The psychoactive effects of THC are the reason cannabis was listed as a controlled substance under Schedule 1 status in the first place. It is because of THC’s impairment potential that the Farm Bill definition of hemp specifically included controls on the level of THC to differentiate cannabis plants as either (federally legal) hemp or (federally illegal) marijuana.
Delta-8 and the Analog Act.
Before the modern cannabis era, the Controlled Substances Analogue Act 21 U.S.C. § 813 passed in 1986. This simple Act states that any chemical which is “substantially similar” to a Schedule 1 or Schedule 2 controlled substance shall be considered a “controlled substance analog”. Further, it states that all controlled substance analogs intended for human consumption be treated as if it is Schedule 1. The illegal status of Delta-8 and Delta-8 products at the federal level is also confirmed because Delta-8 THC is clearly an analog of Delta-9 THC. This Act does not consider the source of the analog, removing the contrived suggestion that D-8 was unique if converted from federally legal hemp-derived CBD.
Delta-8 and the DEA.
Even though the 2018 Farm Bill moved the regulatory oversight authority of hemp cultivation from DEA to USDA, and removed hemp from the CSA, nothing has changed related to the scheduling status or legality of the Tetrahydrocannabinols contained within hemp or marijuana. To clarify this, the DEA stated the following:
“[T]he definition of hemp does not automatically exempt any product derived from a hemp plant, regardless of the D9 -THC content of the derivative. In order to meet the definition of “hemp,” and thus qualify for the exemption from schedule I, the derivative must not exceed the 0.3% D9 -THC limit. The definition of “marihuana” continues to state that “all parts of the plant Cannabis sativa L.,” and “every compound, manufacture, salt, derivative, mixture, or preparation of such plant,” are schedule I controlled substances unless they meet the definition of “hemp” (by falling below the 0.3% D9 -THC limit on a dry weight basis) or are from exempt parts of the plant (such as mature stalks or non-germinating seeds). See 21 U.S.C. 802(16) (emphasis added). As a result, a cannabis derivative, extract, or product that exceeds the 0.3% D9 -THC limit is a schedule I controlled substance, even if the plant from which it was derived contained 0.3% or less D9 -THC on a dry weight basis.”
Even today, despite hemp being legal nationwide and the majority of states having enacted laws legalizing the use of marijuana, THC is still listed as a Schedule 1 Controlled Substance by the DEA (7370 – page 10 line 7). This makes the 0.3 percent THC requirement contained within the legal federal definition of hemp such a critical issue – it is literally the dividing line between federally legal cannabis and federally illegal cannabis.
Cannabis & cannabis products containing LESS than 0.3 percent THC are federally legal, when produced from hemp crops sanctioned by USDA and processed according to state and federal regulations.
Cannabis & cannabis products containing MORE than 0.3 percent THC are NOT federally legal, regardless of origins from hemp crops or state regulated cannabis programs.
The 2018 Farm Bill clearly states that only hemp grown under USDA sanctioned programs, and products derived from those hemp crops, are removed from the definition of “marihuana” and thus exempted from Schedule 1. This means that synthetically produced cannabinoids, including tetrahydrocannabinols, do not enjoy the same legal treatment, because they are not removed from the federal definition of “marihuana”. While definitions of conversion, synthesizing, and even manufacturing with reference to cannabinoids is confusing, USDA recently provided clarification in the newly effective USDA Hemp Final Rule where it is expressly prohibited:
“The [2018 Farm Bill] does not impact the control status of synthetically derived tetrahydrocannabinols (for Controlled Substance Code Number 7370) because the statutory definition of “hemp” is limited to materials that are derived from the plant Cannabis sativa L. For synthetically derived tetrahydrocannabinols, the concentration of D9 -THC is not a determining factor in whether the material is a controlled substance. All synthetically derived tetrahydrocannabinols remain schedule I controlled substances.”
Thus, synthetically producing any tetrahydrocannabinols is federally illegal and equates to creating a Schedule 1 substance. However, some attorneys in the cannabis industry believe there is a legal loophole in the definitions of synthetically produced cannabinoids and have produced several versions of legal opinions. These opinions have backstopped producers and retailers by providing a level of confidence – in an “aggressive” interpretation — which has led to this incredible Delta-8 product bubble that is sweeping the nation. The reality is that there are multiple federal laws that address the legality of synthetically creating cannabinoids, in addition to state laws.
Delta-8 Legality by State.
As stated in the Farm Bill, “states and tribal governments are authorized to put more restrictive parameters on the production of hemp but are not authorized to alter the definition of hemp or put in place policies that are less restrictive than this title.” This means, that while states can add more restrictive regulations to their hemp programs, they are not able to legalize the production of Delta-8 or Delta-8 products. As of March 22nd, 2021, the day USDA’s Final Rule went into effect, 11 states hemp programs had already expressly banned Delta-8 products as illegal: Alaska, Arizona, Arkansas, Colorado, Delaware, Idaho, Iowa, Mississippi, Montana, Rhode Island, and Utah. As of March 27th, both California and Oregon are in the process of enacting regulations for Delta 8 products.
D-8 products are the same as D-9 products.
State and federal regulations of Controlled Substances like alcohol and tobacco are meant to provide regulated distribution of those substances according to accepted standards that provide adequate protections for the health and safety of everyone involved. The distribution of cannabis products that are Controlled Substances (marijuana AND Delta-8) should be no different. State regulated recreational or medical cannabis programs provide the only legal route for D-8 production and distribution. As of today, there are no federal avenues to regulate Controlled Substances in cannabis, which is why they remain Schedule 1. Hemp farmers/processors wanting a truly legal pathway to participate in the Delta-8 market, must convert hemp to CBD, then sell the CBD to state licensed marijuana companies to produce and distribute Delta-8 products through the existing regulated market.
FOCUS on Delta-8 products.
As the Cannabis Health and Safety Organization, FOCUS views the explosion of unregulated Delta-8 products as ridden with risks to public health and safety. It is an untenable situation that has the potential to upend the whole industry, and demands immediate regulatory clarification.
Due to the illegality of Delta-8 products, and the public health and safety risks they present, FOCUS will not engage with or certify any hemp operators who are manufacturing or selling Delta-8 products. This policy will remain in place until which time any regulatory uncertainty around the situation has been resolved.
Foundation of Cannabis Unified Standards
March 26, 2021
The Center for Disease Control (CDC) and the Food and Drug Association (FDA) have separately released new statements regarding Delta-8 THC in a pair of regulatory updates highlighting the latest information coming from the federal government regarding this substance.
In short, the FDA guidance highlights five key pieces of information regarding this cannabinoid: Its current standing regarding FDA Approval, current reports on adverse health effects, levels of psychoactivity associated with Delta-8, how Delta-8 is made, and Delta-8 as it pertains to children and pets. The FDA Update can be found here.
The CDC update on Delta-8 stems from a recent study researching some of the health effects of this cannabinoid through the lens of recent upticks in negative health outcomes. The purpose of this update is to spread awareness to state and local health departments. The CDC update can be found here.