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What’s the Difference between Delta-8 and Delta-9? What are the Laws on Delta-8? Is Delta-8 Regulated by the FDA or States?

 

Plainspeak Summary:

• Delta-8 and Delta-9 products will both get you high, but only one is commonly found in gas stations next to fidget spinners, vape pens, and lottery tickets.
• The legal status of Delta-8 THC is inconsistently regulated in a gray zone between “synthetically derived” THC and “hemp derived” THC.
• While the proliferation of Delta-8 THC products has attracted the attention of federal regulators, federal health advisories are not legally binding in nature and for the most part serve merely as guidance for the industry.
• A hodgepodge of Delta-8 THC state laws has emerged. Cannabis businesses that engage in interstate sales should familiarize themselves with these laws.
• Despite lackluster regulation in Tennessee, there are several proactive steps a cannabis business can take to protect itself from the unknown.

There is a rapidly expanding fad in the United States involving a new(ish) form of THC derived from hemp and commonly referred to as Delta-8 THC, “weed light” or “diet weed.” A growing number of Tennessee dispensaries, convenience stores, gas stations, and let’s not forget e-commerce platforms, have been exploiting a loophole in federal law that appears to allow the unfettered sale of the “federally legal” Delta-9 THC chemical analog.

Hold on! What’s the difference between the two?

When people refer to THC, they are typically talking about delta-9-tetrahydrocannabinol (“Delta-9 THC”), the major, naturally derived cannabinoid in cannabis. Due to its abundance in the plant, it can easily be extracted for profit. Several Delta-9 THC isomers also exist. Isomers are variations of molecules with identical chemical formulas but a distinct arrangement of atoms. Delta-8 THC is an isomer of Delta-9 THC; however, it is a minor cannabinoid that is only found in trace amounts in cannabis. Hence, its extraction from the plant is unprofitable. Most commercial Delta-8 products are created by converting CBD, a hemp derivative, into pure Delta-8 THC using an acid-solvent mixture.

For a comparison of the effects of Delta 8 THC vs Delta 9 THC, get nerdy here.

If it’s THC, what’s the big conundrum?

The 2018 Farm Bill removed hemp defined as cannabis with concentrations of Delta-9 tetrahydrocannabinol (Delta-9 THC) below 0.3%, and hemp-derivatives, from the definition of marijuana in the Controlled Substances Act (CSA).

As a result, two camps of thought have emerged as to the legal status of Delta-8 THC and other hemp isomers such as Delta-10 THC. On one hand, the “Derivative Camp” argues that Delta-8 THC products are exempted from the federal definition of marijuana because Delta-9 THC concentration remains below 0.3% and above all, Delta-8 products are hemp derived. On the other hand, the “Synthetic Camp” argues that such products are “synthetically derived tetrahydrocannabinol,” and per the DEA’s Interim Final Rule (IFR) published in August 2020, synthetic THC belongs on Schedule I of the CSA regardless of the THC content.

The crux of the argument falls on the definition of “synthetically derived” and “hemp derived.” The Food and Drug Administration (FDA) has approved Marinol and Syndros for therapeutic uses in the United States. Marinol and Syndros include the active ingredient dronabinol, a synthetic Delta-9 THC. Another FDA-approved drug, Cesamet, contains the active ingredient nabilone, which has a chemical structure similar to THC and is synthetically derived. Unlike Delta-8 THC, these drugs are entirely lab created and do not rely in any part on the hemp plant.

To date, there have been no official legal interpretations of the term “synthetically derived.” In a warning to the public of the unknown pitfalls of Delta-8 consumption, the FDA called the isomer both: “typically manufactured from hemp-derived cannabidiol (CBD)” and a “synthetic conversion.” Likewise, the DEA has yet to clarify whether it actually takes the position that isomerized Delta-8 THC is a “synthetically derived” THC. But be warned, the federal campaigning has begun.

Does the DEA have the authority to override congressional intent?

Even if the DEA were to take such a position, it is unclear whether it has the authority to declare Delta-8 products illegal absent congressional intent. In Hemp Industries Association v. United States Drug Enforcement Administration, 2021 WL 1734920 (D.D.C., 2021), the Hemp Industries Association challenged the DEA’s authority to amend the CSA to conflict with Congress’ Farm Bill. The Court ultimately concluded that it is powerless to entertain the merits of the case based on procedural grounds. Congress has provided an exclusive pathway for federal-court challenges to final DEA decisions such as the IFR: a petition for review filed in the court of appeals. The Court, accordingly, dismissed the action for lack of subject-matter jurisdiction. The matter will still be in flux until it is brought in front of the proper court.

As of now, it appears that the DEA has no intention of prosecuting any Delta-8 cases; however, Delta-8 retailers are not off the hook. As demonstrated in Kentucky, local governments are cracking down on the Delta-8 market before the DEA gets a bite of the apple.

It’s murky at best on the federal level, but where does Delta-8 fall in Tennessee?

Although law enforcement operations targeting Delta-8 THC products have been lacking in Tennessee, over 18 states have moved to ban Delta-8 THC and about a dozen have moved to ban Delta-10 THC. Public Chapter 916 regarding the growing of industrial hemp in Tennessee mimics federal law and legalizes all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a Delta-9 THC concentration of not more than 0.3%.

Accordingly, the Tennessee Department of Agriculture and local law enforcement have chosen not to address the unregulated sale of Delta-8 THC and similar products. Anecdotally, it is only a matter of time before the local government takes action on the matter. This fall, the Tennessee Growers Coalition (TGC) will be reviewing a Delta-8 Bill that proposes a legal, but regulated market. Although several states have opted for a flat-out ban, a select few have taken the TGC’s route. For instance, Oregon and Nevada updated their approach to treat Delta-8 equal to Delta-9 so that it may only be sold under the states’ regulated cannabis framework. Moreover, in Florida, where there is no legal Delta-9 THC framework, Delta-8 THC made from hemp obtained from intrastate transfers is permitted, as long as it is compliant with State Agriculture Rules and Laws. Florida’s Department of Agriculture and Consumer Services who oversees hemp production recently released the following statement:

“Delta 8: At this time any hemp product intended for human or animal ingestion or inhalation which is sold in Florida must comply with all Florida statutes and rules. Any hemp or hemp extract products offered for sale or sold in Florida must comply with all labeling rules and have a certificate of analysis that shows a total THC (THCA x .8777 + THC Delta 9 = total THC) content of 0.3% or less. Any hemp or hemp extract product that does not comply with all statutes and rules is subject to enforcement and possible destruction by the Florida Department of Agriculture and Consumer Services.”

Similarly, Connecticut recently updated its laws to commercially include Delta 8 within the umbrella definition of THC, but also created many limitations on how Delta 8 positive tests can be enforced against individuals in many situations. Complicated stuff, right?

Interesting! So, how do I protect my cannabis business from the unexpected? 

Despite lackluster regulation in Tennessee, there are several proactive steps a cannabis business selling or producing Delta-8 products can take to protect itself from the unknown, such as:

• Only sell to consumers that are 21 and over;
• Do not market Delta-8 products toward consumers that are 21 and under;
• Implement transparent labeling practices and follow state and FDA labeling requirements for typical food products (i.e., your cookie is still a cookie even if an unregulated substance is included in the ingredient list);
• Keep the product intrastate or speak with an attorney before shipping interstate;
• Include contact information on packaging or website for potential consumer complaints;
• Responsibly educate customers on the effects of your products by including key disclaimers on your product packaging (See below);
• Create a legitimate business entity, establish brand recognition, and comply with all applicable local, state, or federal law, including good manufacturing practices (See below);
• Consider linking to federal agency statements on your website or product packaging (See below);
• Lab test results from a third-party lab that indicates any harmful additives or solvents and any isomer (Delta-8, Delta-9, Delta-10, etc.; See below);
• Insure your risk, and require your vendors and suppliers to have appropriate insurance coverage; and,
• Draft proper business agreements.

 

Compliance with all applicable local, state, or federal law

Even if CBD or D8 products meet the definition of “hemp” under the 2018 Farm Bill, your business nevertheless must comply with all other applicable laws, including state privacy laws, and the Food Drug & Cosmetic Act. Recently, Delta-8 THC has attracted the attention of federal regulators, including the FDA.

The FDA has not approved any CBD or Delta-8 products other than one prescription drug for the treatment of seizures. CBD and Delta-8 have also not been approved as a food additive and do not meet the statutory definition of a dietary supplement; however, CBD cosmetics not intended to affect the structure or function of the body, or to diagnose, cure, mitigate, treat or prevent disease do not require pre-market FDA approval and are not prohibited for sale interstate.

Cannabis products marketed as “dietary supplements” are considered illegal “adulterated” products under federal law and the sale of cannabis food products across state lines is also prohibited; however, there are some exceptions when it comes to hulled hemp seed, hemp seed protein powder, and hemp seed oil as food additives for human consumption. THC and CBD consumables are typically permitted intrastate but local departments of agriculture may require certain food permits. For instance, Florida requires a Hemp Food Establishment permit.

Finally, the FDA recently warned about reported adverse effects in connection with Delta-8 products. The CDC has also published a health alert for Delta-8 products. Although the FDA and CDC warnings have no legal effect on the industry, they can be used by injured consumers to build a product liability claim as discussed below. These warnings can also guide entrepreneurs who wish to self-regulate. For instance, both reports mention the necessity of psychoactive disclaimers on product packaging.

Sample disclaimers to include on your product packaging and website:

• Consuming or using Delta-8 THC products may potentially result in a positive drug test for Delta-9 THC, for which we are not responsible and for which you accept the full risk.
• Do not operate a vehicle or heavy machinery when taking or using this product.
• Delta-8 THC products are not for use by or sale to persons under the age of 21.
• Delta-8 THC products should be used only as directed on the label.
• Hemp-derived products, including Delta-8 THC products, have not been evaluated by the FDA or any other state or federal agency.
• Delta-8 THC products are not intended to diagnose, treat, cure, remedy or prevent any disease, illness, or condition or any other ailment.

 

Product liability lawsuits

Product liability is a creature of state law. Similar to most state product liability laws, in Tennessee, there are three general defects that can result in liability: (1) a manufacturing defect (i.e. mistake during the assembly of the product); (2) a design defect (i.e. the risks of the product could have been reduced by use of a safer option); or (3) a marketing defect (i.e. inadequate labels or warnings).

Either of these three claims can be brought against cannabis businesses. For example, if a product contains well above a safe amount of THC for the average Joe, it can be argued that it has a design defect. In addition, if a manufacturer fails to disclose that a Delta-8 THC product could cause the consumer to fail a drug test, it could be subject to a marketing defect. See e.g. Horn v. Med. Marijuana, Inc., 383 F. Supp. 3d 114 (W.D.N.Y. 2019).

To avoid any sort of lawsuit, entrepreneurs in the cannabis space should invest in proper testing of their products by reputable laboratories. The US Cannabis Council collected 16 samples of Delta-8 products in 2021 across several states and tested them at an independent lab. The results showed that each sample contained a cocktail of isomers. The mean Delta-9 THC value was about 3.4%, rendering each sample illegal under federal law. All samples also contained undisclosed chemical solvents. The businesses selling the products all had certificates of analysis claiming compliance with federal law.

 

About Violaine Panasci

Violaine Panasci, LL.M., studied law at the University of Ottawa before completing an LL.M. in New York with an emphasis in food systems and sustainable supply chains. Her practice areas include agricultural technology, cannabis, copyrights, data privacy, food & beverage, regulation, sustainable supply chains, and trademarks. Read more about Violaine, connect with her, and Calendly her.

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