Intoxicating Hemp-Derived Cannabinoids: Legality of HHC, THCp, Delta-8

Understanding the complex world of hemp-derived cannabinoids can feel like solving a jigsaw puzzle with pieces that keep changing shapes. Knowing the legality of hemp-derived intoxicating cannabinoids, like delta-8 THC and many others, can keep you safe and avoid being suckered in by plant extracts peddlers claiming federally compliant legal status despite lacking any FDA approval.

What Are Intoxicating Hemp-Derived Cannabinoids (IHDs)?

Intoxicating hemp-derived cannabinoids (IHDs) are compounds extracted from hemp and then chemically derived from that extract and can alter users’ mental states, thus influencing their psychoactivity and perhaps dependency.

To be specific, these cannabinoids include various derivatives such as HHC, THCp, Delta-8, THCa, and THC-O, which are notorious for their mind-altering effects and potential to induce euphoria like their natural analog marijuana.

The terms “intoxicating” and “non-intoxicating” serve to differentiate their impact on the users’ psychological experiences. Lot of hemp oil claims to be full spectrum with an entourage of THC and CBD in compliance with the 2018 Farm Bill – but none of it is actually legal because of the Food Drug and Cosmetic Act (FDCA), which has zero GRAS status for any hemp-derived intoxicating cannabinoids intended for human consumption. See 21 USC 342.

The Popularity of HHC, THCp, Delta-8, THCa, and THC-O

HHC, THCp, Delta-8, THCa, and THC-O are intoxicating hemp-derived cannabinoids that have surged in popularity. Enthusiasts claim these cannabinoids offer unique experiences distinct from regular THC.

The market for these cannabinoids has exploded as users seek alternatives to traditional cannabis products. This rapid growth calls for a deeper understanding of their legal implications and health effects.

Delta-8 has been noted for its less-intense psychoactive effects compared to Delta-9 THC.

Experts argue that the surge in popularity comes from the quest for new, legal highs. However, intoxicating hemp-derived cannabinoids raise significant legal and safety concerns. The ambiguities in the legal framework further complicate the situation, making it crucial for consumers to stay informed.

The Marketing Loophole: How These Products Are Sold as Legal

Leveraging ambiguities in federal regulations, a variety of intoxicating hemp-derived cannabinoids, including HHC, THCp, Delta-8, THCa, and THC-O, flood the market. These products are often marketed under the guise of the 2018 Farm Bill, which legalized hemp and its derivatives, provided they contain less than 0.3% Delta-9 THC. However, this loophole overlooks the psychoactive potency of these other compounds.

Understanding FDA Regulations on Hemp-Derived Products

FDA regulations on hemp-derived products like HHC, THCp, Delta-8, THCa, and THC-O do not really exist.  To the extent they do, it is under existing law.  The Supreme Court overturning the Chevron Doctrine undermines FDA authority to even make new regulations governing hemp and its human consumption.  Here are a few bullet points about existing federal law relevant to IHDs.

1. Federal Oversight: The FDA regulates hemp-derived products under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2. Labeling Requirements: Proper labeling is mandatory to ensure consumers are not misled.
3. Health Claims: Any health claims need rigorous scientific support and FDA approval.
4. Adulteration and Misbranding: Products must not be adulterated or misbranded, aligning with federal safety standards.
5. Enforcement Actions: The FDA can enforce actions against companies that violate these regulations.

Understanding these regulations ensures compliance and protects consumer safety.

FDA’s Criteria for Approval of Intoxicating Hemp-Derived Cannabinoids

The FDA follows strict guidelines for approving hemp-derived cannabinoids to ensure consumer safety and product efficacy, regulated under the Federal Food, Drug, and Cosmetic Act (FDCA):

• Scientific Evidence: Products must have substantial scientific evidence proving their safety and effectiveness, as outlined in 21 U.S.C. § 355 for new drug approval.
• Manufacturing Practices: The product must comply with Good Manufacturing Practices (GMP), under 21 CFR Part 117, to avoid contamination and ensure consistency in production.
• Labeling Standards: Clear and accurate labeling is required to inform consumers about the product’s contents and potential effects, as regulated by 21 U.S.C. § 352 for misbranded drugs.
• Health and Safety Assessments: Comprehensive health and safety assessments, including clinical trials when necessary, must be performed as part of the FDA’s approval process for any new drug or dietary supplement.
• Adverse Event Reporting: Post-market reporting mechanisms for adverse events are essential to ongoing product safety under 21 CFR Part 314.80.

These criteria set a high bar for ensuring products meet safety and efficacy standards. Failure to comply with these guidelines can result in significant legal consequences, including product seizures, fines, or criminal penalties.

GRAS Standards and Safety Criteria

Under federal law, the Generally Recognized as Safe (GRAS) standard allows certain substances to be added to food without needing FDA pre-approval, as long as experts agree that the substance is safe for its intended use. This is regulated under 21 U.S.C. § 321(s), which exempts GRAS substances from being classified as food additives, and further detailed in 21 CFR Part 170, which outlines how substances qualify for GRAS status. If a substance isn’t GRAS or FDA-approved, it could be considered an adulterated food product under 21 U.S.C. § 342.

The Marketing Loophole: How These Products Are Sold as Legal

Intoxicating hemp-derived cannabinoids, a subset of controversial substances, exploit legal gray areas. Vendors market these with clever labeling tactics, often emphasizing that they derive from hemp plants, which are federally legal under the 2018 Farm Bill, thus sidestepping regulatory scrutiny.

By focusing on the derivation of a legal crop, retailers utilize the “legality by association” argument. Whether it is HHC, THCp, Delta-8, THCa, or THC-O, sellers highlight that the cannabinoids come from hemp. In many cases, the intoxicating effects are downplayed, allowing these products to be sold legally, even if they skate close to violating federal law.

Exploiting Legal Loopholes

The marketing of intoxicating hemp-derived cannabinoids exploits legal ambiguities.

First and foremost, it is crucial to understand that the 2018 Farm Bill inadvertently created a legal gray area. While the bill legalizes hemp-derived products with less than 0.3% Delta-9 THC, it says nothing about other intoxicating compounds. This omission becomes a vector for legal and commercial exploitation, enabling sellers to push products that conform to the letter but not the spirit of the law.

Intriguingly, this exploitation extends to isolation and synthesis techniques. By chemically altering compounds found in hemp, manufacturers create versions of THC that weren’t explicitly banned. Consequently, variants like HHC and THC-O find legal shelter in this loophole, sidestepping federal regulations while still delivering significant psychoactive effects.

As a consumer, one should remain vigilant. Though marketed under the guise of legality, these products present potential legal and health risks. Law enforcement agencies are gradually catching up, and the FDA has started issuing warnings, earmarking such practices for stringent oversight.

Why IHDs Are Not FDA-Approved

Intoxicating hemp-derived cannabinoids (IHDs) have not gained FDA approval due to both novelty and safety concerns. The FDA maintains rigorous standards in evaluating potential therapeutic and non-therapeutic substances, ensuring that they meet strict criteria for safety, efficacy, and quality before being granted approval.

To date, these cannabinoids (e.g., HHC, THCp) lack comprehensive scientific studies validating their safety, leading to significant regulatory barriers. These studies are imperative for confirming that there are no adverse health effects from consuming such compounds.

Health Risks and Lack of Safety Data

The absence of FDA approval for intoxicating hemp-derived cannabinoids such as HHC and THCp raises significant health concerns. Without approval under 21 U.S.C. § 355 for new drugs, there is insufficient scientific evidence to evaluate these cannabinoids’ safety and effectiveness. However, to the extent the substances are just offered for human consumption and make no claims for therapeutic benefit to not be considered drugs, they could still be:

• Adulterated Products (21 U.S.C. § 342): If the safety of a product has not been established and it could pose health risks, it may be considered adulterated, which can lead to enforcement actions​.
• Misbranded Products (21 U.S.C. § 352): These cannabinoids could also be deemed misbranded if marketed without appropriate labeling that includes potential risks or proper instructions for use.

The lack of robust clinical trials means that consumers are essentially experimenting with unproven compounds. The FDA mandates extensive safety and efficacy testing for drugs under 21 CFR Part 314, which has not occurred for cannabinoids like THCp and HHC. This unregulated market can lead to inconsistencies in product purity, dosages, and formulations, exposing consumers to further risks.

The novelty of these cannabinoids also means the industry has not been subject to the stringent safety and clinical testing standards applied to other drugs, creating an unregulated market where products may not meet appropriate safety thresholds. Without FDA oversight, the potential long-term effects and health risks of these substances do not exist. This underscores the importance of safety testing before they can be marketed to consumers.

State-Level Enforcements and Federal Actions

State and federal laws both regulate intoxicating hemp-derived cannabinoids (IHDs) like Delta-8 THC and THC-O, but states can impose stricter regulations than the federal government allows. Under the 2018 Farm Bill, states are given the power to establish their own regulatory frameworks for hemp, including the ability to make rules more stringent than federal standards. This means that while federal law legalizes hemp with less than 0.3% Delta-9 THC, individual states can implement tougher testing, labeling, or outright bans on certain cannabinoids​.

State-Level Bans and Restrictions

Many states have enacted laws that go beyond federal regulations. For example, some states have banned the sale of intoxicating hemp-derived cannabinoids due to concerns over public health risks, even though these products might be federally legal under the USDA’s definition of hemp. Other states have introduced strict testing and labeling requirements, mandating that companies follow tighter controls to ensure THC levels remain within state-set limits and that products are clearly labeled for consumers.

The 2018 Farm Bill explicitly allows states to enforce more restrictive measures. States can adopt stricter THC concentration limits, safety protocols, or labeling regulations. Failure to comply with these enhanced state laws can result in fines, penalties, or the revocation of business licenses, making it vital for companies to understand the legal landscape in each state​.

FDA Enforcement Actions

At the federal level, the FDA regulates the safety of products intended for human consumption. In 2024, the FDA issued warning letters to companies marketing unapproved cannabinoids like Delta-8 THC and CBD, highlighting its focus on consumer safety. The FDA warned more delta-8 companies in 2022 concerned with companies making unsubstantiated health claims or selling these products as dietary supplements, which is prohibited under federal law unless FDA-approved. Companies found in violation face significant penalties, including product seizures, injunctions, and fines​.

In addition to state-specific requirements, businesses selling these cannabinoids must also navigate FDA regulations, which can further restrict how they are marketed and sold. Ensuring compliance with both state and federal laws is crucial to avoid severe legal consequences.

The Future of Intoxicating Hemp-Derived Cannabinoids

The landscape for intoxicating hemp-derived cannabinoids will undoubtedly evolve as regulatory frameworks develop and scientific research advances. Policymakers, health professionals, and even consumers, will be instrumental in shaping how these substances integrate into society. We recommend natural marijuana being moved to Schedule III of the CSA and the definition of of hemp being clarified to avoid FDA regulation.

Implications for Consumers and Businesses

The evolving legal landscape directly impacts both consumers and businesses involved with intoxicating hemp-derived cannabinoids.

• Compliance Costs: Businesses must navigate complex regulations, incurring costs for legal advice, compliance checks, and potential changes in product formulation.
• Market Uncertainty: Shifting legal statuses create an unstable market environment, affecting investment decisions and long-term business planning.
• Consumer Safety: Non-compliant products may pose health risks, leading consumers to demand higher safety standards and clear labeling.
• Enforcement Actions: Potential penalties for non-compliance include fines, product seizures, and ceasing operations, which can devastate businesses.
• Consumer Trust: Regulatory compliance builds consumer trust, which is essential for market growth and brand loyalty.

Businesses need to stay vigilant and informed to mitigate risks associated with these developments. Lawyers helping these IHD peddlers expose themselves to risk of loss of their law license for facilitating criminal actions not given safe harbor by professional rule changes in jurisdictions that have legalized natural marijuana.

Consumers, on the other hand, should seek transparent information to make informed decisions about their purchases. Stick to the real thing, from licensed dispensaries to be safe.