As expected, Delta-8 THC has become the hottest and most prosperous cannabinoid present on the US market. In the past few months, sales of Delta-8 THC products have exploded, representing the fastest-growing segment of hemp-derived products.
However, despite its growing popularity, the legitimacy of Delta-8 THC, including Delta-8 THC products, remains murky. This post aims to give you a 30,000-foot wide view on this issue.
Federal legal framework
Delta 8 THC
Although all hemp derived from hemp, including Delta-8 THC that is derived from hemp, appears to fall directly within the definition of hemp promulgated under the Agriculture Improvement Act of 2018 ( 2018 Bell Farm)However, doubts remain regarding the federal legitimacy of cannabinoids such as Delta-8 THC which are derivatives of hemp derived from hemp.
Since Delta-8 THC is not expressed in sufficient concentrations in most strains of hemp to make its extraction financially feasible, most of the Delta-8 THC on the market is derived from the chemical conversion of hemp-derived hemp (CBD). This chemical transformation is the origin of legal confusion.
Back in August 2020, the DEA released its Temporary Final Rule (file IFRThe agency stated, in part, that “[a]Ll THC is synthetically derived Controlled substances remain in the first Schedule. ”(Confirmations added).
Given the DEA’s historic hostility to cannabis and its broad interpretation of the term “THC synthetic” (more on that Here), It seems highly plausible that the DEA would treat Delta-8 THC chemically derived from hemp-derived CBD as a “synthetically derived THC” and, therefore, as an illegal schedule controlled substance.
Thus, for this uncertainty to be addressed by the DEA, through legislation or by the courts, anyone interested in venturing into this market must understand the potential risks associated with dealing with this popular hemp.
Delta-8 THC products
Similar to CBD-infused products for human consumption, Delta-8 THC products fall under the jurisdiction of the Food and Drug Administration. This is because the Farm Act of 2018 expressly preserves the agency’s authority to regulate products containing cannabis or compounds derived from it under the Food, Drug, and Cosmetic Act (FDCA) and Article 351 of the Public Health Services Act.
To our knowledge, Delta-8 THC, unlike CBD, has not been approved or investigated by the FDA as a new drug ingredient, which means Drug exclusion rule It should not be applied to this hemp. Readers of this blog will remember that the drug exclusion rule states that any substance that has been approved or verified by the US Food and Drug Administration as a new drug cannot be sold and marketed as a food or dietary supplement – unless the substance is sold and marketed as such prior to the investigation.
Assuming the drug exclusion rule does not apply, the question of whether Delta-8 THC can be sold and marketed as a food or dietary supplement depends on whether this hemp is safe for human consumption. The safety of an additive to conventional food products and nutritional supplements is evaluated by the Food and Drug Administration through pre-approval processes, known as Notifications for Generally Recognized as Safe (GRAS) and New Food Ingredients (NDI), respectively – you can Learn more about the GRAS and NDI notification mechanisms Here And the Here.
Therefore, even if Delta-8 THC falls under the federal definition of “hemp” and is, therefore, treated as a legal substance, Delta-8 THC products intended for human consumption, specifically foods and nutritional supplements, will not be legal under federal law until The substance gets pre-market approval from the Food and Drug Administration – just like CBD and other hemp-infused products.
State legal frameworks
As with CBD and CBD products, Delta-8 THC and Delta-8 THC are legal It varies from country to state.
While many states have adopted the federal definition of “hemp,” which explicitly includes hemp and its derivatives, and removes them from the definition of “marijuana” under the Controlled Substances Act, some states have not yet. Other countries fail to differentiate hemp-derived THC from marijuana. A handful of countries have explicitly included Delta-8 THC in their list of controlled substances.
To complicate matters, some states where Delta-8 THC and derivative products are expressly permitted have implemented their own set of regulations, including registration, marking and testing requirements. This patchwork of state government regulations forces Delta-8 THC product manufacturers and distributors to restrict sales in states where these products are explicitly permitted and regulated. Companies must follow a variety of (sometimes conflicting) regulations in each state in which these products are sold.
Aside from federal law issues, any company planning to manufacture, sell, and market Delta-8 THC products must first obtain a thorough understanding of the relevant state laws to ensure compliance with all applicable laws and regulations. This is the surest possible way to mitigate the risk of enforcement actions, based solely on the fact that the product contains Delta-8 THC.
Nathalie practices outside of Harris Bricken’s Portland office and focuses on the regulatory framework for hemp-derived CBD products (“hemp CBD”). It is an authority concerned with enforcing the Food and Drug Administration, Food, Drug and Cosmetic Act, and other laws and regulations related to hemp and hemp CBD products. It also advises local and international clients on selling, distributing, marketing, labeling, importing and exporting these products. Natalie talks a lot about these issues and has been featured in national media, including NPR. For two years in a row, Natalie has been named a “Rising Star” by Super Lawyers, an honor awarded to only 2.5% of qualified Oregon attorneys. Natalie is also a regular shareholder of her company Kana Lu Blog.