As anticipated, Delta-8 tetrahydrocannabinol ("Delta-8 THC") has become the hottest, most flourishing cannabinoid currently found on the U.S. market. In the past few months, the sales of Delta-8 THC products have exploded, representing the fastest growing segment of hemp-derived products.
Sin embargo, a pesar de su creciente popularidad, la legalidad del THC Delta-8, incluidos los productos que lo contienen, sigue siendo poco clara. Esta entrada del blog ofrece una visión general de este tema.
Marco jurídico federal
THC delta-8
Although all hemp-derived cannabinoids, including hemp-derived Delta-8 THC, seem to fall squarely within the definition of hemp enacted under the Agriculture Improvement Act of 2018 (the "2018 Farm Bill"), uncertainties remain regarding the federal legality of cannabinoids like Delta-8 THC that are derivatives of other hemp-derived cannabinoids.
Dado que el THC-8 no se encuentra en concentraciones suficientes en la mayoría de las variedades de cáñamo como para que su extracción resulte rentable, la mayor parte del THC-8 que se comercializa se obtiene a partir de la conversión química del cannabidiol (CBD) derivado del cáñamo. Esta conversión química es la causa de la confusión jurídica.
Back in August 2020, the Drug Enforcement Administration (the "DEA") released its Interim Final Rule (the "IFR") in which the agency stated, in part, that "[a]ll synthetically derived tetrahydrocannabinols remain schedule I controlled substances." (Emphasis added).
Given the DEA’s historical hostility toward cannabis and its broad interpretation of the term "synthetically derived THC" (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” substance, and thus, as an illegal schedule I controlled substance.
Por lo tanto, hasta que la DEA aclare esta incertidumbre persistente, ya sea mediante legislación o a través de los tribunales, cualquier persona interesada en entrar en este mercado debe ser consciente de los posibles riesgos asociados al comercio de este popular cannabinoide.
Productos con THC-8
Similarly to CBD-infused products intended for human consumption, Delta-8 THC products fall under the jurisdiction of the Food and Drug Administration (the "FDA"). This is because the 2018 Farm Bill expressly preserves the agency’s authority to regulate products containing cannabis or cannabis-derived compounds under the Food, Drug and Cosmetic Act (the "FDCA") and Section 351 of the Public Health Service 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 the Drug Exclusion Rule should not apply to this cannabinoid. Readers of this blog will recall that the Drug Exclusion Rule provides that any substance that has been approved or investigated by the FDA as a new drug cannot also be sold and marketed as a food or dietary supplement-- unless the substance was sold and marketed as such before investigation.
Assuming the Drug Exclusion Rule does not apply, the question of whether Delta-8 THC may be sold and marketed as a food or a dietary supplement depends on whether this cannabinoid is safe for human consumption. The safety of a substance added to conventional food products and dietary supplements is assessed by the FDA through pre-market approval processes, known as the "generally recognized as safe" ("GRAS") and "new dietary ingredient" ("NDI") notifications, respectively - you can learn more about the GRAS and NDI notification mechanisms here and here.
Por lo tanto, aunque el THC-8 entre dentro de la definición federal de «cáñamo» y, por lo tanto, se considere una sustancia legal, los productos de THC-8 destinados al consumo humano —en concreto, los alimentos y los complementos alimenticios— no serán legales según la legislación federal hasta que la sustancia reciba la autorización previa a la comercialización de la FDA, al igual que ocurre con el CBD y otros productos que contienen cannabinoides.
Marcos jurídicos estatales
Al igual que ocurre con el CBD y los productos de CBD, la legalidad del Delta-8 THC y de los productos de Delta-8 THC varía de un estado a otro.
While many states have adopted the federal definition of "hemp," which expressly includes cannabinoids and derivatives of hemp, and removes them from the definition of “marihuana” under the Controlled Substances Act, some states have yet to do so. Other states fail to differentiate THC derived from hemp and marijuana. And a handful of states expressly include Delta-8 THC on their list of controlled substances.
Para complicar aún más las cosas, algunos de los estados en los que el THC Delta-8 y sus productos derivados están expresamente permitidos han establecido su propio conjunto de normas, que incluyen requisitos de registro, etiquetado y análisis. Este mosaico de normativas que varían de un estado a otro obliga a los fabricantes y distribuidores de productos de THC Delta-8 a limitar sus ventas a aquellos estados en los que estos productos están permitidos y expresamente regulados. Las empresas deben cumplir con una serie de normativas (a veces contradictorias) en cada estado en el que se comercializan estos productos.
Dejando a un lado la legislación federal, cualquier empresa que tenga previsto fabricar, vender y comercializar productos con THC Delta-8 debería, en primer lugar, familiarizarse a fondo con la legislación estatal pertinente para garantizar el cumplimiento de todas las leyes y normativas aplicables. Esta es la vía más segura para mitigar el riesgo de que se adopten medidas coercitivas basadas únicamente en el hecho de que un producto contenga THC Delta-8.
