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.
然而，尽管Delta-8 THC及其相关产品日益流行，其合法性仍处于模糊地带。本文将从宏观视角对此问题进行全面探讨。
联邦法律框架
Delta-8四氢大麻酚
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.
由于大多数大麻品种中Delta-8 THC的含量不足以支撑其经济可行的提取，市面上绝大多数Delta-8 THC都是通过化学转化从大麻提取的 cannabidiol（CBD）获得的。这种化学转化正是法律争议的根源所在。
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.
因此，在缉毒局通过立法或司法途径解决这一悬而未决的不确定性之前，任何有意涉足该市场的人士都应充分认识到，经营这种广受欢迎的大麻素可能带来的潜在风险。
Delta-8 THC产品
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.
因此，即使Delta-8 THC符合联邦对"大麻"的定义，因而被视为合法物质，但用于人类消费的Delta-8 THC产品——特别是食品和膳食补充剂——在获得FDA上市前批准之前，仍不符合联邦法律规定。这与CBD及其他大麻素添加产品的处理方式完全一致。
国家法律框架
与CBD及CBD产品类似，Delta-8 THC及其产品的合法性因州而异。
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.
更复杂的是，在明确允许Delta-8 THC及其衍生产品销售的某些州，又实施了各自的监管条例，包括注册、标签和检测要求。这种各州法规参差不齐的局面，迫使Delta-8 THC产品的制造商和分销商将销售范围限制在允许销售且有明确监管的州。企业在销售这些产品的每个州都必须遵守多种（有时相互冲突）的法规。
撇开联邦法律问题不谈，任何计划生产、销售和推广Delta-8 THC产品的公司，都应首先全面了解相关州法律，以确保符合所有适用法规。这是规避执法风险的最可靠途径——仅因产品含有Delta-8 THC这一事实就可能引发执法行动。
