§12.2 Enforcement and Regulation of Cannabis-Derived Ingestible Products
| Jurisdiction | United States |
| Publication year | 2022 |
§12.2 Enforcement and Regulation of Cannabis-Derived Ingestible Products
In light of the regulatory differences at the federal level and the states level, sufficient understanding of the enforcement mechanisms still being employed against entities involved in the cannabis-derived product industry is recommended.
Currently, the Agricultural Improvement Act of 2018 explicitly did not modify the authority of the FDA to regulate dietary supplements, including those containing hemp.17 FDA has also, and thusly, determined that it may apply current dietary supplement regulations to dietary supplements containing CBD or THC.18 FDA has further held that dietary supplements that contain THC or CBD cannot be legally marketed based on 21 U.S.C. 321(ff).19 This is primarily because THC and CBD "do not fall under the definition of dietary supplements," as the ingredients have been included as active ingredients in approved and pending drugs.20 The FDA-approved drugs, believed to prohibit THC and CBD from falling under definition of dietary supplement, include EPIDIOLEX (which includes CBD) and MARINOL and SYNDROS (which include THC).21
In the United States, cannabis-derived ingestible products are regulated at both the federal and state levels.22 Depending on the type of cannabis-derived ingestible product, the two types of regulatory laws may conflict, in which case federal law likely will trump state law under the Supremacy Clause of the U.S. Constitution.23
§12.2.1 Enforcement and Regulation of Cannabidiol (CBD)
FDA enforcement against cannabis-derived ingestible CBD is based on the belief that there is little to no scientific evidence supporting health benefit claims, which often accompany CBD products.24 Further, the FDA warns that CBD has the potential to cause liver injury, male reproductive toxicity, and changes to alertness and mood.25
Warning letters have apparently been the primary means of enforcement against dietary supplements containing CBD.26 Letters are usually issued by the divisions Center for Drug Evaluation (CDER), or Center for Food Safety and Applied Nutrition (CFSAN).27 As Warning Letters from CDER and CFSAN are apparently similar, it is unclear what determines which division will issue a particular Warning Letter and why.28 For dietary supplements, the Warning Letters are performed "to achieve voluntary compliance and to establish prior notice."29 The FDA further has at its disposal the ability to seize product,30 obtain permanent injunctions usually by consent decree,31 or pursue criminal action.32 Actions are brought by the Department of Justice at the request of the FDA.
The Drug Enforcement Agency (DEA), as of this Manual edition issued 2022, does not require a DEA registration for CBD produced from "hemp," with "hemp" being defined under the Agriculture Act of 2014 (7 U.S.C. section 5940) as any part of the Cannabis sativa L. plant having delta-9-tetrahydrocannabidiol concentration of 0.3% or less based on dry weight.33 CBD derived from marijuana is likely still regulated by the DEA due to the fact that marijuana is still listed as a Schedule 1 drug under the Controlled Substance Act, which is likely based on the THC content present in marijuana.34 Thus, the DEA involvement in enforcement action against CBD dietary supplements is likely based on the derivation source of the CBD where the derivation source is best defined as its THC content (more than or less than 0.3% THC based on dry weight). The key cut-off date for significant DEA enforcement against CBD is 2014.35
§12.2.2 Enforcement and Regulation of Hemp-Derived Ingestible Dietary Supplements; Dehulled Hemp Seed, Hemp Seed Oil, Hemp Protein Powder, and CBD
"Hemp" has been defined as Cannabis sativa L. with a delta-9 concentration of 0.3% or less.36 Currently, there are three ingredients derived from hemp that can be used in dietary supplements that have been determined to be GRAS-dehulled hemp seed,37 hemp seed oil,38 and hemp seed protein powder.39
At issue, from the author's point of view, is cannabidiol (CBD) derived from hemp and its permissiveness to be legally added and marketed in dietary supplements. As noted Horn v. Medical, "CBD can be extracted from both the marijuana and hemp varieties of Cannabis sativa."40 Whereas CBD derived from hemp would fall under permissive sale as hemp-derived extracts are removed from the definition of "marihuana" under the Controlled Substance Act,41 the FDA, who still retain the authority to regulate cannabis-derived products, has determined that CBD may not be marketed as part of a dietary supplement because it has been approved as the active ingredient of a drug.42 In light of the FDA's continued stance on CBD, in this author's view, regardless of if CBD is derived from hemp or marijuana, the sale and marketing of CBD as an ingredient in a dietary supplement remains illegal under the Food and Drug Act.43 The FDA has expressed interest in modification regarding CBD marketing in the future through their rule-making authority.44
Following passage of the Agricultural Act of 2018, Courts have noted the lack of FDA advancement in the form of rule-making for CBD, resulting in staying decisions for cases pending the rule-making.45 In Synder v. Green Roads of Fla. LLC, 430 F. Supp. 3d 1297, 1309 (S.D. Fla. 2020), applying the primary jurisdiction doctrine, the court stayed the case, relating to CBD products, until "the FDA completes its rulemaking regarding the marketing, including labelling, of hemp-derived ingestible products."46
Regarding current concerns with marketed hemp-derived ingestible CBD, in view of the FD&C Act, the FDA has focused on the marketing statements that a CBD product is intended to "prevent, diagnose, mitigate, treat, or cure serious diseases, such as cancer."47 The FDA's concerns are not unwarranted, a recently published consumer magazine focused on CBD was replete with marketing claims on the treatment benefits of hemp-derived ingestible CBD.48
§12.2.3 Enforcement and Regulation of Tetrahydrocannabinols ("THC")
§12.2.3.1 0.3% THC as Definitive of "Hemp"
7 U.S.C. section 1439 classifies "hemp" as including delta-9-THC at 0.3% or less.49 Prior to the percentage of allowable THC present in hemp being codified, there were attempts to differentiate and define marijuana, often in the hopes of avoiding criminal conviction.50
An attempt to codify different THC levels present in hemp versus in marihauna was apparently first pursued at the state level through legislation by a member of the New Hampshire state legislature.51 The bill attempted to define "industrial hemp" as having a THC concentration of 1% or less.52 In determining whether federal statute precluded New Hampshire's attempt to differentiate hemp from marijuana, the court embarked on a discussion of the "Marihuana Tax Act of 1937."53
The DEA has amended the Controlled Substance Act to clarify that in order for any product, including derivatives, to qualify as hemp, the product must not exceed 0.3% THC.54 As stated above, qualification as "hemp" is necessary to exclude a scheduled substance from being under the CSA. The permissive of the DEA's amendment and its application has led to the third case in the series Hemp Industries Association v. U.S. Drug Enforcement Administration.55
§12.2.3.2 Natural Tetrahydrocannabinols Versus Synthetic Tetrahydrocannabinols
Further distinctions were made between naturally occurring THC, such as found in hemp, and synthetic THC, as the Drug Enforcement Agency attempted to further limit sales of hemp-derived ingestible products through notices, regulations, and interpretations. In the case series Hemp Industries Ass'n v. Drug Enforcement Administration, the Court held the DEA's attempt to ban hemp-derived ingestible products due to the presence, albeit minute, of THC to be unenforceable.56 In ruling, the court reviewed the legislative and regulatory history of THC being listed as a substance on the Controlled Substance Act. The court noted that since 1968, synthetic THC was determined to be a substance "having a potential for abuse,"57 referring to the Drug Abuse Control Amendment of 1965,58 asserting that regulation excluded naturally occurring THC.59
§12.2.4 FTC Regulatory and Enforcement Action for Cannabis Sativa L.-Derived...
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