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Cannabis Clinical Trials

Laboratory test tubes 2280549
by Emily Burns, Green Light Law Group ---
Clinical trials involving the use or administration of cannabis to human research subjects are subject to a variety of federal and state laws regarding human research subject protections, privacy protections, and informed consent. The federal Food and Drug Administration (“FDA”) is responsible for enforcing the laws and regulations governing clinical trials conducted as part of an Investigational New Drug (“IND”), New Drug Application (“NDA”), and premarket approval of advertisements. A few states have implemented laws authorizing medical research involving cannabis outside the purview of the FDA new drug approval process, including Maryland, New Jersey, and Pennsylvania. It is important to consider the numerous legal issues and challenges associated with state-authorized clinical research programs involving cannabis because dissemination of clinical research results for marketing and advertising purposes could result in an enforcement action by the FDA, Federal Trade Commission (“FTC”), and the Drug Enforcement Administration (“DEA”). Any entity engaged in academic or medical research projects that involve the use or administration of cannabis should tread very carefully when considering whether to participate in state-authorized clinical research, as the failure to comply with federal drug laws could result in the loss of federal funds. It is also important to emphasize that the federal Controlled Substances Act (CSA) prohibits research of Schedule I drugs without DEA registration or approval of the project, other than clinical research conducted as part of FDA new drug applications. This means any entity, including academic institutions, that approves clinical research involving cannabis outside of these specific legal channels risks losing any future opportunities to participate in cannabis research. Why? Well, one of the factors used to determine whether DEA will approve an applicant seeking registration for cannabis research relates to the specific applicant’s compliance with federal and state laws governing controlled substances. It seems rather unlikely that DEA officials will vote in favor of registering an entity engaged in federally illegal conduct, even under the guise of conducting research. Section 5(a) of the FTC Act prohibits “unfair or deceptive acts or practices in or affecting commerce,” and Section 12 of the FTC Act prohibits the dissemination of false advertisements in or “affecting commerce for the purpose of inducing, or which is likely to induce, the purchase of food, drugs, device, services, or cosmetics.” Thus, in order to make a health, safety, and/or efficacy claim in an advertisement, the FTC requires a marketer to possess competent and reliable scientific evidence in support of these claims, which for most disease-related representations means well-controlled human clinical testing. FTC defines competent and reliable scientific evidence as “human clinical testing of such product that is sufficient in quality and quantity, based on standards generally accepted by experts in the relevant field, when considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true.” Such testing shall be (1) randomized, double-blind, and adequately controlled; and (2) conducted by researchers qualified by training and experience to conduct such testing.” The FDA and FTC “will generally arrive at the same conclusion when evaluating unqualified health claims,” and FTC defers to FDA for determinations regarding adequate support for health claims. According to FTC guidance, the existence of a strong body of evidence that contradicts a health claim, even a qualified health claim, is likely to be deceptive. Additionally, clinical trials used to substantiate a health claim must involve the actual product being advertised, so clinical research using a product with a significantly different chemical profile than the advertised product, for example, would not be sufficient for purposes of substantiating health claims related to the safety and efficacy of a product. If an advertisement includes testimony from an expert endorser, advertisers must disclose any material connection between the endorser and advertiser of the product, and ensure that an expert endorser has appropriate qualifications and has conducted sufficient examination or testing of a product that would be sufficient to support the endorsement. An expert endorser is subject to liability for false statements made in advertisements and the advertiser is liable for those same misrepresentations made by the endorser. The primary challenge for cannabis businesses relates to the use of clinical research results obtained via state-authorized cannabis research programs, as any health claims related to this research may not qualify under FTC standards for substantiated health claims. As mentioned above, the FTC has indicated the existence of a strong body of evidence that contradicts a qualified health claim is likely to be deceptive, and unfortunately, the FTC generally defers to FDA for information regarding health claims. Given the FDA’s view of cannabis health claims, it is important to remember that clinical research conducted outside the purview of the FDA and DEA, may not be sufficient to substantiate health claims used in promotions and advertisements. Given the proliferation of press releases related to cannabis research, it is best to utilize expert legal counsel prior to disseminating any FTC-governed advertisements and marketing materials, as failure to do so can result in significant penalties. It is impossible to overstate the significance of reviewing health claims prior to public use, which means conducting due diligence on the clinical research used to substantiate the claim, as well as the research protocol, and any policies and procedures governing the safety and security of patients subject to potential harms resulting from administration of cannabis.