Most cannabis business owners, by now, are familiar with the Food and Drug Administration’s (FDA) actions regarding specific health claims in connection with hemp-derived cannabidiol (Hemp-CBD). While it might at times feel mind-boggling to keep track of so many federal acronyms and regulatory bodies, it is critical to keep in mind the Federal Trade Commission (FTC) standards for health claims, as well.
The FTC has partnered with the FDA on Hemp-CBD warning letters and enforcement efforts to limit the proliferation of deceptive health information regarding Hemp-CBD products. One major challenge for many Hemp-CBD companies making health claims (e.g. CBD “represses hunger,” or “reduces pain”), is finding credible, scientifically sound evidence – as required by the FTC – to support these claims.
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. Such a review includes means conducting due diligence on the clinical research and research protocols used to substantiate the claim, as well a review of any policies and procedures governing the safety and security of patients subject to potential harms resulting from administration of Hemp-CBD. Taking these steps can help protect consumers who may rely on said Hemp-CBD company press releases and are critical for protecting your business because the FTC is actively monitoring the Hemp-CBD product space for unsubstantiated claims.
The FTC Act prohibits “unfair or deceptive acts or practices in or affecting commerce,” and 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” (FTC Act Section 5(a); Section 12.) Thus, in order to make a health, safety, 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.
The 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 must be: (1) randomized, double-blind, and adequately controlled; and (2) conducted by researchers qualified by training and experience to conduct such testing.
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. Legitimate, state-authorized research is certainly credible and sufficient for FTC Act compliance, but such research is scarce and doesn’t necessarily apply to each and every type of hemp and CBD product that is available in the market today.
Companies should be very careful prior to making health claims like Hemp-CBD “stimulates appetite” and is “good for sleep” in order to avoid an FTC enforcement action, which can include heavy fines. The key takeaway? Work with a regulatory attorney to ensure that all health claims subject to the FTC Act have been vetted for compliance purposes. The FTC has indicated the existence of a strong body of evidence that contradicts a qualified health claim is likely to be deceptive, and the FTC generally defers to FDA for information regarding health claims.
You can contact Emily Burns at email@example.com or 503-488-5424.