Lessons for cannabinoid regulation from electronic nicotine delivery system product regulation
Yagi, Brian | Veuger, Stan | Miller, Brian J | Larkin, Paul | Brian J
A recent third-party review by the Reagan-Udall Foundation was critical of FDA for its lack of transparency—finding that application requirements are “vague and frequently changing” and that the center’s decisions to authorize or deny a product lack “clarity, transparency, and communication”—and recommended that FDA pivot from a reactive mode to a proactive mode in order to focus on its primary mission as a product regulator.12 This article, representing a contrasting perspective to current, recent FDA assertions that it lacks authority, examines recent challenges in tobacco product regulation and delineates 3 key lessons learned from the first 14 years of FDA tobacco regulation to inform potential future oversight of cannabis.13 Specifically, we denote the FDA’s failure to exercise its existing authorities to take enforcement action against a litany of currently illegally marketed cannabis products making unauthorized therapeutic claims, outdated guidance that fails to ensure that botanical products meet FDA standards, and other core agency regulatory failures. Any future statutory updates to the Farm Bill or other legislation affecting cannabinoid product regulation should aim to provide clarity regarding regulatory jurisdiction and scope, with a carefully sculpted statutory definition to ensure that the desired agency or agencies has oversight and enforcement authority over the wide variety of cannabinoid products (cannabis; extracts including vaporized products; concentrate/infusible products, eg, edibles, topicals; and synthetic cannabinoids such as delta-8). For example, if a product claims an effect on the structure or function of the body but does not make any therapeutic or health claims, it is categorized as a dietary supplement (with the agency noting that it lacks the authority to use this framework to oversee CBD products).22 The FDA’s Center for Food Safety and Applied Nutrition (CFSAN) regulates dietary supplements, which are subject to significantly less onerous evidentiary requirements for marketing authorization and post-market safety surveillance.32 Recent FDA actions demonstrate how the agency has attempted to learn from its mistakes in tobacco regulation. The FDA has the in-house scientific testing capabilities to identify and quantify all possible chemicals in inhaled tobacco products and has issued $424 million in funding over nearly a decade to academic institutions referred to as Tobacco Centers of Regulatory Science,63-65 with recent commentary noting that there is a sufficient quantity of unbiased scientific evidence to support ENDS product standards.66 Furthermore, recognizing that the APPH standard is an epidemiological standard, FDA should have issued guidance as to its proposed analysis framework and evidentiary burden, so as to guide product manufacturers, internal agency review staff, and public health experts. Therefore, the FDA will need to undertake vigorous enforcement against a litany of currently marketed products with unproven health claims and issue updated botanical products guidance and, as appropriate, product standards for pharmaceutical-grade products that have high-quality scientific evidence in the form of clinical trials that seek marketing approval as a drug.