FDA has just published a remarkably comprehensive and detailed statement of its current positions on hemp, CBD and cannabis as currently marketed in several different categories. The statement comes in a Notice setting a public hearing on May 31, with written comments accepted through July 2, 2019. While FDA has already signaled its positions on certain products and issues, this Notice reflects an effort to address the entire cannabis-based market across multiple fields including drugs, supplements, foods and cosmetics. Many of FDA’s positions in the Notice will come as no surprise to interested observers, and some will surely be debated (e.g. GRAS status), but here and there FDA makes some important concessions. For one, FDA unambiguously admits that “cannabis plants and derivatives that contain no more than 0.3 percent THC on a dry weight basis are no longer controlled substances under Federal law.” To be sure, that is exactly what Congress said a few months ago in the 2018 Farm Bill, but having FDA repeat that position without quibble is significant. Further, with even a modest measure of lawyerly parsing, a few of FDA’s unequivocal statements such as “products that contain THC or CBD cannot be marketed as dietary supplements” do also admit the possibility of regulatory exception or further rulemaking. Indeed, FDA states that one purpose of the public hearing on May 31 is to “inform our regulatory oversight of these products” in order to define a clear pathway to federal acceptance. What is clear from the Notice is that FDA considers the entire cannabis-based field to be within its regulatory sphere, and that FDA is beginning a comprehensive effort to consider and resolve many open issues about developing and marketing safe and effective cannabis-based products in multiple market channels. Stay tuned for further analysis. You may read the entire FDA notice in the Federal Register here https://federalregister.gov/d/2019-06436.