ACKRELL CAPITAL Cannabis Investment Report | December 2017 a dietary supplement but not represented for use as a conventional food or as a sole item of a meal or the diet. A dietary supplement generally is deemed to be a food under the FD&C Act. The FD&C Act does not require foods or food labels to be pre-approved by the FDA, but it does give the FDA broad authority to regulate the safety of food and food labels and to prevent interstate commerce in adulterated or misbranded food. Facilities engaged in manufacturing, processing, pack- ing or holding food for consumption in the United States are required to be registered with the FDA. The FD&C Act requires most foods to bear nutrition labeling and requires food labels that bear nutrient content claims and certain health messages to comply with specific requirements. The FDA is authorized to enforce safety and labeling regulations by conducting inspections, sampling, recalls and seizures, and by pursuing injunctions and criminal prosecutions. Cannabis-Based Foods and Dietary Supplements The FDA has published guidance (most recently updated in August 2017) concluding that (i) the FD&C Act does not permit foods to which THC or CBD have been added to be sold in interstate commerce and (ii) any product containing THC or CBD is not a dietary supplement. For this conclu- sion to be legally correct, based on the FD&C Act provisions cited by the FDA, it would need to be demonstrated that neither THC nor CBD were marketed in or as a food or as a dietary supplement before the occurrence of certain approvals and clinical investigations of drugs that include THC (e.g., Marinol) or CBD (e.g., Sativex or Epidiolex). The FDA publication does not demonstrate that neither THC nor CBD were marketed in or as a food or as a dietary supplement before such occurrences and merely states that the FDA is “not aware of any evidence that would call into question” its conclusion. The FDA’s conclusion has not been subject to any legal challen