Forward-thinking companies across a range of product categories are exploring how to use CBD in foods, beverages, and other consumable products. At the same time, the FDA and individual U.S. states are releasing new regulations that can be confusing if not outright contradictory. Brands looking to incorporate CBD in current and new products, will benefit from understanding how the FDA defines foods, food additives, and dietary supplements—not just to protect themselves legally but to ensure the safety of their customers.
Food vs. Food Additive
Food is defined as essentially anything you can eat. The FDA does not require businesses to have premarket approval before selling food. A food additive, however, is legally different. According to the FDA, a food additive is a substance that is intended to be a component of food or affect the characteristics of a food. The FDA regulates certain ingredients and food additives, which are subject to premarket approvals. As for CBD in food and food additives, the FDA has ruled that CBD may not be present in any food or food additives that are involved in interstate commerce.
Dietary supplements are defined by the FDA as products taken by mouth that contain a “dietary ingredient.” Like food, dietary supplements do not require premarket approval. But dietary supplement manufacturers must notify the FDA if they include any new dietary ingredients in a product. Also, there must be reasonable evidence of the safety of these new dietary ingredients prior to any marketing efforts. Like their ruling on food and food additives, the FDA does not allow dietary supplements containing CBD.
Additional Regulations for Food Manufacturing
The FDA also requires food manufacturers to operate in a safe way. To enforce this, the FDA requires that food facilities must register with the FDA before beginning production. After registration, food facilities are subject to regular inspections by both the FDA and state to make sure they are still compliant. They also must comply with Good Manufacturing Practices (GMP) and other FDA requirements to maintain their registration.
Currently, there are conflicting state and federal laws surrounding CBD in food, food additives, and dietary supplements. Businesses selling or manufacturing consumables containing CBD must stay up to date on regulatory changes, both at the federal and state levels. To help you navigate the evolving CBD regulatory landscape, subscribe to the blog.