America’s hemp and CBD industries, and consumers are anxiously awaiting a regulatory update from the Food and Drug Administration (FDA). The Agency has indicated that the update would be issued this month.
This update is expected to be a positive development for hemp growers, CBD extractors and manufacturers of CBD food, beverage, nutritional, and cosmetic products. And, of course it will hopefully beneficial for the ultimate consumers as well.
Despite the FDA’s rigid policies and regulations regarding the addition of new additives, or Active Pharmaceutical Ingredients (APIs) to food, beverage, cosmetic, and nutritional supplements, our conclusion is that the agency will seek to accommodate America’s new and fast-growing CBD industry. The media attention, actions by individual states to legalize CBD as a food and beverage additive, and pressure from members of Congress make an alternative a non-starter.
The FDA’s regulatory quandary is challenging for the agency. Since CBD is an approved drug, Epidiolex, general FDA regulations don’t allow an API to be used as an additive in food, beverages, cosmetics, or nutritional supplements.
Our conclusion is that the FDA will take a middle-of-the-road approach, as hinted at in a Washington Post op-ed article written in late July by the former FDA Commissioner, Scot Gottlieb.
We also expect the FDA to address whether the agency can establish a special regulatory process for CBD and whether that’s even possible due to current agency regulations. Gottlieb previously stated that a speedier regulatory process for CBD might require legislative action by Congress.