CBD Industry Pressures the FDA and Congress to Establish a Regulatory Pathway
The new Food & Drug Commissioner, Robert Califf, appeared before the House Oversight and Accountability Committee on April 7, 2024, to discuss various topics and issues. One of the topics was cannabis and hemp-derived products. The CBD industry is pressuring the FDA and Congress to establish a regulatory pathway. Since the pathway does not exist, Califf will not yet approve CBD as a dietary supplement.
The FDA has decided that the existing food and dietary authorities cannot manage CBD under the dietary supplement safety standards like it does for currently designated supplements. Therefore, Congress must establish a new regulatory path.
Rep. James Comer of Kentucky asked if the FDA should be more involved in monitoring CBD since it is becoming popular. He called the market “the Wild West,” saying,
“The FDA refusal to regulate hemp products is creating a significant confusion in the market, and resulting in products with intoxicants that can be dangerous to Americans who use these products. It has also halted business trying in good faith to enter the market, while bad actors continue to thrive.”
Califf reiterated his belief that Congress needs to establish a regulatory process for CBD before the FDA can regulate CBD products as supplements. The FDA says current dietary supplement and food additive rules do not fit CBD, so it cannot manage safety risks. The FDA currently monitors CBD research and product marketing when brands claim a CBD product is a supplement or provides health benefits. CBD products are required to meet safety standards and must be accurately labeled. Health claims are not allowed.
Congress is currently negotiating the next Farm Bill, but it may not be presented for a vote until 2025. The result is an impasse. The FDA refuses to regulate CBD products, and Congress has failed to act.
The lack of action by Congress and the FDA is frustrating because most of the dietary supplements the FDA is currently approving for sale have evidence of potential side effects. The side effects are described on the label. In addition, there are many dietary supplements sold today that contain herbs that are not well-researched. The reluctance of the government to control CBD as a supplement is impeding the growth of the CBD market and creating confusion in consumers’ minds.
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