- Congress is pushing the U.S. Food and Drug Administration to adopt rules classifying and regulating food products containing CBD, or hemp-derived cannabidiol. Under language recently passed by a U.S. Senate committee, the agency would have 120 days to put an enforcement discretion policy in place, according to the Capital Press.
- Last week, 26 members of the U.S. House of Representatives wrote acting FDA Commissioner Ned Sharpless, urging the agency to quickly adopt a policy and consider issuing an interim final rule to regulate CBD as a food additive and dietary supplement. They also asked the FDA to move forward with a "robust framework" to assess safety and accurate labeling of CBD products.
- FDA has issued nine warning letters since 2017 to CBD companies for fraudulent or egregious health claims, the letter noted. While they support such actions, the House members said FDA can also eliminate legal and regulatory uncertainty for farmers, retailers and consumers participating in the growing marketplace for hemp-derived products.
The Senate language added last week to the $23.1 billion agricultural appropriations bill would place a four-month deadline on the FDA to adopt an enforcement discretion policy, and the agency would have to give Congress a progress update after 90 days. That proposal will be debated on the Senate floor. If the full Senate agrees, it might have more of an impact than the House letter.
Since December, when Congress legalized industrial hemp as part of the 2018 Farm Bill, lawmakers have wanted the FDA to act faster than the several years it has estimated the final rulemaking process might take. As the House members' letter put it, "Business and consumer interest in CBD and hemp products has skyrocketed, and companies are already capitalizing on the growing demand."
Hemp production could significantly bolster agricultural revenue in some parts of the country. U.S. Sen. Jeff Merkley, D-Oregon, told the Capital Press CBD could be a billion dollar industry for his state. Oregon State University set up a Global Hemp Innovation Center in June, where 40 faculty members from 19 academic areas are doing research on cultivation, food and product testing.
Despite the FDA's position that CBD is illegal for inclusion in foods and beverages, the substance continues to be added to food and beverage products — including beer, coffee, cocktails and jelly beans — at a rapid pace.
Pressure is only going to increase on the agency to clarify the regulation because of the large potential market for CBD-infused food and beverages. Nationwide sales of hemp-derived CBD products could hit $6 billion by 2025, according to Nielsen figures cited by Food Business News. Even without federal regulatory action, some states have developed their own rules relating to these products as consumer demand continues to rise.
Some food and beverage makers are developing products containing CBD, but others are holding back until federal regulations are adopted. At the FDA's first public hearing on the issue earlier this year, manufacturers expressed confusion about the situation and asked for regulatory clarity.
Since then, two top FDA policy officials acknowledged the need to be clear and open about where the agency is headed on CBD regulation. They differentiated between drug-related CBD uses — such as in the epilepsy drug Epidiolex, which is approved — and in food and dietary supplements. They also indicated further research into the safety and effectiveness of CBD is necessary, and emphasized the agency's role "as a science-based regulatory agency committed to our mission of protecting and promoting public health."
Consequently, it's unlikely the FDA will quickly move forward on an interim final rule just to satisfy lawmakers. It also does not seem likely the agency will make such a major move before it has a new permanent commissioner in place. It's been reported the new commissioner will be nominated by the end of October, at the latest. Chances are hemp growers, food and beverage manufacturers and others eagerly awaiting regulatory clarity will have to sit tight a while longer before they get more regulation.