KANSAS CITY — The US Food and Drug Administration’s position on cannabidiol (CBD) continues to restrain food and beverage manufacturers from moving full speed ahead and launching products containing the ingredient.
Companies instead have two options: wait for Congress and the FDA to give a green light, although no one knows when or if that will happen, or maneuver cautiously in states that have laws allowing CBD in foods, beverages and dietary supplements.
The FDA is prepared to work with Congress on regulating CBD, Janet Woodcock, MD, principal deputy commissioner of the FDA, said Jan. 26. The agency believes it needs additional authority to create a new pathway for CBD in dietary supplements.
“I for a long time had been saying that I didn’t think FDA was going to act on this,” said Jonathan Havens, partner, cannabis law practice co-chair for Saul Ewing. “CBD is not an issue they’ve ever wanted to deal with from a consumer product perspective.”
CBD is found in hemp and marijuana, both of which are Cannabis sativa. The Agriculture Improvement Act of 2018 (the most recent farm bill) removed hemp from the Controlled Substances Act, meaning it could be grown commercially in the United States. The farm bill described hemp as having less than 0.3% tetrahydrocannabinol (THC). Marijuana contains levels of THC at or above 0.3%.
The FDA still denies the use of CBD in food, beverages and dietary supplements because the ingredient is in an FDA-approved drug sold under the Epidiolex brand.
“There has been a massive passage of time since the farm bill got passed,” Mr. Havens said. “It would have been nice if FDA said in January of 2019, ‘Hey, we don’t think we have the authority to deal with this. We need Congress to help.’”
He believes Congress will pass a bill that the president, whomever that may be at the time, will sign into law. The FDA then will promulgate rules and implement what the law is.
Safety remains a hurdle. Studies have shown CBD potentially may harm the liver, interact with certain medications and possibly harm the male reproductive system, Dr. Woodcock said. The FDA also found CBD exposure concerning in vulnerable populations such as children and women who are pregnant, according to the agency.
“I’m not saying there is a tremendous amount of data out there, but there is a good amount of data about the safety profile of CBD that has been advanced by some of the leading members of industry,” Mr. Havens said, mentioning a citizen petition from the Natural Products Association to allow the marketing of CBD products as dietary supplements.
The FDA denied that petition and two others on Jan. 26.
“Further research is needed to determine the overall toxicity, dosage recommendations, shelf stability of various product formats, as well as drug and food interactions of CBD,” said Kim Stuck, chief executive officer of Allay Consulting. “These studies require a lot of time and resources, but it’s important to note that CBD has become widely available to consumers since the passage of the 2018 farm bill, but there have been no widespread reports of severe adverse effects, unlike FDA-approved drugs like fentanyl and oxycodone.”
Individual states have different rules regarding CBD.
“State programs vary widely,” Ms. Stuck said. “For example, some have banned inhalation CBD products such as vapes and hemp flower. It just depends where you go.”
Saul Ewing divides them into red, yellow and green states. Red states allow no CBD. Yellow states allow CBD with restrictions. As for green states, “there’s a market there,” Mr. Havens said. Companies must register products in the states of Louisiana, Utah and West Virginia, he said.
“You can’t just assume that every single state has the same rules,” he said. “You really do have to take the time to either yourself look at the rules or hire someone who does.”
Kemin Industries, Des Moines, Iowa, in 2022 launched Luxiva hemp CBD distillates that are certified organic under the USDA’s National Organic Program. Luxiva full-spectrum CBD distillate (0.3%) contains a minimum of 60% CBD content with a THC content of less than 0.3%. Luxiva full-spectrum CBD distillate (0.1%) contains a minimum of 60% CBD content with a THC content of less than 0.1%.
“While the FDA statement on Jan. 26, 2023, regarding the regulation of cannabidiol (CBD) was disappointing, Kemin welcomes the opportunity to work with Congress on a regulatory framework that aligns with CBD use as a dietary supplement,” said Tyler Holstein, global product manager for Kemin.
Food and beverage companies should determine which states they are comfortable selling into based on product composition and individual state laws, he said.
“Kemin is continually tracking state regulations to better support our customers,” Mr. Holstein said, noting California, Colorado and Illinois are some of the states that allow CBD.
“There are other states that allow it in some of these applications, but not all,” he said. “This can change almost daily, so it is always wise to verify with local state agencies on the current status.”