KANSAS CITY – The US Food and Drug Administration’s stance on cannabidiol (CBD) continues to hold back food and beverage manufacturers from moving full speed ahead and launching products containing the ingredient.
Instead, companies have two options: wait for Congress and the FDA to give the green light, though no one knows when or if that will happen, or carefully maneuver into states that have laws allowing CBD in food. in beverages and food supplements.
The FDA is ready to work with Congress to regulate CBD, FDA Deputy Commissioner Janet Woodcock said Jan. 26. The agency believes it needs additional authority to create a new pathway for CBD in dietary supplements.
“I’ve said for a long time that I didn’t think the FDA would act in this direction,” said Jonathan Havens, partner, co-chair of Saul Ewing’s cannabis law practice. “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 sativas. The Agricultural Improvement Act of 2018 (the most recent farm bill) removed hemp from the Controlled Substances Act, meaning it can be grown commercially in the United States. The farm bill describes hemp as containing less than 0.3% tetrahydrocannabinol (THC). Marijuana contains THC levels of 0.3% or higher.
The FDA still denies the use of CBD in food, beverages, and dietary supplements because the ingredient is found in an FDA-approved drug sold under the brand name Epidiolex.
“There’s been a tremendous amount of time since the Farm Bill passed,” Mr. Havens said. “It would be nice if the FDA said in January 2019: “Hey, we don’t think we have the authority to deal with this. We need Congress to help us.”
He believes that Congress will pass a bill that the president, whoever is at the time, will sign into law. The FDA will then issue rules and enforce what is law.
Security remains an obstacle. Research has shown that CBD can damage the liver, interact with some medications and possibly harm the male reproductive system, Dr. Woodcock said. According to the agency, the FDA has also identified the effects of CBD in vulnerable populations, such as children and women who are pregnant.
“I’m not saying there’s a huge amount of data out there, but there is good data on the safety profile of CBD that has been put forward by some leading members of the industry,” Mr Havens said, noting: A citizen is petitioning the Natural Products Association to allow CBD products to be marketed 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, storage stability of various product formats, and drug-food interactions of CBD,” said Kim Stack, 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 the FDA-approved of medicines. like fentanyl and oxycodone.”
Individual states have different regulations regarding CBD.
“State programs are very different,” Ms. Stack said. “For example, some have banned inhaled CBD products such as vape and cannabis flower. It just depends on where you’re going.”
Saul Ewing divides them into red, yellow and green states. Red states don’t allow CBD. Yellow states allow CBD with restrictions. As for the green states, “there’s a market there,” Mr. Havens said. Companies must register products in Louisiana, Utah and West Virginia, he said.
“You can’t just assume that every state has the same rules,” he said. “You really need to take the time to either look up the rules yourself or hire someone who does.”
Kemin Industries, Des Moines, Iowa, launched Luxiva hemp CBD distillates in 2022, certified organic under the USDA’s National Organic Program. Luxiva’s Full Spectrum CBD Distillation (0.3%) contains a minimum of 60% CBD with less than 0.3% THC. Luxiva Full Spectrum CBD Distillation (0.1%) contains a minimum of 60% CBD with less than 0.1% THC.
“While the FDA’s January 26, 2023 announcement regarding the regulation of cannabidiol (CBD) was disappointing, Kemin welcomes the opportunity to work with Congress on a regulatory framework consistent with the use of CBD as a dietary supplement,” said Tyler Holstein. global product manager for Kemin.
Food and beverage companies must decide which states they are comfortable selling to based on the composition of the product and individual state laws, he said.
“Chemin is continually monitoring state regulations to better support our customers,” Mr. Holstein said, noting that California, Colorado and Illinois are among the states that allow CBD.
“There are other states that allow it in some applications, but not all,” he said. “This can change almost daily, so it’s always wise to check with local government authorities about the current status.”