The Food and Drug Administration (FDA) is reportedly planning to announce a regulatory framework for products like CBD derived from legal hemp in the coming months amid concerns about product quality and safety.
CBD products have exploded in the years since the enactment of the 2018 Agriculture Act that legalized industrial hemp – a variety of the cannabis plant that lacks the intoxicating properties of versions grown for consumption as medical or recreational marijuana. That opened the door to the sale of CBD products ranging from drinks and edible gummies to creams and lotions containing no more than 0.3% THC. 21 states.
When asked for comment about the upcoming regulatory plan, an FDA spokesperson gave Fox Business a statement from FDA Chief Deputy Commissioner Janet Woodcock, MD, who is responsible for the agency’s effort to regulate cannabis, who also said: the Wall Street Journal: “Given what we know so far about the safety of CBD, it raises concerns for the FDA about whether these existing regulatory pathways for food and dietary supplements are appropriate for this substance. FDA is currently reviewing three Citizen petitions related to this, and we plan to respond to it quickly.”
CBD products are often touted to relieve pain, reduce anxiety and promote sleep, but currently cannot be branded as dietary supplements or added to foods under FDA rules, and the agency has warning letters issued to various companies about claims they have made regarding their CBD products.
The FDA is investigating the effects of CBD in conjunction with the National Institutes of Health (NIH), and those findings will inform its regulatory recommendations for those products. A study by NIH found that a pharmaceutical-grade CBD product known as Epidiolex helped reduce seizures in patients with epilepsy over the age of 2, but it also caused diarrhea, fatigue, and elevated liver enzymes in some children.
Once the FDA is ready to move forward with regulatory recommendations, it will have to decide whether CBD products can be regulated as food or nutritional supplements instead of drugs, or whether the agency needs to develop a new framework or Congress needs to call for a law to be passed on this.
Because cannabis plants contain dozens of cannabinoid chemicals, including THC and CBD, among others, new cannabis products that emphasize newly discovered cannabinoids pose a challenge to regulators.
For example, the most common form of THC is known as Delta-9, which has intoxicating properties and is illegal at the federal level. But Delta-8 THC can be derived from industrial hemp and falls into a legal gray area where it can be legally produced and marketed despite intoxicating properties like its sister cannabinoid.
Norman Birenbaum, a senior adviser to the FDA who previously worked on cannabis regulation in New York and Rhode Island, told the Wall Street Journal that the agency has “growing and mounting near-term concerns” about these Delta-8 products after a child in Virginia died after eating Delta-8 gummies, while several other teens and children fell ill in Texas and Iowa.
The lack of a federal regulatory framework has led to consumer safety concerns and quality assurance deficiencies that could lead to THC being included in some CBD products intended to exclude it. It has also sidelined a number of companies that eventually plan to enter this emerging market due to legal concerns. Despite that hesitation, a 2021 FDA report found the CBD market was valued at $4.6 billion last year alone and predicted it would quadruple by 2026.
As the FDA’s regulatory process unfolds, the U.S. Department of Agriculture’s regulations for hemp production illustrate the challenges of refining regulations around the production and processing of cannabis products.
A report from the Congressional Research Service found that hemp production in 2021 was estimated at $824 million, spanning about 13,000 grower licenses nationwide, and that a dozen states had harvested more than 1,000 acres of hemp by 2021 — led by Montana with 4,500 acres and Colorado with 3,100 acres. But the CRS report noted that about 20% of the hemp grown in any given year will exceed the legal limit of no more than 0.3% THC, highlighting the “inherent risks to farmers of hemp cultivation within the regulatory framework.” of USDA” demonstrates.