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The Food and Drug Administration (FDA) plans to announce a regulatory framework for products like CBD. legal secret in the coming months amid concerns over product quality and safety.
CBD products have proliferated in the years since the 2018 farm bill legalized industrial hemp — a variant of the cannabis plant that lacks the intoxicating properties of versions grown for consumption such as medical or recreational marijuana. This opened the door to the sale of CBD products, from drinks and edible gums to creams and lotions containing no more than 0.3% THC, the cannabinoid chemical that can get users high and is federally illegal despite legalization. 21 states.
When asked for comment on the upcoming regulatory plan, an FDA spokeswoman provided Fox Business with a statement from FDA Deputy Commissioner Janet Woodcock, who is responsible for FDA’s secretory regulatory efforts. The Wall Street Journal: “Given what we know so far about the safety of CBD, this raises concerns for the FDA about whether the current regulatory pathways for food and dietary supplements are appropriate for this substance. The FDA is currently reviewing three Citizen Petitions related to this, and we plan to do so.” let them answer quickly.”
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Hemp plants grow in the field.
CBD products often help relieve pain, reduce anxiety, and promote sleep, but currently cannot be labeled as dietary supplements or added to food products under FDA regulations, and the agency issued warning letters to several companies about their claims about their CBD products.
The FDA, along with the National Institutes of Health (NIH), is investigating the effects of CBD, and those findings will inform its recommendations on regulations for those products. A Research by the NIH It found that a pharmaceutical-grade CBD product known as Epidiolex helped reduce seizures in epilepsy patients over the age of 2, but also caused diarrhea, fatigue and elevated liver enzymes in some children.
Once the FDA is ready to move forward with making regulatory recommendations, it must decide whether CBD products can be regulated as food or dietary supplements rather than drugs, or whether the agency needs to develop a new framework or challenge Congress. to pass a law on
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Jim Castetter weighs hemp flowers on a scale, April 13, 2021, in Binghamton, New York. (Angela Weiss/AFP via Getty Images)
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 for regulators.
For example, the most common form of THC is known as Delta-9, which has intoxicating properties and is federally illegal. 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 having intoxicating properties like its sister cannabinoid.
FDA senior counsel Norman Birenbaum, who previously worked on cannabis regulation in New York and Rhode Island, told the Wall Street Journal that the agency has “growing and heightened short-term concerns” about these Delta-8 products after a child in Virginia. . Several other teenagers and children in Texas and Iowa have died after eating Delta-8 gum while becoming ill.
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Muscle and Joint Relief Cream is on display at the Cannabis World Congress and Business Exposition trade show on May 30, 2019 in New York City. (AP Photo/Mark Lennihan)
The lack of a federal regulatory framework has led to concerns about consumer safety and lack of quality assurance, which could lead to the inclusion of THC in some CBD products designed to exclude it. It also kept out a number of companies planning to enter this emerging market due to legal concerns. Despite these hesitations, a 2021 FDA report predicted that the CBD market alone was estimated at $4.6 billion last year and will quadruple by 2026.
While the FDA’s regulatory process continues, the USDA’s hemp production regulations highlight the challenges of fine-tuning regulations for the production and processing of cannabis products.
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A report by the Congressional Research Service found that hemp production in 2021 was valued at $824 million across nearly 13,000 cultivation licenses nationwide, and that multiple states had more than 1,000 acres of hemp harvested in 2021 — led by Montana and Colorado with 4,500 acres each. . 3100 hectares. But the CRS report noted that about 20% of hemp grown in a given year will exceed the legal limit of no more than 0.3% THC, indicating “inherent risks for farmers growing hemp under USDA regulation.”
