FDA considers regulating cannabis compound CBD in foods, supplements over safety concerns

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The Food and Drug Administration (FDA) plans to release a regulatory framework for legal hemp-derived CBD-like products in the coming months, amid concerns over product quality and safety. It is said that there are

CBD products have surged in the years since industrial hemp was legalized after the 2018 Farm Bill was enacted. This is a variant of the cannabis plant that lacks the intoxicating properties of versions grown for consumption as medical or recreational marijuana. The door has been opened to the sale of CBD products containing 0.3% or less. 21 states.

When asked to comment on future regulatory plans, an FDA spokesperson provided Fox Business with a statement by FDA Deputy Commissioner Janet Woodcock, MD, who is in charge of the agency’s efforts to regulate cannabis. , it was also given to the wall. Street Journal: “Given what we know so far about the safety of CBD, it raises concerns with the FDA as to whether these existing regulatory pathways in food and dietary supplements are suitable for this substance.” We are currently reviewing three civil petitions related to this and will respond soon.”

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Hemp plants grow in the field.

CBD products, which are often touted as helping relieve pain, reduce anxiety and promote sleep, are currently not branded as dietary supplements or added to foods under FDA regulations. You cannot About their CBD products.

The FDA is working with the National Institutes of Health (NIH) to study the effects of CBD, and those findings will inform regulatory recommendations for these products. An NIH study found that his pharmaceutical-grade CBD product, known as Epidiolex, helped reduce seizures in epileptics over the age of two, but some children had diarrhea, fatigue, and liver enzyme levels. It also caused a rise.

When the FDA is ready to move forward with its regulatory recommendations, whether CBD products can be regulated as foods or dietary supplements rather than drugs, or whether the FDA should develop a new framework or ask Congress. must be determined. enact laws regarding

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Jim Castetter weighs hemp flowers on April 13, 2021 in Binghamton, NY. (Angela Weiss/AFP via Getty Images)

New cannabis products that highlight newly discovered cannabinoids present a challenge for regulators, as the cannabis plant contains dozens of cannabinoid chemicals, including THC and CBD among others.

For example, the most common form of THC, known as Delta-9, has intoxicating properties and is illegal at the federal level. However, Delta-8 THC may be derived from industrial hemp, and despite having intoxicating properties like its sister cannabinoids, it falls into a legal gray area where it can be legally produced and sold. .

Norman Birenbaum, a senior adviser to the FDA who has previously worked on cannabis regulation in New York and Rhode Island, told The Wall Street Journal that the agency “grows and “I have more serious short-term concerns,” he said. While many other teens and children were sick in Texas and Iowa, they died after eating Delta-8 gummies.

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Muscle and Joint Relief Cream was showcased at the Cannabis World Congress and Business Exposition trade show in New York May 30, 2019. (AP Photo/Mark Lenihan)

The lack of a federal regulatory framework has raised concerns about flaws in consumer safety and quality assurance, and some CBD products meant to exclude THC may contain THC. I have. Also, many companies planning to eventually enter this emerging market are on the sidelines due to legal concerns. Despite that hesitation, a 2021 FDA report estimated the CBD market alone at $4.6 billion last year and is projected to quadruple by 2026.

As the FDA’s regulatory process progresses, the U.S. Department of Agriculture’s regulations on hemp production present the challenge of fine-tuning rules governing the production and processing of cannabis products.


According to a Congressional Research Service report, in 2021, hemp production will be valued at $824 million with nearly 13,000 grower licenses nationwide, and 12 states will harvest more than 1,000 acres of hemp in 2021. did. Montana he has 4,500 acres and Colorado 3,100 acres. However, the CRS report notes that about 20% of hemp grown in any given year exceeds the legal limit of 0.3% THC or less, which is “within the USDA’s regulatory framework.” “risks inherent to farmers growing hemp in

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