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The Food and Drug Administration (FDA) plans to announce a regulatory framework for products like CBD that are derived from legal cannabis In the coming months amid concerns about product quality and safety.
CBD products have proliferated in the years following the enactment of the 2018 Farm Bill legalizing industrial hemp – a variant of the cannabis plant lacking the intoxicating versions grown for use as medical or recreational marijuana. . This 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, which is the cannabinoid chemical that can cause users to spike and is Federally illegal despite legalization in 21 states.
When asked to comment on the upcoming regulatory plan, an FDA spokesperson provided Fox Business with a statement from FDA Senior Deputy Commissioner Janet Woodcock, MD, who is leading the effort. of the agency to regulate cannabis, which was also handed over to the The Wall Street Journal: Given what we know about the safety of CBD so far, this raises concerns for the FDA as to whether these existing regulatory pathways for foods and dietary supplements are appropriate for this substance. The FDA is currently reviewing three citizen petitions about it, and we plan to respond to them soon.
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Hemp plants grow in a field.
CBD products are often touted as helping to relieve pain, reduce anxiety, and promote sleep, but currently cannot qualify as dietary supplements or added to food products under FDA rules, and the agency has issued warning letters to several companies about the claims they have made regarding their CBD products.
The FDA is studying the effects of CBD in conjunction with the National Institutes of Health (NIH), and these findings will inform its recommendations on regulating these products. A NIH study A pharmaceutical grade CBD product known as Epidiolex has been found to help reduce seizures in epileptic patients 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 need to decide whether CBD products can be regulated as foods or dietary supplements, rather than drugs. or whether the agency will need to develop a new framework or ask Congress to enact legislation on the subject.
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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 focus on newly discovered cannabinoids present a challenge for regulators.
For example, the most prevalent 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.
Norman Birenbaum, a senior FDA adviser who previously worked on cannabis regulation in New York and Rhode Island, told the Wall Street Journal that the agency has “growing and increasingly intense concerns in the near term.” regarding these Delta-8 products after a child in Virginia. Died after eating Delta-8 gummies while a number of other teenagers and children were sick in Texas and Iowa.
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Muscle and Joint Relief Cream is introduced at the Cannabis World Congress and Business Exposition on May 30, 2019, in New York City. (AP Photo/Mark Lennihan)
The lack of a federal regulatory framework has raised concerns about consumer safety and gaps in quality assurance that could lead to the inclusion of THC in some CBD products intended to exclude it. He has also sidelined a number of companies that may be planning to enter this emerging market due to legal issues. Despite this hesitation, a 2021 FDA report found that the CBD market alone was estimated at $4.6 billion last year and predicted it would quadruple by 2026.
As the FDA regulatory process unfolds, the US Department of Agriculture’s hemp production regulations illustrate the challenges of adjusting rules regarding the production and processing of cannabis products.
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A Congressional Research Service report found that in 2021, hemp production was valued at $824 million from approximately 13,000 grower licenses across the country, and a dozen states had more than 1,000 acres of hemp. harvested in 2021, led by Montana with 4,500 acres and Colorado with 3,100 acres. But the CRS report noted that about 20% of hemp grown in any given year will exceed the legal limit of 0.3% maximum THC, showing the “inherent risks to farmers of growing hemp.” within the regulatory framework of the USDA”.
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