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FDA considers regulating cannabis-based CBD in foods and supplements over safety concerns

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The Food and Drug Administration (FDA) plans to announce a regulatory framework for products like CBD derived from legal cannabis in the coming months amid concerns over product quality and safety.

CBD products have proliferated in the years since the passage of the 2018 Farm Bill that legalized industrial hemp – a variant of the cannabis plant that lacks the intoxicating properties of versions grown for consumption as medical or recreational marijuana. This opened the door to the sale of CBD products, from edible drinks and gummies to creams and lotions that contain no more than 0.3% THC, which is the cannabinoid chemical that can induce highs in users and is illegal in the United States. federal level, 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 Deputy Chief Commissioner Janet Woodcock, MD, in charge of the agency’s efforts to regulate cannabis, which was also delivered to the Wall. Street Journal: “Given what we know about the safety of CBD so far, this raises concerns for the FDA about whether these existing regulatory avenues for food and dietary supplements are appropriate for this substance. The FDA is currently reviewing three Citizens’ Petitions related to that, and we plan to respond to them soon.”

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Hemp plants grow in a field.

CBD products are often advertised as helping to relieve pain, reduce anxiety and promote sleep, but currently they cannot be labeled 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. about their CBD products.

The FDA is researching the effects of CBD in conjunction with the National Institutes of Health (NIH), and these findings will inform its recommendations on regulations for these products. An NIH study 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 make regulatory recommendations, it will have 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 call on Congress to enact a law. about 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 emphasize newly discovered cannabinoids pose a challenge for regulators.

For example, the most prevalent 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 traded despite having 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 “increasing and more intense near-term concerns” about these Delta-8 products after a child in Virginia died after eating Delta-8 gummies, while several other teenagers and children fell ill in Texas and Iowa.

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Muscle and Joint Relief Cream is displayed at the Cannabis World Congress and Business Exposition on May 30, 2019 in New York. (AP Photo/Mark Lennihan)

The lack of a federal regulatory framework has given rise to concerns about consumer safety and deficiencies in quality assurance that may lead to the inclusion of THC in some CBD products intended to exclude it. It has also kept several companies that eventually plan to enter this emerging market on the sidelines 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 regulations on hemp production illustrate the challenges of adjusting the rules around 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 nearly 13,000 grower licenses across the country, and a dozen states had more than 1,000 acres harvested for hemp. in 2021 – led by Montana with 4,500 acres and Colorado with 3,100 hectares. But the CRS report noted that around 20% of the hemp grown in a given year will exceed the legal limit of no more than 0.3% THC, which shows the “risks inherent in growing hemp for farmers within the framework USDA regulatory framework”.

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