FDA officials are concerned about the safety of legal cannabis-infused foods and supplements and may recommend regulating the products later this year, according to a new report.
The products can have drug-like effects on the body and contain CBD (cannabidiol) and THC (tetrahydrocannabinol). Both CBD and THC can be derived from hemp, which was legalized by Congress in 2018.
"Given what we know about the safety of CBD so far, it raises concerns for FDA about whether these existing regulatory pathways for food and dietary supplements are appropriate for this substance," FDA Principal Deputy Commissioner Janet Woodcock, MD, told The Wall Street Journal.
A 2021 FDA report valued the CBD market at $4.6 billion and projected it to quadruple by 2026. The only FDA-approved CBD product is an oil called Epidiolex, which can be prescribed for the seizure-associated disease epilepsy. Research on CBD to treat other diseases is ongoing.
Food, beverage, and beauty products containing CBD are sold in stores and online in many forms, including oils, vaporized liquids, and oil-based capsules, but "research supporting the drug's benefits is still limited," The Mayo Clinic says.
Recently, investigations have found that many CBD products also contain THC, which can be derived from legal hemp in a form that is referred to as Delta 8 and produces a psychoactive high. The CDC warned last year that people "mistook" THC products for CBD products, which are often sold at the same stores, and experienced "adverse events."
The CDC and FDA warn that much is unknown about CBD and Delta 8 products. The CDC says known CBD risks include:
Interference with other drugs you are taking, which may lead to injury or serious side effects
Drowsiness or sleepiness
Diarrhea or changes in appetite
Changes in mood, such as crankiness
Potential negative effects on fetuses during pregnancy or on babies during breastfeeding
Unintentional poisoning of children when mistaking THC products for CBD products or due to containing other ingredients such as THC or pesticides.
"I don't think that we can have the perfect be the enemy of the good when we're looking at such a vast market that is so available and utilized," Norman Birenbaum, a senior FDA adviser who is working on the regulatory issue, told the Journal. "You've got a widely unregulated market."
The Wall Street Journal: "FDA, Concerned About Safety, Explores Regulating CBD in Foods, Supplements."
U.S. Department of Agriculture: "The Agriculture Improvement Act of 2018 (2018 Farm Bill)."
FDA: "Cannabis Derived Products Data Acceleration Plan," "5 Things to Know about Delta-8 Tetrahydrocannabinol – Delta-8 THC."
The Mayo Clinic: "What are the benefits of CBD — and is it safe to use?"
CDC: "CBD: What You Need to Know," "Increases in Availability of Cannabis Products Containing Delta-8 THC and Reported Cases of Adverse Events."
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Cite this: FDA Considers Regulating CBD Products - Medscape - Jan 03, 2023.