The U.S. Food and Drug Administration concluded that there is a need for a new regulatory pathway for cannabidiol (CBD) products. The agency says it is ready to work with Congress on this matter.
A new regulatory pathway would provide "safeguards and oversight to manage and minimize risks related to CBD products," the FDA said in a statement released Friday.
The agency suggests adopting risk management tools, such as clear labels, prevention of contaminants, and CBD content limits. In addition, a minimum purchase age could help mitigate the risk of ingestion by children.
After examining studies related to the CBD-based drug Epidiolex, the FDA’s internal working group did not find adequate evidence that "CBD products could meet safety standards for dietary supplements or food additives."
It remains unclear how much and for how long CBD could be consumed before causing harm.
Epidiolex, a drug for treating childhood epilepsy forms Dravet and Lennox-Gastaut syndrome, is the only FDA-approved CBD product. Research has previously shown that the medication reduces or stops seizures altogether.
The FDA also denied three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.
Doubtful wellness benefits
CBD is a chemical found in marijuana that does not contain tetrahydrocannabinol (THC), a psychoactive substance that produces a high. Cannabidiol products come in various forms, such as oils and tinctures, edibles, capsules, lotions, and vapes.
Despite the lack of solid evidence on health benefits, the U.S. CBD market has been rapidly growing. In 2021, CBD products generated sales of about $5.3 billion and are predicted to reach nearly $16 billion by 2026.
A 2022 survey revealed that more than half of CBD-using Americans (62%) are doing so to reduce stress and anxiety. Some 60% of respondents said CBD products help them to relieve pain, and 58% use them to improve sleep quality.
Some earlier studies in animals and human self-reports indicated that CBD might have pain-relieving and anti-inflammatory properties. Research suggested that these products could be used to treat chronic pain, including in cancer patients, and inflammation related to arthritis. CBD is also thought to have anxiety-reducing properties and helps to improve sleep.
However, CBD raises numerous safety concerns, especially with long-term use.
The FDA says, "Studies have shown the potential for harm to the liver, interactions with certain medications and possible harm to the male reproductive system."
- U.S. Food and Drug Administration. FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward.
- Statista. CBD retail in the United States - Statistics and Facts.
- Statista. Leading reasons why U.S. adults use cannabidiol as of 2022.
- Frontiers. Cannabinoids and Pain: New Insights From Old Molecules.
- National Library of Medicine. Cannabidiol Reduces the Anxiety Induced by Simulated Public Speaking in Treatment-Naïve Social Phobia Patients.