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A variety of cannabidiol (CBD) products incorrectly listed their CBD and tetrahydrocannabinol content, in addition to making therapeutic and cosmetic claims without FDA approval.
A new study found significant evidence of inaccurate and misleading labeling of cannabidiol (CBD) content, according to research published in JAMA Network Open.
Some of these nonprescription products were found to contain amounts of delta-9-tetrahyrdocannabinol (THC), including products that claimed to be THC-free.
“Misleading labels can result in people using poorly regulated and expensive CBD products instead of FDA-approved products that are established as safe and effective for a given health condition,” said study lead author Tory Spindle, PhD, assistant professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine, in a statement.
CBD and THC are commonly known compounds in the plant Cannabis sativa. A key difference between them is that THC can produce a psychoactive “high” effect, whereas CBD does not.
CBD products are popular and widely available to consumers. Products that contain fewer than 0.3% of THC are not considered federally illegal substances under the Agriculture Improvement Act of 2018. This regulation makes it difficult for the FDA to address unapproved claims and mislabeling.
The study included 105 CBD products including lotions, creams, and patches purchased online and at brick-and-mortar retail locations in Baltimore, Maryland, in July and August 2020.
A technology called gas chromatography-mass spectrometry was used to identify the actual amount of CBD and THC the products contained. Only 89 (85%) of the tested products listed the total amount of CBD in milligrams on the label.
Of these 89 products, only 21 (24%) were accurately labeled. There were 52 (58%) products that contained more CBD than advertised and 16 (18%) that contained less CBD than advertised.
The in-store products were found to contain 21% more CBD than advertised on average. Online products contained 10% more CBD than advertised on average; however, CBD label accuracy varied widely across products.
THC was detected in 37 (35%) of the products. Although all of these were within the legal limit of 0.3%, 4 (11%) were labeled as “THC free” and 14 (38%) stated that they contained less than 0.3% THC. Approximately half (51%) of the products did not reference THC on the label.
The presence of THC could impact users of these products.
“Recent research has shown that people who use CBD products containing even small amounts of THC could potentially test positive for cannabis using a conventional drug test,” Spindle explained.
Although this has not been determined for topical CBD products, the authors are currently studying it.
Researchers also found that some of the CBD products made claims that were not approved by the FDA. The FDA has only approved 1 prescription CBD product to treat seizures associated with rare epilepsy disorders and 2 prescription THC products for nausea and vomiting associated with chemotherapy and for loss of appetite and weight loss associated with HIV/AIDS.
Of the total products, 29 (28%) made a therapeutic claim, the most of which were related to pain and inflammation. Cosmetic or beauty claims, such as the ability to alleviate wrinkles, were made by 15 (14%) products. Fewer than half, 47%, noted that they were not FDA-approved.
The other 53% of products included no reference to the FDA on their labels.
“It’s important to note that the FDA has not approved CBD products to treat any of the conditions advertised on the products we tested,” Spindle said.
These findings suggest a need for better regulation of CBD products and labeling, according to the study authors.
“The variability in the chemical content and labeling found in our study highlights the need for better regulatory oversight of CBD products to ensure consumer safety,” Ryan Vandrey, PhD, professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine said in a statement.
The authors suggest such regulation to ensure CBD products meet established standards for quality assurance so consumers can make informed decisions about product selection and are not misled by unproven claims. Regardless of labels or claims, the authors caution that people should check with their health care practitioners before starting a regimen of CBD.
Reference
Study shows widespread mislabeling of CBD content occurs for over-the-counter products. EurekAlert. News Release. July 20, 2022. Accessed July 22, 2022. https://www.eurekalert.org/news-releases/959276