While the U.S. Food and Drug Administration (FDA) has been tasked with regulating the cannabidiol (CBD) industry, the agency has repeatedly asserted it will not do so until it receives sufficient data on the cannabinoid’s safety for consumers.
Yet, according to HempGrower, the agency’s latest report to Congress on July 8 evaluating the CBD marketplace underscores a growing need for regulations, some industry participants say. Of nearly 150 CBD products tested for cannabinoid content, the FDA recently found less than half contain the amount of CBD on the label.
“There’s not much news here. Citing previous testing data and some more recent but limited random sampling, the FDA revealed what we already knew: While more work needs to be done to ensure CBD products consistently meet label claims, the majority of products do not contain unsafe contaminant levels, specifically heavy metals. [This] report emphasizes what we have been arguing for years: It’s high time for the FDA to regulate CBD as a dietary supplement and food additive,” the U.S. Hemp Roundtable wrote in response to the report on its website. “The agency’s current public stance not only impairs hemp farmers and small businesses; an unregulated marketplace poses real health and safety concerns.”
The Consumer Healthcare Products Association (CHPA) also released a statement, saying that “While CHPA welcomes additional input from FDA regarding CBD, we’re concerned that the report conclusion further delays any action to better regulate CBD-containing products. Collectively, these third-party reports consistently confirm that the CBD/hemp product category would benefit from active regulatory oversight by the FDA and legislative action from Congress.”
The FDA’s report is a response to an order from Congress’ to study the current CBD marketplace “to determine the extent to which products are mislabeled or adulterated.” Its latest findings highlight the agency’s initiative to undertake a “more extensive CBD product sampling effort,” the report said.
In its study, the FDA tested 147 products for 11 different cannabinoids, including CBD and total tetrahydrocannabinol (THC) levels.
Of the 102 products that indicated a specific amount of CBD, the FDA found:
• 18 products (18 percent) contained less than 80 percent of the amount of CBD indicated.
• 46 products (45 percent) contained within 20 percent of the amount of CBD indicated.
• 38 products (37 percent) contained more than 120 percent of the amount of CBD indicated.
Of those 147 products, the FDA also found nearly half contained levels of THC (tetrahydrocannabinol) above the limit of quantitation, which was 3.1 mg per serving.
The FDA also tested 133 of those 147 products for levels of arsenic, cadmium, mercury and lead. Only one product—a tincture—had a lead concentration that requires additional evaluation. The rest had contaminant levels that don’t represent a health concern, the FDA says in its report. (The FDA noted that the 133 products sampled cannot be used to draw definitive conclusions.)
In 2019, the FDA studied 34 CBD products by reviewing complaints submitted to the agency and conducting “online surveillance.” Of the 21 products tested in 2019 that specified the amount of CBD in them, only 33 percent were found to be properly labeled. Also, nearly half of the 31 products tested for cannabinoids that year contained THC.
In its report, the FDA said it has developed a long-term sampling plan to continue taking “a representative, random sample of the current CBD product marketplace” in 2020, putting an emphasis on products with a higher market share.
