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, the agency’s latest report to Congress 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.
“[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 writes 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 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 says.
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%) contained less than 80% of the amount of CBD indicated.
46 products (45%) contained within 20% of the amount of CBD indicated.
38 products (37%) contained more than 120% of the amount of CBD indicated.
Of those 147 products, the FDA also found nearly half contained levels of THC above the limit of quantitation, which was 3.1 mg per serving.
“The number of products that appear to be on the market that are inconsistent with their labeling is disturbing,” says Joe Cascone, president of Asterra Labs, a CBD product manufacturing company. “The report mentions that several of the tested products did not contain what was on the label and that some were within 20% of the label claim. A 20% variance is unacceptable.” Cascone adds that guidelines from the U.S. Pharmacopeia (USP), a pharmaceutical regulation non-profit organization, state pharmaceutical products should contain within 10% of what’s stated on the label.
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 notes that the 133 products sampled cannot be used to draw definitive conclusions.)
Consistent with Other Findings
While the FDA’s latest effort to study the CBD marketplace is its most comprehensive yet, its results fall in line with other studies that have been conducted over the years.
A recent study by the Minnesota Hemp Farmers & Manufacturers Association, for example, recently found that 64% of CBD products sold across Minneapolis had cannabinoid concentrations that deviated significantly from the amount indicated on their labels.
And a recent study published in the Journal of Dietary Supplements recently found out of 24 CBD products tested across Mississippi, just two contained accurate labels.
Even previous FDA studies have drawn similar results. Of 23 products analyzed in a 2014 study, for example, only eight were consistent with their labeled amount of CBD, the FDA says in its latest report.
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% were found to be properly labeled. Also, nearly half of the 31 products tested for cannabinoids that year contained THC.
“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 Consumer Healthcare Products Association (CHPA) said in a public statement.
New Study Efforts
In its report, the FDA says 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.
In an effort to move the needle forward, a growing number of CBD companies, including Asterra Labs, are getting involved with a nationwide study to measure the effects of daily use of full-spectrum CBD on the liver.
The study, organized by ValidCare, will involve a minimum of 700 consumers who have consumed CBD orally for at least 60 days. Designed with input from the FDA, the study is expected to start in the third quarter of 2020 and conclude by the end of the year.
While the ValidCare study will be a start to addressing the FDA’s call for expanded data, Cascone says it’s only one piece of the larger issue at hand.
“The ValidCare study will advance our knowledge regarding liver toxicity, but will not address broader quality control issues in the CBD market space,” Cascone says. “Asterra Labs looks forward to further regulation and attention from the FDA to improve public safety. The public deserves products that are safe, reliable, and free of contamination.”