FDA testing of CBD products in recent years did not reveal the presence of heavy metals like arsenic and lead at levels that posed significant health concerns. The results, however, disclosed significant variations between the amount of CBD content declared on the label and the actual amount identified through testing.
In a report recently sent to Congress and widely circulated Wednesday, FDA divulged results from testing of CBD products before and after passage of the 2018 Farm Bill, which removed hemp from Schedule I of the Controlled Substances Act (CSA).
The good news: By and large, FDA was not concerned with the levels of heavy metals found in CBD products tested in 2019 and 2020. FDA testing results confirmed what other studies have shown—significant variations between the amount of CBD declared on the bottle and that actually detected.
The 2019 and 2020 results are based on limited sample sizes and cannot be used to draw conclusions about the general market, FDA cautioned lawmakers.
“There’s not much news here,” the U.S. Hemp Roundtable, whose members include some of the largest CBD marketers, noted in an email to its distribution list. “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.”
The report also disclosed testing results of 78 products prior to enactment of the Farm Bill. FDA referred two of the products to DEA because a CBD oil capsule contained an average of 16 mg/g of THC, while a CBD gummy contained a synthetic cannabinoid known as MMB-FUBINACA at 1.9 mg/gummy.
In 2019, FDA identified 34 CBD products for testing, including those targeting vulnerable populations and products marketed with claims that they treat diseases. The products were marketed as tinctures/oils (16), capsules/powders (1), edibles (7), beverages (4) and pet products (3).
FDA analyzed all the products for such elements as arsenic, cadmium, mercury, lead and manganese. “The levels found in these 34 products did not raise significant public health concerns,” FDA divulged in the report to the House and Senate appropriations committees.
Of the 21 products that specified the amount of CBD, seven or 33%—including four tinctures, one capsule/powder and two pet products—contained the cannabinoid within 20% of the amount indicated. Ten products had less than 80% of the CBD amount indicated, while four (two edibles and two beverages) contained more than 120% of the CBD amount indicated.
Nearly half (15 products or 48%) contained THC, though that’s not necessarily a legal problem or public health concern since the 2018 Farm Bill permits hemp products to contain up to 0.3% THC on a dry weight basis.
FDA obtained one additional sample in 2019 outside its selection and testing process, based on an adverse event report (AER) for a product marketed as a dietary supplement. The product was labeled to contain 50 mg per capsule of CBD, but actually contained 70 mg per capsule, as well as 1.6 mg of THC and 0.3 mg of cannabinol (CBN). FDA did not specify the nature of the adverse event.
Through its work with the University of Mississippi, FDA selected 109 cosmetic products for testing, including 41 (38%) that indicated the product contained CBD. Of 14 products that indicated a specific amount of CBD on the label, eight contained less than 80% of the CBD amount indicated, four fell within 20% of the amount indicated, and two had more than 120% of the CBD amount indicated.
“The 68 cosmetic products tested claiming to contain hemp ingredients, but not specifically claiming to contain CBD, did not contain any measurable cannabinoids,” FDA added.
In 2020, as part of a “near-term sampling plan,” FDA tested 147 products for cannabinoids. Of 133 samples analyzed for heavy metals, 132 did not contain arsenic, cadmium, mercury or lead “at levels that represent a health concern,” the agency stated. FDA detected a concentrate of lead in one tincture that necessitated further evaluation currently underway.
Although the preliminary results did not yield public health concerns, FDA said it plans to analyze a subset of products for microbial contaminants (Salmonella and Listeria monocytogenes), pesticides and residual solvents.
Of the 102 products that indicated a specific amount of CBD, 18 contained less than 80% of the amount of CBD indicated, 46 contained CBD within 20% of the amount indicated and 38 held more than 120% of the amount indicated. "THC levels in the products tested ranged from below the LOQ [limit of quantitation] to 3.1 mg/serving, with 72 products (49%) found to contain THC or THCA at concentrations above the LOQ," FDA stated.
The 2020 “preliminary data” are based on a “limited sample size and cannot be used to draw conclusions about the marketplace,” the agency warned.
FDA also revealed a long-term sampling plan that aims to randomly test products across brands, distribution channels and product categories, “while favoring products with a higher market share.”
As it did with the earlier sampling plan, the agency intends to analyze all the products for 11 cannabinoids, including the total CBD and THC, as well as look for certain heavy metals and conduct further analyses—including microbial testing, pesticides and residual solvents—on a subset of products.
FDA expects the study to begin in 2020, with a third party to perform product sampling and testing. “The results from the planned sampling study will help the agency gain insight into the characteristics of representative products in the current CBD marketplace,” FDA stated.
The Consumer Healthcare Products Association (CHPA) released a statement in response to the report.
“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,” the association said.
FDA’s report, along with data collected by independent and academic groups testing CBD products over the last year, “have all revealed a large percentage of CBD products containing levels of cannabinoids that are either lower or higher than declared on the label,” CHPA added. “Additionally, THC levels in a number of tested products are above the legal limit. 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.”
Editor's note: This article was originally published on Natural Products Insider, sister website to Food Beverage Insider.