FDA report details poor quality control, undisclosed THC in many CBD products
In a report released to the US House and Senate Committees on Appropriations, FDA Commissioner Dr Stephen Hahn, MD, detailed what the agency has found in testing CBD/hemp products from 2014 to the present. The report paints a picture of uneven quality, with many products having less than 80% of the stated amount of CBD or in some cases more than 120% of the amount on the label. Only those products that claimed an amount of CBD on the label were evaluated in this way.
THC found in many products
More worrying to observers was the fact that many of the products contain THC. In one case, a product that was tested before 2018 contained so much THC that it was referred to the Drug Enforcement Administration, the report said.
THC, or tetrahydrocannabinol, is the narcotic fraction of the Cannabis sativa plant. Varieties of this plant used in the CBD/hemp products trade are supposed to have less than 0.3% THC by dry weight in order to qualify as ‘industrial hemp’ in a regulatory sense. Amounts of THC above that level put a product into the schedule one category of controlled substances and move them into the bailiwick of DEA.
The report stated that in all FDA had tested 112 CBD/hemp products through the end of 2018. In a table in the report summarizing those results, FDA found that of the 78 products tested that were marketed as CBD products, 46 contained THC at some level. In addition, 11 of the products contained no detectable levels of CBD. FDA found that in 2014 of the 23 products tested, only 35% met label claim for CBD content. The report did not give further detail on how the other 55 products tested in the 2015-2018 period performed on the CBD content vs label claim front.
Problems persist in 2019 and 2020 testing
In 2019 FDA tested 34 products. FDA selected products to test based on those that were making disease treatment claims and those that had been marketed toward vulnerable populations. FDA stepped up the testing in 2020, analyzing another 147 products to date. The results seemed to indicate the industry has made little progress on the quality control front over the years.
In 2019 FDA tested 16 tinctures or oils, seven edibles, one capsule/powder product, four beverages and three products meant for pets. Of the 10 oil products that made a CBD claim on the label, only 4, or 40%, came within 20% over or under of that amount. In addition, 11 of those products contained THC, even though it was not disclosed on the labels. None of the edible products or beverages that were making a CBD contain claim on the label fell within the ±20% window.
The 2020 testing results were even less reassuring from a quality control perspective. Of the 147 products tested, nine contained no CBD, 18 products (or 18%) were understrength, with less than 80% of CBD amount, 46 products (15%) fell with the ±20% window, and 38 products (37%) had more than 120% of the state CBD amounts. In addition, 72 products (49%) contained THC above the limit of quantification.
Plan in place to test statistically representative sample of what’s on market
Going forward Hahn said the Agency is developing a plan to test a representative selection of products that will give a more comprehensive view of the marketplace. To determine how to go about this the Agency has purchased data on brands, product categories, and distribution channels for CBD products. And FDA is developing its own lists of CBD brands via Internet searches and data analytics.
“These preliminary data are from a limited sample size and cannot be used to draw conclusions about the marketplace and supports the need for the long-term study, which will capture multiple retail sources (on-line and brick and mortar) and a greater number of products,” the report stated.
"The results from the planned sampling study will help the Agency gain insight into the characteristics of representative products in the current CBD marketplace,” it added.
NPA: THC presence could threaten vulnerable populations
While the report might have put to rest some fears about widespread heavy metal, pesticide or synthetic cannabinoid adulteration in these products, it’s far from reassuring, said Daniel Fabricant, PhD, president and CEO of the Natural Products Association.
“The THC thing should be cause for alarm,” Fabricant told NutraIngredients-USA. “Were any of these products labeled for use by children? I think FDA should release the names of these companies and take action against them.”
Fabricant said from NPA’s point of view the results are indicative of an industry that is not well educated on GMP compliance.
“It has been such a gold rush mentality. You have a lot of people who might know hemp farming but they don’t know the GMP regulations,” he said.
Fabricant said beyond the presence of THC, the inconsistent levels of CBD could be a concern, too.
“FDA needs to set a safe level on CBD. How much is too much? For these products that had more than 120% of label claim, are there adverse events associated with that?” Fabricant said.
CHPA: More testing is good, but a regulatory solution would be better
The Consumer Healthcare Products Association said in a statement that it is concerned that FDA's testing plan means even more time will elapse before a regulatory solution is found for this category of products.
"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 organization said. “CHPA respects FDA’s desire to gather more data, but we urge the Agency to take action on a path forward."
Industry runs risk of letting rogue players write the story
Steve Hoffman, principal in the firm Compass Natural Marketing, has been involved in the CBD/hemp marketplace from the beginning, having worked on some of the state ballot initiatives that first opened the door to the trade. Hoffman said the report lays out the risk the industry runs by not banding together to present a unified front advocating for quality.
“I encourage manufacturers of hemp-CBD related products to tune in to regulations governing the dietary supplements industry and to become members of AHPA, NPA and others that promote the highest quality GMPs and regulatory compliance. Also, it is preferable for the industry to encourage standards than to have the FDA’s decision making on hemp CBD be dictated by a few wild west players,” Hoffman said.
Does the 0.3% THC level make sense?
On the THC front, Hoffman said there continues to be disagreement about whether the federal 0.3% limit, which some allege was determined arbitrarily, still makes sense. Nevertheless, the inconsistent levels still speak to ragged quality within the industry.
“Regarding the question of THC, that is particular, and problematic, and the industry should do better. However, Vote Hemp this week issued a petition asking Congress to change the definition of hemp to allow for 1% THC instead of the current, arbitrarily set 0.3%. This will help many farmers and manufacturers stay in business, and 1% THC is still hemp and NOT marijuana,” Hoffman added.