Dive Brief:
- In a report to the U.S. House Committee on Appropriations and the U.S. Senate Committee on Appropriations, the FDA released findings from its sampling study on the current CBD marketplace and determined that many of the products tested were mislabeled, containing either less or more CBD than advertised.
- Two hundred products were randomly chosen for testing this year, including tinctures, oils, capsules, edibles, drinks and pet products. Testing for cannabinoids was done for 147 of the 200 products and found that 49% contained some THC. Out of the 102 products that listed a specific amount of CBD, 18% of products contained significantly less than the amount indicated and 37% contained significantly more than indicated.
- For the 20 edible and beverage products tested that had an amount of CBD marketed on their labels, five had less than 80% of the amount of CBD indicated and six had more than 120% of the CBD marketed on its label.
Dive Insight:
As CBD remains in a gray area, these studies could bring the FDA a step closer to federal regulation. The agency said in the report that further understanding the CBD products on the market right now is "critical to making informed decisions about how best to protect public health in the current marketplace."
This report comes as the FDA's fiscal year 2021 spending bill is currently in markup and appropriators have said that some of the funding will be put toward a potential framework for regulating CBD, Politico reported. In order to continue its larger testing plans on CBD products, a funding boost could help. The agency said these preliminary study results are from a limited sample size and supports the need for a bigger and longer-term study, which will look at products both online and in brick-and-mortar outlets.
Betsy Booren, senior vice president of regulatory and technical affairs at the Consumer Brands Association, said in a statement that this FDA report on labeling accuracy further emphasizes the need for federal regulatory clarity.
"Allowing bad actors to continue to put products on the market, unchecked, is a threat to consumer safety everywhere," she said. "The consumer packaged goods (CPG) industry applauds FDA's efforts and urges Congress to provide more funding and resources to FDA to move quickly through this process."
It has been more than a year since the FDA's first public hearing on CBD, where manufacturers expressed confusion about regulation and pushed for clarity. In the new report, the FDA said that its public hearing last year and its open docket provided useful information and raised concerns about the quality and content of CBD products on the market. But FDA said testing has been limited in scope and has not yet provided a broader understanding of the market, which is why they are now pushing for further testing.
The 2018 Farm Bill no longer classified hemp and its derivatives as controlled substances, so the crop can be grown and distributed in most states, but under the federal Food, Drug and Cosmetic Act, it is still illegal to add CBD to food. However, states have passed their own laws and CBD continues to be added to a variety of products, including beer, snacks, coffee, cocktails and jelly beans. Lawmakers have expressed wanting the FDA to move faster on regulation than the several years anticipated because the crop's production has the potential to boost agricultural revenue.
Last year, the agency released an update about CBD, saying that it couldn't give the ingredient generally recognized as safe status or approve products that contain it. FDA has continued to issue warning letters to companies wrongly using or advertising CBD and more could be coming as its testing continues.