On July 8, the Food and Drug Administration (FDA) submitted a report to Congress describing the results of the agency’s sampling and testing of products in the CBD marketplace. The Further Consolidated Appropriations Act, 2020 required FDA to perform the study to help determine the extent to which such products are mislabeled or adulterated. In this report, FDA summarized its test results and future sampling plans. The agency did not address its CBD activities more broadly.

FDA’s Recent CBD Activities

Recognizing the public interest in CBD products, and at the direction of Congress to work toward finding a pathway for the use of CBD in food and dietary supplements, FDA has recently undertaken information gathering activities on the labeling and marketing of such products and their potential impact on public health. FDA held a 2019 public hearing, opened a docket for public comment on a wide variety of CBD issues, and has begun issuing Congressionally-mandated reports addressing CBD issues. In March 2020, FDA submitted a report to Congress evaluating potential regulatory pathways for CBD products (our client alert discussing this report is available here).

In addition, FDA has previously prepared reports on the results of its CBD product sampling and testing activities. In this most recent report, FDA explained that its previous information gathering activities, which were not comprehensive, raised concerns about the characteristics of marketed CBD products, including whether the actual CBD content in the products matched their labeling and whether they contain other cannabinoids (such as THC) or contaminants (such as heavy metals and pesticides).

FDA’s Findings

In this report to Congress, FDA described CBD product testing results from 2014 to 2018, 2019, and 2020, and the agency’s near- and long-term sampling plans. FDA’s testing analyzed the presence of THC, CBD, and other cannabinoids, and its more recent testing also analyzed potentially hazardous elements such as arsenic, cadmium, mercury, and lead. While FDA’s testing for these elements did not identify significant public health concerns, cannabinoid testing revealed that many products had more or less CBD than advertised and that many products contained THC.

From 2014 to 2018, FDA tested 78 CBD products. 88% contained cannabinoids, 86% contained CBD, and many contained THC and/or other cannabinoids. FDA referred two products to the Drug Enforcement Agency (one product for containing 16 mg/g THC and one product for containing MMB-FUBINACA (a Schedule I synthetic cannabinoid) at 1.9 mg/gummy). Of the 23 products FDA analyzed in 2014, 35% accurately declared the amount of CBD in the product.

In 2019, FDA tested 34 CBD products for certain elements and 31 of those for cannabinoid content. The results of elemental testing did not raise significant public health concerns. Of the tested products labeled to declare the amount of CBD, only one third contained CBD within 20% of the labeled amount. 40% of products that did not declare the CBD amount contained no CBD. About half of the products tested for cannabinoid content contained THC.

FDA also tested hemp and/or CBD-containing cosmetic products for CBD, THC, and other cannabinoids, 41 of which were labeled as containing CBD. All 41 did contain CBD and 12 contained THC, although none were labeled as containing THC. Of the 14 products that declared specific amounts of CBD on the label, only four contained within 20% of the declared amount.

FDA indicated that it intends to undertake a more extensive CBD product sampling effort, with near-term results informing the long-term sampling plan. The agency is currently analyzing 200 CBD and hemp products marketed online. FDA has completed testing of 147 of those for cannabinoids, 49% of which contained THC. Two products labeled as containing CBD did not. Of the 102 product labels that declared a specific amount of CBD, only 45% contained CBD within 20% of the labeled amount. FDA also analyzed 133 products for arsenic, cadmium, mercury, and lead. All but one, which FDA is still evaluating, did not contain these elements at levels that represent a health concern.

In the long-term, FDA plans to create a representative, random sample of the CBD product marketplace, as FDA does not know the extent to which previous sampling was representative. FDA is currently compiling data that it will use to randomly sample products across brands, product categories, and distribution channels, while favoring products with a higher market share. FDA will test products for 11 cannabinoids, including CBD and THC, and arsenic, cadmium, mercury, and lead, and will test a subset for pesticides, residual solvents, and microbes. FDA expects this long-term study to be initiated in 2020, and the agency will provide another report on the near- and long-term studies when complete data sets are available.

Impact of FDA’s Report

The purpose of FDA’s marketplace surveillance was to determine the extent of CBD product mislabeling and adulteration. In general, FDA’s findings are not likely to assuage the agency’s stated concerns about appropriate manufacturing controls and the accuracy of the labeling for CBD products, as FDA identified a substantial number of CBD products with CBD content that does not fall within 20% of the amount of CBD indicated on the product labeling. That said, FDA acknowledged that the “products tested are from a limited sample size and cannot be used to draw definitive conclusions.” Looking ahead, FDA’s reports on its long-term sampling efforts, which aim to include a representative, random sample of the entire CBD marketplace, may provide further insight into FDA’s perspective on the CBD sector. 

If you have any questions concerning the material discussed in this client alert, please contact the following members of our Food, Drug, and Device practice.