The U.S. Food and Drug Administration (FDA) recently sent an overdue report to Congress regarding its review of cannabidiol (CBD) products for mislabeling and adulteration. The FDA report revealed that mislabeling and adulteration are not widespread, it did find that the actual CBD content in many products did not match the content described in these products’ labeling.
According to the FDA, its findings support the need for additional studies. “FDA believes that understanding the characteristics of marketed CBD products is critical to making informed decisions about how best to protect public health in the current marketplace,” the report states.
FDA Report on CBD Products
The FDA report, which was mandated under a 2019 Congressional appropriations bill, recognizes the increasing popularity of CBD, as well as the lack of data regarding products on the market. “FDA recognizes the significant public interest in CBD products,” the FDA wrote. “However, there are many questions about the characteristics of currently marketed CBD products because the Agency lacks significant information on what CBD-containing products are on the market and there are little data available on those products themselves.”
The FDA report discusses the CBD product testing conducted both before and after the passage of the Agriculture Improvement Act of 2018 (2018 Farm Bill). The studies conducted by the FDA focus on whether or not the CBD content on the product label matches the actual concentrations in the product, as well as whether or not the products contain other cannabinoids like THC or harmful contaminants, such as pesticides or heavy metals.
In 2019, the FDA identified 34 CBD products for the testing of certain characteristics, including cannabinoid content and elements such as arsenic (As), cadmium (Cd), mercury (Hg), lead (Pb,), manganese (Mn), nickel (Ni), copper (Cu), zinc (Zn), selenium (Se), molybdenum (Mo), antimony (Sb), barium (Ba), cobalt (Co), lithium (Li), tin (Sn), and vanadium (V). The levels found in the 34 products did not raise significant public health concerns. Of the 31 products tested for cannabinoids, 21 products specified the amount of CBD in the product (e.g., CBD amount per serving). Of these 21 products, seven products (33 percent) contained CBD within 20 percent of the amount indicated. Of the 10 products that did not indicate the amount of CBD included in the product, six contained CBD, and four did not. In addition, 15 of the 31 products (48 percent) contained THC. As the FDA noted, because the results were derived from a limited sample size, they “could not be used to draw definitive conclusions.”
The FDA report also discusses the agency’s work with the University of Mississippi to develop a method to detect and quantify CBD ingredients in cosmetic products. Out of 41 products purporting to contain CBD, 12 also contained THC. Additionally, out of the 14 products indicating that they contained a specific amount of CBD, eight of those products contained less than 80 percent of the amount indicated, and two contained greater than 120 percent of the amount indicated.
The report goes on to outline the FDA’s plans for more comprehensive product sampling going forward. As described by the agency, the FDA has developed a sampling plan that is divided into two phases: near- and long-term. To date, the short-term plan has involved testing 147 products for cannabinoids, 138 of which contained CBD. “Of the 102 products that indicated a specific amount of CBD, 18 products (18 percent) contained less than 80 percent of the amount of CBD indicated, 46 products (45 percent) contained CBD within 20 percent of the amount indicated, and 38 products (37 percent) contained more than 120 percent of the amount of CBD indicated,” the report found. Only one of 133 samples had potentially hazardous materials.
As part of its long-term sampling plan, the FDA is purchasing data on brands, product categories, and distribution channels for CBD products, as well as developing its own comprehensive list of brands operating in the CBD market space. According to the FDA, it intends to leverage both data sets to randomly sample products across brands, product categories, and distribution channels, while favoring products with a higher market share. The FDA expects the sampling protocol to include most, if not all, of the following product categories:
- Tinctures, oils, and extracts
- Capsules and powders
- Water and other beverages
- Other conventional foods
- Leave-on cosmetic products, like face and body lotions
- Device and combination products, like personal lubricants, tampons, and suppositories
- Vape cartridges
- Products sold for consumption by pets
Product sampling and testing will be conducted by a third party, and FDA expects this long-term study to be initiated in 2020. As was done in the near-term study, all products will be analyzed for 11 cannabinoids, including a quantitative determination of total CBD, total THC, and the elements As, Cd, Hg, and Pb.
Future FDA Oversight Over CBD
Federal lawmakers continue to call on the FDA to increase its oversight over CBD products. A subcommittee of the House Appropriations Committee recently allocated $5 million for the FDA to continue its review of CBD products in the 2020-21 budget year. The appropriations bill specifically states:
The Committee provides an increase of $5,000,000 for enforcing the law to protect patients and the public while also providing a potential regulatory pathway for cannabis and cannabis derived products. The Committee maintains its concern about the proliferation of foods and dietary supplements marketed in violation of the Federal Food, Drug and Cosmetic Act (FFDCA), including products containing cannabis and cannabis-derived ingredients. Non-FFDCA-compliant products continue to pose potential health and safety risks to consumers through unsubstantiated and misleading claims such as treating a wide-range of life-threatening diseases and conditions. The Committee expects the FDA to continue to prioritize consumer-safety through application of the law.
As discussed in greater detail in prior articles, the FDA is currently in the process of determining how to approach CBD regulation. In March, the agency informed Congress that it is still working to determine if CBD can safely be allowed in dietary supplements. In the meantime, it is “evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding FDA’s enforcement priorities while FDA potentially engages in the process of a rulemaking.”
“FDA is currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors FDA intends to take into account in prioritizing enforcement decisions,” the FDA further explained. “Any enforcement policy would need to balance the goals of protecting the public and providing more clarity to industry and the public regarding FDA’s enforcement priorities while FDA takes potential steps to establish a clear regulatory pathway.”
The FDA’s latest report on CBD mislabeling and adulteration confirms that FDA oversight CBD-containing products will benefit both cannabis companies and consumers by allowing the industry to grow while eliminating “bad actors.” In the absence of clear regulations, it is imperative to stay up-to-date on the latest legal developments and to consult with an experienced cannabis attorney who understands how to navigate the complex and rapidly evolving regulatory landscape.
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If you have any questions or if you would like to discuss the matter further, please contact me, Dan McKillop, or the Scarinci Hollenbeck attorney with whom you work, at 201-806-3364.