[co-author: Ariane Beckman]

As of January 2019, all consumable CBD products—including extracts and isolates—were confirmed as novel foods for England and Wales, and therefore must be approved by the Food Standards Agency (FSA) before they can be sold legally in England and Wales. Novel foods are “any food that was not used for human consumption to a significant degree within the Union before 15 May 1997” and that fall within a number of categories. This is similar to the United States FDA standards for foods that are generally recognized as safe (GRAS).

Those wishing to sell CBD products in Great Britain must submit a “full application” to the Food Standards Agency, which typically takes about a year to process. There have been many complaints about the novel foods application process as many CBD applicants have been rejected for seemingly arbitrary or inconsistent reasons. These reasons include allowing greater amounts of synthetic THC than naturally derived and unclear standards for what types of studies and data meet the safety determination requirements. The FSA has stated that publicly available studies are insufficient to support individual product safety, which has frustrated applicants. Additionally, companies that made significant capital investments to comply with the application process and product safety are frustrated at the lack of enforcement against non-compliant businesses. Currently, 131 products have been approved by the FSA, while there have been applications for at least 12,117 products.

While producers and consumers may be frustrated with the regulatory process for CBD Novel Foods, the regulators in the UK—like those in the US—are struggling to find ways to best determine safe levels and appropriate regulations CBD. To inform their rulemaking decision process, the Home Office requested the Advisory Council on the Misuse of Drugs (ACMD) review the available scientific literature, consult with industry and analytical labs, and generally request information from the public regarding consumer CBD products. This request resulted in the ACMD’s Consumer Cannabidiol (CBD) Products Report issued in December 2021, which sought to establish:

• A maximum dose for any non-negligible effect for Δ9-THC, THCV and CBN and the cannabinoid Δ9-THCA-A
• Whether consumer CBD products are likely to have ill effects or be abused
• If controlled substances can be recovered from such products
• What the current analytical capability is to test products for cannabinoid content

Key Findings and Recommendations from the ACMD’s Consumer Cannabidiol (CBD) Products Report

• There is not sufficient evidence available in the current scientific literature to establish dosage levels for Δ8-THC, THCV (tetrahydrocannabivarin), and CBN (cannabinol), but that the threshold doses for THCV and CBN are substantially higher than Δ9-THC
• Due to the variations in product types, the way people use products, individuals themselves, and the challenges of accurately measuring phytocannabinoid levels, it can be challenging to accurately measure the effects of Δ9-THC and cannabinoids in general. The dose limit for Δ9-THC, including Δ9-THCA, should be 50 micrograms per unit of consumption or less to have no psychoactive effects on the user. This assumes that the user only takes one unit of consumption at a time
• At these recommended levels, the controlled phytocannabinoids present in consumer CBD products are highly unlikely to produce any adverse effects. They also note that it is quite unlikely that plant-derived CBD products would contain enough controlled phytocannabinoids other than Δ9-THC to cause any pronounced psychoactive effects unless purposely added to the product. Extracting controlled phytocannabinoids from consumer CBD products is unlikely to be a viable means of obtaining these drugs for illicit use due the very low levels of controlled phytocannabinoids in consumer CBD products, and the cost and time it would take to extract a usable amount of these phytocannabinoids from CBD products
• The report recommends setting levels for Δ9-THC in consumer CBD products using either a level of controlled phytocannabinoids as a percentage of CBD content or setting levels for different products
• Notably, the Report indicated that the current analytical methods available to test products for cannabinoid content are not sufficiently robust in regards to sensitivity, accuracy, and reproducibility to accurately and consistently quantify the various phytocannabinoids in consumer CBD products. This is mainly due to the various techniques labs will use to test for phytocannabinoids other than CBD. While these different techniques generally get the same results for the amount of CBD in a product, results vary for the amount of other phytocannabinoids. Additionally, CBD makes it harder to detect trace amounts of other phytocannabinoids because of their similar structures
• The Report also emphasizes the pros and cons of its recommendation to set levels for Δ9-THC in consumer CBD products using either a level of controlled phytocannabinoids as a percentage of CBD content, or to set levels for different products. These methods have potential drawbacks and challenges. First, setting a percentage using the amount of CBD in a product means that a product with large quantities of phytocannabinoids could be produced by increasing the amount of CBD. When calculating this ratio of Δ9-THC to CBD, the error in the estimations of each would be compounded when taking the ratio. Secondly, separate legislation would be required to limit the content of controlled phytocannabinoids in any new consumer products containing uncontrolled phytocannabinoids such as CBC or CBG. Third, setting levels for individual products means that there would be increases in the variability and complexity of regulations, and regulators would have to consider what is actually feasible in terms of the sensitivity for measuring different phytocannabinoids

While regulators struggle to determine safe limits for CBD products, businesses and companies are caught in the crossfire as they try to comply with changing regulatory standards. While the current novel foods system is frustrating for those in the industry, Parliament does appear to be amenable to change. The All-Party Parliamentary Group (APPG) recently suggested that CBD and CBD products should not be subject to novel foods regulations.

As FDA and various states such as New Hampshire and South Dakota are considering regulating consumable hemp, it’s important to consider the findings and lessons learned from the UK and other jurisdictions.

https://www.jdsupra.com/legalnews/lessons-learned-from-the-regulation-of-8506584/