Following the passage of the 2018 Farm Bill, the production of industrial hemp with THC concentration of no greater than 0.3% by weight was permitted in the U.S. Still, FDA does not consider CBD legal to sell as a food, dietary supplement, or any other type of product. Despite the fact that there is no regulatory framework by which ingestible CBD can be sold, and FDA is concerned with a number of potential health risks associated with long-term CBD use, a myriad of companies have launched CBD-containing ingestible products, through a grey area established by the Farm Bill before regulators bridged the gap between legalizing production of hemp and the sale of hemp in food and dietary supplements.
Since 2016, a nearly 65% increase has occurred in cannabis research funding, from $115 million to $189 million, CCSS reports. “However, the dollars flowing in remain insufficient to keep up with public demand for CBD-containing products, with some estimates projecting CBD sales surpassing $20 billion by 2024. By reopening the public docket and ‘extending it indefinitely,’ FDA signaled that regulatory oversight and continued evaluation remain stymied by the dearth of existing scientific data and information on cannabis or cannabis-derived compounds,” CCSS said in a statement.
The 2019 public hearing aimed to assist the agency in gathering scientific data and related quality, marketing, and labeling information for CBD and related products for the purposes of developing a robust regulatory framework. Many individuals and organizations, including CCSS participants, engaged in the 2019 hearing, encouraging FDA to establish a clear path forward for safe, high-quality products containing CBD.
“We must ensure consumers can trust the safety and quality of CBD-containing products and can rely on the product’s claims where appropriate,” Sally Greenberg, Executive Director of the National Consumers League and CCSS Steering Committee member, said. “The importance of a separate regulatory pathway for CBD-containing produccts is underscored by the current spread of the coronavirus and false, dangerous claims and misinformation about CBD that have accompanied the pandemic. In all cases, consumers remain at risk. FDA must continue to take action toward developing a regulatory pathway for CBD and begin mitigating threats posed by poor-quality products.”
CCSS reports that FDA’s actions against illegal actors in the realm of CBD has spiked over the past twelve months, even as COVID-19 ahs consumed much of the agency’s bandwidth for the duration of the pandemic thus far. The agency has issued 30 CBD-specific warning letters since the public hearing, a 50% increase compared to pre-hearing statistics going back to 2015.
“Though these steps are necessary and important, still more needs to be accomplished to protect public health and safety and remain on par with other national regulatory bodies – such as the United Kingdom, Sweden, and Australia – addressing CBD for their consumers,” CCSS said.
“FDA has adopted a cautious approach to addressing the us of CBD in dietary supplements – it still does not consider CBD a legal dietary ingredient, nor recognize it to be ‘generally recognized as safe,’ or GRAS in food,” Steve Mister, president and CEO of Council for Responsible Nutrition and CCSS Steering Committee member, said. “FDA should continue to advance efforts that address the research gaps it has identified around CBD and establish a clear evidence-based path forward for their regulation of CBD-containing products as they are already widespread on pharmacy, grocery, and convenience store shelves nationwide absent of a federal regulatory framework.”
Following the public hearing in 2019, FDA reopened the public docked on cannabis and cannabis-containing products in March of this year to allow stakeholders to provide the agency with new and emerging information, while protecting confidential data that should be accessible to regulators. FDA indicated that clinical studies regarding safety, tolerability, driving impairment, alcohol interaction, and dermal penetration are most needed to address data gaps, as are systematic surveillance reports, which should be opportune given that CBD is broadly available and some data about exposure and outcomes might not be feasible using traditional clinical trials or studies. At the state level, a number of enforcement actions have passed mostly dealing with claims that CBD can cure, prevent, or treat diseases, most of which are against specific companies.
According to CCSS, the U.S. is mostly on pace with other international regulatory agencies in regard to establishing regulatory frameworks. In Australia, CBD is currently listed as a Schedule 4 prescription-only medicine, but a proposal is at play to move it to schedule 3, which would be a pharmacist-only medicine, subject to safety and regulatory approvals with a maximum dosage of less than 60 mg for adults 18 years or older.
The U.K. has deemed CBD products containing over 1 mg TH per container illegal. Currently, no new products are allowed on the market, and the Food Standards Agency has posed a March 2021 deadline for companies to submit and have validated a European Union novel food application on CBD. There is a proposed maximum of 70 mg daily for healthy adults, with attached advice to consult a doctor before using CBD products.
In Sweden, CBD products are illegal if they contain any amount of THC, and its possession is illegal without a prescription. The Swedish Medical Products Agency considers all CBD products to be medical products which require approval from the MPA before they are allowed to be sold.