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22. June 2020
News Regulation Trends & Insight

Market Insight: Global Regulators Drive Requirement for Increased Research on CBD Safety

Global regulators are placing increasing pressure on the CBD industry to produce research and scientific data that will demonstrate the safety of CBD ingredients, amid rising consumer use, and impending novel food assessments.

A recent announcement, that seven US CBD companies would be sponsoring research to evaluate the impact of daily CBD use on the liver function of healthy adults, highlights the growing need for industry participants to improve the level of research and data available to regulators making decisions around CBD safety.

Regulators taking cautious CBD approach

With more countries around the world requiring novel food applications for products containing CBD ingredients, regulators are looking to the CBD industry to help improve the current data and scientific understanding of the effects of CBD. Research that can provide tangible data to allay safety fears is increasingly becoming a critical requirement for the whole industry.

In the United States, regulators continue to adopt a cautious approach. The FDA still does not consider CBD a legal dietary ingredient, or recognise it to be ‘generally recognised as safe’ (GRAS) in food.

In a recent announcement the FDA stated that it had made “substantial progress” towards a goal of providing additional guidance on ingestible CBD products, but offered no specific details and continued to emphasize its ongoing questions and concerns about the science, safety, effectiveness, and quality of CBD products

The White House Office of Management and Budget (OMB) is currently reviewing draft guidance from the FDA for a federal plan on marijuana and CBD research.

Commenting on the draft document, titled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research” an FDA spokesperson has indicated that it is related to the agency’s ongoing work to develop broader CBD regulations that could eventually allow for the marketing of cannabis products as dietary supplements or food items.

We recognize that there is substantial public interest in marketing and accessing CBD for a variety of products. We are working toward a goal of providing additional guidance, and have made substantial progress,” FDA said in a statement. “There are many questions to explore regarding the science, safety, effectiveness and quality of products containing CBD, and we need to do our due diligence.

As part of our work, the FDA continues to explore potential pathways for various types of CBD products to be lawfully marketed,” the statement continues. “An important component of this work is obtaining and evaluating information to address outstanding questions related to the safety of CBD products that will inform our consideration of potential regulatory frameworks for CBD while maintaining the FDA’s rigorous public health standards.”

What remains to be seen is whether the FDA plans to wait for this specific guidance to be finalised and for the resulting research to be completed before it gets around to issuing final rules for CBD products in general.

In the UK, the FSA issued CBD safety guidance for the first time earlier this year, advising those who are pregnant, breastfeeding or taking any medication not to consume CBD products. Healthy adults are also advised to think carefully before taking CBD, and the FSA recommends no more than 70mg a day (about 28 drops of 5% CBD) unless under medical direction.

The precautionary advice was based on findings by the government’s Committee on Toxicity. In making the statement, Emily Miles, Chief Executive of the Food Standards Agency, said: “We are advising that CBD could be risky for vulnerable groups, and suggesting an upper limit of 70mg a day for everyone else taking the product.

“The actions that we’re taking are a pragmatic and proportionate step in balancing the protection of public health with consumer choice. It’s now up to industry to supply this information so that the public can be reassured that CBD is safe and what it says it is.

At the same time, Professor Alan Boobis, Chair of the UK’s Committee on Toxicity, said: “My committee has reviewed the evidence on CBD food products and found evidence there are potential adverse health effects from the consumption of these products. We are particularly concerned about pregnant or breast-feeding women and people on medication.

“We don’t know enough to be sure about such a risk but I am pleased with the sensible and pragmatic approach the FSA is taking.

Internationally, requests for more evidence are coming from national food safety agencies alongside calls from EFSA and the UN.

Industry Response

The US-based Collaborative for CBD Science and Safety has called on industry, researchers, academia, healthcare practitioners, and regulators to accelerate research and the development of an appropriate federal regulatory framework for cannabidiol (CBD) and CBD-containing products.

Sally Greenberg, executive director of the National Consumers League and CCSS Steering Committee Member, recently said; “We must ensure consumers can trust the safety and quality of CBD-containing products and can rely on the product’s claims where appropriate. The importance of a separate regulatory pathway for CBD-containing products is underscored by the current spread of the coronavirus and the 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 towards developing a regulatory pathway for CBD and begin mitigating threats posed by poor-quality products.

Since 2016, there has been a nearly 65% increase in cannabis research funding, in the US, from $115 million to $189 million, but that amount remains insufficient to keep up with public demand for CBD-containing products, according to the CCSS.

ValidCare (a clinical trial outsourcing and market research company), announced earlier this month that it would be undertaking observational research to evaluate the impact of daily CBD use (both full-spectrum, hemp-derived CBD and CBD isolate) on the liver function of healthy adults, results of which will be provided to the U.S. Food and Drug Administration (FDA) for consideration in its efforts to regulate CBD.

The study which has been sponsored by a group of seven major US CBD brands (Boulder Botanicals & Bioscience Labs, CBDistillery, CBD American Shaman, Charlotte’s Web Holdings, Columbia Care, HempFusion, and Kannaway) will aggregate data from at least 700 consumers, which will be combined with information regarding personal history, blood tests, and product information.

The collection of leading US CBD brands sponsoring the research it demonstrates the leading role that industry needs to be taking in order to ensure that regulators have sufficient, scientifically-proven, data upon which they can base key policy and regulatory decisions.

In the UK, The Association for the Cannabinoid Industry has announced plans to lead a CBD Safety Study Consortium to generate data to assess the safety of CBD and to discern exactly what the recommended daily dose should be.

The ACI’s CBD Safety Study Consortium will grant the opportunity for companies to provide the evidence these organisations are calling for whilst sharing the burden of costs of such studies. The study will identify data gaps and generate analytics based accordingly. The goal is to generate data to be used across a broad range of secondary (finished) products.

In a statement, Dr Parveen Bhatarah, Regulatory and Compliance Unit Lead, The ACI, said; “Regulators in the UK and internationally are looking for evidence about CBD safety, toxicity, dosing and the cumulative effect of ingesting CBD. Along with safety issues related to other known cannabinoid impurities present in the CBD products and possible associated harms.  ACI is assisting the CBD industry to generate this data in a most cost effective manner.”

The study will assess different modes of delivery and bioavailability, for example ingestion, absorption and inhalation. The study will also assess if there are any potential vulnerable groups (for example children, adolescents or pregnant and lactating women). We will also identify any overlap of therapeutic dose levels from approved drug products, with potential exposure from other uses including food, dietary supplement or cosmetics. The outcomes will help define a maximal acceptable daily intake of CBD for all products.

The ACI is combining forces with Advanced Development & Safety Laboratories (ADSL) to meet the safety and toxicity challenges of assessing CBD. ADSL is a leading regulatory and compliance company with full scale laboratory and analytical testing capabilities.

CBD isolate has been identified as the first primary product for this work. This will provide a baseline for finished product assessment. The same approach can then be applied for all primary CBD products; including isolate, narrow spectrum, broad spectrum or full spectrum.

Looking forward

With novel food regulation placing requirements on manufacturers to provide data that can demonstrate safety, there is a huge financial and research burden associated with generating that evidence. Therefore industry partnerships and collaboration that can collectively help produce this evidence make both strategic and financial sense for achieving those goals.

Over the coming months we will likely see additional research and industry-sponsored studies announced, in a bid to help grow this global CBD knowledge-base, and ensure that the market can continue to grow and operate within any new regulatory frameworks.

Author: Matthew Driver, Senior Consultant

Market Analysis | Insight & Trends