CBD, a non-psychoactive compound derived from cannabis plants, has gained significant attention for its potential therapeutic and medicinal properties.
Consumers are using CBD products for various purposes, ranging from pain management and seizure control to anxiety relief. However, the rapid growth of the CBD market has outpaced the establishment of comprehensive safety standards and regulations.
Regulatory agencies play a crucial role in shaping the supervisory frameworks for CBD products and thus ensuring consumer safety.
These entities include government bodies, such as the Food and Drug Administration (FDA) in the United States, the European Commission in the EU, Health Canada in Canada and the Therapeutic Goods Administration (TGA) in Australia.
They are responsible for developing and enforcing regulations, conducting risk assessments and monitoring the safety and quality of CBD products.
Industry associations, consumer advocacy groups and scientific organisations also contribute to the regulatory landscape by providing input, conducting research and advocating for clear and science-based regulations.
These stakeholders work collaboratively with regulatory agencies to establish standards, promote transparency and address emerging issues in the CBD industry.
The regulatory landscape
The regulatory landscape for CBD products varies significantly across different countries and regions. In the US, the FDA has yet to establish a comprehensive regulatory framework for CBD for therapeutic and dietary use, which has led to a patchwork of state-level regulations and varying enforcement practices.
In January 2023, the FDA concluded that the existing regulatory frameworks for foods and supplements were not appropriate for cannabidiol.
In the EU, CBD products are subject to the Novel Food Regulation. According to the European Food Safety Authority (EFSA), CBD is a novel food ingredient and companies must obtain authorisation before placing CBD-containing products on the market.
EFSA identified several knowledge gaps that need to be addressed before the evaluation of CBD can be finalised, encompassing toxicity to the liver, gastrointestinal tract, endocrine system, nervous system, psychological function and reproductive system.
Canada has established a comprehensive regulatory framework for CBD products. Under the Cannabis Act, CBD derived from cannabis plants is regulated as a controlled substance and can only be sold by authorised retailers.
However, CBD derived from hemp with less than 0.3% tetrahydrocannabinol (THC) is not subject to the same restrictions and can be sold as a natural health product or as an ingredient in foods and beverages.
In Australia, the CBD regulatory framework is complex and depends on the specific product category. CBD products with therapeutic claims are regulated as medicines by the TGA.
Approved low-dose CBD-containing products for use by adults (up to a maximum of 150 mg/day) can be supplied “over the counter” by a pharmacist without a prescription. Other CBD products, such as those intended for general wellness, fall under the jurisdiction of the Australian Consumer Law.
THC and controlled cannabinoids
Regulating THC levels in CBD products is a critical aspect of ensuring consumer safety and legal compliance. THC is the psychoactive compound found in cannabis that produces the characteristic "high" associated with marijuana.
Although CBD itself is non-intoxicating, the presence of THC in CBD products must be carefully monitored to prevent unwanted psychoactive effects.
Regular testing by accredited laboratories is necessary to accurately measure THC levels throughout the product’s shelf-life and ensure compliance with the applicable limits during the entire lifetime of the product.
Different regulatory markets have varying requirements and permissible limits for THC in CBD products. These requirements are influenced by factors such as the legal status of cannabis and its derivatives, public health concerns and the intended use of CBD products.
CBD content and other quality control measures
CBD product safety standards require accurate measurement and disclosure of the CBD content. This includes specifying the concentration of CBD per serving or per unit, typically expressed in mg.
To ensure accuracy, third-party accredited laboratory testing of CBD products is often conducted to verify CBD content and purity. Manufacturers must adhere to specific quality control measures to maintain product consistency and integrity.
This includes following good manufacturing practice (GMP) and conducting regular audits to assess compliance with quality standards.
In addition to CBD content, other constituents of the plant or chemicals that are part of the extraction or production process must be tested, such as other cannabinoids or terpenes and/or other contaminants including pesticides, heavy metals, residual solvents and microbial pollutants.
These contaminants can pose health risks if present in significant amounts.
Although the underlying principles of GMP are generally consistent across regulatory markets, there may be variations in terms of the specific requirements and implementation methods.
By working with a CBD testing and consulting specialist such as Broughton, manufacturers can ensure that their product meets the required standards.