The US Food and Drug Administration (FDA) declared on January 26, 2023 that a new regulatory pathway is needed for hemp-derived CBD products. Working with Congress, the agency intends to devise a comprehensive strategy. The FDA has highlighted concerns regarding the safety of hemp-derived CBD products and the lack of understanding regarding its effects. These laws will override current CBD laws at a state level.
Marketing of CBD Prohibited
It is already illegal to market products that contain cannabidiol (CBD) as dietary supplements. The FDA has determined that CBD products cannot be classified as dietary supplements or food additives. This conclusion was based on the findings from multiple sources, including scientific publications, working review studies, and public submissions. The FDA has denied three citizen petitions that requested the opposite.
Lack of Evidence on CBD’s Safety
According to the FDA, there is inadequate evidence to determine the amount of CBD that can be consumed safely and for how long. As a result, the FDA does not plan to pursue rulemaking that would allow the use of hemp-derived CBD in dietary supplements or conventional foods. FDA Principal Deputy Commissioner, Dr. Janet Woodcock, stated, “We have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods.”
Popularity and Anecdotal Evidence
The popularity of hemp-derived CBD products has increased rapidly, and anecdotal evidence of its effects abounds. Christopher McCurdy, President of the American Association of Pharmaceutical Scientists, says the FDA faces a unique situation with CBD.
There is a need to balance the consumer demand for these products with a regulatory framework to ensure their safety. McCurdy, who is also a professor at the University of Florida’s College of Pharmacy, says, “The important thing to take away is that they’re trying to balance the consumer desire for the products with a regulatory framework to ensure the safety. That’s what the FDA’s role is.”
Potential Risks and Safety Concerns
The FDA has highlighted the potential risks and safety concerns associated with the use of hemp-derived CBD, such as harm to the liver, interactions with certain medications, effects on the male reproductive system, exposure to children, and pregnant individuals. Possible strategies for risk management could include rules on labeling, content limits, minimum purchase age, and oversight of CBD products for animals. Consumers could be exposed to CBD through animal products such as meat, milk, and eggs.
Rapidly Growing Market
The CBD market has grown rapidly in recent years and is estimated to be worth $4.6 billion. Forecasts predict that the market will quadruple by 2026. The FDA has warned about the emerging Delta-8 THC market, which typifies many of the safety concerns associated with emerging cannabinoids. Unlike CBD, Delta-8 THC is psychoactive.
The US Centers for Disease Control has issued an official health advisory for Delta-8 THC, warning that these products have the potential to be confused with hemp-derived CBD products, exposing consumers to the risk of unexpected or increased intoxication.
Test Case for CBD
Christopher McCurdy says that hemp-derived CBD products pose an “interesting test case,” and any steps taken will certainly set precedents. The whole dietary supplement industry is regulated to some extent, and McCurdy says that CBD and its many products will be no exception. The FDA intends to work with Congress to create a comprehensive regulatory pathway for CBD products to ensure their safety for consumers.
It can be expected that once the regulatory framework is updated for CBD labeling, that several other alternative cannabinoids like Delta-8, Delta-10, THC-O, HHC, and several others can expect similar regulations.
