A Conversation with Douglas Stearn and Kristi Muldoon-Jacobs
The FDA has been receiving an increasing number of adverse reports about cannabidiol (CBD) containing products that consumers may confuse for conventional foods and beverages.
Douglas Stearn and Kristi Muldoon-Jacobs discuss FDA’s concerns with companies selling CBD containing products that may result in accidental consumption or overconsumption of CBD. This is particularly true for CBD containing products in forms that are appealing to children, such as gummies, hard candies and cookies. Many of these products can easily be mistaken for conventional foods that are commonly consumed by children and may cause harm.
What exactly is CBD and how is it different from THC?
CBD is a chemical compound found in the cannabis plant. Marijuana is a term for cannabis plants that contain high levels of THC, a compound that produces the “high” from marijuana. Cannabis plants with lower levels of THC are known as hemp. Hemp plants often contain high levels of CBD. THC and CBD are very similar in chemical structure. Even though CBD generally isn’t considered intoxicating, both CBD and THC affect the brain and the body.
What is the FDA’s position on CBD in products?
We want to be clear that the data on CBD point to real risks that need to be considered. Risks include liver injury, harm to the male reproductive system, and side effects, such as changes in alertness and other symptoms. In addition, drug interactions – taking CBD with other medications -- may increase or decrease the effects of other medications, which may lead to more side effects from, or decreased effectiveness of, the other medications.
Risks are managed differently in the context of approved drugs. The FDA has approved one drug containing CBD to treat certain severe seizure disorders. As part of the drug review and approval process for Epidiolex, it was determined that the benefits outweigh the risks for the population for which it was intended, when used under close medical supervision.
Why is CBD in food a concern?
Food ingredients must be shown to be safe to be lawfully added to food. That means, there must be a reasonable certainty that an ingredient’s intended use won’t cause harm. This safety standard considers both potential exposure and different types of consumers—such as someone who consumes it every day throughout their lifetime or throughout pregnancy. We haven’t found sufficient information showing how much CBD can be consumed, and for how long, before causing the various types of harm we’re concerned about. For example, to date, we don’t know whether regular or long-term CBD consumption could negatively affect fertility. CBD may also interact with other substances and alter their effect on the body. Studies suggest CBD may increase and/or prolong caffeine’s effects, which could be a problem for people who are sensitive to caffeine.
Additionally, using food to administer CBD makes it hard for people to control how much CBD they’re taking. Consumers eat food for other reasons than to take CBD, and they may end up taking more CBD than they meant to. It can also be easy for someone to consume CBD accidentally when it’s in an ordinary-looking food. This is especially true for children when CBD is in the form of a snack or a candy.
Are you holding CBD to the same standard as other substances that are intentionally added to food?
Yes, we’re holding CBD to the same standard that we would any other substance that is intentionally added to food, like sweeteners or preservatives. Consumers should be able to have confidence that food additives won’t harm them.
What is the FDA doing about CBD?
We know that there’s great public interest in CBD products, even though CBD cannot lawfully be added to foods or dietary supplements. We recently issued warning letters to companies for illegally selling foods with CBD, including products that are appealing to children, products that may be mistaken for traditional foods, and caffeinated beverages. Caffeine is one of CBD’s possible drug interactions. While we continue exploring policy solutions to address the large, violative market of CBD products, we will continue to monitor the marketplace and take action, as needed, against companies that pose the greatest risk of harm to the public.
What do you most want people to know?
We are concerned that people might mistakenly believe that using CBD “can’t hurt” and that the FDA has evaluated CBD products and determined they’re safe. Data on CBD points to real risks, and the FDA is especially concerned about the risks to children, people who are pregnant or breastfeeding, and people taking other medications. Consumers should be aware of the risks and should speak with a medical provider about the use of any CBD product. We want people to make informed choices about their health.