13. What is FDA’s position on cannabis and cannabis-derived ingredients in cosmetics?
A. THC (dronabinol) is the active ingredient in the approved drug products, Marinol capsules (and generics) and Syndros oral solution. CBD is the active ingredient in the approved drug product, Epidiolex.
21. Does the FDA have concerns about administering a cannabis product to pregnant and lactating women?
Questions and Answers
A. The FDA is aware that several states have either passed laws that remove state restrictions on the medical use of cannabis and its derivatives or are considering doing so. It is important to conduct medical research into the safety and effectiveness of cannabis products through adequate and well-controlled clinical trials. We welcome the opportunity to talk with states who are considering support for medical research of cannabis and its derivatives, so that we can provide information on Federal and scientific standards.
These GRAS conclusions do not affect the FDA’s position on the addition of CBD and THC to food.
7. Has the agency received any adverse event reports associated with cannabis use for medical conditions?
The GRAS conclusions can apply to ingredients for human food marketed by other companies, if they are manufactured in a way that is consistent with the notices and they meet the listed specifications. Some of the intended uses for these ingredients include adding them as source of protein, carbohydrates, oil, and other nutrients to beverages (juices, smoothies, protein drinks, plant-based alternatives to dairy products), soups, dips, spreads, sauces, dressings, plant-based alternatives to meat products, desserts, baked goods, cereals, snacks and nutrition bars. Products that contain any of these hemp seed-derived ingredients must declare them by name on the ingredient list.
Vaping THC oil involves heating the oil and inhaling it through a vaporizing device like a vape pen or an e-cigarette. Some people believe that vaping THC oil is safer than smoking because it doesn’t involve inhaling smoke. But the issue is that vaping hasn’t been around long enough and there isn’t enough research to really determine whether or not it’s safer.
Marijuana use, and more specifically vaping THC oil, is on the rise according to the National Institute on Drug Abuse. In fact, in 2018, more than 11.8 million young adults had used marijuana in the last year. Meanwhile, the number of teens in 8th and 10th grades who say they use it daily also has increased. Additionally, nearly 4% of 12th graders say they vape THC daily.
In fact, a study that appeared in the Journal of the American Medical Association found that first-time and infrequent users of marijuana were more likely to experience adverse reactions from vaping THC oil. They indicated that these negative impacts were largely due to the enhanced delivery of the oil through vaping. The participants in the study also had more pronounced effects from the drug and experienced significant impacts to their motor skills and cognitive abilities.
What You Need to Know
THC also affects your body differently than CBD does. Even though it works like CBD to impact neurotransmitters in your brain, THC is the main psychoactive compound found in marijuana and is the substance that will make you feel “high.”
Recent research suggests that vaping THC oil, especially oil that contains vitamin E acetate, can be particularly harmful to your lungs. Vitamin E acetate, which is regularly added to THC when preparing it for use in e-cigarettes and vaping devices, is particularly harmful when it’s inhaled.
Additionally, it’s believed that in addition to giving you a euphoric feeling, THC also impacts pain, mood, and other feelings. CBD on the other hand does not make you high and is believed to work with other receptors in the body to produce an overall feeling of well-being.
For instance, in September 2019, health officials began investigating an outbreak of a severe lung disease associated with vaping and e-cigarettes. By December 2019, more than 2,800 cases of the lung disease, often referred to as EVALI, had been reported across the United States.