21. Does the FDA have concerns about administering a cannabis product to pregnant and lactating women?
A. With the exception of products such as the hemp seed ingredients discussed in Question #12, which have been evaluated for safety, it is important to protect children from accidental ingestion of cannabis and cannabis-containing products. FDA recommends that these products are kept out of reach of children to reduce the risk of accidental ingestion. If the parent or caregiver has a reasonable suspicion that the child accidentally ingested products containing cannabis, the child should be taken to a physician or emergency department, especially if the child acts in an unusual way or is/feels sick.
When this statutory prohibition applies to a substance, it prohibits the introduction into interstate commerce of any food to which the substance has been added unless FDA, in the agency’s discretion, has issued a regulation approving the use of the substance in the food (section 301(ll)(2) of the FD&C Act [21 U.S.C. § 331(ll)(2)]). To date, no such regulation has been issued for any substance.
FDA has approved Epidiolex, which contains a purified form of the drug substance CBD for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 1 years of age and older. It has also approved Epidiolex for the treatment of seizures associated with tuberous sclerosis complex in patients 1 year of age or older. That means FDA has concluded that this particular drug product is safe and effective for its intended use.
Research and Expanded Access
A. It depends, among other things, on the intended use of the product and how it is labeled and marketed. Even if a CBD product meets the definition of “hemp” under the 2018 Farm Bill (see Question #2), it still must comply with all other applicable laws, including the FD&C Act. The below questions and answers explain some of the ways that specific parts of the FD&C Act can affect the legality of CBD products.
 Hayatbakhsh, et al. Birth Outcomes associated with cannabis use before and during pregnancy. Pediatric Research. 2012; 71 (2): 215-219.
8. Is it legal for me to sell CBD products?
Children and Pregnant/Lactating Women
A. The FDA has approved Epidiolex, which contains a purified form of the drug substance CBD, for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 1 years of age and older. It has also approved Epidiolex for the treatment of seizures associated with tuberous sclerosis complex in patients 1 year of age or older. That means the FDA has concluded that this particular drug product is safe and effective for its intended use. Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring cannabis-derived treatments to patients. Because of the adequate and well-controlled clinical studies that supported this approval, and the assurance of manufacturing quality standards, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes.
A. To date, the agency has not approved a marketing application for cannabis for the treatment of any disease or condition. FDA has, however, approved one cannabis-derived and three cannabis-related drug products. These approved products are only available with a prescription from a licensed healthcare provider.
Taking CBD along with THC has also been shown to help reduce some of the unwanted effects that THC may have. For example, one study suggests that CBD may potentially reduce some of the negative cognitive effects of regular cannabis use. For example, people who use cannabis, particularly when it has high THC levels, may have a greater risk of experiencing psychiatric symptoms such as paranoia, anxiety, and psychosis. Studies have found, however, that CBD may help mitigate these effects.
Neurotransmitters are chemical messengers that relay signals between nerve cells in the body. They play an important role in a wide range of functions including sleep, pain, appetite, mood, and the immune system.
NIDA also notes that THC alters how the hippocampus and orbitofrontal cortex function. These areas of the brain are important in the formation of new memories and the ability to shift attention from one thing to the next. This not only affects a person’s ability to learn and form new memories, but it also makes it difficult for people to perform difficult tasks.
Research has found, for example, that as many as 70% of CBD products are mislabeled and contain significantly more THC than labels suggest. Because of the lack of regulation of these products, it is difficult to know exactly how much THC you are actually getting.
Which One Should You Take?
This interest is likely to continue to grow as cannabis and marijuana products become legal in more states. A number of different products have emerged that contain CBD, THC, or both that are designed to alleviate ailments such as stress, anxiety, and insomnia. In order to understand the side effects and potential benefits of these products, it is important to first understand the differences between CBD and THC.
Psychoactive (produces a high)
Because THC is the main psychoactive substance in marijuana, it can be detected on most standard drug tests. CBD may be detectable as well, but many drug tests are not designed to look for cannabidiol.
Some evidence suggests that the combined effects of CBD and THC may be dependent on dose. A 2019 study, for example, found that low doses of CBD actually played a role in amplifying the psychoactive effects of THC, while high doses of CBD reduced THC’s effects.
When choosing CBD products, it is also important to consider its formulation. Isolate products contain only CBD. Broad-spectrum products contain other cannabinoids with the exception of THC, while full-spectrum CBD products contain CBD, THC, and other cannabinoids.