Understanding the Approval of CBD Products

Cannabidiol (CBD) is a compound found in marijuana that is not harmful and does not cause a “high”. Hemp is defined as any part of the cannabis sativa plant with no more than 0.3% tetrahydrocannabinol (THC). The Food and Drug Administration (FDA) has approved one cannabis-derived drug and three cannabis-related drugs, all of which are only available with a prescription from a licensed healthcare provider. The FDA has also approved Epidiolex, a drug containing purified CBD from hemp, to help treat rare seizure disorders.

However, other marketed products and uses of CBD may not be approved by the FDA. The use of CBD during pregnancy is not recommended due to potential health effects on developing fetuses. We don't know if CBD is transmitted to the baby through breast milk, so people who are breastfeeding are advised to avoid CBD. We also don't know the effects of CBD on children's developing brains, so it is important to store products that contain CBD or THC in child-proof containers and out of the reach of children.

Currently, we don't know how CBD consumption affects a person over time or the different ways of using CBD (smoking, vaping, eating, applying it to the skin, etc.). Many companies that sell hemp and CBD products also sell products that contain THC, so people should be careful not to confuse THC products with hemp or CBD products. Products containing THC can cause psychoactive effects and adverse events. In addition, most CBD products are not regulated by the FDA.

Therefore, consumers should keep in mind that products labeled as hemp or CBD may contain other ingredients, such as THC, pesticides, heavy metals, bacteria or fungi. If consumers experience adverse effects from products containing THC or CBD that pose an immediate health hazard, they should call the local or regional poison control center at 1-800-222-1222 or 911 or seek medical attention at the local emergency room and inform healthcare providers about the ingredients of the products they have consumed. Currently, the only plant-based drug approved by the FDA that contains CBD is Epidiolex, produced by GW Pharmaceuticals. Epidiolex treats two rare forms of epilepsy in children over two years of age, Lennox-Gastaut syndrome and Dravet syndrome.

The Congressional bill makes hemp subject to the same regulations as any other dietary supplement, subject to the presentation of new dietary ingredients, good manufacturing practices (GMP) and labeling and marketing provisions. The recent approval by the FDA of epidiolex (CBD) as a treatment for certain pediatric seizure disorders will accelerate the programming of CBD and will likely alter the application by the FDA of the Federal Food, Drug and Cosmetic Act (FD&C). A cosmetic containing hemp-derived CBD can be manufactured, marketed and sold to consumers without explicit prior authorization or approval from the FDA, provided that the use of CBD and other ingredients used in the manufacture of cosmetics is safe. It is illegal to sell CBD products that are not approved by the FDA under the Federal Food, Drug and Cosmetic Act.

While Epidiolex's approval will hasten CBD programming, it's not as clear how it will influence FDA enforcement priorities in relation to hemp-derived CBD products.

Mae Bedee
Mae Bedee

Extreme sushi junkie. Subtly charming social mediaholic. Hipster-friendly coffee specialist. Proud web ninja. Avid internet lover. Infuriatingly humble beer advocate.

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