CBD or Cannabidiol, one of the many active ingredients found in the cannabis plant, has become increasingly popular since its legalization. People use it for various reasons such as pain relief, reducing anxiety, combating seizures, and other health benefits. However, FDA approval is a crucial factor when it comes to the legality and safety of CBD. So, let’s explore the truth behind ‘Is CBD FDA Approved?’
What is FDA Approval?
The US Food and Drug Administration (FDA) is a federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of drugs, medical devices, biologic products, cosmetics, and more. FDA approval indicates that the product or drug meets the agency’s standards for safety, reliability, and effectiveness through proper testing, clinical trials, and extensive research.
Is CBD FDA Approved?
No, currently, the FDA has only approved one CBD-based drug known as Epidiolex. The drug contains pure CBD and is used to treat rare forms of epilepsy, such as Lennox-Gastaut syndrome and Dravet syndrome in children over two years old. Epidiolex is the first drug approved specifically for treating seizures associated with these conditions, and it has undergone extensive clinical trials, which is the reason for FDA approval.
Why hasn’t the FDA approved other CBD products?
The major reason for FDA’s concern with CBD products is the lack of reliable information available about their safety and efficacy. Since CBD has only recently come into light, studies are still ongoing, and data is limited. The FDA does not approve CBD oil, capsules or any other products because of the lack of substantial evidence on their safety. For a drug to be approved for medicinal use, it must also meet the standards of quality, consistency, and efficacy. The FDA has not established these same requirements for over-the-counter products or supplements like CBD oils.
Is CBD legal?
Yes, CBD is federally legal under the 2018 Farm Bill, which removed hemp-derived CBD from the Controlled Substances Act. However, several states have differing laws regarding the legalization of CBD products. Therefore, it is essential to look for state-specific laws before buying and using CBD products.
How to ensure the safety and quality of your CBD product?
Since FDA approval isn’t currently available for CBD products, it is essential to take extra measures to ensure safety and quality. When buying a CBD product, look for companies that have third-party lab testing and provide a certificate of analysis (COA) for their products. The COA shows the potency, purity, and safety of the CBD oil or product. It is also essential to avoid buying from companies that make unrealistic health claims, sell products unsafely, or have a history of regulatory non-compliance.
What are some potential side effects of CBD?
Even though CBD is generally safe, some potential side effects reported from Epidiolex clinical trials include diarrhea, fatigue, decreased appetite, sleepiness, and elevated liver enzymes. CBD can also interact with some medications, including blood thinners, and increase the risk of liver damage. Therefore, it’s always essential to speak to a medical professional before taking any CBD products, especially if you’re on other medications or have underlying health issues.
The Bottom Line
Although CBD has various potential health benefits, its FDA approval status is still limited. The FDA has only approved one CBD-based drug, Epidiolex, for a rare form of epilepsy in children over two years old. Other CBD products remain unapproved because of various safety and efficacy concerns raised by the FDA. Nevertheless, CBD consumers can ensure quality and safety by buying third-party tested and certified products from reputable companies.
FAQ
- Q: Why hasn’t the FDA approved CBD products?
- A: The major reason for FDA’s concern with CBD products is the lack of reliable information available about their safety and efficacy. Since CBD has only recently come into light, studies are still ongoing, and data is limited.
- Q: Is CBD legal?
- A: Yes, CBD is federally legal under the 2018 Farm Bill, which removed hemp-derived CBD from the Controlled Substances Act.
- Q: How can I ensure the safety and quality of my CBD product?
- A: Look for companies that have third-party lab testing and provide a certificate of analysis (COA) for their products. The COA shows the potency, purity, and safety of the CBD oil or product.
- Q: What are some potential side effects of CBD?
- A: Even though CBD is generally safe, some potential side effects reported from Epidiolex clinical trials include diarrhea, fatigue, decreased appetite, sleepiness, and elevated liver enzymes. CBD can also interact with some medications, including blood thinners, and increase the risk of liver damage.
References
- U.S. Food & Drug Administration. (2021). What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD. Retrieved from FDA.
- S. Department of Agriculture. (2020). Hemp Production and the 2018 Farm Bill. Retrieved from USDA.
- Chan, J. (2019). Everything You Need to Know About CBD Oil. Healthline. Retrieved from Healthline.