As an expert in the field of CBD oil, I have seen firsthand the confusion and misinformation surrounding its federal approval. Many people are under the impression that all CBD products are approved by the U. S. Food and Drug Administration (FDA), but this is simply not true.
In fact, to date, the FDA has only approved one CBD-based treatment, Epidiolex, for serious seizure disorders. This means that any other CBD products on the market are not federally approved and should be approached with caution. It's important to understand that the FDA has not approved any application for the marketing of cannabis for the treatment of any disease or condition. This includes CBD products, which are derived from cannabis. While there is ongoing research into the potential therapeutic benefits of CBD, the FDA has not yet approved any other CBD products for medical use. So why is Epidiolex the only federally approved CBD product? The answer lies in its unique formulation.
Unlike other CBD products, Epidiolex contains a purified form of CBD and has undergone rigorous clinical trials to prove its safety and effectiveness. It has been approved by the FDA for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients older than 1 year, as well as seizures associated with tuberous sclerosis complex in patients aged 1 year and older. But what about other cannabis-derived drugs? While there are currently no other FDA-approved drugs that contain CBD, there are three drugs related to cannabis that have been approved for therapeutic use in the United States. These include Marinol and Syndros, which are used to treat anorexia associated with weight loss in AIDS patients, and Cesamet, which is used to treat nausea and vomiting caused by chemotherapy. It's important to note that these drugs do not contain CBD, but rather a synthetic form of delta-9-tetrahydrocannabinol (THC), which is considered to be the psychoactive component of cannabis. This highlights the fact that the FDA has not yet approved any other CBD products for medical use. Despite the lack of federal approval, there are still many products on the market that claim to contain CBD and are marketed for therapeutic or medical uses.
These products are often sold online and are available across the country. However, it's important to be aware that these products have not been proven to be safe or effective by the FDA. In fact, the agency has sent warning letters to companies in the past for illegally selling CBD products that claim to prevent, diagnose, treat, or cure serious diseases such as cancer. So why is it important to only use FDA-approved CBD products? The answer is simple: safety and effectiveness. Unlike FDA-approved drugs, products that haven't undergone FDA review have not been evaluated to determine if they work, what dosage is appropriate, how they might interact with other medications, or if they have dangerous side effects or other safety issues. It's also worth noting that there is an exception to section 201 (ff) (B) of the FD&C Act if a substance was marketed as a dietary supplement or conventional food before the drug was approved or before new drug research was authorized.
However, based on available evidence, the FDA has concluded that this is not the case with THC or CBD. This means that these substances are excluded from the definition of a dietary supplement under Article 201 (ff) (B) of the FD&C Act. While there may be ongoing debate about the legality of CBD and THC in dietary supplements and food products, it's important to remember that these substances have not been approved by the FDA for these uses. The agency is not aware of any evidence that would challenge its current findings, but interested parties are welcome to submit any relevant evidence for review. It's also worth noting that the FDA has not issued any regulations for the use of CBD or THC in dietary supplements or food products. This means that any products containing these substances are not legal under the FD&C Act and should be approached with caution. So what about hemp seeds? While they are derived from the Cannabis sativa plant, they do not naturally contain THC or CBD.
However, during harvest and processing, the seeds can come into contact with other parts of the plant and collect traces of these substances. This means that while hemp seed-derived ingredients may contain small amounts of THC and CBD, they are not capable of producing a psychoactive effect. In fact, the FDA has recently issued GRAS (Generally Recognized as Safe) notifications for certain ingredients derived from hemp seeds. These ingredients have been deemed safe for human consumption and can be used in a variety of products, including beverages, soups, sauces, desserts, baked goods, cereals, snacks, and nutrition bars. However, it's important to note that these ingredients must be declared by name on the ingredient list. It's also worth mentioning that these GRAS findings do not affect the FDA's position on the addition of CBD and THC to foods.
While there may be ongoing debate about the legality of these substances in food products, it's important to remember that they have not been approved by the FDA for this use. Finally, it's important to be cautious when considering using CBD products that have not been approved by the FDA. While expanding access to investigational medical products may seem like a good idea for patients with serious or life-threatening illnesses or conditions, it's important to remember that these products have not been proven to be safe or effective. The FDA takes many factors into account when deciding whether or not to initiate enforcement action against products that violate the FD&C Act, including the potential threat to public health.
