As an expert in the field of cannabis and its derivatives, I am often asked about the legal status of cannabidiol (CBD) in the United States. With the growing popularity of CBD products, it's important for consumers to understand the laws and regulations surrounding this compound. In this article, I will provide an overview of the federal and state laws regarding CBD and discuss the FDA's stance on its use for medical purposes. At the federal level, CBD derived from the hemp plant and containing no more than 0.3% THC is legal. However, each state has its own regulations on CBD, so it's best to contact your local government to confirm the laws in your area.
Some states have strict and specific laws regarding the use of CBD, so it's important to be aware of these before purchasing or using any CBD products. The FDA has not approved any applications for the marketing of cannabis for the treatment of any disease or condition. However, they have approved one drug derived from cannabis and three related to cannabis. These approved products are only available with a prescription from a licensed healthcare provider. The first FDA-approved drug containing CBD is Epidiolex, which is used to treat seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients over 1 year old. It has also been approved for the treatment of seizures associated with tuberous sclerosis complex in patients over 1 year old.
This means that the FDA has deemed this medication safe and effective for its intended use. In addition to Epidiolex, the FDA has also approved Marinol and Syndros for therapeutic uses in the United States. These drugs contain the active ingredient dronabinol, a synthetic form of delta-9-tetrahydrocannabinol (THC), which is considered to be the psychoactive component of cannabis. These medications are used to treat anorexia associated with weight loss in AIDS patients. Another FDA-approved drug, Cesamet, contains the active ingredient nabilone, which has a chemical structure similar to THC and is also synthetically derived. The FDA is concerned about the increasing number of products claiming to contain CBD and marketed for therapeutic or medical uses, even though they have not been approved by the agency.
These products are often sold online and can be purchased across the country. The sale of unapproved products with unfounded therapeutic properties not only violates the law, but also puts consumers at risk as these products have not been proven to be safe or effective. This misleading marketing of unproven treatments also poses significant public health problems, as patients may choose to forego approved therapies for serious and even fatal diseases in favor of unproven CBD products. Unlike FDA-approved drugs, products that have not undergone FDA review as part of the drug approval process have not been evaluated for their effectiveness, appropriate dosage, potential interactions with other medications, or potential side effects or safety concerns. There is an exception to this rule if the 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 determined that this is not the case with THC or CBD. The FDA has not found any evidence that would challenge their current findings that THC and CBD products are excluded from the definition of a dietary supplement under section 201 (ff) (B) of the FD&C Act.
Interested parties can submit evidence to the agency related to this topic, but so far, the FDA has not changed their conclusions. When a substance is excluded from the definition of a dietary supplement under section 201 (ff) (B) of the FD&C Act, this exclusion applies unless the FDA has issued a regulation, after prior notice and comment, determining that the substance would be legal under the Act. To date, no such regulation has been issued for any substance. THC (dronabinol) is the active ingredient in approved medications such as Marinol capsules and Syndros oral solution. CBD is the active ingredient in the approved drug Epidiolex.
It's important to note that hemp seeds, which are the seeds of the Cannabis sativa plant, do not naturally contain THC or CBD. The ingredients derived from hemp seeds that are the subject of GRAS (Generally Recognized as Safe) notifications contain only trace amounts of THC and CBD. These traces can be picked up during harvest and processing when the seeds come into contact with other parts of the plant. Consuming these ingredients derived from hemp seeds will not result in any psychoactive effects. The findings of GRAS may apply to ingredients for human consumption marketed by other companies, as long as they are manufactured in a manner consistent with the warnings and specifications listed. Some of the intended uses for these ingredients include adding them as a source of protein, carbohydrates, oils, and other nutrients to various food and beverage products. Products that contain any of these ingredients derived from hemp seeds must declare them by name on the ingredient list.
However, these GRAS findings do not affect the FDA's position on adding CBD and THC to foods. According to the FDA, a cosmetic is defined as an article intended to be rubbed, poured, sprayed or otherwise applied to the human body or any part of it to clean, beautify, promote attractiveness, or alter appearance. This definition also includes items intended to be used as a component of any of those articles, with the exception of soap. The FDA has previously sent warning letters to companies that illegally sold CBD products claiming to prevent, diagnose, treat, or cure serious diseases such as cancer. Some of these products also violated the FD&C Act by being marketed as dietary supplements or by having CBD added to food.
When a product violates the FD&C Act, the FDA takes many factors into account before deciding whether or not to take enforcement action. These factors include the agency's resources and the potential threat to public health. The FDA may also consult with federal and state partners when making decisions about initiating federal law enforcement action. As the popularity of CBD continues to grow, it's important for consumers to be aware of the laws and regulations surrounding this compound. By staying informed and understanding the FDA's stance on CBD, consumers can make informed decisions about their health and well-being.
