FDA & CBD? What is going on?


CBD, as it is commonly called, means Cannabidiol. It is the main ingredient found in the hemp plant (a part of the cannabis Sativa plant). Just to make it clear, CBD is not marijuana. Cannabis, which is the plant species from which marijuana comes, is also the same plant species that hemp comes from. Marijuana and hemp look similar but there are some minor differences such as tree height and width. Another major difference is seen in their THC levels. CBD is derived from the hemp plant through the process of extraction. CBD oil is not Hemp seed oil which is derived by processing hemp seeds together.

CBD is the naturally occurring compound found in the plant and contains a non-addictive substance called “phytocannabinoids”. Over the past few years, CBD has become quite popular around the world, mainly for its medicinal use. It can be effective in fighting many different conditions such as seizures, anxiety, pain and depression.

The main benefit of CBD oil is the way it affects the brain. Cannabidiol helps the brain to deal with pain, mood and mental function by way of the chemical, phytocannabinoid, that is found in CBD. Additionally, CBD is said to be beneficial for the skin. Some skin concerns such as dryness, inflammation can be relieved with CBD. There are also the antioxidant benefits associated with it. The greatest benefit of the CBD oil is that it does not give you that “high” and is pretty safe for consumption even in younger people. Intoxication and feelings of euphoria do not occur with CBD.

The majority of the products that are marketed as CBD are not approved by the FDA but can still be marketed and sold in certain instances. The FDA has only approved one CBD product. A medication specifically made for tuberous sclerosis. However, there is a broad range of products that can be bought that has CBD as an ingredient in it. Some of these products include lotions, creams, oil, edibles, pills, e-cigarettes, and more.

Who is the FDA?

The FDA is an acronym that stands for the Food and Drug Administration and is a part of the Health and Human Services department of the US government. Their main responsibility is to ensure that products that will be consumed by people are safe. They ensure the effectiveness of medications for relief of symptoms and cure from diseases. Companies must adhere to the FDA regulations and the laws that they have in place. Lack of adherence to the rules and regulations of the FDA can result in severe legal battles.

Through the FDA, consumers can trust that what is available on the market is safe for human consumption.

Topicals and the FDA

Topicals refer to any substance that is applied to the surface of the skin. They come in the form of gels, creams, foams, ointments, salve and lotions. CBD is available in its most potent state as an oil but it is also available in topical forms. The FDA stance on topicals is that if the active ingredient is insoluble in the vehicle (cream, ointment, gel etc) uniformity of the distribution must be ensured. The mix must be properly done and the same throughout all products. Particle size must be controlled and the mixing process must be validated.

The particle size of the topical affects the activity of the drug substance. The smaller the particle size the greater the surface it is able to cover. Particle size also affects the likelihood of the product being an irritant. Smaller particle; less irritation.

What is the FDA’s Stance on CBD and Consumer products?

As mentioned earlier, the FDA has approved only one CBD product. On July 31, 2020, the FDA approved Epidiolex. Epidiolex contains a purified substance derived from Cannabis. This substance is CBD. Currently, it is illegal to market CBD products by adding CBD to food labeling. The main reason is that there is not enough research conducted on the use and benefits of CBD. As a result, the FDA does not have any proof of CBD being safe for use in human and animal food.

More scientific research needs to be done on the efficacy of CBD for it to be considered safe for use by the FDA. As of now, the FDA has many concerns for the general public concerning the use of CBD. There are many potentially dangerous side effects and possible interactions with other drugs. It might be years before CBD can be considered safe to use in humans and animals as scientific research continues to develop. The FDA is not against CBD in totality. Their stance is that more research needs to be done to ensure its safety for use with certain conditions. This stance comes from the fact that CBD does not cause intoxication or euphoria of individuals. They have drafted a brief guide to encourage clinical research related to cannabis. They are also working to find out more about the uses and benefits of CBD. The FDA has made a clear statement that they are working to clarify their regulatory approach in respect to CBD.

As much as CBD is hailed for its unsubstantiated beneficial claims, there is great potential for harm. Hence, the FDA stance is from that of a safety concern for all persons.

CBD, because of limited research, can have a completely different effect on two different persons with the same condition. The FDA is not refuting the claims of benefits from the CBD community. However, it is their job to ensure safety for all.

CBD is not quite legal but it is not quite illegal either. CBD products with less than 0.3 percent THC (chemical causing intoxication and euphoria) are legal on a federal level. However, under some state laws, the compound is still considered illegal, even under the 0.3 percent THC.

CBD and CBD related products are receiving a lot of attention these days for their health benefits. These benefits, if scientifically proven, will aid significantly in the development of more effective medicines for diseases ranging from cancer to arthritis to various skin conditions and ailments.

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Useful Links:

CBN Oil: Sleep, Other Uses, Safety, and More (healthline.com)

FDA Advances Work Related to Cannabidiol Products with Focus on Protecting Public Health, Providing Market Clarity | FDA

CBD oil: Uses, health benefits, and risks (medicalnewstoday.com)

Marijuana or Hemp: FDA Says Beware Of CBD For These Reasons​ (forbes.com)

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