What Should You Know About FDA Regulations for CBD?

cbd and fda

CBD in the United States

Cannabis has been a part of America’s history since the first colony arrived and stepped foot on the shorelines. Since then, our country, laws and regulations pertaining to cannabis have drastically changed. Today, there is significant interest in developing consumer products and medicinal therapies derived from cannabis and hemp, specifically Cannabidiol (CBD). Let’s take a closer look at how cannabis and CBD are both handled by the FDA and DEA.

How Does the FDA & DEA Treat Cannabis?

Federally, cannabis is a Schedule 1 controlled substance that has been in effect since 1970 under the Controlled Substances Act (CSA). Schedule I classification implies that cannabis has no medicinal benefits. This classification, as a result, has hindered the federal government and medical companies in their ability to conduct research studies to further prove the medicinal attributes of cannabis.

THC plays a large role in why cannabis is currently not accepted as a medicinal plant due to the psychoactive effects of this cannabinoid. With that being said, the FDA is taking a closer look at CBD and its therapeutic properties. This has resulted in the declassification of CBD and this cannabinoid is currently considered a Schedule 5 drug.

There are 5 classes of controlled substances; Schedule 5 drugs are the lowest classification and are being ranked as less addictive with a lower potential for abuse than Schedule 4 drugs. The FDA and DEA have stated that Schedule 5 drugs may consist of analgesic, antitussive or antidiarrheal drugs. For example, Lyrica and Robitussin AC are classified as Schedule 5. Schedule 5 drugs do provide medicinal benefit, and thus this reclassification of CBD is well-appreciated by researchers and consumers who are interested in greater clinical and scientific studies on CBD.

What Does the FDA Say About CBD?

While THC is highly scrutinized by the FDA, the FDA is looking at other phytocannabinoids that may possibly carry medicinal benefits. To-date the FDA has approved one cannabis-derived and three cannabis-related drug products that are only available with a prescription. The FDA has approved Epidiolex, which is a purified form of CBD, and is used to treat seizures associated with Dravet syndrome and Lennox-Gastaut. The FDA has also approved Syndros and Marinol for therapeutic treatment of anorexia that is associated with weight loss in AIDS patients, as well as to help nausea associated with chemotherapy.

Can You Advertise CBD as Medicinal?

While the FDA has approved a few cannabis-derived products, to-date they have not approved any marketing applications for CBD products without a presecription as it directly relates to the treatment of any disease or condition. Thus, the FDA has not determined that cannabis is effective for any disease or condition, even though they have approved several cannabis-related medications. Although there have been many scientific studies which have demonstrated the therapeutic effects of cannabinoids—like CBD—we are still early in cannabinoid research and are looking to what the future holds in clinical studies.

The FDA is most concerned with providing the safest, most effective and highest-quality products to American citizens; and is taking steps to allow CBD and other cannabinoids the proper analysis and research it deserves. Since the 2018 Farm Bill was passed, this has removed hemp from the Controlled Substances Act, and has allowed for Hemp Extract Oil—including CBD Oil—to be manufacturered and sold. At Veré, we meticulously adhere to all laws and regulations, especially those concerning the DEA and FDA. 

The 2018 Farm Bill has allowed researchers to study hemp and its derivatives like CBD. With the declassification of CBD to a Schedule 5 Drug, we are certainly on the right path to new research and clinical studies on cannabinoids to further demonstrate their beneficial effects.

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