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FDA Considers New Regulations on CBD

FDA regulations on CBD
Learn where FDA regulations on CBD may be headed in the near future!

The newest buzzy ingredient in the natural world of health right now is CBD. While you’ve probably heard of it, there’s still a lot of mystery around the subject. Not only are people confused about what CBD is, but there’s also confusion among U.S. state and federal government officials, as well as regulatory groups like the Food and Drug Administration (FDA), over what should be legal and what should not. Keep reading to clarify some of what’s going on in the world of CBD and where FDA regulations may be headed in the near future.

What is CBD?

CBD (cannabidiol) is one of the main active and naturally occurring ingredients in a family of chemicals known as cannabinoids, which are found in the Cannabis sativa plant. One of the other cannabinoids found in these plants is THC (tetrahydrocannabinol). CBD is non-psychoactive, which means it does NOT get you high, unlike THC, which does.

The Cannabis sativa plant has different species – hemp and marijuana. The major difference between the two plants is how much CBD and THC they produce. CBD itself is found in both hemp and marijuana plants.

Marijuana, which is still illegal in most states, is high in THC, with as much as 40 percent making up its total cannabinoid content. Hemp, on the other hand, contains less than 0.3% of THC and instead contains more CBD. The CBD oil used in creams and tinctures, for example, is derived from the hemp plant and contains no more than 0.3 % of THC.

There are different variations of CBD used in products sold commercially. CBD isolate is 100% pure CBD; whereas, full-spectrum CBD contains other cannabinoids and could actually trigger a positive result on a drug test. Meanwhile, products containing hemp seed-derived ingredients do not naturally contain THC or CBD. In most states, CBD is available over the counter, but as soon as you add any THC, you would need a prescription (available only in states where it is legal).

The Current Legal Status of CBD

Because of the very low THC content in CBD, in 2015, the FDA began allowing researchers to study the effects of CBD. Some studies have since concluded that CBD may offer a natural way to cope with chronic pain, as well as help support sleep and temporarily relieve symptoms of stress and anxiety, but further clinical trials and research are needed.

A few years later, the 2018 Farm Bill by the U.S. federal government fully recognized hemp as a legal agricultural product that licensed farmers can grow for industrial purposes. (Hemp fibers have been used for many years to make rope, textiles, paper products, and more, but now hemp is being grown for health reasons as well.)

Although hemp can now be grown freely under federal law, each individual state has its own laws regarding hemp, CBD, and CBD derivatives. To see if CBD and related ingredients are legal in your state, check this online guide from Americans for Safe Access.

Setting an historical precedent in 2018, the FDA approved EPIDIOLEX (cannabidiol) oral solution as the first plant-derived cannabinoid prescription medicine available on the market. It is used for the treatment of seizures associated with rare forms of pediatric epilepsy. There are no other FDA-approved products that contain CBD available at this time.

FDA Regulations on the Horizon

On May 31, 2019, the FDA held a public hearing regarding the safety, sale, and use of products containing cannabis and cannabis-derived compounds, including CBD. The FDA’s concern is over the misinformation and mislabeling of products containing cannabis and cannabis-derived compounds in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act) and that may put the health and safety of consumers at risk.

Specifically, the FDA is questioning whether the CBD products on the market today work, what the proper dosage of CBD is, how these products interact with other drugs, or if they have any dangerous side effects or other safety concerns.

Due to this confusion, the FDA has concluded that THC and CBD products are not considered dietary supplements, which means they cannot be labeled or sold as such. However, this may change in regard to CBD in future months as CBD dosages and formulas come under scrutiny.

In addition, under the FD&C Act, the FDA does not have to approve the sale of cosmetics or personal care products that contain CBD, as long as they make no medical claims and are considered safe for use and labeled appropriately with all ingredients and intended usage.

According to a report by NPR, One potential strategy to regulate CBD may be to set a threshold. High-dose products could be restricted and require a prescription, while low-dose products similar to many of the CBD oils currently on the market would be widely available.

The public is welcome to submit additional comments online regarding the subject of CBD concerns to the FDA through July 16, 2019.

What to Know About CBD Supplements

Keep in mind there’s still a lack of research on the long-term effects of CBD. As with all herbal supplements, various ingredients may affect individual users differently or may interact with certain medications, so always first consult with your healthcare provider. If you plan to use CBD products on your pets, check with your veterinarian as well.

With so many different unregulated CBD products flooding the market, it’s difficult to know exactly what you are buying. When you shop for CBD, be sure to select only high-quality, natural brands that offer formulas that have been third-party-tested for quality assurance. Natural Healthy Concepts offers a great selection of such CBD brands that have also been vetted by a certified nutritionist for purity and safety.

Whether you’re just curious about CBD and getting started on your CBD journey, or you’re already using CBD products, you’ll love the CBD options NHC has to offer! Try our best-selling CBD brands, including Charlotte’s Web, HempFusion, Cannaroo, Lidtke, Irwin Naturals, Solaray, Innovative CBD, Wild Theory CBD, Barlean’s Organic Oils, Flourish, and Ancient Nutrition.

Have you tried CBD, or are you planning on trying it? Share your thoughts or concerns in the comments section below!


*Update from the FDA as of July 17, 2019: The FDA is issuing warning letters to companies for selling CBD products with unsubstantiated health claims, such as treating cancer, Parkinson’s, or dementia. In addition, the FDA tested the products, and many were found not to contain the levels of CBD they claimed to contain. As we learn more, we will continue to update the public about our path forward and provide information that is based on sound science and data.