Rising Concerns with CBD Products: FDA’s Role in the Research and Medical Use of Cannabis

We recently described how medical marijuana labeling problems have led to errors. In this issue, our focus is on cannabidiol (CBD) products. These products have flooded the market and are widely available in stores and through online retailers without a prescription.

As stated in \this article, the two most notable cannabinoids in marijuana are tetrahydrocannabinol (THC) and CBD. THC affects the mind, behavior, and coordination, causing symptoms similar to intoxication such as euphoria (happiness), relaxation, and pain relief. THC has been linked to marijuana addiction. On the other hand, CBD does not produce euphoria or lead to marijuana addiction. Initial studies suggest that CBD may help reduce inflammation, pain, nausea and vomiting, anxiety, and seizures from epilepsy.

Unfortunately, there are still many unanswered questions about the science, safety, and quality of CBD products. The only marijuana-based product approved by the US Food and Drug Administration (FDA) is Epidiolex (cannabidiol), which is available with a prescription to treat seizures. In the US, the FDA has also approved two synthetic marijuana-based products available with a prescription: Marinol and Syndros (both dronabinol), used to treat nausea and vomiting caused by cancer medicines and loss of appetite in people with human immunodeficiency virus (HIV) infection. Importantly, FDA has not approved any other marijuana-based or CBD products that are currently available on the market. These unapproved products may have possible health risks and are often marketed with unproven claims of cures for certain diseases and conditions.

Misunderstood FDA Regulations

Under the Controlled Substances Act, certain types and parts of the marijuana plant are considered controlled substances and must adhere to FDA regulations. In December 2018, the Agricultural Improvement Act of 2018 (called the Farm Bill) removed hemp and marijuana products with extremely low concentrations of THC from the definition of “marijuana” in the Controlled Substances Act. However, the Farm Bill continued FDA’s authority over hemp and CBD-only products, which must meet the same requirements as other FDA-regulated medicines.

Nonetheless, there is still a misunderstanding that all products made from hemp and CBD-only are now legal to sell across state lines. The result—CBD now appears in a wide variety of products, including foods, skin creams and balms, oral tinctures and sprays, dietary supplements, veterinary products, and cosmetics. If you can envision it, the CBD product likely exists. There are edible CBD gummies, peppermint flavored CBD vape juices, and even CBD-infused bottled water. At present, any food or product containing CBD sold between states is in violation of FDA standards.

Unproven Claims of Cures

One of the biggest safety concerns is the marketing of CBD products that have not been approved. Many of these CBD products stand behind unproven claims to prevent, diagnose, lessen, treat, or cure serious diseases. For example, various CBD products claim to cure cancer or treat Alzheimer’s disease. Such products may stop consumers from seeking proven, safe medical therapies for serious illnesses, possibly risking their health or life by delaying standard proven treatment.

Possible Bad Side Effects

Common side effects when taking CBD products include headache, diarrhea, upset stomach, restlessness, and sleepiness or the inability to fall or stay asleep. But most of these side effects should go away when CBD is stopped or when the dose is lowered. However, consumers should also be aware of more serious possible risks when using CBD products.

Liver Injury. CBD products may cause injury to the liver, especially when taken with other medicines that impact the liver. This serious risk can be managed when a CBD product is used under the direction of a physician. But it is less clear how the risk might be managed when CBD is used without medical supervision. Early signs of liver injury are first noticed with blood tests. Thus, liver injuries caused by CBD products might not be detected early in consumers who are not being monitored by a healthcare provider.

Drug Interactions. Taking CBD with other medicines may affect the dose of CBD that can be taken safely. Taking CBD with other medicines can also increase or decrease the effects of other medicines. This could lead to worse side effects or could lower the effectiveness of medicines and CBD products. In addition, little is known about the effect of taking CBD products with herbals or vitamins.

Male Reproductive Side Effects. Studies in animals showed male reproductive side effects linked to CBD use, including smaller testicles, slow sperm growth and development, and a decrease in testosterone levels. These side effects were even found in the male offspring of female animals that had been treated with CBD. Although these findings were only seen in animals, they raise the concern that CBD could negatively affect a man’s fertility. Further testing and evaluation are needed to better understand this possible risk.

In addition to the risks listed above, the FDA is currently examining the cumulative effects of using CDB products. For example, what happens if you eat food with CBD in it, use a CBD-infused skin cream, and take other CBD-based products on the same day? How much CBD is absorbed from your skin cream? What if you use these products daily for a week, a month, a year? FDA is also trying to learn about the effects of CBD products when used by the elderly, children, adolescents, pregnant and breastfeeding women, and even by pets and food-producing animals.

Possible Unsafe Manufacturing Processes

FDA is also looking into possible unsafe manufacturing processes for products containing CBD. There are many reports of CBD-only products containing either no detectable CBD, or significantly more CBD than is on the label. Furthermore, testing has confirmed that some CBD-only products contain detectable amounts of THC. This means patients may unknowingly become impaired as well as test positive on urine drug screen tests for THC.

Conclusion and Recommendations

FDA continues to encourage further research and development of CBD products and is considering the possibility of new legal pathways for CBD products to enter the market. The agency feels it is critical to continue to support the science needed to develop new drugs from marijuana components, including CBD. FDA continues to promote the drug approval process as the best way to identify new CBD products that are safe and effective for consumers, and to protect consumers from products that are not what they claim to be.

Meanwhile, if you are using a CBD product, talk to your healthcare provider to be sure it is a safe and effective treatment for your condition. Be sure to let your healthcare provider know about your CBD product use so you can be properly monitored before possible bad side effects occur. Also let your pharmacist know if you use any CBD products so he or she can check for possible drug interactions with the other medicines you take. Use caution when combining CBD products with herbals, vitamins, or other dietary supplements, as little information about possible interactions is known.

Note: Most of the content for this article came from recent Congressional testimony by Douglas Throckmorton, MD, Deputy Director for Regulatory Programs at the FDA Center for Drug Evaluation and Research, before the House Committee on Energy and Commerce, Subcommittee on Health: www.ismp.org/ext/340.

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