Natural Doesn’t Mean Safe: Why FDA Regulation of CBD-Based Products Matters

(BPT) - As CBD, or cannabidiol, continues to be explored for its potential therapeutic benefits and risks, more and more products that contain it are appearing on retail shelves, at dispensaries, and online. Their popularity seems to be driven by a common misconception among consumers that because these CBD-based products are naturally derived, they are safe. Not only is this thinking false, it can be dangerous.

First, it’s important to remember that the majority of CBD products on the market today are not recognized by the U.S. Food and Drug Administration (FDA) as medicine: they have not been studied in placebo-controlled, publicly disclosed clinical trials with large patient populations to evaluate their safety, effectiveness, and recommended dosage. Therefore, they have no scientifically proven therapeutic benefit.

To date, only one prescription medication containing CBD has been approved by the FDA, and it is only approved for the treatment of seizures associated with three rare and severe neurological disorders. You can learn more about it here. While the FDA has approved this product, the agency has made it clear that CBD has no proven benefit in any other conditions and that it is still being studied for its long-term effects on the body and how it interacts with other medications[1].

Apart from CBD, it’s also important to note that while some of today’s medicines contain naturally derived ingredients—artesunate, used to treat malaria, is a derivative of artemisinin,[2] which is found in sweet wormwood,[3] and paclitaxel[4], used to treat certain cancers, contains a compound from the Pacific yew tree[5]—these products underwent rigorous FDA review and approval[4],[6] to ensure their safety profiles were well understood within the context of a specific condition before they could be marketed. All medications carry some risk and the FDA determined that the expected benefits of these medications outweighed their potential risk to patients. This assessment is informed by scientific evidence about safety and effectiveness gathered during large clinical trials.

So while CBD is a naturally occurring chemical found in the cannabis plant that has proved beneficial for a very specific population, more research is needed to understand its benefit outside of this context. But companies hoping to profit from the idea that natural means safe have been making false claims about the benefits of their CBD-based products since entering the marketplace. The unproven idea that CBD can be a natural remedy for a variety of conditions ranging from chronic pain, anxiety, and depression has clearly taken hold. According to a recent report, the global CBD market is valued at 2.8 billion dollars and is only expected to grow[7]. Consumers should approach these types of products with healthy skepticism. Companies that are making claims about the therapeutic benefits of their products are doing so without conducting robust research and lengthy clinical trials. All of this needs rigorous FDA review to determine if these products have been evaluated for safety and efficacy, are appropriate for a specific condition, and produced according to Current Good Manufacturing Practices (cGMPs).

In 2019 the FDA issued more than a dozen warning letters to companies making false claims about the therapeutic benefits of their products[8]. It also put out consumer-facing guidance to raise awareness about the lack of knowledge around CBD outside of the testing conducted for the one CBD-based medicine it approved[1]. Taking it one step further, the agency stated that it could not generally recognize CBD as safe to consume[8],[9].

Along with the FDA’s actions, voices within the scientific community have raised concerns about contamination that can occur during the cultivation, manufacturing, and packaging of cannabis, the plant from which CBD is derived. Heavy metals, including cadmium and lead, and pesticides, such as fungicides and insecticides, have all been found in unregulated cannabis-based products.[10]

So before you reach for that CBD product that claims to provide natural relief for your aching hip or COVID-induced anxiety, think twice about whether that product truly has any proven benefit, what risks it might have, and, as always, consult your healthcare provider.

To learn more visit www.straightfactscbd.com.



[1] Food and Drug Administration. What you need to know (and what we’re working to find out) about products containing cannabis of cannabis-derived compounds, including CBD. https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis. Accessed June 15, 2021.

[2] NIH National Library of Medicine. National Center for Biotechnology Information. A semi-synthetic derivative of artemisinin, artesunate inhibits prostaglandin E2 production in LPS/IFNy-activated BV2 microglia. https://pubmed.ncbi.nlm.nih.gov/25074847/. Accessed July 6, 2021.

[3] Sloan Kettering Cancer Center. Artemisia annua. https://www.cancer.gov/research/progress/discovery/taxol. Accessed July 6, 2021.

[4] NIH National Cancer Institute. Paclitaxel. https://www.cancer.gov/about-cancer/treatment/drugs/paclitaxel. Accessed July 6, 2021.

[5] NIH National Cancer Institute. A Story of Discovery: Natural Compound Helps Treat Breast and Ovarian Cancers. https://www.cancer.gov/research/progress/discovery/taxol. Accessed July 6, 2021.

[6] Food and Drug Administration. FDA Approves Only Drug in U.S. to Treat Severe Malaria. https://www.fda.gov/news-events/press-announcements/fda-approves-only-drug-us-treat-severe-malaria. Accessed July 6, 2021.

[7] Grand View Research. Cannabidiol market size, share & trends analysis report by source type (hemp, marijuana), by distribution channel (B2B, B2C), by end-use (medical, personal use), by region, and segment forecasts, 2021-2028. https://www.grandviewresearch.com/industry-analysis/cannabidiol-cbd-market. Accessed June 15, 2021.

[8] Food and Drug Administration. FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns. https://www.fda.gov/news-events/press-announcements/fda-warns-15-companies-illegally-selling-various-products-containing-cannabidiol-agency-details. Accessed June 15, 2021.

[9] Food and Drug Administration. Generally recognized as safe (GRAS). https://www.fda.gov/food/food-ingredients-packaging/generally-recognized-safe-gras. Accessed June 15, 2021.

[10] Montoya, Z., Conroy, M., Vanden Heuvel, B., Pauli, C., and Park, S. Cannabis Contaminants Limit Pharmacological Use of Cannabis, Frontiers in Pharmacology, Frontiers in Pharmacology, 2020

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