Products with CBD (cannabidiol) are being widely sold, but there are unknown risks to the health of women, breast-feeding infants, or a developing fetus.
Jul 15, 2019Chronic Fatigue Syndrome
Photo courtesy of Michael D. Miller, MD, Senior Policy Advisor, HealthyWomen
As you may have noticed, products with CBD are now touted for all sorts of conditions, including pain relief (for fibromyalgia, for example), anxiety, depression, insomnia, Parkinson's, Alzheimer's and cancer. But how effective is CBD, what risks are associated with using CBD and why are we suddenly seeing it advertised and sold everywhere? (For example, this flag has appeared outside a small pharmacy across the street from where I live.) Many important questions do not yet have answers.
The proliferation of CBD products is an important women's health issue for several reasons. First, chronic pain is a concern for many women – it's the focus of HealthyWomen first scientific summit, Chronic Pain in Women, on July 17 and 18. Second, as a fat-soluble compound, CBD (like THC), crosses the placenta, and is present in breast milk. And third, it is possible that CBD products could cause a woman to fail a drug test. (If a CBD product contains THC (the chemical in marijuana that causes a "high") above the 0.3% threshold allowed under the new federal law, or a drug test is sensitive enough to detect low levels of THC, an individual could test positive. Likewise, if an individual has used a lot CBD products containing low levels of THC, or if a test is specifically looking for CBD, a positive drug test is possible.)
What is CBD?
CBD is cannabidiol, one of many compounds found in the cannabis family of plants, which includes marijuana and hemp. Products containing CBD can be "pure" (if it is the single compound), or it can be "full spectrum" when they contain all the compounds extracted from the plant material, (i.e., hemp), and some products many indicate "active hemp extract" without mentioning CBD.
Why All the CBD Products Now?
The manufacturing and sale of CBD products have exploded since a December 2018 federal law removed CBD from the list of controlled substances and allowed hemp production, as long as the hemp doesn't contain more than 0.3% THC.
What Might CBD Be Good For?
So, what might CBD good for? The FDA has approved a medicine with CBD (Epidoliex®) for two very rare forms of childhood epilepsy. Some of the advertised CBD products tout benefits for neurological conditions, which may be based on research showing CBD interacts with certain types of neuroreceptors, and some limited clinical data. This information was summarized in a 2017 report from the National Academy of Medicine: "The Health Effects of Cannabis and Cannabinoids." However, CBD (like its psychoactive cousin THC) has not been rigorously studied outside of the clinical trials for the FDA-approved medicine, and most of the claims about CBD are based upon anecdotes or poorly conducted investigations. What this means for women's health is that there are significant unknowns and many questions still to be researched.
The FDA is moving forward with developing rules about CBD. A hearing was held in late May, but it is unclear how long it will take FDA to develop and implement new regulations. (See the FDA's Q&A page about CBD, related products and its regulatory activities here.) In this regulatory void, some states have enacted rules about how CBD products can be sold, marketed, or labeled.
Until the FDA acts, CBD products (with the exception of Epidoliex®) are not being regulated as prescription drugs, over-the-counter medicines, vitamins or as foods, (including dietary supplements). Therefore, adding CBD to any of those products is in violation of federal rules. Because of potential risks to consumers, the FDA has sent warning letters to some companies selling CBD products, particularly when claims are made about the CBD product as if it were a medicine, such as a treatment for cancer or other medical conditions.
Using CBD products rather than FDA-approved or physician-prescribed treatments is another risk associated with the proliferation of CBD products. As the FDA Commissioner wrote about CBD products in April 2019, "We also don't want patients to forgo appropriate medical treatment by substituting unapproved products for approved medicines used to prevent, treat, mitigate or cure a particular disease or condition."
Safety and Quality Concerns
The major safety and quality concerns about CBD products can be divided into a few categories:
Conclusions about CBD for Women's Health: Buyer Beware
The bottom line is that you likely can get CBD oil, capsules or foods where you live, but are there possible harms? Yes. But what these harms may be is still largely unknown. Therefore, until there are clear rules about the types of CBD products that can be sold and quality manufacturing requirements, including the information that manufacturers and sellers must make available (perhaps similar to the labels on foods or for OTC medicines), what is appropriate dosing, and of course, what CBD might actually be good for, it is "buyer beware."