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Michael D. Miller, MD

Dr. Miller is a health care and life sciences expert. For more than 30 years, Dr. Miller has worked to improve clinical and economic outcomes by advancing the development and adoption of innovations including biopharma products, medical devices, care delivery models, clinical practices, to self-care actions by individuals. His company, HealthPolCom helps organizations create and implement programs that integrate patient perspectives with those of others to achieve multi-stakeholder alignment. His work spans, policy, advocacy, program management and communications, and he has written extensively and made many presentations about the interactions across the health care delivery, financing, research, and public health systems. Dr. Miller received his B.A. from Williams College in chemistry and his M.D. from the Yale, and has held many volunteer, non-profit board positions, and is the longstanding honorary "Team Physician" for the political satire troupe the Capitol Steps.


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CBD Here, There, Everywhere!

CBD Here, There, Everywhere! CBD and Women's Health

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.

Medication Safety

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:

  1. The good news is that there doesn't seem to be many direct side-effects of CBD for most people – although the clinical trials for Epidoliex® found some patients developed liver problems. However, outside of the studies on children with rare forms of epilepsy, large well conducted trials are limited, which especially raises concerns about health effects from long-term use. For women with chronic conditions and taking prescription medicines (including birth control pills), the unknown side effects and drug-drug interactions could be particularly important.
  2. Quality, dosing and contamination issues are also serious concerns. How CBD is manufactured or purified is important because different extraction and purification methods produce different mixtures of compounds. Also, extraction from cannabis plant material has traditionally been done using butane or propane, which can leave petroleum residues in the final product. There are potentially other quality and safety problems that can arise in manufacturing – particularly when there is so little oversight or regulations. Specifically, researchers have found CBD products can contain THC, pesticides, lead or other heavy metals. The lack of data also means there is great uncertainty about what appropriate dosage levels might be for particular people or for different uses. And, of course, accurate dosing is a problem when quality control is inconsistent, i.e., how do you know how much CBD you are receiving, if the manufacturer may not be certain about the concentration of CBD in their products.
  3. And why is CBD being added to foods (both for humans and pets) despite this violating FDA regulations because CBD is an active ingredient in an approved medicine? Maybe it is trendy and sounds like a great new thing? Or maybe it is a revenue-driven marketing strategy that is leveraging off state laws allowing the legalization (and taxation) of medical and recreational marijuana – despite marijuana still being illegal under Federal law.

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."

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