Unlike the FDA-approved CBD drug product, unapproved CBD products, which could include cosmetics, foods, products marketed as dietary supplements, and any other product (other than Epidiolex) making therapeutic claims, have not been subject to FDA evaluation regarding whether they are effective to treat a particular disease or have other effects that may be claimed. In addition, they have not been evaluated by the FDA to determine what the proper dosage is, how they could interact with other drugs or foods, or whether they have dangerous side effects or other safety concerns.
Despite the 2018 Farm Bill removing hemp — defined as cannabis and cannabis derivatives with very low concentrations (no more than 0.3% on a dry weight basis) of THC — from the definition of marijuana in the Controlled Substances Act, CBD products are still subject to the same laws and requirements as FDA-regulated products that contain any other substance.
Unproven medical claims, unsafe manufacturing practices
The FDA continues to believe the drug approval process represents the best way to ensure that safe and effective new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy. The agency is committed to supporting the development of new drugs, including cannabis and cannabis-derived drugs, through the investigational new drug and drug approval process.
The FDA is concerned that people may mistakenly believe that using CBD “can’t hurt.” The agency wants to be clear that we have seen only limited data about CBD’s safety and these data point to real risks that need to be considered. As part of the drug review and approval process for the prescription drug containing CBD, it was determined that the risks are outweighed by the benefits of the approved drug for the particular population for which it was intended. Consumer use of any CBD products should always be discussed with a healthcare provider. Consumers should be aware of the potential risks associated with using CBD products. Some of these can occur without your awareness, such as:
The FDA is working to answer questions about the science, safety, and quality of products containing cannabis and cannabis-derived compounds, particularly CBD.
But, ultimately, if you like it, you’re not experiencing bothersome or dangerous side effects, and feel like it works, that’s what matters most.
If you’re worried about a purely topical CBD product getting into your bloodstream, Dr. Tishler explains that’s unlikely. CBD is hydrophobic (meaning it isn’t water-soluble) and lipophilic (attracted to lipids, like oils) and tends to stay on the outer layer of skin or possibly accumulate in the sebaceous glands unless it’s paired with “enhancers” (ingredients designed to help them make it through the skin, at which point they would instead be transdermal). Making a truly “water-soluble CBD” has been a challenge for the industry, although there are a variety of patents out there.
But some studies have found essentially zero side effects of high-dose CBD (900mg) and those that researchers do see—like drug interactions—aren’t considered to be issues when CBD is used topically.
So…is CBD cream just an expensive placebo?
And even though the lotion was applied topically in the rat study, it wasn’t applied locally to the knee. Instead, the researchers were really using the topical application to get it into the rats’ bloodstream, or what’s called systemic administration. But you’d likely need a different dose for it to be effective locally (if you applied it just to your aching shoulder, for instance) in a human. We have no idea what that dose should look like.
“It actually is a very promiscuous compound,” Kevin Boehnke, Ph.D., research fellow in the department of anesthesiology and the Chronic Pain and Fatigue Research Center at the University of Michigan, tells SELF. “It will bind to receptors in multiple different pathways,” which makes it difficult to know how it might cause noticeable effects.
But if you’re reading this, you are probably not a rat, which means these results aren’t directly applicable to your life. Although we know that rats do share much of our physiology—including CB1 and CB2 receptors—these studies don’t really tell us if humans would have the same results with CBD.
Two other common reasons people take CBD are to manage anxiety and sleep issues, two things we know can contribute to pain, Boehnke says. If you're dealing those kinds of issues in addition to pain, any reduction in pain you feel could be an indirect effect of it helping you manage anxiety or sleep. (But those are still unlikely to be affected by a topical formulation.)
The manufacturers of skin creams that contain cannabidiol (CBD) claim that these products ease pain and reduce inflammation, making them beneficial for people with certain health conditions. However, experts say that more research is necessary to validate these claims.
CBD is one of many chemicals present in the Cannabis Sativa plant. CBD skin care products usually contain little or no tetrahydrocannabinol (THC), which is the psychoactive compound of the plant that makes a person feel high.
Acne, psoriasis, and eczema
A 2017 review of data and studies found that some of the most common side effects of CBD products include tiredness, diarrhea, and a change in appetite or weight. However, the same review also notes that CBD products have fewer side effects than other drugs that doctors use to treat the same conditions.
The creams and lotions can provide relief at both the surface and deeper muscle levels. In some cases, they can also aid relaxation to help an individual sleep.
A 2016 study in rats found that some CBD products may have long lasting therapeutic effects on inflammation and behaviors associated with arthritis.