Unlike drugs approved by the FDA, there has been no FDA evaluation of whether these unapproved products are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns. In addition, the manufacturing process of unapproved CBD drug products has not been subject to FDA review as part of the human or animal drug approval processes. Consumers may also put off getting important medical care, such as proper diagnosis, treatment and supportive care due to unsubstantiated claims associated with CBD products. For that reason, it’s important that consumers talk to a health care professional about the best way to treat diseases or conditions with existing, approved treatment options.
The two warning letters were issued to:
Under the FD&C Act, any product intended to treat a disease or otherwise have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug. The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy.
“The opioid crisis continues to be a serious problem in the United States, and we will continue to crack down on companies that attempt to benefit from selling products with unfounded treatment claims,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “CBD has not been shown to treat opioid addiction. Opioid addiction is a real problem in our country, and those who are addicted need to seek out proper treatment from a health care provider. There are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD, and we will continue to work to protect the health and safety of American consumers from products that are being marketed in violation of the law.”
The U.S. Food and Drug Administration has issued warning letters to two companies for illegally selling unapproved products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act). This action is a continuation of the FDA’s efforts to pursue companies that illegally market CBD products with claims that they can treat medical conditions, including opioid addiction or as an alternative to opioids.
In March, the FDA provided updates on its work related to CBD products with a focus on protecting public health and providing market clarity. The FDA continues to be concerned that some people wrongly think that the myriad of CBD products on the market have been evaluated by the FDA and determined to be safe, or that using CBD “can’t hurt.” The FDA remains focused on educating the public about the number of questions that remain regarding CBD’s safety. There may be risks that need to be considered before using CBD products outside of the monitored setting of a prescription from your health care provider.
The FDA has requested responses from the companies within 15 working days stating how they will correct the violations. Failure to correct the violations promptly may result in legal action, including product seizure and/or injunction.
At three time points – immediately after the CBD or placebo administration ; 24 hours after the CBD or placebo administration ; and 7 days after the third and final CBD or placebo administration – p articipants were exposed to drug – related and neutral cues . The 3-minute neutral cue condition consisted of a video showing relaxing scenarios, such as scenes in nature. The drug cue condition was a 3-minute video that showed intravenous or intranasal drug use, depending on the participant’s reported preferred route of drug use . Immediately after the presentation of the videos , participants were also exposed to neutral objects or to heroin – related paraphernalia (e.g., syringe, rubber tie, and packets of powder resembling heroin) for 2 minutes. Authors examined whether patients who received CBD, compared to those who received placebo, showed differences in opioid craving, anxiety, positive and negative emotions, or vital signs , after being exposed to the drug or neutral cues.
This was a randomized clinical trial with 42 participants who received one of two different CBD medication doses or a placebo once daily for 3 days and were then exposed to drug-related or neutral cues to see whether CBD could reduc e opioid cravings and anxiety – factors strongly associated with relapse to opioid use .
The study medication used in this study, EPIDIOLEX, is a n FDA-approved medication that is dispensed through a pharmacy (not to be confused with “medical marijuana , ” which is comprised of a wide variety of non- federally- regulated cannabis projects ) . EPIDIOLEX is a plant-derived CBD liquid formation. P articipants were randomly assigned to receive 400 mg of CBD, 800 mg of CBD, or a placebo medication. CBD or placebo was administered once daily for 3 days . In addition to measuring the effect of the medication on opioid craving, anxiety, the authors also collected measures of positive and negative emotions, vital signs (skin temperature, blood pressure, heart rate, respiratory rate), and salivary cortisol levels , which measure stress response.
WHAT DID THIS STUDY FIND?
Participants were recruited through advertisements. Most participants indicated preference for intranasal heroin use, most reported currently using more than 10 bags of heroin (one bag = 1 g) daily, and on average, participants had been using heroin for over 10 years. The majority of participants (64.3%) had been abstinent from heroin use for less than 1 month.
One of the hypothesized factors contributing to these barriers is that methadone and Suboxone can be misused or diverted because they can produce euphoria . Consequently, discovering effective alternative medications that can also treat opioid use disorder that circumvent concerns about their psychoactive properties could help more of those affected . To address this problem , the authors investigated whether the cannabinoid , CBD , which is thought to be safe and non-addictive, could be useful in the treatment of opioid use disorder .
I ndividuals receiving the non-psychoactive cannabinoid CBD medication reported less craving after being exposed to drug cues compared with i ndividuals receiving placebo . This effect lasted at least a week after the CBD or placebo administration, when i ndividuals receiving the high-dose of CBD (but not the low-dose) still reported less craving compared with those receiving placebo . In addition, CBD reduced measures of stress response after the drug cue – such as heart rate and salivary cortisol increases . I ndividuals receiving CBD reported less anxiety after being exposed to drug cues compared with i ndividuals receiving placebo (though t here w ere no significant difference s in anxiety between participants receiving the low-dose vs . the high-dose of CBD ) . There was no effect of CBD on positive affect or on any cognitive measures.
WHAT PROBLEM DOES THIS STUDY ADDRESS?
The widespread use of heroin and prescription opioids in the United States during the past decade has resulted in an unprecedented epidemic of opioid addiction, and few treatments for heroin use disorders are currently available. In this study, authors conducted a clinical trial to test whether cannabidiol (CBD), a non-intoxicating cannabinoid that is found in the cannabis plant, could reduce drug craving and anxiety in recently-abstinent individuals with heroin use disorder. The study found that, compared to those who received a placebo, individuals who received a dose of CBD medication showed a reduction in craving for heroin as well as reduced anxiety, which lasted for about a week after taking the CBD medication.
In the past decade, there has been an unprecedented spike in opioid use disorde r , which has led to more than 300,000 opioid-related deaths in the United States . O pioid use disorder medications such as methadone and buprenorphine (often prescribed in a formulation with naloxone , known by the brand name S uboxone ) help reduce opioid use and reduce risk for opioid-involved overdoses . In some areas, however, t hese medications are often underutilized and therefore can be difficult to access, creating a treatment gap in which those who need medications face barriers to actually receiving them. Further, 20-40% of opioid use disorder patients do not want to take agonist treatments .