The US FDA’s Center for Drug Evaluation and Research tells us about the hazards of untested and unapproved cannabis treatments.
The US Center for Drug Evaluation and Research (CDER) is the division of the Food and Drug Administration (FDA) responsible for monitoring and regulating the production and sale of therapeutic drugs. We speak with CDER about the challenges involved in regulating cannabis and CBD and the dangers of unsubstantiated marketing claims.
What is the role of CDER within the US healthcare landscape?
CDER performs an essential public health task by making sure that safe, effective and high-quality drugs are available to improve the health of people in the United States.
As part of the FDA, CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines – for example, fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens are all considered drugs.
It is a consumer watchdog in America’s healthcare system. CDER’s best-known job is to evaluate new drugs before they can be sold. The Center’s review of new drug applications not only prevents quackery, but also provides doctors and patients with the information they need to use medicines wisely.
CDER makes sure that safe, effective and high-quality drugs are available to improve the health of consumers. It helps ensure that prescription and over-the-counter drugs, both brand name and generic, work correctly and that the health benefits outweigh known risks.
What are the key criteria a drug or medicinal product must meet in order to receive FDA approval?
The FDA’s role in the regulation of drugs, including cannabis and cannabis-derived products, includes review of applications to market drugs to determine whether proposed drug products are safe and effective for their intended indications. The FDA’s drug approval process requires that clinical trials be designed and conducted in a way that provides the agency with the necessary scientific data upon which the FDA can base its approval decisions. Without this review, the FDA cannot determine whether a drug product is safe and effective or offer assurance that a drug product meets appropriate quality standards. For certain drugs that have not been approved by the FDA, the lack of FDA approval and oversight means the safety, effectiveness and quality of the drug – including how potent it is, how pure it is, and whether the labelling is accurate or false – may vary considerably.
What challenges has the FDA faced in regulating cannabis and cannabinoid products?
The FDA continues to be concerned at the proliferation of products asserting to contain CBD that are marketed for therapeutic or medical uses although they have not been approved by FDA. Often such products are sold online and are therefore available throughout the country. Selling unapproved drugs with unsubstantiated therapeutic claims puts patients at risk, as these products have not been proven to be safe or effective; and is a violation of the law. This deceptive marketing of unproven treatments also raises significant public health concerns because patients and other consumers may be influenced not to use approved therapies to treat serious and even fatal conditions.
The FDA has issued warnings to several CBD producers and retailers who have claimed that their products can be used to assuage or treat COVID-19. How harmful are these unsubstantiated claims?
The FDA considers the sale and promotion of fraudulent products with claims of treating COVID-19 to be a threat to the public health. These fraudulent products that claim to cure, treat, or prevent COVID-19 have not been evaluated by the FDA for safety and effectiveness. The FDA is particularly concerned that these deceptive and misleading products might cause Americans to delay or stop appropriate medical treatment, leading to serious and life-threatening harm, or give people the false perception that they are protected from contracting the virus.
We have a surveillance programme that routinely monitors online sources for health fraud products, especially during a significant public health issue such as this one. The FDA is exercising its authority to protect consumers from companies selling unapproved drugs and making false or misleading claims, including, by pursuing warning letters, seizures, or injunctions against products and companies or individuals that violate the law.
What other diseases and conditions have cannabis and CBD producers claimed to be able to treat without the necessary clinical evidence?
The FDA is aware that unapproved cannabis and cannabis-derived products are being marketed as treatments for a number of medical conditions, including cancer, Alzheimer’s disease, diabetes, pain, COVID-19, and opioid use disorder. There has been no FDA review of data from rigorous clinical trials to support the claims that these unapproved products are safe or efficacious for the various therapeutic uses for which they are marketed. By contrast, caregivers and patients can be confident that FDA-approved drugs have been carefully evaluated for safety, efficacy and quality, and are monitored by the FDA once they are on the market. However, the use of unapproved cannabis and cannabis-derived products can have unpredictable and unintended consequences, including serious safety risks.
Is misinformation a significant issue in determining and enforcing regulation of cannabis and cannabinoids?
We remain concerned that some people wrongly think that the myriad cannabis and cannabis-derived products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe and effective, or that trying cannabis or cannabis-derived products ‘can’t hurt.’ While one prescription drug (Epidiolex) has been approved to treat seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, or tuberous sclerosis complex (TSC), and three other prescription drugs containing cannabinoids (Marinol, Cesamet, and Syndros) have been approved for non-seizure-related indications, no other cannabis-related or derived products have been approved by the FDA.
We want to be clear that a number of questions remain regarding the safety of cannabis and cannabis-derived products – including reports of products containing contaminants, such as pesticides and heavy metals – and there are real health risks that need to be considered. We recognise the significant public interest in cannabis and cannabis-derived products; and we must work together with stakeholders and industry to fill in the knowledge gaps about the science, safety and quality of many of these products.
What are the key risks to patients – particularly children – of using illicit or unapproved cannabis products to treat conditions and symptoms?
We understand that parents are trying to find treatments for their children’s medical conditions, and some adults are also choosing to take cannabis products to treat their own various conditions or symptoms. However, the use of untested drugs can have unpredictable and unintended consequences. Caregivers and patients can be confident that FDA-approved drugs have been carefully evaluated for safety, efficacy, and quality; and are monitored by the FDA once they are on the market.
The FDA continues to support sound, scientifically-based research into the medicinal uses of drug products containing cannabis or cannabis-derived compounds and will continue to work with companies interested in bringing safe, effective, and quality products to market. With the exception of Epidiolex, Marinol, Cesamet, and Syndros, no product containing cannabis or cannabis-derived compounds (either plant-based or synthetic) has been approved as safe and effective for use in any patient population, whether paediatric or adult.
Center for Drug Evaluation and Research
Food and Drug Administration
www.fda.gov/about-fda/fda-organization/center-drug-evaluation-and-research-cder
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