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Keywords: CBT; SNRI; SSRI; chronic pain; depression; myalgia.
Fibromyalgia is a complex disease process that is as prevalent as it is poorly understood. Research into the pathophysiology is ongoing, and findings will likely assist in identifying new therapeutic options to augment those in existence today that are still insufficient for the care of a large population of patients. Recent evidence describes the use of cannabinoids in the treatment of fibromyalgia. This study provides a systematic, thorough review of the evidence alongside a review of the seminal data regarding the pathophysiology, diagnosis, and current treatment options. Fibromyalgia is characterized by widespread chronic pain, fatigue, and depressive episodes without an organic diagnosis, which may be prevalent in up to 10% of the population and carries a significant cost in healthcare utilization, morbidity, a reduced quality of life, and productivity. It is frequently associated with psychiatric comorbidities. The diagnosis is clinical and usually prolonged, and diagnostic criteria continue to evolve. Some therapies have been previously described, including neuropathic medications, milnacipran, and antidepressants. Despite some level of efficacy, only physical exercise has strong evidence to support it. Cannabis has been used historically to treat different pain conditions since ancient times. Recent advances allowed for the isolation of the active substances in cannabis and the production of cannabinoid products that are nearly devoid of psychoactive influence and provide pain relief and alleviation of other symptoms. Many of these, as well as cannabis itself, are approved for use in chronic pain conditions. Evidence supporting cannabis in chronic pain conditions is plentiful; however, in fibromyalgia, they are mostly limited. Only a handful of randomized trials exists, and their objectivity has been questioned. However, many retrospective trials and patient surveys suggest the significant alleviation of pain, improvement in sleep, and abatement of associated symptoms. Evidence supporting the use of cannabis in chronic pain and specifically in fibromyalgia is being gathered as the use of cannabis increases with current global trends. While the current evidence is still limited, emerging data do suggest a positive effect of cannabis in fibromyalgia. Cannabis use is not without risks, including psychiatric, cognitive, and developmental as well as the risks of addiction. As such, clinical judgment is warranted to weigh these risks and prescribe to patients who are more likely to benefit from this treatment. Further research is required to define appropriate patient selection and treatment regimens.
Declaration of Competing Interest The authors have no conflicts of interest to disclose.
Conflict of interest statement
The agencies added that Advanced Spine and Pain’s “CBD Oil” could not be labeled or sold as a food, and that Advanced Spine and Pain might be violating the FTC Act by advertising that its product could prevent, treat or cure human disease without possessing “competent and reliable scientific evidence,” including, when appropriate, well-controlled human clinical studies, substantiating that the claims were true at the time they were made.
The warning letter to Advanced Spine and Pain illustrates the FDA and FTC’s concerns:
In April, the agencies sent warning letters to three companies: Nutra Pure LLC, PotNetwork Holdings, Inc. and Advanced Spine and Pain, LLC (d/b/a Relievus), which market and advertise products containing CBD, such as “CBD Salve,” “CBD for Dogs,” “Hemp Oil,” “CBD Softgels,” “Liquid Gold Gummies” and “CBD Oil.” The letters explain that the agencies had reviewed the companies’ websites and believed that the advertised products might violate the FTC Act by making false or unsubstantiated health claims about their ability to effectively treat diseases including cancer, Alzheimer’s disease, fibromyalgia and “neuropsychiatric disorders.”
The agencies further explained that they determined Advanced Spine and Pain’s “CBD Salve” and “CBD Oil” products as drugs under the FD&C Act because they were intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease and/or because they were intended to affect the structure or function of the body. They reached this conclusion even though Advanced Spine and Pain’s “CBD Oil” products were not labeled as dietary supplements because their directions for use stated “[a]s a hemp supplement. . . .” Based on this language, the agencies said, it appeared that Advanced Spine and Pain might “intend to market” the product “as a dietary supplement.” According to the government, however, it did not meet the definition of a dietary supplement under the FD&C Act because the FDA concluded that CBD products were “excluded from the dietary supplement definition” and CBD may not be used as an ingredient in food or dietary supplements.
Agencies’ Concerns About CBD
The letters contained many examples of statements by marketers that the agencies indicated were of concern. Among many others, they included:
In a sign that the government will take an active enforcement role in a budding industry, the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) have sent warning letters to three companies that are advertising and selling products containing cannabidiol (CBD).
While the FDA has recently approved CBD use in one anti-epilepsy drug, many retailers and producers have seized the opportunity of legalization to make a wide variety of dubious medicinal claims about CBD.
Examples of Challenged Statements
For decades, hemp, a close biological relative of marijuana, was regulated as a Schedule I drug under the Controlled Substances Act (CSA), alongside marijuana, heroin and other narcotics. Marijuana and marijuana-derived products – defined generally as plants containing more than .3% tetrahydrocannabinol (THC), the chemical that produces a high – remain illegal under the CSA. But the 2018 Farm Bill that was passed in December legalized hemp – defined generally as plants containing less than .3% THC – and CBD derived from hemp plants.
Possessing, using, distributing, and/or selling marijuana or marijuana-based products is illegal under federal law, regardless of any state law that may legalize or decriminalize such activity under certain circumstances. Although federal enforcement policy may at times defer to states’ laws and not enforce conflicting federal laws, interested businesses and individuals should be aware that compliance with state law in no way assures compliance with federal law, and there is a risk that conflicting federal laws may be enforced in the future. No legal advice we give is intended to provide any guidance or assistance in violating federal law.