As public interest in medical cannabis has grown, so has the Food and Drug Administration’s (FDA) scrutiny—but this can only be a good thing. Like all healthcare practitioners bound to the Hippocratic oath, the FDA aims to protect consumers and promote public health as “a science-based regulatory agency.”
A hearing in May 2019 allowed stakeholders to provide feedback and share their experiences about cannabis and cannabis-derived compounds.
This stringent review process can finally put order in the wild west of the CBD market and advance brands grounded in science like CBD CLINIC™ so we can uphold our duty to keep our consumers safe.
The FDA treats “substances derived from cannabis just like … any other substances, and they are subject to the same authorities as any other substance. That said, some other relevant laws have changed, and so has the market,” said FDA Principal Deputy Commissioner, Amy Abernethy, MD., Ph.D. and FDA Principal Associate Commissioner for Policy, Lowell Schiller, J.D.
This commitment to research is part of the ongoing FDA Analgesic Monograph review process, a set of rules laid down by the FDA, concerning the safety and efficiency of over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic pharmaceutical agents. In addition to the monograph for internal medications, there is one for external analgesics as well. These rules dictate how OTC painkillers can be made and sold and how to appropriately label them. (Products sold as food, supplements, and cosmetics have a different set of regulations).
All this is with the end-goal of protecting the consumer and guiding the professionals.
Although the Agriculture Improvement Act of 2018 (Farm Bill) removed cannabis and its derivatives that are very low in THC (below 0.3%) from the definition of marijuana in the Controlled Substances Act (CSA), the FDA still retains responsibility for these products.
Abernethy and Schiller reassured the public, “Because the 2018 Farm Bill removed hemp from the definition of marijuana in the CSA, this change may streamline the process for researchers to study hemp and certain cannabis derivatives, including CBD, which could speed the development of new drugs from those substances.”
Thus, a revision in the monograph can revolutionize CBD as a standard in medicine.
What are the benefits of adding CBD and other Cannabinoids to the FDA Monograph?
The FDA has recognized that there’s an understandable high level of public interest in CBD and cannabinoids, which has led to related laws being relaxed in a number of states.
If sold as a drug, cannabinoid products still need either approval from the FDA or to be included in an FDA monograph if sold as an over-the-counter medication. However, the new law permitting CBD on the market found itself a loophole, situating itself somewhere between dietary supplements, cosmetics and drugs.
Now, the FDA is attempting to rectify this confusion to protect the public.
As it stands now, only the CBD product Epidiolex has been approved by the FDA, which is a prescription drug for treating rare and severe forms of epilepsy. Research is ongoing to determine how CBD and other cannabinoid products might be approved by the FDA for medical use in other ways.
That said, they are not dismissing the other potential benefits of CBD. On the contrary, they are taking steps to make science-based decisions on the safety of CBD.
The FDA is currently reviewing “written comments submitted to the public docket, including comments on safety (such as whether there is a threshold level that could appropriately be considered safe for foods and dietary supplements), manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.”
According to one government report, “CBD has been shown to be well tolerated at doses greater than 1000 mg per day. No reports of adverse effects attributable to oral CBD were located in the published literature.”
However, the FDA would like to see more data on:
- How much CBD is safe to consume in a day? How does it vary depending on what form it’s taken?
- Are there drug interactions that need to be monitored?
- What are the impacts on special populations, like children, the elderly, and pregnant or lactating women?
- What are the risks of long-term exposure?
Of course, as with any active ingredient, it’s important to ensure its safety. It is scientific data that helps to determine the FDA’s decisions.
This review process could help differentiate safe medical products from questionable products on the market. Moreover, it can help medical professionals and health care practitioners use the five rights of medication management with their patients:
- Right Patient- What happens if a patient’s order gets mixed up? Are there special populations who can’t take CBD?
- Right Drug/ Product- Which CBD product should a patient take?
- Right Dose- How much CBD should the patient take internally or externally? How much should they smoke?
- Right Route- Should the patient be given a topical, internal drop, or a vaporizer? What happens if a patient accidentally uses a product in an unintended manner?
- Right Time- How often should the patient take CBD? When should they take it?
In addition, an updated set of FDA guidelines with appropriate warnings and labels for CBD can help consumers safely use non-prescription CBD products.
Ultimately, the FDA’s job is to protect people from harm and help them get the relief they need — just like clinicians and pharmaceutical companies like CBD CLINIC.
Why the FDA’s CBD Reviews Matter to You and CBD CLINIC
CBD clinic takes the FDA’s incentives for clinical research seriously for the following reasons:
- Protects patients and health practitioners: By standardizing the market, the products with genuine health benefits will stand out against the products without value on your shelves.
- Helps gives the CBD industry credibility: CBD products that are backed up by science and data will support the claims that you as a clinician and CBD companies can and cannot make about the products.
- Gives clinicians alternative therapies they can offer their patients for safe, natural, non-addictive pain relief: Clinicians can help patients decrease or stop using OTC pain relievers and prescription opiates that carry serious side effects and/or the risk of addiction.
- Offers an incentive for research and drug development: It gives clinicians and pharmaceutical developers incentive for research and drug development that is safe, natural, and non-addictive.
- Helps clinicians advance their training and clinical toolkit: Clinicians can maintain their licenses with mandatory continuing education units (CEUs) by studying the endocannabinoid system, phytocannabinoids, and other relevant topics in the medical cannabis industry—which they can add to their clinical offerings.
- Helps clinicians diversify their income: Clinicians can sell a new class on products or use them for their treatments (and charge more for those sessions).
As the industry moves forward, so will CBD CLINIC so your patients can get the relief they need.
Appendix: The History of the FDA Analgesic Monograph
The FDA’s oversight of drugs has not been around as long as you might think. Many of us might even be older than their monographs.
Internal Analgesic Monograph
The rules concerning internal analgesic drugs were first proposed back in 1977, followed by greater discussion until 1980. After a final ruling in 1984, a “Tentative Final Monograph” was published in 1988, corrected in 1989, with further comments added in 1990. In 2002, ibuprofen was added as a GRASE (generally recognized as safe and effective) active ingredient.
According to the current internal monograph, over-the-counter analgesics include acetaminophen, aspirin, ibuprofen, ketoprofen, and naproxen sodium. Most of these analgesics are also included in the group of non-steroidal anti-inflammatory drugs (NSAIDs). OTC NSAIDs include aspirin, ibuprofen, ketoprofen, and naproxen sodium.
Until recently, hydrocodone codeine was used as an active ingredient in numerous over-the-counter agents including cough medicines and antihistamines. From 1 February 2018, any products that contain codeine became prescription only due to abuse and misuse—with particular concerns about children.
Proposals and final changes to the monograph were made to require warnings for a number of potential side effects from analgesic medications including Reye’s syndrome, stomach upset from excessive intake, myocardial infarction (heart attack), alcohol warnings, liver and stomach bleeding, and stomach upset.
External analgesic monograph
The external analgesic monograph followed a similar timeline, starting in 1979. A tentative final monograph was introduced to the public in 1983, with some revisions along the way.
As of now, the monograph divides analgesics by active ingredients for products and subdivides it by types of pain associated with muscle and joint pain, itch and rashes, cuts and scrapes, minor skin conditions, insect bites, genital pain and itching, and other common ailments that people would like to self-treat with topicals.
Since the list is exhaustive, we’ll highlight the pharmaceuticals that we use, which include: menthol, camphor, and lidocaine —all naturally-derived except lidocaine, which we use with natural ingredients for consumers who are sensitive to counterirritants.
Like internal analgesics, the external analgesic monograph has been continuously updated as new drugs or risks have arisen, with the last update in 2008 on the safety of non-monograph ingredients.
Unlike the internal analgesic monograph, the FDA did not continuously add warnings about side effects, as most topical ingredients are generally recognized as safe and effective (GRASE). That said, the tentative FDA monograph for external analgesics states, “Many ingredients that are generally recognized as safe are still capable of causing side effects, allergic reactions, etc,” thus they require manufacturers to provide “warnings against unsafe use, side effects, and adverse reactions.”
In short, these monographs and updates give rules for safe combinations of ingredients, accurate labeling of products, and guidelines on claims that a manufacturer can make.
Now, we are upon a new phase of research with the introduction of CBD to the market intended to continue to protect the public.