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CBD Basics. What the Rules Say and Why

Janna Bauer, RN, BSN, CDE on December 18

 

As an educator, I am frequently asked questions about the use of CBD products. Today I am providing some background into the classification system used for drugs and dietary supplements and how it may frame some important conversations.

First and foremost are some basic guidelines before we start…

As a nurse, I have a scope of practice. That is to say I have a license which indicates I have a certain level of knowledge and education as well as defining what I am allowed to do and say within the framework of that license. There are laws and rules that govern our healthcare system just as there are in other professions. The US Food and Drug Administration (FDA) also provides rules and regulations for things such as what can be added to our food, the ingredients of a supplement, or what a pharmaceutical company is allowed to say about a drug they manufacture. The basic foundation is to ensure the greatest benefit with the least amount of risk.

This applies as well to products that contain cannabinoids such as CBD. For instance, you may see a statement on a product or website that reads “These statements have not been evaluated by the FDA. These products are not intended to diagnose, treat, cure, or prevent any disease.” This is meant to inform the consumer that this product has not been through a formal FDA approval process such as for prescription drugs, or medical devices and the FDA will not allow claims related to treatment, cure, or prevention of a disease be made that they have not formally substantiated or approved. For example, if a company that makes a facial cleansing product includes on their package that this product can also be used to treat eczema, that is a claim that was not submitted to the FDA for approval as a new drug or existing OTC,  therefore that claim cannot be made. If the manufacturer of a drug approved for the treatment of cold sores also claims it can be used to prevent skin cancer, the claim for skin cancer prevention cannot be included on the label unless it is submitted and approved as well by the FDA. 

Also part of the process for FDA approval are specific instructions for dosage or use of the product. For some products that may not be very complicated as in the case of over the counter (OTC) products such as dandruff shampoo but it may be very specific for another OTC product that contains acetaminophen  to prevent overdose that can lead to permanent organ damage or even death. Supplements do not have these same dose requirements, instead the have serving size or nutrient amount listed but no specific rules which limit the size. You may also see ‘suggested use’, but not dose because that terminology is used for drugs.

Products can be categorized as drugs (over the counter (OTC) or  prescription), supplements, cosmetics and soap-which is a category that is surprisingly more complicated than you would imagine. So where does CBD fall? Well, the answer to that looks similar to a multiple choice response like ‘both A and B’, ‘neither A nor B’, or maybe ‘to be determined’.  Because cannabis was previously all lumped together under the DEA classification as marijuana which is a schedule I drug (schedule I drugs have currently no accepted medical use (illegal) and a high potential for abuse), there was limited clinical trial data focused on medical use and no legal federal market (certain states began selling cannabis products prior to this). The law designating cannabis with a THC content of less than 0.3% as hemp and thus removed from the federal controlled substances list, opened the market and products containing CBD became hugely popular. The FDA definition of supplement was understandably applied by many. The FDA’s definition of supplement was defined in the Dietary Supplement Health and Education Act of 1994, stating a dietary supplement is a product  that contains a “dietary ingredient” intended to supplement the diet. The dietary ingredients in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. This places dietary supplements under the general umbrella of ‘foods’ and not drugs. By law, the manufacturer of a dietary supplement is responsible for ensuring that the products are safe before they are placed on the market, but unlike drug products there is no premarket formal approval process. Also, the claims that can be made differ. Per FDA regulations, dietary supplements can claim health benefits, but only FDA approved drugs can make claims to prevent, treat or cure disease. Things changed however when the prescription drug Epidiolex was approved by the FDA in 2018. Why did this change things? Epidiolex is a CBD based drug approved for the use in two specific forms of pediatric epilepsy. The manufacturer of Epidiolex, GW Pharmaceuticals, submitted a patent for its product as well as FDA approval. The cost of the approval process which involves clinical trials etc has long been a push-pull issue between the pharmaceutical companies who set the prices for their products and the consumers who pay for them. As per the DSHEA, dietary supplements cannot contain substances that are active ingredients in an FDA approved drug or authorized investigational new drug. This regulation was passed in 1994 when there were about 4,000 unique products in the dietary supplement market. Today there are over 80,000 and three out of four American consumers take dietary supplements on a regular basis. This rate rises to four out of five with older Americans. It seems inevitable that an overlap between supplements and drugs will occur in this new frontier of medicine. For instance fish oil supplements are one of the most commonly consumed dietary supplements. They are a source of omega-3 fatty acids which have many health benefits. In December 2019, the FDA approved Vascepa, made by pharmaceutical company Amarin. Vascepa is derived from omega-3 fish oil and requires a prescription. The retail cost of the drug is about $300.00 a month and will be submitted to insurance for coverage approval. According to an ABC news article on December 16, 2019 Vascepa “could be prescribed to millions of patients” and it went on to quote Dr. Deepak Bhatt, the executive director of the Interventional Cardiovascular Program at Brigham and Women’s Hospital who was involved in the study of Vascepa as saying “I believe this is the biggest thing since statins.” So is fish oil a dietary supplement or a drug? If someone asks how they are going to benefit from fish oil, does one first have to ask if they are referring to the the supplement or the drug  because they can only discuss potential health benefits for the supplement version but for the drug version they can discuss potential prevention and treatment...really?

What does this mean for CBD? Potentially a lot. CBD and other cannabinoid products are on the forefront of what could be a transforming time in healthcare. There is an identifiable overlap of what until now has been an either or approach to our health. I personally believe there is room for everyone at the table and it is imperative that we view health with a much wider lens. The bottom line is providing the best options for health and well being, and providing them safely and as expediently as possible to the benefit of all concerned.