For decades, medical marijuana has been legalized in several U.S. states, but it wasn’t until 2013 that CBD oil and other derivative products became legalized. Now, the CBD industry is projected to grow to 16 billion dollars by 2025.
While CBD is not the same as medical marijuana, many of the claims surrounding its health benefits are similar to medical marijuana products. Since the use of CBD for medicinal purposes is such a new frontier, it can be difficult to distinguish between research-backed claims, and what may be CBD pseudoscience conclusions. Consumers would also be hard-pressed to find long-term studies on the efficacy of CBD products since the issue of legality has long stood in the way of science and research for cannabis-derived products. But fortunately, there are several, high-quality studies available on the benefits of CBD.
What is pseudoscience?
Pseudoscience is a collection of practices, beliefs, or claims that aren’t backed by the scientific method. Anything that strays from mainstream science or medicine is often accused of being pseudoscience. It could mean the allegations were disproved via the scientific method, are unable to be scientifically tested, or the claims lack supporting evidence. Some examples of pseudosciences include:
- Handwriting analysis
- Feng shui
- Body language analysis
The term pseudoscience is often used as a pejorative, and entered the popular lexicon in the late 1800s with the invention of the term, “snake oil salesman.”
What is the history of the snake oil salesman?
In the late 1800s, the use of rail travel exploded in the U.S., as did the practice of Western expansion. The U.S. needed laborers to build the Transcontinental Railroad. With the demand, an influx of workers and immigrants from China settled in the U.S. to build the railways.
The snake oil that the Chinese immigrants brought with them was made from the Chinese water snake, and the oil was full of beneficial omega-3 fatty acids, which are known to reduce inflammation and pain. Originally, snake oil was effective for treating the pain of arthritis and bursitis and had been used for hundreds of years in China. According to legend, the Chinese immigrants would share the oil with American railway laborers, who were impressed with the medicine’s effects.
At this point in U.S. history, there was no FDA or any other governing authority which oversaw the manufacture, sale, or use of medicines. Anyone could potentially sell a “medicine” and not incur any fines or legal issues. At the time when traditional Chinese snake oil was becoming popular with railway laborers, so too were patent medicines.
Patent medicines were tinctures, oils, supplements, and powders sold in the back of the newspaper, and they claimed to cure a range of different health issues. They are similar to the over-the-counter medicines that people enjoy today. The problem with patent medicines in the Victorian era is that there was little to no oversight regarding their manufacture, sale, and marketing claims. Anyone could potentially create and sell a patent medicine marketed to cure a common ailment.
Unscrupulous patent medicine manufacturers took note of the increasing popularity of traditional Chinese snake oil in the American West. To capitalize on this new trend in medicine, patent medicine manufacturers started to make their own versions of Chinese snake oil. These snake oils were often marketed as “cure-alls,” claiming to alleviate any health ailments a person might have – from burns, headaches, arthritis, and even kidney problems.
Unfortunately, these versions were not sourced from the Chinese water snake and did have large amounts of beneficial omega-3 fatty acids in them. Also, some patent medicine snake oils didn’t contain any beneficial properties at all. Because of the influx of useless patent medicines in the U.S. during the late 1800s, the term “snake oil” became synonymous with pseudoscience and fraudulent medical claims.
What “cure-alls” have there been in U.S. history?
Before government oversight was established with the FDA, many patent medicines marketed themselves as cure-alls. Patent medicines were relatively unregulated, and marketers could make any claims they wanted. The most popular of these medicines were marketed as cure-alls for any issues a person had with their appearance, and they could allegedly fix a person’s complexion, figure, and even their hair. These cure-alls were frequently manufactured as liquid tonics, balms, or ointments. A few cure-alls were also labeled as dual-use. Some of the most popular cure-alls at the time were S.B. Goff’s Magic Oil Liniment and Minard’s King of Pain Liniment.
In 1912, Congress enacted legislation that banned manufacturers from making false, fraudulent “cure-all” claims on medicines. Once this happened, cure-alls started to disappear from the drug market. Because of legislation like this, it is illegal for manufacturers to make false therapeutic claims on vitamins and supplements.
What are the dietary supplement claims?
According to the FDA, the makers of dietary supplements can legally make four types of claims on their product labels. These claims are :
- Nutritional Claims
- Claims of well-being
- Health Claims
- Structure or function claims
However, dietary supplements cannot make false, therapeutic claims about the treatment of disease. But, it is legal for manufacturers to make structure or function claims as long as they include an FDA-approved disclaimer. For example:
- Effect on physiology
- Effects on cellular structure
- Mechanism of action
- Results on chemical or lab tests
- Claims regarding maintenance
- Non-disease claims
The FDA does not review structure or function claims. Any supplements or products that have labels with structure or function claims must include the disclaimer, “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
Consumers often misunderstand structure or function claims on supplements, which is why the FDA requires that manufacturers include the disclaimer. For example, consumers may believe that a supplement that claims to help “maintain clear skin” will treat acne lesions, but that is not necessarily true. Supplements that claim to support an already healthy function are not claiming that they will cure a disease or prevent a disease, and are therefore operating within the legal bounds the FDA has put forth for supplement manufacturers.
In contrast, drugs and medicines can legally make claims that they treat, prevent, or cure certain diseases. Drugs have been through rigorous testing to prove such claims, while supplements and similar products have not. A supplement cannot make a claim like “used to treat and prevent blood clots,” like the prescription medicine Coumadin. Instead, a supplement could make a claim, “promotes healthy circulatory functioning,” along with the FDA disclaimer.
What research is behind some of the most popular CBD claims?
The use and legality of CBD is a politically charged issue. It wasn’t until recently that CBD became legal in the majority of states in the U.S. Because of the issue of legality, there aren’t very many reliable, long-term studies conducted on CBD. However, the studies that have been conducted appear promising for CBD regarding its therapeutic effects. Both animal and human studies have found CBD beneficial for chronic pain, high blood pressure, and nausea. Promising preliminary data on CBD show that the health benefits of CBD are based in real science and medical research, and are not CBD pseudoscience.
Currently, the FDA recognizes that there are many potential therapeutic opportunities for CBD products and supplements. Many legal gray areas currently surround the use, sale, and shipping of CBD products and a lack of standardization for the products. Many manufacturers of CBD are marketing their products in violation of FDA regulations by making structure or function claims without the use of a disclaimer. The good news is, the FDA is interested in making it easier for CBD companies for marketing their products lawfully.
On May 31, 2019, the FDA will hold a public hearing for CBD stakeholders. Stakeholders can share the challenges they’ve experienced with lawfully marketing their products, and also share their experiences regarding the safety and claims of CBD products and how they fit in with FDA regulations. The FDA also has available an open docket for the public to freely submit their comments regarding the use and sale of CBD products.
With the recent FDA approval of the cannabis-derived drug Epidolex for epilepsy, it is apparent that the FDA is interested in making cannabis products available to the public that is safe, standardized, and marketed lawfully. For consumers of CBD Products, it is crucial that they thoroughly research the CBD manufacturer they intend to purchase form, their state laws, and also consult their physician before trying a CBD product.