- September 14, 2019
- Posted by: Roger Walker
- Category: Reviews
Over the years there has been an increased interest in hemp and hemp-derived products for cosmetic therapy, treatment of medical conditions as alleviation of symptoms, and dietary supplements. CBD, the non-psychoactive chemical compound found in cannabis, is believed to be beneficial in many ways and the people who have been applying it to their lives give constructive and positive feedback. The Food and Drug Administration (FDA) is still in the stage of analysis. Understanding the current FDA stance on CBD requires some research, so we’ve done it for you and attempted to summarize the core issues.
Because the industry is currently largely unregulated, make sure you only buy CBD from reputable, quality CBD companies that publish lab results from third-party laboratories. This way, you know exactly what you are getting.
The Food and Drug Administration
Like any other product that is used for medical purposes, there must be a regulatory body. This body takes care of making sure that products are used correctly and safely by the public. The FDA is that body in the US. It is responsible for these regulations and for understanding how CBD can be marketed correctly. They also determine for what purposes CBD is legitimately useful.
The FDA is the agency responsible for overseeing the safety of all drugs, cosmetics, foods, and other health-related products. This amounts to a colossal number of products to research and test. Since they cannot test every single product out in the market, they do their best to create regulations and guidelines for controlling the market and administering goods. This means, for example, that they limit what companies can claim about products without official FDA approval.
The FDA acknowledges the increased growth on the demand for CBD oil products; however, they have not yet finished their assessment. They say that in taking a “science-based approach” to the issue, there is still not enough information about the product to determine its safety and efficiency. The agency is working on answering these questions with feedback from a recent FDA hearing. They are also utilizing data and information gathered from a public docket that was open until July. The FDA wants more thorough research and detailed information on the long-term effects of CBD, so they haven’t been able to provide a timeline for approval.
Effect of 2018 Farm Bill
Changes on the 2018 Farm Bill made hemp legal in the United States, as long as it had less than 0.3% of THC (the compound responsible for getting people high). At that time, the FDA clarified that it was still their right and duty to regulate the use of the product and that even though it was legal to use it for cosmetic and medical purposes, it is still illegal in commercial food products.
CBD is widely marketed, even though regulation is still pending. The FDA has yet to scientifically verify, to their standards, if the product truly brings all the benefits claimed by the general public. They also want to investigate any and all consequences and long-term side effects. Regardless, even big retailers like CVS already have CBD products on their shelves. Large food brands are still waiting for FDA regulations to be able to start producing and selling products with CBD added to it- but in time they most likely will do so.
The Uses of CBD
Many people are still somewhat confused about hemp and CBD and what it can do- and not do. Hemp is just another name for the Cannabis sativa plant, also known as marijuana. However, hemp products found on shelves, also known as industrial hemp, have negligible amounts of the THC compound, as legalized by the Farm Bill. Therefore, it is not possible to use it for recreational purposes, something on which not all consumers have been educated.
There is a high concentration of the CBD compound in hemp. It is the CBD to which we attribute responsible for the calming effects of these products and for the alleviation of symptoms on conditions such as Parkinson’s Disease, hyperactivity, and many others. It is an active ingredient in Epidiolex, a prescription drug used to treat severe cases of epilepsy. Epidiolex, interestingly, has actually received approved by the FDA.
FDA Stance on CBD
If a product is marketed specifically as a drug, meaning it has therapeutic effects such as curing a disease, there must be FDA approval over that good. Food is regulated a bit differently, but still with the end-goal of protecting the health of consumers. CBD, since it is subject to clinical investigations to analyze its potential medical uses addition to food, can still not be considered as an additive to food.
The FDA must identify any possible contraindications that any food or drug can have. So even with something that seems generally very safe and side-effect free, they must exercise extreme caution and explore every possibility. The FDA Commissioner Scott Gottlied spoke in April 2019 about the agency’s concerns over the possible effects that cannabis-derived products could have on the general public. In July 2019, Lowell Schiller, the principal associate commissioner for policy, gave a statement where he clarified:
“While we recognize the potential benefits of CBD, questions remain regarding its safety… unsubstantiated therapeutic claims — such as claims that CBD products can treat serious diseases — can lead consumers to put off getting important medical care. The FDA also tested the chemical content of cannabinoid compounds in some of the products, and many were found not to contain the levels of CBD they claimed to contain.”
One of the major problems with the lack of regulation is that consumers must perform their due diligence to vet and assess their CBD supplier. Not all products are created equal, and so it’s important to always make sure you buy from a company with verified third-party lab results.
FDA Goals for CBD
The legalization of hemp is a relatively recent change. CBD has many, many potential uses as an oral or sublingual treatment, a topical, and as well as a food product. There is a huge amount of interest from the public in using these products. Therefore, the FDA must engage in very thorough, detailed testing over time to learn all the effects and information for every possible use.
Further, the FDA wants to explore the effects of different dosages of CBD so that they can understand how much it takes to be effective, and how much it takes to be too much. The primary goal of the FDA is the safety and education of the general population, and the regulations on hemp are a way of securing such well-being.