Part IV: CBD Oil… Hype, Harm, or Heck Yeah!
Now that I’ve provided an introduction to CBD oil, stated some of its precautions, reviewed the legal restrictions of cannabis, and begun a review of its medical indications, it’s time to step back from the science.
This is because you want to understand the caveats and considerations of the product you are using. Now that it is so popular and profitable for many companies, you want to make sure you get a good quality and standardized CBD oil.
Now, let’s get into it.
The Legality of CBD Oil…Confusing Indeed!
The division between federal and state laws makes the legality of cannabis and its constituents hard to decipher for even the most astute consumer. The FDA website is quite stern and concise regarding its authority of regulation of CBD and THC; however, states have their own laws. For instance, prior to the passage of the Farm Bill in December 2018, CBD oil was legal only in 30 states where medicinal and/or recreational marijuana was legal (WebMD).
An article from June 2018 (pre Farm Bill) in Racked stated the following regarding the legalities of the compounds of cannabis and hemp:
This is where it gets even muddier. Hemp oil is legal everywhere. THC is only legal in states where marijuana is legal. But no one really knows how to classify CBD yet. People who sell it say it is legal in all 50 states. Technically, according to Above the Law, it is illegal, but it can be considered legal if it’s derived from certain types of hemp plants. Confusing!
Individual states are still considering what to do about CBD. Target briefly sold it online last year, then quickly removed it. Sellers on Amazon are confused, but it is definitively on the retailer’s no-sell list. When you search “CBD oil” on Amazon, about 700 listings for hemp oil pop up. Who knows what they actually contain.
To complicate matters, the legality of hemp, though technically “legal,” had caveats. (source, source, source, source) There were various rules and restrictions in each state and country for its cultivation, production, labeling (<.3% THC in the U.S.), part of the plant permitted for extraction, and other issues.
Recently, the waters for hemp use became less murky and much clearer with the latest passage of the Farm Bill. Although the bill has many other components to it besides hemp, the main focus was that it legalized hemp which led many to celebrate.
The Agriculture Improvement Act of 2018 changes certain federal authorities relating to the production and marketing of hemp, defined as cannabis (Cannabis sativa L.), and derivatives of cannabis with extremely low (less than 0.3 percent on a dry weight basis) concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC). These changes include removing hemp from the Controlled Substances Act, which means that it will no longer be an illegal substance under federal law. However, Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the FD&C Act and section 351 of the Public Health Service Act. Please see the FDA’s statement on the signing of the Agriculture Improvement Act of 2018. (see the full bill here.)
In a short, yet detailed, review of hemp and CBD’s legality, the press statement by FDA commissioner, Scott Gottlieb, MD (12/20/18) was included to clarify the confusion. Below is an excerpt from the full press statement, that gives the details of hemp and CBD federal regulation:
Additionally, it’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements. Under the FD&C Act, it’s illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements. This is a requirement that we apply across the board to food products that contain substances that are active ingredients in any drug.
We’ll take enforcement action needed to protect public health against companies illegally selling cannabis and cannabis-derived products that can put consumers at risk and are being marketed in violation of the FDA’s authorities. The FDA has sent warning letters in the past to companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.
While products containing cannabis and cannabis-derived compounds remain subject to the FDA’s authorities and requirements, there are pathways available for those who seek to lawfully introduce these products into interstate commerce. The FDA will continue to take steps to make the pathways for the lawful marketing of these products more efficient.
These pathways include ways for companies to seek approval from the FDA to market with therapeutic claims a human or animal drug that is derived from cannabis. For example, in June 2018, the FDA approved a drug, Epidiolex, that contains cannabis-derived CBD for the treatment of seizures associated with two rare and severe forms of epilepsy. That approval was based on adequate and well-controlled clinical studies, which gives prescribers confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes.
In addition, pathways remain available for the FDA to consider whether there are circumstances in which certain cannabis-derived compounds might be permitted in a food or dietary supplement. Although such products are generally prohibited to be introduced in interstate commerce, the FDA has authority to issue a regulation allowing the use of a pharmaceutical ingredient in a food or dietary supplement. We are taking new steps to evaluate whether we should pursue such a process. However, the FDA would only consider doing so if the agency were able to determine that all other requirements in the FD&C Act are met, including those required for food additives or new dietary ingredients.
It should also be noted that some foods are derived from parts of the hemp plant that may not contain CBD or THC, meaning that their addition to foods might not raise the same issues as the addition of drug ingredients like CBD and THC. We are able to advance the lawful marketing of three such ingredients today. We are announcing that the agency has completed our evaluation of three Generally Recognized as Safe (GRAS) notices related to hulled hemp seeds, hemp seed protein and hemp seed oil and that the agency had no questions regarding the company’s conclusion that the use of such products as described in the notices is safe. Therefore, these products can be legally marketed in human foods for these uses without food additive approval, provided they comply with all other requirements and do not make disease treatment claims.
Given the substantial public interest in this topic and the clear interest of Congress in fostering the development of appropriate hemp products, we intend to hold a public meeting in the near future for stakeholders to share their experiences and challenges with these products, including information and views related to the safety of such products.
(Note from me: Here is summary press release from 2017 of the warning letters regarding claims for CBD for treating diseases such as cancer.)
Although the political and legal hoops still exist, the excitement of the Farm Bill’s passage has not faded. There is now an anticipation by cannabis specialists that this could pave the way for CBD and marijuana laws to become more permissive. Some are even making a case for legislation for CBD regulation to be important as a potential remedy to the opioid epidemic.
The Legality of Cannabis and Marijuana
Currently, cannabis is regulated by local, state, federal, and international laws. State laws often mirror federal law. This article provides a good summary of this. This 2017 review includes a table that lists indications for use by state.
For those who are in a state where cannabis and marijuana are legal, CBD oil restrictions are not as much of an issue. Still, there are the federal laws to consider.
Although this article is for doctors and prescribers, it is a good resource which summarizes some of the considerations for prescribing and legal status.
You can find more details on cannabis regulation in Part II here.
Potential Problems with the Popularity of CBD (Cannabidiol) Oil… Buyer Beware
Besides legality, I briefly touched on some of the other potential pitfalls of haphazardly succumbing to the latest “panacea” claims without considering safety, limitations in research, and drug interactions. There’s also another big concern.
The fact that we are in a “Weird Wild West time for CBD oil” regarding regulation leads us to issues of quality control, standardization, and labeling integrity. As discussed in this article, samples of different brands of CBD oil were tested to determine the difference between label claims of what was in the product and what the actual testing found. The authors stated, that in “many cases the analyzed cannabinoid content strongly differed from the claimed content on the label, while in 7 samples no cannabinoids (CBD or THC) were found at all. Such deviations were found in home-made as well as commercially obtained products.”
Furthermore, even if you are getting CBD oil, the amount needed for a therapeutic effect is still not fully elucidated for a variety of conditions. Some studies have reported a “U” shaped curve of efficacy and absorption. This is the “goldilocks” dosage of “just right.” This means too much or too little may produce different effects than intended, especially regarding mood.
Furthermore, many have argued for the “entourage effect” of cannabis and that it may be more effective when the whole plant is used. This means including the essential oils (which contain mostly terpenes) as well as a little bit of that psychoactive stuff. (source, source, source, source, source) We love synergy, right essential oil lovers!?
This leads us into another question…
Is CBD Oil an Essential Oil?
This is a very good question.
Cannabis does contain essential oils (see above), but does your CBD oil?
Most of the CBD oil in the U.S. is not technically the “essential oil of CBD.” CBD is a constituent in cannabis, you cannot extract an essential oil from a compound. CBD oil has different extraction methods than steam distilled essential oils. (source, source) This link provides a basic explanation for the most common type, fatty oil extraction.
According to Robert Tisserand, an internationally respected essential oils expert, there is a steam distilled CANNABIS essential oil available in Canada, Switzerland, and France.
Please stay tuned for an article that goes into more detail on cannabis essential oils.
Closing and Summary on CBD Legal Status
The bottom line on legality is this: hemp is currently legal under federal law while CBD is regulated by the FDA. Due to the fact that THC and CBD have patentable drugs, the marketing and use of such products is still murky.
You can purchase hemp oil with CBD oil in it, but it cannot be marketed as a CBD product or make health claims for CBD. Furthermore, it’s important to note the source, as CBD can be derived from hemp or marijuana. Obviously, if it is derived from cannabis and not hemp in states where marijuana is not legal, this can be a problem. The CBD extracted from hemp is quite a bit lower in potency and dosage for therapeutic effect is a factor.
So, as you can see the legality issues and quality of CBD oil adds up to quite a number of considerations is in a process of continual change. Hopefully, I helped answer some of your questions.
Coming up, I will be doing a review of its efficacy from various trials, including clinical ones.
This material is for information purposes only and is not intended to diagnose, treat, or prescribe for any illness. You should check with your doctor regarding implementing any new strategies into your wellness regime. These statements have not been evaluated by the FDA. (Affiliation link.)
Disclaimer: This information is applicable ONLY for therapeutic quality essential oils. This information DOES NOT apply to essential oils that have not been tested for purity and standardized constituents. There is no quality control in the United States, and oils labeled as “100% pure” need only to contain 5% of the actual oil. The rest of the bottle can be filled with fillers and sometimes toxic ingredients that can irritate the skin. The studies are not based solely on a specific brand of an essential oil, unless stated. Please read the full study for more information.