Thesis: There is a pressing need for standardized formulations and labelling in the CBD product industry.
With the medical and recreational statewide legalization of “marihuana” across the United States over the past decade, a wide variety of products began hitting the marketplace aside from the simple smokable plant joints. As these various new products were released in the highly regulated medical and recreational “marihuana” marketplace, strict controls and criteria were implemented to insure consumer safety. However, with the rapid proliferation of CBD containing industrial-hemp derived ingredients, no such control and regulation currently exists.
This phenomenon has led to an expansive national and global marketplace in which CBD containing products are produced, transported, sold, purchased, and consumed with little to no regulation. As a result, consumers have little idea as to what exactly they are consuming, specifically regarding the bioactive components of cannabis sativa including CBD, THC, CBG, CBC, and CBN. The current regulatory framework for CBD and cannabinoid containing products is untenable, and there exists an urgent need to standardize industrial hemp-derived products, including manufacturing practices, compliance, regulations, definitions, and labelling.
As many individuals will likely be recommending solutions to the FDA regarding definitions and labelling, this commentary will focus on the need for standardized formulations given the confusion, misinformation, and malpractice that currently occurs within the industrial hemp-derived ingredient marketplace. With this focus in mind, the general production steps in industrial hemp ingredient manufacturing will first be outlined in order to paint a clear picture of why further product standardization is needed. Starting with the crop itself, industrial-hemp grade cannabis sativa is defined by the FDA as any cannabis sativa plant grown within a state’s industrial hemp program that contains less than 0.3% THC (or like components) by mass in the flowering portion of the plant. This definition is satisfactory and provides a clear threshold for separating “marihuana” from industrial hemp. However, complexities immediately enter the ingredient manufacturing supply chain upon further processing. The next step in the manufacturing supply chain is extraction. During this process a solvent or compressed gas is used to extract the phytochemicals from the raw hemp flower in order to concentrate the valuable cannabinoid components. During this process most cannabinoids see a roughly 3x concentration moving from raw hemp flower to crude extract. This means CBD content goes from anywhere between 1-20% to 3-60%. This in and of itself is not an issue, however THC content similarly increases by 3x. Crude extract typically has a THC content anywhere from 0.45-1.0%. This product is no longer FDA compliant industrial hemp material. Next the crude extract is typically winterized and distilled. Without belaboring the chemical processing steps, the point of note in these two steps is that they similarly increase the THC content yielding winterized hemp extracts and distillates with far greater than 1.0% THC, commonly in the 2-3% THC range. These products also do not comply with the FDAs guidelines for industrial hemp.
Currently many “bad” actors are fine with selling these THC enriched products as industrial hemp derived products and have not been subject to much pressure from the FDA. A major concern with this practice of selling THC enriched products is the consumer. These THC containing products should not be legal to sell to a consumer outside of medicinal or recreational “marihuana” shops, as they could get a consumer high. Additionally, these products generally cannot be sold in “marihuana” shops because they were not produced in the highly controlled state regulated “marihuana” grow facilities. Given this dilemma many ingredient manufacturers in the industrial hemp industry have opted to pursue some sort of THC removal or THC remediation process. Though this is a great step for both FDA compliance and consumer protection, there are a variety of THC removal processes and no clear labelling or classification for the end products derived from these processes.
It is these THC removal or remediation processes, and the products they generate, that will be the focus of attention for the remainder of this commentary as they greatly alter the hemp extract or distillate derived from them. The most common method of THC remediation is dilution. With this process a foreign oil is added to the THC containing product in order to dilute the THC levels back below the 0.3% by mass FDA limit. In and of itself this process can be harmless, but issues arise when manufacturers do not disclose the additive ingredients, or the fact that the entire hemp extract (initially containing high levels of cannabinoids) has been greatly diluted. This becomes an issue in the marketing of natural “Full Spectrum” or “Broad Spectrum” products that are supposed to contain the minor cannabinoids CBG, CBC, and CBN in addition to CBD. Not miring the discussion in the actual definition of these terms “Full” and “Broad Spectrum”, the consumer of THC compliant diluted hemp extracts is often deceived into thinking they are containing a cannabinoid rich oil, when in reality CBG, CBC, and CBN are often at undetectable levels. This is because these minor cannabinoids occur at relatively the same concentration as THC in industrial hemp flower and correspondingly extracts and distillates. There are methods to truly remove the THC from industrial hemp extracts and distillates without dilution, while maintaining high contents of the minor cannabinoids CBG, CBC, and CBN, but because of a lack of clarity in labelling, testing, and definitions the consumer likely will not know this. All this is to highlight the need for not only standardized formulations, but definitions and testing within the industrially hemp derived CBD ingredient marketplace.
In this vein, it is useful to discuss what aspects of the phytochemical extract mixture need to be focused on to understand industrial hemp derived ingredients and illustrate why standardized formulations are a must for the industry moving forward. The primary components of industrial hemp ingredients of interest to consumers are the cannabinoids, terpenes, and fatty acids that naturally occur in the plant. Terpenes are responsible for the distinct odor associated with cannabis and cannabis derived products, though their medicinal effects, if any, have yet to be substantially validated by science. Fatty acids on the other hand are common to all life, though specific fatty acids and their relative mixtures can be unique to some plants. Given these two constituents of industrial hemp derived ingredients are primarily responsible for smell, aesthetics, and common throughout all plant derived products, it is my opinion little focus need be paid to them regarding standardized formulations, labelling, and definitions. It benefits the consumer to know what terpenes are in their products, and at what levels they are at, as they may have some medicinal benefits and can create unique tastes and smells. However, because terpenes are so common in all plants that this sort of regulation seems to be overkill. Similarly, though it may be useful to know the identify and amounts of the fatty acids in hemp derived ingredients to detected additives, diluents, or other processing steps, the consumer need not necessarily be made aware of this.
The cannabinoids, however, are the main phytochemical component of the plant responsible for the physiological and psychological effects of cannabis sativa, and it is my opinion much more thought and effort must be put into the standardization, labelling, and definition of these key components in hemp derived ingredients. Though only CBD and THC have been studied at length, and only THC is shown to psychoactive effects, there are over 70 known naturally occurring phytocannabinoids in cannabis sativa. Since these molecules are primarily responsible for the medicinal effects of the plant, and of most import to the consumers, it is my opinion that industrial hemp derived ingredients should have very clear reporting guidelines for the cannabinoids in any product. This will ensure the consumer knows exactly how much, and the identity of what cannabinoids they are consuming. This labelling should help clarify and enforce any accepted definitions of “Full” or “Broad Spectrum” products. In addition to the above points, the medicinal relevance of cannabinoids for consumers also highlights the importance of standardized formulations. Extracts, distillates, and final consumer products, from different strains of hemp (or even identical hemp strains obtained from different locations within a field) can exhibit vastly different cannabinoid profiles. Since these profiles are responsible for the medicinal effects of any consumer product, the need to standardize the cannabinoid profile of end product formulations is evident.
How can there be any consumer confidence in a product when the most important active ingredients, the cannabinoids, are not always in the same well controlled amounts and proportions? How can a consumer safely consume a product with the goal of obtaining some nutritional benefit when they don’t know if the same product, from the same supplier, will have the same affect based on the strain of hemp, region of harvest, or even time of harvest year? Until standardized hemp extract and distillate formulations are defined and required, consumers cannot have any confidence that the products they are consuming will have the desired, if not medically validated, effects. There is a pressing need for standardized formulations, regard to the cannabinoids, in the industrial hemp derived ingredient industry, and until regulations force manufacturers to be transparent and compliant in the formulations the consumers assume all the educational responsibility and risk.