Read about the different aspects of how regulatory authorities can formally acknowledge CBD as a dietary supplement.
The manufacturing and processing of CBD-containing products has implications not only for quality control of the products, but also whether products meet the confusing array of current FDA-approved policy and safety guidelines for cannabidiol.
It is legal to grow hemp (Cannabis sativa) for industrial purposes as long as the varieties used have less than 0.3% THC content (dry weight). Growers selectively breed hemp plants to be high in valuable CBD and other cannabinoids while remaining low in THC for extraction into an oil for future use.
The growth of the CBD “health” market has seen an explosion of cannabidiol containing products, manufactured from both “full-spectrum” botanical hemp extracts and from isolates.
Hemp extracts are the result of three common extraction processes:
Watch this 2.05 minute video “How CBD Is Extracted From Cannabis | TODAY”.
First, growers harvest the flowering tops of the hemp plants, and crush and pass the plant through the solvents to draw-out the desired cannabinoid compounds as a “crude extract” oil. The mixture is “crude” because it still contains hundreds of plant compounds such as fatty acids, chlorophyll, and a mixture of flavonoids, terpenes, and cannabinoids, including CBD.
The initial CO2 extraction produces a raw hemp extract, which manufacturers then treat with heat to convert the cannabidiolic acid into CBD to produce a “decarboxylated hemp extract”. Then they will process this further by distillation to remove unwanted compounds and increase the CBD concentration. With sufficient processing, one can end up with an almost pure CBD isolate.
Pharmaceutical purposes in licensed medicines such as Epidiolex are the main users of pure CBD isolates. Non-pharmaceutical over the counter products are predominantly based on “full-spectrum hemp extracts” containing a diverse mixture of constituents beyond just CBD and THC. This cocktail of substances may have beneficial, synergistic effects, in what is called the “entourage effect”. This would make CBD products ideal as “dietary supplements”.
A study of patients treated with CBD rich cannabis extracts for refractory epilepsy showed that they needed less CBD to control their symptoms compared to patients receiving CBD isolates. Patients also described less adverse side effects when using CBD extracts instead of CBD isolates. These findings are encouraging researchers to look at the interactions between the major and minor components of industrial hemp extract in more detail. The minor constituents include flavonoids, terpenoids, and lignamides that have demonstrated anti-inflammatory properties, which may offer wider beneficial results than CBD alone. This corroborates the legalization of cannabidiol as a dietary supplement.
Although in theory CBD isolates are more predictable in their effect on the body, their use has highlighted risks of liver-cell toxicity, raising concerns for consumer safety when using CBD generally. However, purified CBD isolates differ significantly in chemical composition from hemp extracts, and it seems sensible to treat the two separately in terms of regulation as a food supplement or active drug.
Recent animal trials have provided safe and tolerable dosage levels of CBD derived from hemp that regulatory authorities could use to establish safety guidelines for CBD as a dietary supplement. However, even without these guidelines, where manufacturers follow approved “Good manufacturing processes” and use legal hemp plant sources, they have a legal precedent to use CBD extracts as food additives. As we know, the current conflicting legality of CBD and FDA guidelines still prevent the marketing of CBD as dietary supplements.
Countries such as Australia are also exploring this issue, and in 2020 have published a new framework for CBD regulation that suggested the relaxation of restrictions on low-dosage products. They suggest a recommended daily dose of 60 mg or less of CBD, limiting packaging to a 30-day supply, and controlling the possible variability of their interactive effects by setting a limit for the content of minor cannabinoids to below 2%.
This approach realistically acknowledges the differences between full-spectrum extracts marketed potentially as dietary supplements and the purified pharmaceutical preparations sold as pharmaceutical drugs. However, in recognizing the large potential variability in crude extract products, as a result of their unique plant origin and processing/ extraction methods, experts recommend that each product should be treated as unique with safety tested before release to the market. This could facilitate the position of CBD as a dietary supplement.
The authors of the cited article provide the interesting analogy of comparing and regulating “coffee vs isolated caffeine”. The best practice for an all-natural product is to test it and to provide a detailed explanation of its “unique identity” rather than generalizing that “significantly different botanical products [have] the same chemical composition and biological activity”.
Marinotti O, Sarill M. Differentiating Full-Spectrum Hemp Extracts from CBD Isolates: Implications for Policy, Safety and Science. J Diet Suppl. 2020;17(5):517-526. doi: 10.1080/19390211.2020.1776806. Epub 2020 Jun 16. PMID: 32543253.
Walker LA, Koturbash I, Kingston R, ElSohly MA, Yates CR, Gurley BJ, Khan I. Cannabidiol (CBD) in Dietary Supplements: Perspectives on Science, Safety, and Potential Regulatory Approaches. J Diet Suppl. 2020;17(5):493-502. doi: 10.1080/19390211.2020.1777244. Epub 2020 Jun 16. PMID: 32543246.