Author: Gwen Coleman
CBD (Cannabidiol) products and the companies that distill them continue to enter the market in rapidly growing numbers. To date, the FDA has not approved a new drug marketing application (i.e NDA) for naturally cultivated cannabis used for the treatment of any disease or condition. The FDA has, however, approved one cannabis-derived (Epidiolex) and three cannabis-related drug products: Marinol, Syndros, Cesamet. These approved products are only available with a prescription from a DEA licensed healthcare provider. There are no other FDA-vetted and approved products that contain CBD. The FDA continues to be concerned at the proliferation of products asserting to contain CBD that is marketed for therapeutic or medical uses although they have not been validated by the FDA. Often such products are sold online and are therefore available throughout the country. Selling unvetted and unapproved products with unsubstantiated therapeutic claims is not only a violation of the law but also can put patients at risk, as these products have not been proven to be safe or effective. This deceptive marketing of unproven cures and treatments also raise significant public health concerns because patients and other consumers may be influenced not to use approved therapies to treat serious and even fatal diseases. (1). It is the concern of the FDA to ensure patients are kept safe and reach for only those products that are shown to be safe and efficacious for the diseases or conditions intended. As a result, there has been much discussion and debate around the testing that should be performed on CBD products for safety and efficacy as well as purity and potency. Consumer organizations and health professionals strongly urge CBD companies to perform these tests and share results as the minimum responsibility to consumers.(2) The choice of which tests and frequency of testing that are most validating remain up to the supplier-manufacturer chain of CBD products. Unfortunately, even if companies perform tests to assess purity and potency, the published results (in the form of a Certificate of Analysis- C.O.A.) are often found to not match their product claims. (3). The increasingly growing market of unapproved CBD products can result in inconsistent and frustrating (potentially unsafe) experiences for consumers seeking reliability and relief for their health ailments. Finding products that consistently perform as consumers prefer and expect is a challenge. Inconsistent experiences can vary from brand to brand, and even more alarming – within the same product line or batch. For consumers with sensitive dosing needs and especially with children, this can add more stress and anxiety while attempting to alleviate symptoms and ailments with CBD products. (4)
There are too few CBD companies performing tests for safety and efficacy in addition to purity and potency; and even fewer who are raising the bar by providing additional, transparent product testing using live cell culture. There exists the option to perform even greater pre-market rigorous testing for CBD products called Human Cell Culture Tests (i.e in-vitro), animal testing (i.e ex vivo), and ultimately randomized controlled human trials (i.e. Phase3/4). (5) The Human Cell Culture Tests specifically measure cell growth and differentiation (i.e cell viability studies) of cells treated with CBD products. This type of test is commonly used by pharmaceutical and cosmetic companies to study the efficacy of their products and determine dosages. (6) To help address the safety and efficacy issues with CBD products, CBD companies should not only perform independent third-party purity and potency testing, but also in-vitro and ex-vivo testing. These scientifically rigorous testing efforts can offer consumers the most assurance concerning safety, efficacy, purity, and cannabinoid content. Potency testing checks whether the product contains the cannabinoid content promised but it doesn’t reveal much about product safety or efficacy. Purity testing checks CBD products for the presence of “contaminants” such as microbes, heavy metals, pesticides, or residual toxins but again does not reveal safety and efficacy. The data is contained within a Certificate of Analysis (C.O.A.) that reports findings for each of these categories, broken down, and then usually summarized as a “pass” or “fail”. (7). Human Cell In-Vitro studies determine the effects of drugs, biologics and nutraceuticals (including cosmetics in some cases) upon living cells. Mett Naturals is one of the first CBD companies to perform these more rigorous studies with human cell targets using their CBD products of oil drops, creams, roll-on oil, and oil capsules. Mett Naturals engaged PhytoLife, LLC to perform human cell culture testing on all Mett Naturals CBD Products and shared 9 samples of Mett CBD products as well as 4 samples from competitor CBD companies. The Mett Naturals muscle pain creams were impractical for evaluation due to lack of solubility. Additional testing was performed on the samples in the research studies at the end of the experiments to further evaluate the effects on inflammatory pathways in their cell cultures. These additional tests evaluated inflammatory cytokines, IL-1b, IL-6, TNF-alpha and IFN-gamma. Cytokines function to regulate inflammation produced by differentiated immune cells (e.g PBMC, peripheral blood mononuclear cell). All samples were processed and evaluated via incubation and freezing processes. Then, a careful microscopic examination was performed of the cell cultures at the start and again at the termination of the experiment. These examinations revealed no bacteria contamination. In their (PhytoLife, LLC) considerable experience studying samples containing CBD, the precision of cell testing strongly indicates an interesting observation. It indicates that small differences can be detected in cell growth between different samples and different concentrations. This is of significance as high purity CBD typically shows a drop in cell growth at higher concentrations. In the Mett Naturals samples observed, the growth observed at 4ug/mL and 8ug/mL suggests that other components of their distillates, like terpenes and flavonoids contributed to additional cell growth as well as cytokine modulation. (6)
For customers seeking a more thoroughly evaluated CBD product beyond the more commonly tested purity and potency measures, Mett Naturals products should be considered. Mett Naturals is one of the first companies to perform in-vitro human cell culture tests specifically for measuring the potency (i.e dose) and efficacy (i.e response) of reducing inflammation in cells with their CBD products. The Mett Naturals Brand outperformed all competitors in side-by-side testing conducted by the 3rd party independent lab PhytoLife, LLC. Specifically, Mett Naturals roll-on line was most effective when looking at cell growth. Mett Naturals 1000mg Orange Cream and 500mg Lemonade tinctures had the greatest effect on cellular suppression of cytokine release.(6)
Consumers have more CBD product choices to choose from in the marketplace than ever before. To assist in making the best choice, consumers now have access to more resources to evaluate CBD companies’ actions to test and evaluate their CBD products. CBD companies, like Mett Naturals, choosing to test their products with “seed to cellular to shelf to consumer” research deserve a closer look by consumers.
References
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(2021, January 22). FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD). U.S. Food and Drug Administration. https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-deriv ed-products-including-cannabidiol-cbd
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Greenberg, Sally. (2021, October 11). The FDA can help keep consumers safe when it comes to CBD. Morning Consult. https://morningconsult.com/opinions/the-fda-can-help-keep-consumers-safe-when-it-comes-to-cb d/
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Bonn-Miller, M. O., Loflin, M. J. E., Thomas, B. F., Marcu, J. P., Hyke, T., & Vandrey, R. (2017). Labeling Accuracy of Cannabidiol Extracts Sold Online. JAMA, 318(17), 1708. https://doi.org/10.1001/jama.2017.11909
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Herrington, A. J. (2021, June 30). New Report Finds 25% Of CBD Products Are Not Tested For Purity. Forbes. https://www.forbes.com/sites/ajherrington/2021/06/30/new-report-finds-25-of-cbd-products-are-no t-tested-for-purity/?sh=43eeb94e2627
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(2017, November 24). The FDA's Drug Review process: Ensuring drugs are safe and effective. U.S. Food and Drug Administration. https://www.fda.gov/drugs/information-consumers-and-patients-drugs/fdas-drug-review-process-e nsuring-drugs-are-safe-and-effective
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Torres, MD, A. R. (2021, October). Cell proliferation and inflammatory cytokine report for Mett Naturals Products on Human Peripheral Blood Mononuclear Cells (PBMC). PhytoLife Laboratories, LLC.
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Stone, E. F. (2021, August 15). CBD Buyer Beware: Leafreport Decided to Uncover Which CBD Brands are Testing, and Which are Not. Www.Leafreport.Com. https://www.leafreport.com/education/cbd-buyer-beware-leafreport-decided-to-uncover-which-cbd -brands-are-testing-and-which-are-not-10643
