Category C: Marketing, Labeling, Sales

Category C: Marketing, Labeling, Sales

Comments to the Food & Drug Administration on CBD and Cannabis

Consumers need to know what they’re consuming. One of the fundamental functions of the FDA is to ensure just that. It’s no different for cannabis and CBD products – consumers need to know how much and the source of the CBD and THC they are consuming. Thus far, however, there has been little federal oversight for manufacturing CBD products, and this has fostered confusion and deception.

The Journal of the American Medical Association and other sources have reported that many unregulated, hemp-derived CBD oil products are mislabeled as to CBD and THC content. 41424344 Some hemp-derived CBD brands have falsely claimed full-spectrum CBD-rich oil is in their products, but lab tests of several samples revealed only one cannabinoidCBD – was present, indicating that these products were made with a CBD isolate rather than a more efficacious whole plant CBD-rich extract. 45 There are other mislabeling issues, as well, that warrant careful scrutiny, including (but not limited to) exaggerated or unsubstantiated medical claims that CBD businesses make about their products.

Question 4: Suggestions

Most labeling problems are easily correctable and preventable with requisite lab testing and sensible regulations. Labels that accurately reflect the content of CBD products are essential for consumers who seek to make informed decisions about using CBD as a health aide. Accordingly, Project CBD suggests the following:

  • Regulations should require specific information on CBD product labels, including the amount of CBD and THC per serving, not just the total cannabinoid content for the entire product.
  • Labels should indicate whether the product contains a CBD isolate, a full-spectrum CBD-rich oil extract, or a so-called broad-spectrum extract without THC.
  • Given the possibility of drug interactions when a large dose of CBD is consumed by people taking pharmaceuticals, the FDA should require a warning label for products consisting of high-dose CBD isolates (See Appendix D).
  • Poorly processed CBD oil may be contaminated with toxic solvent and pesticide residues, thinning agents, corn syrup, artificial flavors and colors, and other toxins. Product labels must indicate any additive ingredients that are present in CBD oil products.

Some CBD hemp companies make false claims that the CBD in their products is extracted from hemp seeds and/or hemp stalk. The stalk of the hemp plant is not a viable source of CBD oil, which is concentrated on the flower tops and to a lesser extent on the leaves of cannabis. While hemp seeds are an excellent source of protein-rich omega 3 fatty acids, the seeds themselves don’t contain CBD, THC or any other cannabinoids. CBD oil in not the same as “hemp oil” or “hempseed oil,” and this should be clearly indicated on product labels to avoid confusion.

Question 4: Honor the whole plant

When the endocannabinoid system doesn’t function properly, our health suffers. Scientific studies have shown that the endocannabinoid system is dysregulated in nearly all pathological conditions. According to Pal Pacher and Geroge Kunos, leading scientists with the National Institutes of Health, “[M]odulating endocannabinoid system activity may have therapeutic potential in almost all diseases affecting humans, including obesity/metabolic syndrome, diabetes and diabetic complications, neurodegenerative, inflammatory, cardiovascular, liver, gastrointestinal, skin diseases, pain, psychiatric disorders, cachexia, cancer, chemotherapy induced nausea and vomiting among many others.” 46

By modulating the endocannabinoid system and improving endocannabinoid tone, CBD-rich and THC-rich cannabis can slow, or in some cases stop, the progression of various diseases. 47 The federal government, however, refuses to acknowledge what people have known for thousands of years – that cannabis is a medically useful plant.

Medical scientists know a great deal about how cannabis components confer various effects through multiple molecular pathways. The therapeutic use of cannabis for millennia is a testament to its safety and efficacy. Ensuring the safety and quality of CBD-rich and cannabinoid-based products, while creating an avenue to study the medical impacts of this versatile plant, should be the FDA’s utmost priority in crafting regulation.

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Footnotes

  1. Bonn-Miller, Marcel O et al. “Labeling Accuracy of Cannabidiol Extracts Sold Online.” JAMA vol. 318,17 (2017): 1708-1709. doi:10.1001/jama.2017.11909
  2. Freedman, D.A. and Patel, A.D., 2018. Inadequate Regulation Contributes to Mislabeled Online Cannabidiol Products. Pediatric Neurology Briefs, 32, p.3. DOI: http://doi.org/10.15844/pedneurbriefs-32-3
  3. Jikomes, Nick, and Michael Zoorob. “The Cannabinoid Content of Legal Cannabis in Washington State Varies Systematically Across Testing Facilities and Popular Consumer Products.” Scientific Reports, vol. 8, no. 1, 2018, doi:10.1038/s41598-018-22755-2.
  4. Justin L. Poklis, Haley A. Mulder, Michelle R. Peace, The unexpected identification of the cannabimimetic, 5F-ADB, and dextromethorphan in commercially available cannabidiol e-liquids, Forensic Science International, Volume 294, 2019, Pages e25-e27, ISSN 0379-0738, https://doi.org/10.1016/j.forsciint.2018.10.019.
  5. CBD & Hemp Extract Supplements Review.” ConsumerLab.com, 8 Feb. 2019, www.consumerlab.com/reviews/cbd-oil-hemp-review/cbd-oil/PREVIEW/.
  6. Pacher, Pál, and George Kunos. “Modulating the endocannabinoid system in human health and disease–successes and failures.” The FEBS journal vol. 280,9 (2013): 1918-43. doi:10.1111/febs.12260
  7. Russo, Ethan B. “Clinical Endocannabinoid Deficiency Reconsidered: Current Research Supports the Theory in Migraine, Fibromyalgia, Irritable Bowel, and Other Treatment-Resistant Syndromes.” Cannabis and Cannabinoid Research, vol. 1, no. 1, 2016, pp. 154–165., doi:10.1089/can.2016.0009.