“There is a knowledge gap in our current understanding of Cannabidiol.”
This month, cannabis experts were able to pipe up about the challenges surrounding the industry. As part of the “early stages” of its establishment of regulatory guidelines for Cannabidiol (CBD), the US Food and Drug Administration (FDA) held its first-ever public hearing on the subject, asking industry experts to provide “reliable information” on CBD products.
The FDA certainly got what it asked for: approximately 100 stakeholders (including scientists, physicians, CBD retailers, and others) provided 10 hours of testimony, with major topics including scientific studies on CBD; proposed labeling for CBD products; and whether CBD should be regulated as a dietary supplement or drug.
One of the session’s most anticipated speakers was KGK Science’s very own CEO, Najla Guthrie. Her presentation focused on the need for science-backed CBD claims, discussing the deficiencies of current scientific research; expounding the findings of recent CBD studies; and providing suggestions for future CBD product labels and regulatory guidelines.
Ultimately, the FDA and members of the industry agreed with Najla Guthrie and KGK Science’s position that further research — in the form of scientifically-validated clinical trials — is required for CBD to be properly monitored.
Read on to learn more about Guthrie’s consultation with the FDA.
Guthrie’s presentation, entitled “Inclusion of Hemp-derived CBD Extracts as Food Additives and Dietary Ingredients,” began with an examination of the shortcomings of today’s CBD regulations and research. In recent years, she noted, many products have made “outlandish health claims” about the benefits of CBD — something which is “a clear abuse of the rules set forth by the FDA and FTC.”
To combat this, she suggested that the FDA regulate CBD products as dietary supplements or food constituents. By doing so, producers would be required to submit New Dietary Ingredient Notifications (NDINs) and Generally Regarded As Safe (GRAS) affirmations for each product. In turn, this would require additional research into claims made by manufacturers — which would necessitate clinical trials.
“Clinical trials are essential to the substantiation of structure/function benefit claims,” said Guthrie. “They will support competent and reliable evidence for the safety and efficacy of CBD, and will allow lawful companies to make scientifically-validated, qualified assertions about their goods.”
A Safe Bet
As had been requested from the FDA, Guthrie also commented on the safety of CBD, revealing the results of a variety of previous clinical trials. She noted that most studies have shown that at daily doses of between 100 and 800mg, CBD has no impact on embryonic development, low toxicity, and an almost non-existent capacity for addiction. However, further research is needed to determine whether it has any effect on the immune system, possible drug interactions, or carcinogenic potential.
The Final Word
Guthrie concluded her presentation with a call for amendments to labeling regulations for CBD products. Specifically, she suggested that products containing CBD include a separate identity statement, as well as a “standardized, hemp-derived CBD symbol,” to notify consumers of their contents — and ensure their overall safety.
Overall, Guthrie’s address spearheaded the meeting’s general message: that the industry’s comprehension of CBD’s effects leaves something to be desired. While a variety of claims have been made about the health benefits of this compound, clinical trials are vital in verifying their truth.
“There is a knowledge gap in our current understanding of Cannabidiol,” Guthrie concluded. “To combat this, further studies are required.”
If you’d like to contribute scientific data about products containing CBD or cannabis, the FDA has released a public docket for you to do so. Comments will close at 11:59 PM on July 2, 2019.
About Najla Guthrie
Najla Guthrie is a leader not only in the growth of KGK Science, but in the field of nutritional science as a whole. Over the past 22 years, she has published over 50 papers in peer-reviewed journals, and has been recognized as an influential expert and speaker in her industry. During this time, she has also developed and strengthened KGK’s integrated research and product development team, which now maintains a reputation for world-class nutraceutical science and cannabis studies.