• Jeffrey Friedland

The Food and Drug Administration (FDA) is planning on public hearings in April regarding CBD

Scott Gottlieb, the Commissioner of the Food and Drug Administration (FDA) indicated yesterday that the Agency will hold its first public hearings to discuss the use of CBD as a food additive in April. While the Farm Bill legalized CBD, it established a role for the FDA in regulating CBD as a food additive and for health, wellness and nutritional purposes. Gottlieb has stated, “We’re planning to seek broad public input on this pathway, including information on the science and safety behind CBD. But we know that this process could take time. So we’re also interested in hearing from stakeholders and talking to Congress on possible alternative approaches to make sure that we have an appropriately efficient and predictable regulatory framework for regulating CBD products.” We’ve concluded that CBD as a food additive will be approved by the FDA as Generally Recognized as Safe (GRAS) much sooner than the Agency taking action on the use of CBD as a health, wellness or nutritional supplement. Complicating the use of CBD as a food additive or as a health, nutritional or wellness supplement is the status of CBD as an FDA approved drug, Epidiolex. Epidiolex is plant-derived, pure CBD, to treat primarily pediatric epilepsy. FDA policy indicates that once an Active Pharmaceutical Ingredient (API) is approved as a drug, that API cannot be sold as a food supplement, or for health, nutritional or wellness purposes. Because of Epidiolex, CBD is an API and a drug. Phyto Intel’s conclusions are that the FDA’s CBD policy is definitely a moving target. Our current conclusions are:

● The FDA will allow CBD to be used as a food additive once a company takes the steps to prove that it’s GRAS, or the Agency acknowledges that it’s GRAS. ● Scott Gottlieb has hinted that it’s possible that the FDA may regulate the quantity of CBD used as a food additive. We don’t view this as a major problem. ● Gottlieb has also indicated that he may seek to have Congress change the status of CBD. We believe it’s unlikely that Congress will do anything. ● Because of the status of CBD as an FDA approved drug, the Agency may approve CBD as a food additive or for health, wellness or nutritional purposes, but may require that it not be marketed as CBD, and instead as something else, perhaps something similar to “hemp flower oil,” “full-spectrum hemp flower oil,” or “phytocannabinoid rich hemp oil.”

● CBD as a food additive will be approved by the FDA long before CBD is approved for any health, nutritional or wellness purpose

This will likely create consumer confusion due to the tremendous consumer awareness of CBD and its benefits and consumers understanding the difference between “hemp seed oil,” and “hemp flower oil,” “full-spectrum hemp flower oil,” or “phytocannabinoid rich hemp oil,” it would solve the FDA’s issue of CBD being an approved drug. What action should a CPG food or beverage company take? Phyto Intel’s conclusion is that CBD will be approved as a food supplement relatively quickly by the FDA, but “relatively quickly” is itself an unknown with a regulatory agency, even one that puts an issue on a fast-track basis, which is what the FDA is doing with CBD. Our conclusion is that this will take at least six months. In the interim, our recommendation is that CPG food or beverage companies should proceed now in formulating products with CBD, so that they’re ‘ready to go” once the regulations become clear. This will enable CPG food and beverage companies to be “first to market,” or “early to market,” which will definitely be advantageous. About Phyto Intel Phyto Intel is a behavioral, intelligence-driven consultancy for companies seeking to capitalize on America’s fastest-growing new industry, CPG products formulated with hemp or CBD. Phyto Intel is an experienced resource in helping brands launch properly. Our market intelligence enables companies large and small to find the right product, at the right time, and serve the right market. Phyto Intel provides a strategic approach and hands-on assistance for CPG companies seeking to develop and market hemp or CBD products, industry, those who want to disrupt their industry.

©2019 by Phyto Intel Inc.