What does this mean for food, beverage, and dietary supplement companies?
Lowell Schiller, the Food and Drug Administration’s (FDA’s) principal associate commissioner for policy, spoke last week to a group of nutritionists. Schiller is leading an FDA panel that is investigating CBD as an ingredient in food, beverages, and dietary supplements. He stated that the agency’s greatest concern was whether CBD was safe to consume. He also indicated that the FDA did not have sufficient data to determine if CBD was safe for long-term use, especially for vulnerable populations.
Schiller also indicated that the agency was under pressure from numerous groups to establish a legal pathway for using CBD as an ingredient, but would not be rushed into establishing a policy for CBD.
Schiller’s comments were made at a Council for Responsible Nutrition conference, He said that the FDA is taking the position that CBD is not risk-free, pointing to reports regarding potential liver toxicity and drug reactions. He also stated that animal studies indicated that there was a risk for the male reproductive system.
Schiller stated to the group of nutritionists, “We look at an FDA-regulated product containing CBD the same as we would look at an FDA-regulated product containing any other substances. We apply the same tools and authorities and statutory provisions.”
He also said, “At FDA, we don’t have one set of rules for cannabis-derived substances and another set of rules for other substances. We don’t approach CBD or other cannabis-derived substances with any sort of animus or imposing new burdens.”
Schiller indicated that without first establishing that CBD was safe, that granting a special exception for cannabinoid from standard FDA procedures could set a dangerous precedent for other unregulated substances, encourage additional bad actors to enter the CBD market, and slow-down the agency’s ability to identify and address CBD safety violations. He also voiced concern that establishing special rules for CBD would send the wrong message, that the agency had determined that CBD was in fact safe.
Our Conclusion for CBG Food, Beverage, and Dietary Supplement Companies
I’ve been closing monitoring the FDA’s position on CBD since GW Pharmaceuticals initiated its clinical trials for what eventually became the CBD drug, Epidiolex. Epidiolex was approved as a prescription drug by the FDA in June 2018. As a result, Schiller’s comments are no surprise to me.
The issue for consumer packaged goods (CPG) food, beverage, and dietary supplement companies is that the FDA has taken the position that CBD is not “Generally Regarded as Safe” (GRAS). I’ve stated on numerous occasions that the primary reason for the FDA taking this position is because no CBD company has proven, based on FDA requirements, that CBD was GRAS. The main reason for this is simple. Prior to the 2018 Farm Bill, which legalized CBD federally, no CBD company had the economic incentive to proceed with safety trials.
Since the Farm Bill was signed into law, many states have established and are establishing their own CBD policies. Since there are “first to market,” or “early to market” advantages, many CPG companies have launched and are launching food, beverage, and dietary supplements that include CBD, relying on state rather than federal regulations.
Products that include CBD now in the marketplace include numerous beverages, snack food products, baked goods, protein and energy bars, and ice cream. It’s likely that dozens of additional products in a variety of categories will be launched over the coming months.
While it’s one thing to manufacture CBD products it’s another for retailers to agree to sell them. The number of major retailers that are carrying CBD food, beverage or nutritional supplements continues to grow and includes Wegman’s and Sprouts.
Our general advice to food, beverage, and dietary supplement companies who have been considering adding CBD products to their product line, is to proceed now, rely on state laws and regulations, and “stake out your turf.”