The company issued the following statement: “CV Sciences’ top priority is consumer safety. We have conducted and published pre-clinical toxicology studies to establish the safety of our unique hemp extract made through a proprietary process. FDA stated it cannot conclude that CBD is generally recognized as safe (GRAS), because the GRAS designation is directly linked to a specific ingredient under the specific conditions of use in labeling. CV Sciences has scientific studies to support the safety of our specific ingredients that provides a specific amount of CBD with other naturally-occurring hemp phytocompounds. We believe FDA’s comments that “CBD is not GRAS” are directed toward companies that have piggy-backed on our science with significantly different ingredients and different levels of CBD.?
The company also expressed disappointment with the tone of the FDA’s communications, stating: “CV Sciences supports FDA’s recent enforcement actions against bad actors who make unsubstantiated claims that CBD-containing products can treat cancer, Alzheimer’s disease, opioid withdrawal, etc. These companies put consumers at risk, while giving responsible companies a black eye. That said, CV Sciences is disappointed that FDA’s consumer update, released simultaneously with the warning letters, used an inappropriately alarmist tone.?
“CV Sciences is concerned that FDA is creating a narrative that questions the safety of CBD to try to address the significant number of fly-by-night companies entering the CBD industry. There are more direct ways for FDA to address bad actors, while still working with responsible companies to establish the appropriate scope of hemp-derived ingredients for supplements based on sound research.?
“CV Sciences continues to advocate the industry’s limitation of CBD to dietary supplements and topical applications and not add CBD to food. We stated this at the May 31, 2019 FDA public meeting and continue to stand by them. Supplements allow for a controlled serving size and labels to warn sensitive sub-populations to avoid, food does not. CV Sciences continues to be optimistic that FDA has a shared goal to create a clear, regulatory path for science-based, hemp-derived CBD ingredients as dietary supplements, which provide an appropriate and safe level of CBD. FDA has the authority to develop regulation that allows for CBD as a dietary supplement, provided responsible industry steps up with sound science and CV Sciences welcomes this opportunity.”?
News 
Market Data 
Discover 
AI
