Response to Recent Communications by the FDA
Dear Valued Partner,
As I am sure that you are already aware, the FDA has recently issued several warning letters to companies selling products that contain CBD. We commend and support the FDA for taking action against any and all companies that are making unsubstantiated claims stating that CBD treats or cures disease. It is not only irresponsible for companies to make such claims but it’s also illegal. These companies are unfortunately making it more difficult for companies that are “Doing It Right” like HempFusion and many others. Making these radical and unsubstantiated claims places consumers at risk, the retailers at risk and the industry as a whole completely at risk. Retailers and Leading Industry associations should hold these companies accountable. If we continue to support companies that are acting badly and making illegal claims we could potentially be risking the future for CBD as a whole.
Consumer safety is of the utmost importance to us here at HempFusion. In addition to the warning letters, the FDA also released an additional consumer communication taking an alarmist stance on the safety of taking a product that contains CBD. They made very broad stroke statements without addressing the key factors that would be related to these potential safety issues. Factors that would include serving size, high CBD levels and form that may absolutely impact safety. It is important to mention that this is true of almost everything. It is for this reason that there is a path for evaluating the safety of ingredients used in supplements, foods and beverages. Reviewing toxicological effects of CBD is an important step that all companies selling CBD should embrace.
It is for all of the reasons above that I am proud to share that for the last 18 months we have been proactively involved with a full Toxicological and Safety review of our proprietary hemp extract containing CBD. This voluntary action demonstrates our commitment to safety for the consumer and illustrates the necessary steps that should be taken by all companies. These results will be published in early January 2020. Furthermore we will have our full GRAS Affirmation (Peer-Reviewed / Self –Affirmed) by March 2020. These steps are important and will confirm that the HempExtract used in HempFusion products are safe.
We absolutely agree with the FDA that there are products on the market that present potential safety risks related to marketing to children and most importantly high levels of CBD. High levels of CBD are where most risk factors have been identified. It is our belief at HempFusion that we should embrace as close to what nature offers. It is for that reason that we do not market high levels of CBD in our products nor do we market our products to at risk target consumers, such as children.
In closing, We at HempFusion believe in integrity and radical transparency. Please visit us at HempFusion.com and click on the Trust and Safety tab to review how we address quality & safety with regards to our products. You can even access sample or batch specific analytical reports on any one of our products.
I would also like to invite you to contact me directly for any questions that you may have as I would be honored to share with you whatever helps you understand how HempFusion can serve your needs best and what steps we are taking to preserve the safe consumption of our products.
Jason Mitchell, N.D.
Co-Founder & President