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We’re excited our blog has generated the conversation and interest on a topic that, quite frankly, should’ve been addressed long ago. The reason for our bringing this conversation to the table is because bold claims are not to be taken lightly and will most likely bring inevitable regulation. What we hope any person involved in this industry will understand is that IT DOES NOT MATTER what study has been done on Whole Body Cryotherapy. If the FDA is not approving and classifying each individual manufacturer and unit for these outcomes and stating the results as intended uses, we as an industry cannot and should not claim or advertise them publicly. In other words, if you’ve seen a Whole Body Cryotherapy study on its stimulation of the vagus nerve and the resulting benefits, it doesn’t mean the FDA has accepted it or that the study was conducted according to their guidelines for being able to state this as an intended use. NOTE – We are not against research! It needs to be done and done responsibly, but ANY claims that are deemed medical in nature by the FDA are a serious no-no. Yes, we have all seen and heard of anecdotal evidence from our clients and have read the published studies on the great benefits of WBC, but until it is approved by the FDA it is a Bold Claim and irresponsible to publicly advertise. Please contact us directly for further explanation and how we as a company have had direct conversations with the FDA regarding WBC. Let's keep this conversation going! We want to see this industry continue to grow and succeed, and we want to be able to do so without inciting harsh regulation and possible shut down from the FDA.
You want the best for your athletes and your team. You want them to be at the top of their game so they can perform their best. Whole Body Cryotherapy can be just the thing to assist, but it’s not making them a better athlete. Here’s everything you need to know about cryotherapy for athletes without being told it’s going to make them a faster, stronger, better athlete.
Whole Body Cryotherapy is an explosive trend across the US and the globe in the world of recovery. It has grown tremendously in public popularity since CryoUSA officially launched the industry in the US in 2011. As we watch the market grow and evolve, competition, both good and bad, has seemingly diluted and misconstrued exactly what the original intended uses for Whole Body Cryotherapy were. The bold claims we see across the industry today insinuate what would be considered 'bold medical claims'. The original message was to provide a safe environment that supplied hyper-cooled air within a confined compartment, delivering cold to an individual’s body surfaces “in order to soothe, comfort, and provide relief”. Anything beyond that is in direct violation of the FDA guidelines laid out for us as we began to take these devices through the FDA 513g process. This may be the limit of what we can say, but it is certainly not the limit of what people experience. As industry leaders, it is important to remember to let people speak about their own experiences and not let those experiences turn into claims that we post on our website and beyond. This practice by other distributors and manufacturers only fuels the potential for false expectations and could potentially incur unwanted attention and federal regulation.