CryoAction response to FDA Consumer Update 5th July 2016

On July 5th 2016, the US Food and Drug Administration posted a consumer update entitled, “Whole Body Cryotherapy (WBC): A “Cool” Trend that Lacks Evidence, Poses Risks”. As one of the leading providers of Whole Body Cryotherapy equipment, this update requires a response from CryoAction.

Perhaps somewhat surprisingly, we agree, in part.

Firstly, the primary issue is one of terminology. The majority of systems sold in United States are not Whole Body Cryotherapy units and the unit illustrated in the FDA consumer update is not a Whole Body Cryotherapy unit. The cylindrical units installed into spas and clinics, require the patient’s head to be outside of the unit and should correctly be termed Partial Body Cryotherapy. A true Whole Body Cryotherapy system is a complete immersion experience into a walk-in chamber and certainly includes the head. This allows for better temperature control and a more robust treatment. It is these Whole Body Cryotherapy systems that have formed the basis of all research conducted into the effectiveness of treatment. In contrast, no evidence exists as to i) the effectiveness of these Partial Body Cryotherapy units, and ii) research into the treatment of medical illness and complaints. For these reasons, vendors of such Partial Body Cryotherapy systems and services have “borrowed” or subverted the proven evidence surrounding “true” Whole Body Cryotherapy units. This evidence has then been twisted and exaggerated to the detriment of all.

Secondly, the majority of Partial Body Cryotherapy units sold in United States would never meet the safety guidelines required to meet approval. The direct injection of liquid nitrogen into the area occupied by the patient, places them at risk of frostbite, burns and eye injury, as disclosed in the FDA update. This evaporated liquid nitrogen gas contained within the cylinder also carries a serious health risk as the density of the mixed substance in which the patient stands contains a low level of oxygen, the ingestion of which renders the patient at risk of asphyxiation. In addition, the absence of oxygen sensors, either in the equipment or the room where the unit is located, also places both the patient and the operating staff at risk of potential asphyxiation. Liquid nitrogen has a large expansion ratio on evaporation – one litre of liquid nitrogen can result in about 700 litres of gas – so only a relatively small volume of liquid nitrogen has to evaporate within a room to result in an oxygen deficient atmosphere. It is for these reasons that two of the world’s leading suppliers of liquid nitrogen, have issued a global ban on supplying gas for use in Partial Body Cryotherapy units.

Thirdly, the design of such units with an open aperture for the patient’s head does not allow for a stable treatment temperature. To counteract this, many devices periodically burst liquid nitrogen into the unit with the effect that large variances are created with instability in the temperature and treatment results that are largely ineffective.

Where our opinion does differ to that of the FDA is in the availability of evidence to prove the positive impact of true Whole Body Cryotherapy technology to alleviate symptoms of certain ailments. There is a wealth of supported research conducted by European research scientists to validate the effectiveness of the technology. The over 1000 patients treated daily in clinics operated by our partners are testimony to this fact.

A considerable number of European Whole Body Cryotherapy technology vendors, including that sold by CryoAction, have already undergone the stringent analysis and testing required to meet and obtain certification as a medical device from the European Union. This is no paper exercise and in order to meet these criteria, safety standards of the highest order are implemented into the design and manufacture of these systems. It is inconceivable that any Partial Body Cryotherapy system could meet the criteria necessary to obtain the certification.

To come to the case in point, we call upon the fledgling cryotherapy industry to put our own house in order.

  • Cease the outlandish claims that are made without the support of evidence or research.
  • Put an end to the misuse of the phrase ‘Whole Body Cryotherapy’.
  • Invest in research studies to demonstrate the effectiveness of the equipment and treatment.
  • For vendors, seek approval for your equipment and your claims from the FDA.

Additionally, we call on vendors to join together to form a trade association to establish the highest ideals in safety and quality of manufacture; to invest in research; to work with bodies such as the FDA to meet the criteria required to meet certification and to establish a code of practice to avoid the situation that has given rise to this consumer update. CryoAction will take a lead role in the formation of this association and will be writing to vendors in due course.

CryoAction will address the concerns of FDA directly to the organisation and will also seek their approval for equipment supplied by the company.