Liquid Nitrogen for Cryotherapy Medical Gas?

By Thomas L. Badstubner

Cryotherapy saunas are becoming more popular. GAWDA members and major gas companies are providing liquid nitrogen to cryotherapy saunas. Since this application is relatively new in the United States, there are some unexpected regulatory issues for suppliers of liquid nitrogen.

Here are a series of questions and answers that will provide a status update for those of you who have questions, or who may be considering supplying liquid nitrogen to customers to use for that purpose.

Q. Should the liquid nitrogen for cryosaunas be medical grade (NF)?

A. Not at this time.

The appropriate grade of liquid nitrogen is difficult to resolve within our current regulatory framework. Health benefits have been advertised for cryotherapy (such as weight loss, enhanced blood and lymphatic circulation activity, pain relief, stimulation of cellular regeneration, sleep improvement, etc.). On the other hand, the U.S. Food and Drug Administration (FDA) has limited the “Approved Uses” for medical nitrogen in the “Food and Drug Administration Safety and Innovation Act” (FDASIA), signed into law on July 9, 2012. (See bit.ly/FDASIA-GAWDA)

“APPROVED USES (emphasis added)— A designated medical gas for which a certification is granted under paragraph (2) is deemed, alone or in combination, as medically appropriate, with another designated medical gas or gases for which a certification or certifications have been granted, to have in effect an approved application under section 505 or 512, subject to all applicable postapproval requirements, for the following indications for use: … (II) In the case of nitrogen, use in hypoxic challenge testing.”

Cryotherapy is not included in the hypoxia indication. The FDA has established approval processes for emerging technologies. These processes broadly fall into the New Drug Application or the Device 510(k) Pre-market Notification/Device Premarket Approval. We are not aware of any formal FDA drug/device approvals for cryosaunas.

Cryotherapy seems to have some “drug” and some “device” similarities. However, it doesn’t fit well into either the current drug or device definitions, since cryosaunas are designed so that the liquid nitrogen does not contact the body. Perhaps someday the FDA will deem cryotherapy a drug or device application. Until then, we generally recommend that medical grade nitrogen not be supplied to cryosaunas. If you have a specific request from a licensed medical professional for cryotherapy liquid nitrogen to be medical grade, please contact tom@asteriskllc.com and we can discuss the regulatory implications in your case.

Q. What grade of liquid nitrogen should I supply to cryosaunas?

A. This may surprise you – we recommend food grade liquid nitrogen be used for cryotherapy.

Cryotherapy is clearly not a food application by any reasonable definition.

So why use food grade liquid nitrogen for cryotherapy? Simply, food grade gas practices provide better protection than industrial grade gases with minimal restrictions. The FDA enforces significant regulations governing the appropriate marketing and usage of drug and device gases. However, the agency has not established the same level of restrictions (for instance, prescription only) for food grade gases.

Additionally, food grade liquid nitrogen has a significant benefit over industrial grade gases for cryotherapy uses. Food grade products are produced, handled and distributed using Current Good Manufacturing Practices (CGMP). Food grade CGMP is far less burdensome than drug or device CGMP.

Q. What food grade CGMP measures should we implement for cryotherapy liquid nitrogen?

A. If you already have a food safety program in place, cryotherapy liquid nitrogen will not be a difficult product to produce or distribute.

Here are some key provisions of food gas practices that would assist in your cryotherapy supply business:

  • Supplier Qualification – food grade gases are produced by qualified suppliers.
  • Product Qualification – food grade liquid nitrogen is produced at a registered FDA food gas manufacturer. The Air Separation Unit tests the product to assure it meets specifications. Unless your standard operating procedures or hazard analysis specifies differently, you are not required to do further product testing.
  • Product Tracking – food grade liquid nitrogen is tracked from the manufacturer to you and from you to your customer by the use of lot numbers. If there is ever the need for a recall on a specific lot of nitrogen, you have the records to facilitate customer contact.
  • Written Procedures – the filling and handling of liquid nitrogen food grade containers is covered by written procedures.
  • Documented Employee Training – food grade regulations already require that employees be trained in allergen awareness and sanitation.

A sample compliance program with all these features is available to GAWDA distributor members. The program includes free written procedures, monthly webinars, training and resources. Contact tom@asteriskllc.com if you are not already subscribed to this free benefit.

IN SUMMARY

After review of the regulations and uses, the upshot is this: Until the FDA or industry consensus indicates otherwise, we recommend adding cryotherapy liquid nitrogen to your food safety program.