By: Jack Hercik, Asterisk, LLC

A recent series of advisories and safety alerts have been issued by various government agencies and industry associations warning of the risks associated with products prepared with liquid nitrogen at the point of sale. (See references, below.) These include confectionery products marketed as ‘Dragon’s Breath’, ‘Heavens Breath’, ‘nitro puff’ or other similar market names. These products include cereals, snacks and alcoholic and non-alcoholic drinks infused with liquid nitrogen that emit a misty fog like vapor simply as a novelty. These applications have resulted in a growing number or reports of serious injury to unwitting consumers and under-trained or untrained customer employees. Adding to this list is the supply of liquid nitrogen to the cryosauna/cryotherapy industry. While the applications are totally different, the risks and exposure of liability to your company are very similar.

The popularity of these products is rapidly growing, while at the same time, there is an increasing number of reported injuries and potential life-threatening events directly attributed to the misuse or the mishandling of liquid nitrogen for these applications.

This article does ​not ​advise GAWDA Members to avoid supplying liquid nitrogen for these applications. Neither does it encourage supplying these markets. At this time, we are simply advising Members to know and understand the potential risks associated with supplying liquid nitrogen for these and other risky applications. Consider these items:

  • Know and understand how your customer intends to use your products and consider their reputation for safety and employee training requirements.
  • Consider the potential harm to their employees/customers and minimize your risk exposure as a supplier of liquid nitrogen.
  • Assure your customers have been informed of the hazards of using liquid nitrogen in these applications. Provide your customers with
    • CGA SA-29, Hazards of Liquid Nitrogen in near Consumer Applications
    • CGA RA-211, FDA advises consumers to avoid eating, drinking or handling Food products prepared with Liquid Nitrogen at Point of Sale
    • The FDA Advisory – FDA Advises Consumers to Avoid Eating, Drinking, or Handling Food Products Prepared with Liquid Nitrogen at the Point of Sale.
  • Hold Harmless – To further limit risk, we advise the use of a ‘Hold Harmless’ letter as a part of the supply agreement between the customer and the supplier. A sample ‘Hold Harmless’ letter template has been put together by GAWDA Counsel, Richard Schweitzer. The sample document is available in the GAWDA Sample Food/Beverage Gas procedures and below. The sample ‘Hold Harmless’ letter can be used as a guide in developing language appropriate for your Company.
  • Consider being listed as additional insured on the customers liability policy, verifying coverage amounts and getting the proper document from the insurance carrier. Update the coverage as the policy renews.
  • Encourage your customers to buy CGA P-12, Safe Handling of Cryogenic Liquids. This publication provides more detailed information on the properties, safe handling and use of liquid nitrogen.
  • And finally, as a reminder to Members, we advise that only food grade nitrogen be supplied for these confectionery and cryotherapy applications. This is our position until the Food and Drug Administration offers additional guidance. We understand that cryotherapy applications are not food applications, but the Good Manufacturing Practices required by food gases may help you document the quality of the gas as well provide product traceability in case of potential problems.

Contact Tom Badstubner (tom@asteriskllc.com) with further questions regarding the supply of liquid nitrogen to confection or cryotherapy customers.

Refences:

 

CGA logo

CGA Regulatory Alert (RA-211), FDA Advises Consumers to Avoid Eating, Drinking, or Handling Food Products Prepared with Liquid Nitrogen at the Point of Sale

Please be aware of the following CGA Regulatory Alert regarding the following Safety Alert issued by the U.S. Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition through its Constituent Update subscriber list:

Center for Food Safety and Applied Nutrition
Constituent Update
The following is an advisory from FDA of interest to our
Constituent Update subscribers.
FDA Advises Consumers to Avoid Eating, Drinking, or Handling Food Products
Prepared with Liquid Nitrogen at the Point of Sale

August 30, 2018

The U.S. Food and Drug Administration alerts consumers and retailers of the potential for serious injury from eating, drinking, or handling food products prepared by adding liquid nitrogen at the point of sale and immediately before consumption.

These products are often marketed under the names “Dragon’s Breath,” “Heaven’s Breath,” “nitro puff” and other similar names. Liquid nitrogen, although non-toxic, can cause severe damage to skin and internal organs if mishandled or accidently ingested due to the extremely low temperatures it can maintain.

The Alert advises consumers and retailers of the potential for serious injury from eating, drinking or handling food products prepared by adding liquid nitrogen at the point of sale, immediately before consumption. The Alert notes that the FDA is aware of serious and possibly life-threatening injuries that have been caused by liquid nitrogen still present in the food or drink. The Alert does go on to note that other foods treated with liquid nitrogen prior to the point of sale and before consumption do not pose a significant risk. The full text of the Alert is available here.

CGA has previously issued Safety Alert 29, Hazards of Liquid Nitrogen in Near-Consumer Applications, to identify the potential hazards of using liquid nitrogen in near-consumer applications for food or beverage preparation and consumption and to entertain the patrons with vapor clouds and “smoke” effects at the front end of food and beverage establishments and to identify mitigation actions. CGA P-12, Safe Handling of Cryogenic Liquids, provides more detailed information on the properties, safe handling and use of liquid nitrogen.

RA-211 is available on CGA’s website at: https://portal.cganet.com/Document/Details.aspx?id=12214

Please feel free to contact me if you have any questions regarding this Regulatory Alert.

Regards,

Jill Thompson (Ms.)
Compressed Gas Association, Inc.
Committee Administrator
703-788-2720 – phone
703-961-1831 – fax
jthompson@cganet.com

View a SAMPLE HOLD HARMLESS AGREEMENT

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GAWDA’s FDA and Medical Gases Consultant Thomas L. Badstubner is president of AsteRisk, LLC in Lewisville, TX. Members can reach him at 508-883-0927 and tom@asteriskllc.com.

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