Plumbing Contractors • Oxygen Bars

In this article I will examine two issues that periodically resurface from the GAWDA membership and continue to perplex our industry: Is it legal to sell Nitrogen NF to plumbing contractors, and how does FDA continue to let oxygen bars stay in business?

Plumbers and Nitrogen NF
Purchasers of medical gases must be “authorized” entities in accordance with the requirements of the Federal Food, Drug, and Cosmetic Act, and are typically health care facilities and individuals with a prescription. However, FDA has authorized some exemptions by exercising their enforcement discretion, the most notable and longstanding of which allow trained first aid responders to purchase and administer emergency oxygen.

A more recent enforcement accommodation to the medical gases industry involves plumbing firms that require Nitrogen NF when installing health care bulk systems. The 1999 version of the NFPA 99 code introduced the requirement to purge hospital piping with Nitrogen NF when performing brazing operations. Since these firms are technically not authorized to purchase medical gases, your consultants petitioned FDA for clarification. Because NFPA 99 is a national standard and FDA was involved in promulgating the requirement, provided certain provisions are followed, the agency now accepts plumbing and other contracting firms as authorized to purchase and use Nitrogen NF. At present this is an unofficial industry accommodation, as there is no official position statement from FDA on this issue.

The key proviso to this accommodation is that this gas must only be used for pipeline purging at healthcare facilities. To adequately document these accounts, we recommend firms have on file a letter from each contractor to whom they sell Nitrogen NF, on the contractor’s company letterhead, stating the contracting firm performs health care pipeline installations and repairs, and the Nitrogen NF gas will be used for purging of these systems in accordance with NFPA 99, section 5.3.10.7.5.

Oxygen Bars
Since the first appearance of oxygen bars in the 1990s, FDA has advised they have regulatory authority over this application. This is true even if medical gases are not used, and the product is offered strictly for recreational use. Under the Federal Food, Drug, and Cosmetic Act, any type of oxygen used by people for breathing that is administered by another person is defined as a prescription drug. Although oxygen bars that dispense oxygen without a prescription violate FDA regulations, the agency has decided to apply regulatory discretion and permit the individual state boards of pharmacy licensing to enforce the requirements pertaining to the dispensing of oxygen.

Many states, such as Nevada, have chosen to allow oxygen bars to proliferate; other states, such as Tennessee and Kentucky, actively prohibit these businesses by requiring strict compliance with FDA requirements and regulations. Many other states appear to have simply turned a blind eye to the issue, and generally allow oxygen bars to exist as long as no notable press surrounding the issue occurs in their state. However, if a purveyor of oxygen were to make health claims for oxygen, such as curing cancer or AIDS, or helping ease arthritis pain, we would expect these would be aggressively investigated by the FDA. Those interested in reading the agency’s position on medical gases, which FDA published in a 2002 article entitled “Oxygen Bars: Is A Breath Of Fresh Air Worth It?,” can view it online at http://www.fda.gov/cder/dmpq/gases.htm.

A quick Google search for oxygen bar equipment turns up dozens of Web pages offering this type of equipment and accessories for sale, and GAWDA members frequently ask us if they can sell Aviator’s Breathing Oxygen (ABO) for this application. The answer really depends on which state the member resides in. If your state board of pharmacy permits oxygen bars, then a grade of oxygen manufactured, tested and documented as suitable for human respiration like ABO is a good option. If your state does not permit oxygen bars, then avoiding this application is probably the best and only option. The same guidance applies to selling or renting oxygen concentrators for oxygen bar applications.

The bottom line is that involving your business in the oxygen bar application depends on the individual regulations in your state. Business owners also need to recognize there are some risks in the oxygen bar application, as a concentrated form of oxygen is likely being handled and sold to the public by poorly trained individuals, who may be unaware of the dangers of an oxygen-rich environment, which is always a concern in today’s highly litigious society.

Gases and Welding Distributors Association
Meet the Author
GAWDA Medical Gases Consultant J. Robert Yeoman is president & CEO of B&R Compliance Associates LLC in Lehigh Valley, Pennsylvania. Members can reach him at (610) 868-7183 and at bob.yeoman@brcompliance.com.