Regulatory Focus™ > News Articles > FDA Says Medical Device Popular With Elite Athletes Regularly Misbranded

FDA Says Medical Device Popular With Elite Athletes Regularly Misbranded

Posted 22 August 2013 | By Alexander Gaffney, RAC

If you're an avid reader of the US Food and Drug Administration's (FDA) Warning Letters, which regularly detail alleged deficiencies found during facility inspections or in marketing materials, you've likely noticed a trend in the last three weeks: letters to manufacturers and marketers of hyperbaric oxygen therapy products.

Now the agency has confirmed that trend, saying while its clinical benefits have been proven for some uses, those uses do not include a huge range of treatments-cancer, autism, diabetes and AIDS, among others-for which some companies are trying to market them as being effective.


Hyperbaric chambers have long been on FDA's radar, with four Warning Letters sent out by the agency in the year 2000 referencing the products, and another six between 2000 and 2011.

The products, which are regulated as Class II medical devices requiring clearance through the premarket notification [510(k)] process, act as a pressurized chamber through which a person breathes oxygen, simulating living at a higher or lower altitude. The result is either greater oxygenation of the blood, allowing for quicker recovery times from strenuous activities, or lower oxygenation, which can help the human body become acclimated to the stresses of doing activities (like running or biking) at a higher altitude over time.

In addition, FDA has recognized 13 medical uses for the devices, such as the treatment of gas embolisms, carbon monoxide poisoning, decompression sickness and thermal burns.

The devices are understandably popular with elite athletes, but a perusal of six recent Warning Letters sent in June 2013 and August 2013 illustrate that some companies have failed to realized the products are actually medical devices, requiring the submission of premarket applications for clearance or approval, as well as the registration and inspection of manufacturing facilities.

Recent letters include:

Why the Class II specification? FDA explains in a statement that patients undergoing hyperbaric oxygen therapy (HBOT) are at risk of developing injuries, including mild ones like sinus pain or pressure in the ears, up to and including serious issues like embolisms and paralysis. And, due to the presence of oxygen, there is also a high risk of fire, FDA wrote.

Marketing Problems

But despite the six Warning Letters from the last three months, the recent announcement from FDA hints at an expanding crackdown, one focused largely on improper marketing claims made by companies.

Regulators wrote that various companies had been found to be marketing HBOT for unapproved disease claims, including AIDS, HIV, Asthma, Alzheimer's disease, Bell's palsy, brain injuries, cerebral palsy, heart disease, hepatitis, migraine, Parkinson's disease, multiple sclerosis and more.

These claims, FDA said, have been received over the last three years in the form of at least 27 complaints. Outside of the six letters recently sent, FDA has only sent one other Warning Letter in the last three years-one in May 2010 to a company that failed to maintain medical device reporting (MDR) procedures, rendering it misbranded.

The lack of any enforcement action focused on the claims listed by FDA would seem to imply that either FDA has been resolving these complaints without the use of Warning Letters, or that it is preparing a more focused enforcement effort related to the products based on those reports.

Whatever the enforcement paradigm, FDA notes it is "concerned that using HBOT in the absence of other proven treatments for certain diseases or conditions can endanger your health."

FDA Consumer Update

Warning Letters Mentioning HBOT

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