FIRM'S CANNED AIR MUST BE REGULATED AS A DRUG, FDA SAYS

The FDA has warned a company that makes and markets portable "oxygen enriched" air for the treatment of a variety of ailments that it is selling a drug without an approved new drug application.

The FDA's letter, issued July 21 and posted on the agency's website Aug. 7, warns BetterThanAir that it was making false and misleading promotional claims when it said that the company's canned air could cure or treat AIDS, lung cancer, cystic fibrosis, tuberculosis and high blood pressure.

Among other products, BetterThanAir markets canned air under the brand names "Hangover Air," "Oxygen Kit," "B1ueAir," the "Personal Oxygen System," "O 2 Go," "Oxycan," "Oxygen Shot," the "3rd Lung Kit" and the "BetterThanAir Emergency Oxygen M6 Travel Unit."

The company claims its products can cure chronic mountain sickness, sleep apnea and hyperventilation and prevent other diseases. "Oxygen deprivation can, and is believed by the Medical Society to cause life-threatening diseases such as cancer," the company's website reads.

"Today's breathable air is less than 21 percent oxygen," the website says. "At one time our breathable air contained more than 50 percent oxygen. [The] cost is evident in the number of cases of cancer, AIDS, Heart Attacks and other illnesses that cripple and kill our bodies Certain health specialists say oxygen therapy is now a critical adjunct treatment for cancer, AIDS, diabetes, stroke, depression, chronic fatigue, lupus and fibromyalgia."

Because BetterThanAir's "oxygen enriched products" are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and to affect the structure or function of the body, they are drugs, the FDA said.