canula.jpgWithout going into how much fun it is to look like a geriatric smoker walking around with an attractive nose cannula, there seems to be more and more interest in breathing in oxygen (at least air that has more oxygen than normal). There was even an oxygen bar at BIO this year. Now, the air may be sucked out of the market if these products are deemed drugs.

The Food & Drug Administration has stepped in and warned a company that makes and markets portable “oxygen enriched air” (OEA) for the treatment of a variety of ailments that it is selling a drug without an approved new drug application.

The FDA’s letter 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. The BetterThanAir website claims that the proof of the effects of normal air (what they consider low oxygen) is the number of cases of cancer, AIDS, heart attacks and other illnesses that cripple and kill our bodies.

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,” according to their website. BetterThanAir claims “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, the FDA considers these to be drugs, as defined by Section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (Act), [21 U.S.C. § 321(g)(1)].

Moreover, the FDA claims that these products are new drugs, as defined by section 201(p) of the Act, [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. Under sections 301(d) and 505(a) of the Act, [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it.

Further, the FDA claims that these oxygen products are also prescription drugs within the meaning of section 503(b)(1) of the Act, [21 U.S.C. § 353(b)(1)], because they are not safe for use except under the supervision of a practitioner licensed by law to administer such drugs. Therefore, the FDFA contends that the “BetterThanAir™ oxygen enriched products” are misbranded within the meaning of section 503(b)(1) and 503(b)(4) of the Act, [21 U.S.C. §§ 353(b)(1) and 353(b)(4)] because they are marketed without a prescription and they lack the statement, “Rx only.” The inclusion of the disclaimer, “Not for medical and prescription use,” on the product’s label does not remove the product from the prescription dispensing requirement of section 503(b)(2) of the Act [21 U.S.C. § 353(b)(2)].

The FDA feels that because these products are offered for use for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layperson can use these products safely for their intended uses. Thus, the “BetterThanAir™ oxygen enriched products” labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under Section 502(f)(1) of the Act, [21 U.S.C. § 352(f)(1)]. These products are not exempt from the adequate directions for use requirement because they do not meet the conditions set forth in 21 CFR § 201.100.

Finally, these products are considered misbranded under section 502(o) of the Act, [21 U.S.C. § 352(o)] and the products are subject to the Current Good Manufacturing Practice (CGMP) regulations at 21 CFR Parts 210 and 211. They may be considered adulterated under section 501(a)(2)(B) of the Act, [21 U.S.C. § 351(a)(2)(B)], if the methods used in, or the facilities or controls used during the product’s manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP.

The FDA has directed BetterThanAir to immediately correct these violations.

I noticed that BetterThanAir will host parties and events featuring oxygen-enriched air with and without aroma. No word on the effects of the aromas.

See the Warning Letter here.

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