New York, NY – August 19, 2019 – The National Advertising Division has referred advertising claims made by 3B Medical, Inc. for its Lumin CPAP Cleaner to the Federal Trade Commission and Food & Drug Administration for possible enforcement action after the company stated it would not comply with NAD’s recommendations to discontinue certain claims that a competing CPAP cleaner’s use of ozone as a germicide rendered it unsafe and dangerous to consumers’ respiratory health. This challenge was initiated by SoClean, Inc., maker of the competing SoClean CPAP Cleaner.

NAD is an investigative unit of the advertising industry’s system of self-regulation and is a division of the BBB NP’s self-regulatory and dispute resolution programs.

Continuous Positive Airway Pressure (CPAP) is the leading therapy for sleep apnea. A CPAP device – a face or nasal mask worn while sleeping – is connected to a pump that provides a positive (pressurized) flow of air into the nasal passages, keeping the airway open. Both parties make CPAP cleaning devices, the purposes of which is to keep the device clean and safe from germs, bacteria and mold that can form and accumulate in the CPAP device, reservoir, mask, and tube. The advertiser’s Lumin device accomplishes this by use of a UV-C light source, whereas the challenger’s SoClean2 employs the use of ozone to clean the CPAP device and its components.

The challenged claims, which appeared in online and email advertisements, paid review websites, and third-party retailer websites, quoted from the Federal Code of Regulations concerning labeling of medical devices and special requirements for specific devices regarding the maximum acceptable level of ozone. These claims noted that levels of ozone beyond those permitted by the FDA can cause chest pain, coughing, may worsen chronic respiratory diseases such as asthma, compromise the body’s ability to fight respiratory infections and can cause sufficient irritation to lungs resulting in pulmonary edema. These claims are then linked, either expressly or impliedly, with the challenger’s SoClean2 CPAP cleaning device, reasonably conveying the message that the SoClean2 is unsafe — indeed — dangerous to consumers’ respiratory health.

NAD noted that advertising should not suggest greater scientific certainty than actually exists, particularly with respect to competitors’ products and the negative impact that they may confer on consumers – especially on consumers’ health.

After careful review of the testing provided by 3B Medical in support of its claims, NAD concluded that the evidence was insufficiently reliable to provide a reasonable basis for the advertiser’s claims regarding the use of ozone in the challenger’s SoClean2 CPAP cleaning device and the purported dangers and deleterious health consequences to consumers sanitizing their CPAP (and components) and recommended that such claims be discontinued. NAD further recommended that the advertiser avoid any language characterizing the use of ozone in the challenger’s SoClean2 CPAP cleaning device as dangerous or deleterious to consumer health or reasonably conveying such unsupported messages.

In its advertiser’s statement, 3B Medical stated that it “rejects NAD’s decision and will not comply with it.” The advertiser further stated that it “stands behind every statement made about the dangers of ozone exposure in general and the problems with the SoClean2 device, in particular” and that it “believes all advertising claims subject to this proceeding are fully substantiated.” According to the 3B Medical, in light of the errors in NAD’s decision, it “welcomes a referral to the appropriate governmental agency where it is confident it will receive a reasoned and impartial decision.”

In light of the advertiser’s decision against complying with NAD’s recommendations, pursuant to its procedures NAD has referred the matter to the FTC and FDA for possible enforcement action.