The long-awaited Food and Drug Administration deal with supplement maker Breath of Life regarding its devices goes into effect this week, leading to confusion from some that the FDA has now signaled it’s OK for anyone to sell something to support breathing, thereby removing further curbs on such growth.
The Breath of Life devices were administered to thousands of people with rare lung diseases such as tuberous sclerosis. The devices, which are sensitive to alcohol and tobacco, had previously been banned by the FDA in 2016.
There is still some concern.
The Breath of Life company, that had self-funded the manufacturing and testing of these devices, can now use that funding to bring these devices to market, the company tweeted, and should be able to begin selling them as soon as Jan. 18.
Duan Burnham Vascular’s breath-based oxygen generator uses the human breath to breathe in oxygen and then turns it into “brown gas” that travels out of the mouthpiece with the breath.
The company, in a statement, said: “We are cautiously optimistic that there will be a lot of interest from patients with respiratory disease.”
Meanwhile, we’re glad the FDA has moved this. It keeps the science alive. — Dr. Emma Harrison (@doctoremma) November 20, 2017
The clinical trial that led to the FDA’s approval was conducted in 2015 to test the devices against traditional exhaled oxygen or exhaled breath concentrates, according to a report in Forbes.
The devices help to prevent painful symptoms from tuberculosis, chronic obstructive pulmonary disease, systemic laryngotracheitis and open-heart surgery, according to the company.
But when Breath of Life approached the FDA with a plan to expand their products to include inflatable devices to help people with chronic lung disease, the FDA responded with a firm “no.”
The FDA’s stringent product approval process has made it difficult for foreign-based innovators like Breath of Life to get the manufacturing work done and therefore to get the devices approved. This led the company to source the funding necessary to manufacture the devices in the U.S.
Founders Seán Berthon Jr. and Kyle Berthon had to invest heavily in R&D efforts to make their products work well. It involved spending more than $50 million over four years. The venture received no venture capital funding.
The preliminary FDA review found that their device had “proven to be effective in using the breath to generate oxygen and oxygenated breath,” in the trial.
In a statement released before the FDA’s approval, the company said “We are proud of the rapid and effective collaboration with the FDA that allowed us to get these critical products into the market.”
In an interview last summer, Laura Veghten, senior analyst with Mintel, a research firm in Chicago, said the agency’s recent steps have “obviously shifted over the last four years” from primarily regulating supplements, which can be marketed in much the same way as prescription drugs, to regulating medical devices that are likely going to be used in a clinical setting.
“To me, it really depends on the medical outcomes. Is it going to be of benefit? If the product’s going to benefit a patient and be a legitimate medical use, then they can do it,” she said, adding that the FDA’s focus on safety was necessary and sometimes controversial.
There will likely always be pockets of innovation. According to data from Mintel, only 11 percent of U.S. healthcare revenue comes from the drug and device industry.
“All I can tell you is that the government’s given us somewhat of a go ahead to proceed,” Mr. Berthon Jr. said. “So we’re hopeful we can put this to bed with the agency and move on to the next big thing.”
This story originally appeared on FoxNews.com.