I’m a sucker for the episodic comedy/drama where a consultant with some special skill aids the police to catch a criminal. It’s certainly not a unique formula—Elementary, Castle, Lie to Me, Bones, and The Mentalist are all examples. Recently, I found a new entry to the genre—High Potential.

I bring this up not to discuss my questionable television choices, but rather highlight the subject matter of one of the episodes. It involved development of a device called Canary, which was supposed to have a healthcare benefit, although the show really never fully explained what it was. The idea for the product came from someone using a kazoo with essential oil dripped over the opening at the top and having their child inhale. After further research and an optimized design, the product was launched to the market. Unfortunately, the poorly developed device was exposing the user to PFAS via inhalation (the show seemed to barely have a passing understanding of what PFAS are). 

As problematic as the premise of the technology was, it got me thinking about wellness products. When questioned, one character on the show explained that the therapy was homeopathic and not a medical device, therefore not regulated by the FDA—at least they got one aspect correct. This led me to consider why the agency doesn’t regulate wellness products. 

Per its guidance—General Wellness: Policy for Low Risk Devices—FDA defines wellness products as “intended for only general wellness use…and present a low risk to the safety of users and other persons.” They do not have an active pharmaceutical ingredient and are “unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition.” This encompasses quite a collection of items, from smartphone “healthy living” apps to supplements to some over-the-counter products found in a pharmacy. In fact, a search on Amazon for “wellness devices” reveals multiple pages of numerous products, some with FDA clearance and others not. 

I reviewed those results on Amazon and further investigated a few I thought sounded like possible medical devices. As it turned out, the first two I researched were, in fact, FDA cleared. But the third device I examined was not—the SaltAir by Halosense. According to the Canadian firm’s website, this product “is an ultrasonic air salinizer that replicates the environment of [a] natural salt cave (mine) in the comfort of your home.” 

Curiously, on the same website, the company refers to the unit as a “medical device.” It also claims to improve breathing for those with a variety of respiratory conditions—asthma and shortness of breath, cystic fibrosis, COPD, and allergies and sinus infection. Some of these explanations certainly sounded like “treatments” to me. 

For asthma, the device “improves pulmonary ventilation, diminishes attacks, and reduces the need for medication over time.” For cystic fibrosis, it “improves lung function, reduces infections, and clears the mucus from airways.” For those with COPD, it “lowers inflammation of airways, kills bacteria & germs resulting in easier breathing.” For allergies, SaltAir “prevents allergy, sinusitis and nasal obstruction, clears the sinuses and alleviates inflammation of mucous membranes.”

I’m not here to debate the medicinal effects of salt therapy on the lungs. I’m sure I’d find those that swear it works, while others would quickly dismiss it as snake oil. My issue here is the way the device is marketed. It sounds like a medical device that treats a number of lung and breathing conditions. As such, it could be assumed the FDA has given it an official OK. Unless I missed it, this is not the case. SaltAir is a wellness product and not required to gain FDA clearance. Further, while it does sell to customers in the U.S., it is not a U.S.-based company, which may excuse some of the language used on its site. 

I support having the freedom to buy what I want and am not seeking government oversight to the point of limiting my options. If I want to buy a SaltAir because I find value in the environment it generates, I believe I should have that right. However, what I would like to see is a requirement stating on the company’s website as well as every commercial outlet (e.g., Amazon) that the product is a wellness product and, as such, has not been verified by the U.S. FDA on any therapeutic claims made. I’m not advocating for its removal from the market, but I am in favor of making it clearer the technology is not a medical device per the FDA’s definition. 

Should wellness devices be required to have a disclaimer regarding their lack of FDA review, or should it be the consumer’s responsibility to research and find out more about the product on their own? What say you?

Sean Fenske, Editor-in-Chief
sfenske@rodmanmedia.com