Developers hope to enter new category with inhalable vitamin product
Designed by California startup Inhale Health, the new product is positioned in what the developers believe to be a new, ‘blue sky’ niche, an inhalable product that is meant to promote a user’s health. As such, it is not intended to be viewed as a dietary supplement, though with its list of ingredients (vitamins B1, B2, B6 and B12), it is aimed as some of the same health targets.
Inhalation for health
“The genesis of the product was a little more than two years ago,” cofounder and CEO Daniel Wolf told NutraIngredients-USA. “I was a former cigarette smoker, and I thought, why couldn’t that inhalation experience be healthful? Your body is designed to use inhalation to bring the things it needs into the body. Why couldn’t we use that delivery technique to deliver good things to your bloodstream?”
Vape pens have been used as a drug delivery system and as a consumption mode for both tobacco and cannabis. In the latter sphere some developers have started to play around with the technique as a delivery method for CBDs, non-narcotic fractions of the hemp plant that have health supporting properties of their own. FDA has stated unequivocally that CBDs are not appropriate ingredients for a dietary supplement application (though that has hardly slowed some of the more adventurous product developers). It is in their choice of ingredients—neither active pharmaceutical agents nor compounds like CBD that are located under an FDA cloud—that sets the new Vitamin Vapor product apart, the developers say. The product stands at the cusp of what they believe will develop into an entire new category of products.
“The entire inhalation space is shifting. What we are going to see over the next few years is a number of of health-promoting inhalables,” said Mario Danek, company cofounder and director of biomedical development.
Danek said the company has done pilot studies with human subjects that show that use of company’s vitamin-loaded vape pens for about 8 minutes a day delivers a significantly greater amount of the vitamins in question to the bloodstream than does a standard multivitamin. For
Danek, this becomes a matter of truth in advertising. He says he can show hard data on uptake, data that is not influenced by what food matrices are present in a consumer’s gut at a given time or by other variables such as individual digestive differences.
“Consumers think they are getting what’s listed on the bottle. But that’s not true; they are getting what they can metabolize,” Danek said.
Shifting the collective consciousness
The company says it uses “USP pharmaceutical grade” vitamins in an organic base of vegetable glycerin. The second-hand vapor ought to be entirely innocuous, but the product will still have to deal with some of the preconceptions around vaping, and where and when it’s appropriate.
“The majority of vaping regulations are centered on an extension of tobacco regulation. We are trying to reprogram the collective consciousness on inhalation toward health. It’s going to be an uphill battle,” Danek said.
The steepness of that slope is set by current regulations. Denver-based attorney Justin Prochnow, a shareholder in the firm Greenberg Traurig who has advised many dietary supplement and food clients, said if you’re not a food, your room to maneuver as a health-promoting product is restricted.
"Any product, regardless of the delivery method, that is meant to affect the structure or function of the body likely will be seen by FDA as a drug, unless it is a food. The definition of drug included in the Federal Food, Drug and Cosmetic Act specifically excepts food, which includes dietary supplements, as the only types of products, other than drugs, which can make structure/function claims,” Prochnow said.
