AeroShots: Can a puff be a supplement?

FDA said it will investigate a new product, AeroShots, after Sen.  Charles Schumer (D-NY) requested the agency review the product, which he called a "caffeine inhaler," according to a report from the Associated Press.

AeroShots contain caffeine and B vitamins, and is dispensed in a lipstick-sized container. It comes out it "puffs," according to the company's website. Yet, the label directions say the shots are meant to dissolve in the mouth, not be inhaled. Sen. Schumer, and many media outlets including the AP, have said this product is actually inhaled, despite what the label claims say.

Sen. Schumer asked FDA to review AeroShots in a letter he sent to the agency in December, and he said FDA's decision to review the product is a positive sign given that the product's safety hasn't been established. Schumer was especially concerned with how AeroShots may affect teenagers who take the product with alcohol. We need to make sure that AeroShot does not become the next Four Loko by facilitating dangerous levels of drinking among teenagers and college students," Schumer stated in a press release.

Schumer also sent a letter to the company highlighting many of the same concerns, and the company said it changed its marketing to indicate the product is intended for adults 18 years and older.

AeroShots entered the market in New York and Boston in January, but has been available in France for some time.

Here's the big question: Is this a supplement or is this a drug? Last year, we all got a lesson on what is considered a food or a supplement (brownies are definitely a food). In this case, it depends on how the product is consumed.

Marc Ullman, Partner, Ullman, Shapiro & Ullman, said FDA regulates on intended use, not by just what's said on the label. "If the company is telling the truth about it enters the body and the instructions for use are accurate, its a dietary supplement under the law," Ullman said.

Therefore, it depends on the actual size of the caffeine, B vitamin and other ingredient molecule size. If they're small enough, they can be inhaled.

"Dry powder inhalers (DPIs) are a type of aerosol device used to deliver asthma drugs," said Steven Dentali, Ph. D., chief science officer, the American Herbal Products Association (AHPA). Clearly, the pharmaceutical technology exits to deliver powders via inhalation, probably including caffeine. While it has been reported that the powder from this product falls into the mouth and is then swallowed, I don't have enough information to say whether or not any, or how much, of it is likely to be inhaled."

Marketing that appears on the website is vague about how it enters the body. In the FAQ section, it says "Each AeroShot will give you four to six puffs. You can choose to take it all at once, or take a puff and save the rest for later." They also call the product "Breathable Energy."  Yet, other sections of the website say it is a powder that is swallowed.

To me, "take a puff"  and "breathable" means inhale. But this marketing, Ullman said is, "all just puffery. It's marketing hype that may not be prudent because it attracts attention from people like Sen. Schumer. Some of the advertising may be intentionally  unclear, but if you read the directions for use, it's very clear, and that's what counts. It's not a caffeine inhaler."

And if it's not inhaled, FDA should find no safety concerns with the combination of caffeine and B vitamins, as numerous supplements offer this combination.

We'll see what FDA says in its review. I haven't seen the product and can't say if it's inhaled or swallowed. Either way, it will be interesting to see how what actions the agency will take.