FDA to Review Inhalable Caffeine Product

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FDA to Review Inhalable Caffeine Product


BOSTON -- The Food and Drug Administration is taking a closer look at the new inhalable caffeine product AeroShot. The news comes two weeks after one federal lawmaker asked the agency to review it.

AeroShot hit store shelves in Massachusetts and New York in late January. The lipstick-sized tube contains 100 milligrams of caffeine powder -- about the same amount as a large cup of coffee -- plus vitamin B, as CSNews Online previously reported. It can be found in convenience stores, liquor stores and online.

Soon after coming to market, Sen. Charles Schumer (D-NY) asked the FDA to review the product. He cited fears that AeroShot would be used as a club drug. After meeting with the lawmaker, FDA Commission Margaret Hamburg agreed to review the safety and legality of AeroShot, according to the Associated Press.

"I am worried about how a product like this impacts kids and teens, who are particularly vulnerable to overusing a product that allows one to take hit after hit after hit, in rapid succession," Schumer said.

An FDA official who was at the meeting also confirmed the decision, telling the Associated Press that the review will include a study of the law to determine whether AeroShot qualifies as a dietary supplement. The product will also be tested to determine whether it's safe for consumption, the official said. The official spoke on the condition of anonymity because of not being authorized to discuss the matter.

Biomedical engineering professor David Edwards created AeroShot and said the product is safe and does not contain common additives used to amplify the caffeine effect in common energy drinks.

"We will cooperate fully with the FDA's review to address the issues raised by Sen. Schumer and are confident that it will conclude that AeroShot is a safe, effective product that complies with the FDA regulations," Tom Hadfield, CEO of Breathable Foods, said in a statement. Breathable Foods is the company that developed the product.

In the statement, posted on the product's website, he said that when used in accordance with its label, AeroShot provides a safe amount of caffeine and B vitamins for ingestion. AeroShot is not recommended for those under 18 years old and it is not marketed to children, he added.

In addition, Hadfield said that unlike energy drinks that can be mixed with alcohol, AeroShot is not designed to have its contents poured into alcoholic beverages and is not intended to be mixed with any liquids.