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FDA To Review Safety Of Caffeine Product

AeroShot Inventor Says Product 'Thoroughly Tested' Before Introduced

POSTED: 5:15 am EST February 22, 2012
UPDATED: 10:19 am EST February 22, 2012
Food and Drug Administration officials plan to investigate whether a form of caffeine sold in lipstick-shaped containers is safe for consumers.

The inventor touts AeroShot as caffeine without the coffee, soda, tea or a pill, but a U.S. lawmaker questions whether it's safe.

The product comes in a lipstick-shaped dispenser that puffs out a powdery mixture of caffeine and B vitamins into your mouth, where it dissolves and is swallowed.

Pre-filled devices can be purchased online or in convenience stores in New York and Boston for about $3.

"No calories. No liquid. No limits," its website says. "Hitting the books. Hitting the gym. Taking a roadtrip. Staying awake at your desk after devouring a bacon double cheeseburger at lunch. AeroShot is specifically designed with you in mind."

But New York's Sen. Charles Schumer said he has some concerns.

"This product could be very dangerous," Schumer said. "There might be legitimate uses. The business man staying up late who doesn't want to drink that cup of coffee, that's OK. But what about kids who go to bars and take several shots of AeroShot so they can drink more?"

Schumer sent a letter to the Food and Drug Administration in December urging it to examine the safety and legality of the product.

The FDA said it will review the senator's concerns and respond to him directly.

AeroShot inventor David Edwards says the product is safe and was "thoroughly tested" before it was introduced.

"There are energy shots on the market that have 10 times the amount of caffeine in a single energy shot than we have in the AeroShot ... The fact is we don't have that much caffeine in the product," he said.

One AeroShot contains 100 milligrams of caffeine dispensed in three to six puffs.

"The amount of caffeine that you would get from one puff of AeroShot is equivalent to about the amount of caffeine in a decaffeinated large Starbucks coffee, so it's really not that much caffeine," said David Schardt, a Senior Nutritionist at The Center for Science in the Public Interest.

"For most healthy adults, moderate doses of caffeine --- 200mg to 300mg, or about two to four cups of brewed coffee a day aren't harmful," according to The Mayo Clinic. It warns more than 500mg or 600mg daily can cause problems like insomnia, fast heartbeat, muscle tremors and stomach upset.

Schumer has said he is worried that the product could go on sale without government testing.

"The bottom line is this product asks more questions than we have answers and to have it on our shelves before those questions are answered is a serious, serious, serious mistake," he said in a news conference Sunday.

AeroShots fall under the FDA regulations for "dietary supplements." Those products include vitamin C pills at the drug store, some weight loss products and certain energy drinks.

The company making them is responsible "for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading," according to the FDA website.

It's rare for the agency to prohibit a supplement. In 2004, it stopped the sale of the diet supplement Ephedra, but only after deaths and other serious side effects were reported.

"Manufactures are free, basically, to sell almost any product they want and to make any claims they want about dietary supplements" Schardt said. "It's the burden of the Food and Drug Administration to prove that a product is unsafe and the dietary supplement industry has lawyers to defend their products and it's a long involved process."

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