FDA probe threw 'wet blanket' over caffeinated food trend, but consumers still crave energy, says Datamonitor

By Elaine Watson

- Last updated on GMT

Related tags Caffeine

The flow of caffeinated foods hitting the US market “slowed to a trickle” after Wrigley pulled its Alert Energy gum in the wake of the FDA probe into caffeine, says Datamonitor. But it’s too early to write off this trend just yet, as consumers still crave energy, and caffeine delivers. 

Datamonitor Innovation insights director Tom Vierhile was speaking to FoodNavigator-USA after the makers of CaffeinAll​, a non-bitter caffeine shaker that you sprinkle onto food in controlled 100mg doses, said they were seeking funding to help bring the product to a broader audience.

CaffeinAll is marketed as a dietary supplement by Caffex Company. The product, which was developed by serial entrepreneur and food scientist Steve Kingsley (who created the now-defunct CaffeMallows caffeinated marshmallows line), contains maltodexrin, caffeine, and vegetable oil.

Each shaker contains 200 'shots', which each deliver a controlled 100mg dose of caffeine (a can of Red Bull contains 80mg), while the label advises consumers that they are using it at their own risk if they have more than 300mg (three shakes) a day.

There is also a warning that CaffeinAll is “not for minors, persons with heart conditions or caffeine sensitivity, and pregnant women”.

Tom Vierhile: Wrigley move ‘threw a wet blanket’ on the caffeinated foods sector   

Asked whether the product had consumer appeal, Vierhile said: “Ithink the idea of a caffeinated ‘sprinkle’ product that you shake onto food is innovative.

“The flow of caffeine-added foods slowed to a trickle in mid-2013 after Wrigley pulled Alert Caffeine Gum from the market after the FDA expressed consternation at the direction of caffeine-added foods and beverages. 

“That threw a wet blanket on the sector and launches have dwindled since then, suggesting that few companies are willing to brave possible legal action to launch a new caffeine added food product.”

The idea of being able to add caffeine to any food product is an attractive one, though

But he added: “The idea of being able to add caffeine to any food product is an attractive one, though, and consumers are very concerned about issues like fatigue and alertness.”

In fact, a 2014 survey by Datamonitor Consumer found that Americans ranked ‘tiredness/fatigue’ as the #2 medical condition of 47 options in terms of immediate levels of concern. Stress was #1.

And both conditions “have links to caffeine as a potential management tool”, ​noted Vierhile.

However, the risk with a product such as CaffeinAll is the potential to over-indulge, said Vierhile, who said he would not be surprised if regulators “were less than thrilled” ​about the product.

He added: “There is no recommended serving size for caffeine, but the fact that a ‘sprinkle shot’ can supply 100mg of caffeine suggests that it would be quite easy to ingest a larger than desired dose.”

Caffeine and the legal landscape

So what is the legal landscape around caffeine?

While the FDA has expressed concerns about the proliferation of new caffeine-containing products, experts who reviewed an Institute of Medicine report on an FDA-brokered workshop on caffeine last August said it was unlikely that FDA would make sweeping changes to the way caffeine is regulated.

Meanwhile, data suggests that the vast majority of caffeine comes from coffee and soft drinks (not energy drinks - click HERE​).

Caffeine is listed as GRAS (generally recognized as safe) for use in cola-type beverages at 71 mg per 12oz. If it is used in energy drinks or other foods/beverages, manufacturers must be able to prove it is safe for its intended use and in the amount used.  

However, as CaffeinAll is marketed as a dietary supplement, “GRAS status is irrelevant”, ​Justin Prochnow, an attorney in the Denver office of law firm Greenberg Traurig, told FoodNavigator-USA.

He added: “The fact people may add it to food is up to them; for the purposes of selling the product as a dietary supplement, an ingredient must be a dietary ingredient.  If it was marketed as a dietary ingredient prior to October 15, 1994, it is not a New Dietary Ingredient and no notification is needed. 

“Caffeine was, so it is a permissible dietary ingredient for which no notification is required.”

But product liability lawsuits always a risk

Meanwhile, there is no legal requirement to providing warnings about caffeine on labels, he said, “although due to the attention caffeine has received over the last year or two from the FDA and other bodies, a warning about the use of caffeine is certainly not a bad idea”.

So are products such as CaffeinAll likely to raise any legal issues at all?

“Issues regarding use of the product would likely be from a civil standpoint”, ​observed Prochnow.

“If consumers sustained adverse health conditions from using the product, we could see a products liability case or a failure to warn of dangerous ingredients case like those levied against some of the energy drink companies.  The warning provided is likely an attempt to mitigate any potential action if issues arise.”

CaffeinAll: We aren't really concerned about abuse

A CaffeinAll spokesman told FoodNavigator-USA that Caffex was seeking money through crowd funding site IndiGoGo (click HERE​) to fund a big production run.

He added: “The people that have bought CaffeinAll online absolutely love it.”

Asked whether it was a good idea to sprinkle a stimulant on food, he said: “We believe energy drinks don't give you the choice on how much caffeine you need, and therefore they supply you with outrageous amounts of weird and foreign substances.

“We aren't really concerned about abuse.”

Single doses of caffeine under 400mg do not increase the frequency of cardiac arrhythmias in healthy people

Addressing safety concerns about caffeine in a 2013 webinar (click HERE​), toxicologist  James R. Coughlin, PhD, CFS, said that “clinical studies show that single doses of caffeine under 400mg do not increase the frequency of cardiac arrhythmias in healthy persons or patients with ischemic heart disease or those with serious ventricular ectopia.”

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