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FDA Investigating Caffeine-Laced Products

FDA Investigating Caffeine-Laced Products

All your caffeinated gums, maple syrups, and candy might be in danger

Caffeinated maple syrup and gum are under review.

Scary news caffeine junkies: those extraneous ways to get your buzz (ahem, pixie candy dust) are under investigation by the FDA, meaning they could be on the chopping block.

AP reports that the Food and Drug Administration plans to investigate the safety of caffeinated food products, as an investigation of energy drinks and energy shots is already underway. As FDA deputy commissioner of foods Michael Taylor notes, the FDA only explicitly approved caffeine additions in the 1950s for sodas. And the caffeinated food scene right now is "beyond anything FDA envisioned. It is disturbing," Taylor told AP.

Energy drinks and shots are already under investigation after reports found Monster Energy Drinks linked to five deaths. In the past, the agency has also halted the sale of alcoholic caffeinated beverages like Four Loko, saying the booze and caffeine combo could lead to people being "wide-awake drunk," which leads to alcohol poisoning, car accidents, and assaults.

As for caffeinated foods? While one serving of, say, caffeinated jelly beans won't hurt anyone, the Center for Science in the Public Interest noted in a letter to the FDA that "the concern is that it will be increasingly easy to consume caffeine throughout the day, sometimes unwittingly, as companies add caffeine to candies, nuts, snacks, and other foods." FDA is looking at the general number of caffeinated products in the market, but Michael Jacobsen, director of the Center for Science, asks, "Could caffeinated macaroni and cheese or breakfast cereal be next?" We know a couple of college kids who would be into that. We're just going to go back to coffee.


FDA slams “Real Water” linked to liver failure water plant manager MIA

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The Food and Drug Administration on Wednesday admonished Nevada-based company Real Water for being uncooperative in a multi-state health investigation linked to its “alkalized” water products. The company is accused of poisoning its customers, causing acute liver failure and other serious health problems in adults, children, and pets.

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In an investigation update Wednesday, the FDA said its work has been hamstrung by Real Water’s failure to hand over critical records for two of its product facilities. Real Water has also failed to notify its distributors of the March 24 recall of all its water products, which are still being offered for sale by online retailers, the FDA noted. In addition, the FDA reported that the company is still promoting its products on social media, despite the recall and serious health claims.


FDA examines need to govern caffeine in foods

Who needs coffee for breakfast when you can pour Wired Wyatt’s caffeinated maple syrup over your Wired Waffles? Remember Cracker Jack? This year saw the advent of Cracker Jack’d Power Bites, with as much caffeine per serving as a cup of coffee.

Americans, it turns out, are willing to gobble up caffeine in all kinds of foods &mdash from potato chips to sunflower seeds to beef jerky. Not to mention gummy bears and marshmallows. Energy-boosting foods racked up more than $1.6 billion in domestic retail sales last year, up nearly 50 percent from five years ago, according to the market research firm Euromonitor International.

The trend, experts say, reflects a rush by food manufacturers to cater to consumers’ increasingly frenetic lives &mdash and to cash in on the popularity and profitability of high-caffeine energy drinks.

“This is something that’s going to continue to grow,” said Roger Sullivan, founder of Wired Waffles, based in Marysville, Wash. He says his product is popular with endurance runners, long-haul truck drivers and sleep-deprived college students. “It’s definitely a market where I think a lot of large companies are figuring out how to jump in.”

But the growing interest of big food companies might mean the party is over, at least for now.

The Food and Drug Administration threw a wet blanket on the caffeine-laced food craze recently when it asked foodmakers to take a timeout. Concerned about the potential health effects on children, as well as Americans’ cumulative caffeine intake, officials said they want to investigate whether new rules are needed to govern caffeine in foods.

“It’s a trend that raises real concerns,” Michael Taylor, the FDA’s top food safety official, said in an interview. “We’re not here to say that these products are inherently unsafe. We’re trying to understand, what are the right questions to be asking? . . . We have to figure out, what are the right ways to approach this?”

The agency, which has watched the proliferation of caffeinated foods with increasing alarm, took action after Wrigley launched a caffeinated gum, Alert Energy, in late April with full-page newspaper ads, a promotion at 7-Eleven stores and a NASCAR car plastered with the gum’s logo. Each stick contains the caffeine of half a cup of coffee.

“When you start putting [caffeine] in these different products and forms, do we really understand the effects?” Taylor said, describing the concerns he and others shared with Wrigley executives who met with FDA officials shortly after the rollout of Alert gum. “Isn’t it time to pause and exercise some restraint?”

The company, which declined an interview request, quickly pulled its new gum from the market. While noting that it had put the caffeine content on the label and marketed Alert only to people over 25, Wrigley said in a statement that it was halting production “out of respect for the FDA” while the agency developed “a new regulatory framework” for caffeinated food and drinks.

Taylor said FDA officials have long been aware of smaller manufacturers making niche caffeinated food. He said the agency became concerned when food giants such as PepsiCo &mdash which owns Frito-Lay, the maker of Cracker Jack’d &mdash and other companies began dipping their toes into the caffeinated food market.

What the FDA might do to revamp its oversight of caffeinated foods remains unclear, and it probably will take months or even years before it settles on any new rules. More detailed labeling requirements for caffeine in foods seem likely, and the agency eventually could decree that some products should not contain caffeine.

In any case, top officials decided the status quo was not working.

“We believe that some in the food industry are on a dubious, potentially dangerous path,” Taylor said recently, adding that, if necessary, “we are prepared to go through the regulatory process to establish clear boundaries and conditions on caffeine use.”

The only time the FDA explicitly approved adding caffeine as an ingredient was for sodas. That was in the 1950s, long before the agency could have predicted the proliferation in caffeinated food products.

Researchers have said 400 milligrams of caffeine per day &mdash roughly 4 to 5 cups of coffee &mdash is generally safe for adults. There is no set level for children, although the American Academy of Pediatrics has discouraged any caffeine consumption for young people, citing concerns about “its effects on the developing neurologic and cardiovascular systems and the risk of physical dependence and addiction.”

Manufacturers must include caffeine on their lists of ingredients, but they are not required to detail how much is in each product.

The FDA’s move to halt the increase of foods with added caffeine comes on the heels of other efforts to investigate the safety of beverages loaded with the stimulant.

In late 2010, the agency essentially forced a handful of products off the market after concluding that adding caffeine to alcoholic drinks was unsafe. More recently, the agency has been investigating the safety of caffeinated energy drinks.

Taylor said he is not especially concerned about an individual food product but rather about the cumulative amount of caffeine some people consume, particularly children, given the ever-widening universe of caffeinated products.

And why, exactly, has that universe been growing in recent years?

Roland Griffiths, a behavioral biology professor at Johns Hopkins University who has studied the effects of caffeine for decades, said the caffeinated food trend may be part of a larger cultural shift in how people consume caffeine. “Coffee used to be the primary delivery system,” he said, but “we have a whole new generation of people coming up who are not exclusive coffee drinkers.”

Abraham Palmer, a researcher at the University of Chicago who has researched how caffeine affects people differently, does not see much to worry about in the growth of caffeinated foods. The food merely acts as a different delivery vehicle for the drug, he said, and it is a lot harder to scarf down half a dozen Wired Waffles than it is to drink several cups of Starbucks coffee.

“Caffeine is a well understood drug billions of people around the world use it,” Palmer said. “It’s hard for me to understand why these newer formulations are causing such alarm. . . . I fear that maybe this is much ado about nothing.”

Still, he agreed with Griffiths that companies should, at a minimum, disclose the amount of caffeine in their products.

The Grocery Manufacturers Association, which represents the largest food and beverage companies, has said it intends to work with the FDA to make sure the products on grocery shelves are “safe, wholesome, quality products.” But the group is not making any anti-caffeine promises.”Caffeine has been a part of the human diet for centuries. It is a naturally occurring substance found in leaves, seeds or fruits of more than 60 plants, many of which are staples in our diets,” the group said in a statement.

The nonprofit Center for Science in the Public Interest urged the FDA in November to crack down on caffeinated snack foods, saying they could lead to “troublesome or serious health problems,” especially if consumed along with more traditional caffeine products.

“I fear that we’ll see caffeine, or coffee, being added to ever more improbable drinks and snacks, putting children, unsuspecting pregnant women, and others at risk,” the group’s executive director, Michael Jacobson, wrote at the time. “How soon before we have caffeinated burgers, burritos, or breakfast cereals?”

The group also wrote to companies such as PepsiCo and Kraft, which produces caffeinated MiO Energy water-flavoring drops, arguing that caffeine “is totally inappropriate to be included in foods consumed by children.”

The nonprofit center acknowledged that the companies had not marketed products such as Cracker Jack’d directly to kids but said that “it’s hard to imagine that the products will not be attractive to children.”

With the big food companies attracting most of the attention, small-time purveyors such as Roger Sullivan have continued with business as usual.

Sullivan said he and his wife dreamed up Wired Waffles after the economic crash in 2008 prompted them to close their coffee distribution business. Their fledgling caffeinated waffle company has produced about $30,000 in sales since the fall, mostly online. Sullivan said he supports more detailed labeling requirements for caffeine and has been transparent about the caffeine content of his waffles and syrup.

But despite the FDA’s concerns, Sullivan does not plan to stop selling anytime soon.

“That’s not going to happen,” he said. “If we waited on the government to figure things out, we’d be out of business.”


Think Caffeine Is Harmless? Chew On This.

If you thought caffeine was harmless, you’re about to change your thinking.

Not only has it been used to create an “energy drink” market, caffeine is now available in Wrigley chewing gum.

It’s being touted “for adults who are already using caffeine for energy,” according to a Wrigley spokesperson.

When exactly did caffeine become a source of energy? Do you recall Coca-Cola or coffee being called an “energy drink” back in the day?

If you want energy, have a coconut oil-stuffed medjool date or a banana or something.

Caffeine is not a source of energy it is, however, one more example of how marketing spin can change the definition of a word.

As a consequence, we have forgotten what caffeine can do to a body. And it’s not pretty… especially in children.

Energy drinks are at the center of a wrongful death lawsuit because a 14-year-old girl died of cardiac arrest after drinking just 2 of them in a 24-hour period.

Five people have, in fact, died shortly after drinking Monster brand energy drinks over the last 8 years and there were over 13,000 hospital visits in 2009 related to drinking these caffeine-laced energy drinks.

The FDA is also investigating claims about other deaths related to those now-common 5-hour energy “shots.”

The way so-called energy drinks work is with a combination of niacin (vitamin B3) and caffeine. The niacin opens up the blood vessels and drives the caffeine deep into the cells of the body, sometimes with catastrophic results.

This idea behind these drinks does not work with compounds naturally found in the body and can easily overload susceptible people.

And now caffeine is being slipped into chewing gum — another good reason that gum is not on The Hallelujah Diet!

But what about all of the so-called benefits of “just a little” caffeine?


Let’s Curtail the Glamorization of Caffeine

All over Chicago I’m seeing billboards for “guilt-free” caffeine. It’s a new campaign for Caffeinated Club, a calorie-free club soda with the same amount of caffeine as a can of soda. The local company Rocky’s Beverages, LLC, is aiming to transform the way America gets its daily caffeine.

Caffeinated Club® is the perfect choice for every caffeine lover at all hours of the day. This unique beverage can easily transition from a simple morning alternative to coffee, to a convenient midday pick-me-up, to a light and refreshing alcohol mixer in the evening.Without sugars, colors, artificial sweeteners, or calories, this is an appealing alternative for health conscious individuals. To sum it up, “We make club soda fun!”

Then this weekend, I find the caffeine-spiked Aspire drinks at a Chicago street fair. I chatted with the folks handing out samples of the beverages who told me that each can burns 200 calories. Oh really? Here’s how the website describes the product:

First launched in the UK by two friends and fast becoming a globally recognised brand. Aspire is a tasty, refreshing, lightly carbonated soft drink now available in two flavours, Cranberry and Apple with Acai. It’s unique blend of good-for-you ingredients aid calorie burning, weight loss, body fat reduction and target the main cause of cellulite. Aspire can be drunk any time of day, as replacement for your morning tea/coffee, during lunch/dinner, before, during or after any form of exercise.

Described as “Created by Nutritionists. Backed by Scientists,” the drinks contain 80 mg of caffeine per can from green tea and guarana seed extract, and are fortified with a ton of B vitamins — including 200% vitamin B6, 70% niacin, and 70% vitamin B12. The brochure handed out with the samples claimed “Aspire increases metabolism through thermogenics, burning calories and giving you the energy to do the things you do.” Seems like one study was conducted with 20 individuals, as reported here. The analysis:


Sounds very good, but basically there was only a 27 cal increase in calories burned over three hours, compared to a control group having a drink with similar calories but no other ingredients (e.g. green tea). To put this in perspective, if you laughed for about 10 minutes you’d probably burn the same calories. The main point is that the 200 calories are not extra calories burnt, they are background calories, which just goes to show you that clever marketing makes all the difference! By all means drink it, but don’t expect the weight to fall off, and if you consume a lot, then it may have the reverse effect!

I’m growing so weary of claims like this, especially for a product that may carry some risks. That’s why I’m happy to see Oregon, Washington and Vermont announce last week that they’re filing a lawsuit against makers of the popular 5-Hour energy drink, accusing the company of misleading advertising. The claim is against Living Essentials LLC and Innovation Ventures LLC, makers of the highly popular energy booster. Attorneys for the states want a permanent injunction against the parent companies’ misleading marketing and are seeking civil penalties. The three states join 33 others investigating the product’s advertising claims. According to the suit, 5-hour Energy leads consumers to believe the energy drink’s potency is the result of a unique blend of ingredients. Instead, the suit contends, the drink is effective thanks to a concentrated dose of caffeine.

5-Hour Energy has been linked to 13 deaths, so this is serious stuff. Now there’s a new FDA warning about powdered pure caffeine that’s being sold in bulk bags on the internet after the death of an Ohio teen. These products are 100% caffeine a single teaspoon of the powder contains as much caffeine as 25 cups of coffee. The FDA said it’s investigating caffeine powder and will “consider taking regulatory action.” In the meantime, the agency said it’s recommending consumers stay away from it.

The Center for Science in the Public Interest is calling for FDA to keep powdered caffeine off the market. Unfortunately, there are many online companies like Read Pure that are making it easy to buy — and tempting teens and adults with claims about increased alertness and attention, along with messages about lowering your risk of heart disease and diabetes, and increasing metabolic rate.

So if you like cheap, safe and pure caffeine that you can add to your meals or drinks, than caffeine powder is exactly what you need. This will restore your alertness and give you energy so you can continue working/studying for the rest of the day.

Scary stuff. Unfortunately, people are putting a lot of faith into caffeine-containing ingredients like green tea and green coffee beans. Then it’s easy to jump to the idea that more is better. I’m hopeful this cycle will stop. Enjoy your cup of coffee or tea. Drink “real.” Don’t buy up products that are heavily fortified with these isolated forms of caffeine. And step up your activity to increase the amount of calories you burn. Don’t expect any “calorie-burning” drink to make a big difference. Lastly, spread the word about the dangers of powdered caffeine. This has got to stop.

What is going on with caffeine these days? As CSPI’s Jim O’Hara said:

…the Center for Science in the Public Interest wrote FDA in June on the need for the Agency to prevent harms from caffeine-laced energy drinks by issuing a public health warning against their consumption, especially by youths, limiting the amount of caffeine in those products, and slapping a warning label on them. The overuse and misuse of caffeine in the food supply is creating a wild-west marketplace, and it’s about time the sheriff noticed and did something.

Images: Caffeine powder from Read Pure, 5-Hour Energy from Tom Gao on flickr


In Focus: Caffeinated food has FDA buzzing

The agency asked food manufacturers to stop adding caffeine as it considers health risks.

Who needs coffee for breakfast when you can pour Wired Wyatt’s caffeinated maple syrup over your Wired Waffles? Remember Cracker Jack? This year saw the advent of Cracker Jack’d Power Bites, with as much caffeine per serving as a cup of coffee.

Americans, it turns out, are willing to gobble up caffeine in all kinds of foods — from potato chips to sunflower seeds to beef jerky. Not to mention gummy bears and marshmallows. Energy-boosting foods racked up more than $1.6 billion in domestic retail sales last year, up nearly 50 percent from five years ago, according to the market research firm Euromonitor International.

Additional Photos

The trend, experts say, reflects a rush by food manufacturers to cater to consumers’ increasingly frenetic lives — and to cash in on the popularity and profitability of high-caffeine energy drinks.

“This is something that’s going to continue to grow,” said Roger Sullivan, founder of Wired Waffles, based in Marysville, Wash. He says his product is popular with endurance runners, long-haul truck drivers and sleep-deprived college students. “It’s definitely a market where I think a lot of large companies are figuring out how to jump in.”

But the growing interest of big food companies might mean the party is over, at least for now.

The Food and Drug Administration threw a wet blanket on the caffeine-laced food craze recently when it asked foodmakers to take a timeout. Concerned about the potential health effects on children, as well as Americans’ cumulative caffeine intake, officials said they want to investigate whether new rules are needed to govern caffeine in foods.

“It’s a trend that raises real concerns,” Michael Taylor, the FDA’s top food safety official, said in an interview. “We’re not here to say that these products are inherently unsafe. We’re trying to understand, what are the right questions to be asking? … We have to figure out, what are the right ways to approach this?”

The agency, which has watched the proliferation of caffeinated foods with increasing alarm, took action after Wrigley launched a caffeinated gum, Alert Energy, in late April with full-page newspaper ads, a promotion at 7-Eleven stores and a NASCAR car plastered with the gum’s logo. Each stick contains the caffeine of half a cup of coffee.

“When you start putting [caffeine] in these different products and forms, do we really understand the effects?” Taylor said, describing the concerns he and others shared with Wrigley executives who met with FDA officials shortly after the rollout of Alert gum. “Isn’t it time to pause and exercise some restraint?”

The company, which declined an interview request, quickly pulled its new gum from the market. While noting that it had put the caffeine content on the label and marketed Alert only to people over 25, Wrigley said in a statement that it was halting production “out of respect for the FDA” while the agency developed “a new regulatory framework” for caffeinated food and drinks.

What the FDA might do to revamp its oversight of caffeinated foods remains unclear, and it probably will take months or even years before it settles on any new rules. More detailed labeling requirements for caffeine in foods seem likely, and the agency eventually could decree that some products should not contain caffeine.

In any case, top officials decided the status quo was not working.

“We believe that some in the food industry are on a dubious, potentially dangerous path,” Taylor said recently, adding that, if necessary, “we are prepared to go through the regulatory process to establish clear boundaries and conditions on caffeine use.”

The only time the FDA explicitly approved adding caffeine as an ingredient was for sodas. That was in the 1950s, long before the agency could have predicted the proliferation in caffeinated food products.

Researchers have said 400 milligrams of caffeine per day — roughly 4 to 5 cups of coffee — is generally safe for adults. There is no set level for children, although the American Academy of Pediatrics has discouraged any caffeine consumption for young people, citing concerns about “its effects on the developing neurologic and cardiovascular systems and the risk of physical dependence and addiction.”

Manufacturers must include caffeine on their lists of ingredients, but they are not required to detail how much is in each product.

The FDA’s move to halt the increase of foods with added caffeine comes on the heels of other efforts to investigate the safety of beverages loaded with the stimulant.

In late 2010, the agency essentially forced a handful of products off the market after concluding that adding caffeine to alcoholic drinks was unsafe. More recently, the agency has been investigating the safety of caffeinated energy drinks.

Taylor said he is not especially concerned about an individual food product but rather about the cumulative amount of caffeine some people consume, particularly children, given the ever-widening universe of caffeinated products.

And why, exactly, has that universe been growing in recent years?

Roland Griffiths, a behavioral biology professor at Johns Hopkins University who has studied the effects of caffeine for decades, said the caffeinated food trend may be part of a larger cultural shift in how people consume caffeine. “Coffee used to be the primary delivery system,” he said, but “we have a whole new generation of people coming up who are not exclusive coffee drinkers.”

Abraham Palmer, a researcher at the University of Chicago who has researched how caffeine affects people differently, does not see much to worry about in the growth of caffeinated foods. The food merely acts as a different delivery vehicle for the drug, he said, and it is a lot harder to scarf down half a dozen Wired Waffles than it is to drink several cups of Starbucks coffee.

“Caffeine is a well understood drug billions of people around the world use it,” Palmer said. “It’s hard for me to understand why these newer formulations are causing such alarm. . . . I fear that maybe this is much ado about nothing.”

The nonprofit Center for Science in the Public Interest urged the FDA in November to crack down on caffeinated snack foods, saying they could lead to “troublesome or serious health problems,” especially if consumed along with more traditional caffeine products.

“I fear that we’ll see caffeine, or coffee, being added to ever more improbable drinks and snacks, putting children, unsuspecting pregnant women, and others at risk,” the group’s executive director, Michael Jacobson, wrote at the time. “How soon before we have caffeinated burgers, burritos, or breakfast cereals?”

The group also wrote to companies such as PepsiCo and Kraft, which produces caffeinated MiO Energy water-flavoring drops, arguing that caffeine “is totally inappropriate to be included in foods consumed by children.”

The nonprofit center acknowledged that the companies had not marketed products such as Cracker Jack’d directly to kids but said that “it’s hard to imagine that the products will not be attractive to children.”

With the big food companies attracting most of the attention, small-time purveyors such as Roger Sullivan have continued with business as usual.

Sullivan said he and his wife dreamed up Wired Waffles after the economic crash in 2008 prompted them to close their coffee distribution business. Their fledgling caffeinated waffle company has produced about $30,000 in sales since the fall, mostly online. Sullivan said he supports more detailed labeling requirements for caffeine and has been transparent about the caffeine content of his waffles and syrup.

But despite the FDA’s concerns, Sullivan does not plan to stop selling anytime soon.

“That’s not going to happen,” he said. “If we waited on the government to figure things out, we’d be out of business.”


FDA set to clamp down on caffeine in food

Who needs coffee for breakfast when you can pour Wired Wyatt's caffeinated maple syrup over your Wired Waffles? Remember Cracker Jack? This year saw the advent of Cracker Jack'd Power Bites, with as much caffeine per serving as a cup of coffee.

Americans, it turns out, are willing to gobble up caffeine in all kinds of foods -- from potato chips to sunflower seeds to beef jerky. Not to mention gummy bears and marshmallows. Energy-boosting foods racked up more than $1.6 billion in domestic retail sales last year, up nearly 50 percent from five years ago, according to the market research firm Euromonitor International.

The trend, experts say, reflects a rush by food manufacturers to cater to consumers' increasingly frenetic lives -- and to cash in on the popularity and profitability of high-caffeine energy drinks.

"This is something that's going to continue to grow," said Roger Sullivan, founder of Wired Waffles, based in Marysville, Wash. He says his product is popular with endurance runners, long-haul truck drivers and sleep-deprived college students. "It's definitely a market where I think a lot of large companies are figuring out how to jump in."

But the growing interest of big food companies might mean the party is over, at least for now.

The Food and Drug Administration threw a wet blanket on the caffeine-laced food craze recently when it asked foodmakers to take a timeout. Concerned about the potential health effects on children, as well as Americans' cumulative caffeine intake, officials said they want to investigate whether new rules are needed to govern caffeine in foods.

"It's a trend that raises real concerns," Michael Taylor, the FDA's top food safety official, said in an interview. "We're not here to say that these products are inherently unsafe. We're trying to understand, what are the right questions to be asking? . . . We have to figure out, what are the right ways to approach this?"

The agency, which has watched the proliferation of caffeinated foods with increasing alarm, took action after Wrigley launched a caffeinated gum, Alert Energy, in late April with full-page newspaper ads, a promotion at 7-Eleven stores and a NASCAR car plastered with the gum's logo. Each stick contains the caffeine of half a cup of coffee.

"When you start putting (caffeine) in these different products and forms, do we really understand the effects?" Taylor said, describing the concerns he and others shared with Wrigley executives who met with FDA officials shortly after the rollout of Alert gum. "Isn't it time to pause and exercise some restraint?"

The company, which declined an interview request, quickly pulled its new gum from the market. While noting that it had put the caffeine content on the label and marketed Alert only to people over 25, Wrigley said in a statement that it was halting production "out of respect for the FDA" while the agency developed "a new regulatory framework" for caffeinated food and drinks.

Taylor said FDA officials have long been aware of smaller manufacturers making niche caffeinated food. He said the agency became concerned when food giants such as PepsiCo -- which owns Frito-Lay, the maker of Cracker Jack'd -- and other companies began dipping their toes into the caffeinated food market.

What the FDA might do to revamp its oversight of caffeinated foods remains unclear, and it probably will take months or even years before it settles on any new rules. More detailed labeling requirements for caffeine in foods seem likely, and the agency eventually could decree that some products should not contain caffeine.

In any case, top officials decided the status quo was not working.

"We believe that some in the food industry are on a dubious, potentially dangerous path," Taylor said recently, adding that, if necessary, "we are prepared to go through the regulatory process to establish clear boundaries and conditions on caffeine use."

The only time the FDA explicitly approved adding caffeine as an ingredient was for sodas. That was in the 1950s, long before the agency could have predicted the proliferation in caffeinated food products.

Researchers have said 400 milligrams of caffeine per day -- roughly 4 to 5 cups of coffee -- is generally safe for adults. There is no set level for children, although the American Academy of Pediatrics has discouraged any caffeine consumption for young people, citing concerns about "its effects on the developing neurologic and cardiovascular systems and the risk of physical dependence and addiction."

Manufacturers must include caffeine on their lists of ingredients, but they are not required to detail how much is in each product.

The FDA's move to halt the increase of foods with added caffeine comes on the heels of other efforts to investigate the safety of beverages loaded with the stimulant.

In late 2010, the agency essentially forced a handful of products off the market after concluding that adding caffeine to alcoholic drinks was unsafe. More recently, the agency has been investigating the safety of caffeinated energy drinks.

Taylor said he is not especially concerned about an individual food product but rather about the cumulative amount of caffeine some people consume, particularly children, given the ever-widening universe of caffeinated products.

And why, exactly, has that universe been growing in recent years?

Roland Griffiths, a behavioral biology professor at Johns Hopkins University who has studied the effects of caffeine for decades, said the caffeinated food trend may be part of a larger cultural shift in how people consume caffeine. "Coffee used to be the primary delivery system," he said, but "we have a whole new generation of people coming up who are not exclusive coffee drinkers."

Abraham Palmer, a researcher at the University of Chicago who has researched how caffeine affects people differently, does not see much to worry about in the growth of caffeinated foods. The food merely acts as a different delivery vehicle for the drug, he said, and it is a lot harder to scarf down half a dozen Wired Waffles than it is to drink several cups of Starbucks coffee.

"Caffeine is a well understood drug billions of people around the world use it," Palmer said. "It's hard for me to understand why these newer formulations are causing such alarm. . . . I fear that maybe this is much ado about nothing."

Still, he agreed with Griffiths that companies should, at a minimum, disclose the amount of caffeine in their products.

The Grocery Manufacturers Association, which represents the largest food and beverage companies, has said it intends to work with the FDA to make sure the products on grocery shelves are "safe, wholesome, quality products." But the group is not making any anti-caffeine promises."Caffeine has been a part of the human diet for centuries. It is a naturally occurring substance found in leaves, seeds or fruits of more than 60 plants, many of which are staples in our diets," the group said in a statement.

The nonprofit Center for Science in the Public Interest urged the FDA in November to crack down on caffeinated snack foods, saying they could lead to "troublesome or serious health problems," especially if consumed along with more traditional caffeine products.

"I fear that we'll see caffeine, or coffee, being added to ever more improbable drinks and snacks, putting children, unsuspecting pregnant women, and others at risk," the group's executive director, Michael Jacobson, wrote at the time. "How soon before we have caffeinated burgers, burritos, or breakfast cereals?"

The group also wrote to companies such as PepsiCo and Kraft, which produces caffeinated MiO Energy water-flavoring drops, arguing that caffeine "is totally inappropriate to be included in foods consumed by children."

The nonprofit center acknowledged that the companies had not marketed products such as Cracker Jack'd directly to kids but said that "it's hard to imagine that the products will not be attractive to children."

With the big food companies attracting most of the attention, small-time purveyors such as Roger Sullivan have continued with business as usual.

Sullivan said he and his wife dreamed up Wired Waffles after the economic crash in 2008 prompted them to close their coffee distribution business. Their fledgling caffeinated waffle company has produced about $30,000 in sales since the fall, mostly online. Sullivan said he supports more detailed labeling requirements for caffeine and has been transparent about the caffeine content of his waffles and syrup.

But despite the FDA's concerns, Sullivan does not plan to stop selling anytime soon.

"That's not going to happen," he said. "If we waited on the government to figure things out, we'd be out of business."


From ‘Wired Waffles’ to gum with a jolt, caffeinated foods making FDA jittery

Who needs coffee for breakfast when you can pour Wired Wyatt’s caffeinated maple syrup over your Wired Waffles? Remember Cracker Jack? This year saw the advent of Cracker Jack’d Power Bites, with as much caffeine per serving as a cup of coffee.

Americans, it turns out, are willing to gobble up caffeine in all kinds of foods — from potato chips to sunflower seeds to beef jerky. Not to mention gummy bears and marshmallows. Energy-boosting foods racked up more than $1.6 billion in domestic retail sales last year, up nearly 50 percent from five years ago, according to the market research firm Euromonitor International.

The trend, experts say, reflects a rush by food manufacturers to cater to consumers’ increasingly frenetic lives — and to cash in on the popularity and profitability of high-caffeine energy drinks.

“This is something that’s going to continue to grow,” said Roger Sullivan, founder of Wired Waffles, based in Marysville, Wash. He says his product is popular with endurance runners, long-haul truck drivers and sleep-deprived college students. “It’s definitely a market where I think a lot of large companies are figuring out how to jump in.”

But the growing interest of big food companies might mean the party is over, at least for now.

The Food and Drug Administration threw a wet blanket on the caffeine-laced food craze recently when it asked foodmakers to take a timeout. Concerned about the potential health effects on children, as well as Americans’ cumulative caffeine intake, officials said they want to investigate whether new rules are needed to govern caffeine in foods.

“It’s a trend that raises real concerns,” Michael Taylor, the FDA’s top food safety official, said in an interview. “We’re not here to say that these products are inherently unsafe. We’re trying to understand, what are the right questions to be asking? . . . We have to figure out, what are the right ways to approach this?”

The agency, which has watched the proliferation of caffeinated foods with increasing alarm, took action after Wrigley launched a caffeinated gum, Alert Energy, in late April with full-page newspaper ads, a promotion at 7-Eleven stores and a NASCAR car plastered with the gum’s logo. Each stick contains the caffeine of half a cup of coffee.

“When you start putting [caffeine] in these different products and forms, do we really understand the effects?” Taylor said, describing the concerns he and others shared with Wrigley executives who met with FDA officials shortly after the rollout of Alert gum. “Isn’t it time to pause and exercise some restraint?”

The company, which declined an interview request, quickly pulled its new gum from the market. While noting that it had put the caffeine content on the label and marketed Alert only to people over 25, Wrigley said in a statement that it was halting production “out of respect for the FDA” while the agency developed “a new regulatory framework” for caffeinated food and drinks.

Taylor said FDA officials have long been aware of smaller manufacturers making niche caffeinated food. He said the agency became concerned when food giants such as PepsiCo — which owns Frito-Lay, the maker of Cracker Jack’d — and other companies began dipping their toes into the caffeinated food market.

What the FDA might do to revamp its oversight of caffeinated foods remains unclear, and it probably will take months or even years before it settles on any new rules. More detailed labeling requirements for caffeine in foods seem likely, and the agency eventually could decree that some products should not contain caffeine.

In any case, top officials decided the status quo was not working.

“We believe that some in the food industry are on a dubious, potentially dangerous path,” Taylor said recently, adding that, if necessary, “we are prepared to go through the regulatory process to establish clear boundaries and conditions on caffeine use.”

The only time the FDA explicitly approved adding caffeine as an ingredient was for sodas. That was in the 1950s, long before the agency could have predicted the proliferation in caffeinated food products.

Researchers have said 400 milligrams of caffeine per day — roughly 4 to 5 cups of coffee — is generally safe for adults. There is no set level for children, although the American Academy of Pediatrics has discouraged any caffeine consumption for young people, citing concerns about “its effects on the developing neurologic and cardiovascular systems and the risk of physical dependence and addiction.”

Manufacturers must include caffeine on their lists of ingredients, but they are not required to detail how much is in each product.

The FDA’s move to halt the increase of foods with added caffeine comes on the heels of other efforts to investigate the safety of beverages loaded with the stimulant.

In late 2010, the agency essentially forced a handful of products off the market after concluding that adding caffeine to alcoholic drinks was unsafe. More recently, the agency has been investigating the safety of caffeinated energy drinks.

Taylor said he is not especially concerned about an individual food product but rather about the cumulative amount of caffeine some people consume, particularly children, given the ever-widening universe of caffeinated products.

And why, exactly, has that universe been growing in recent years?

Roland Griffiths, a behavioral biology professor at Johns Hopkins University who has studied the effects of caffeine for decades, said the caffeinated food trend may be part of a larger cultural shift in how people consume caffeine. “Coffee used to be the primary delivery system,” he said, but “we have a whole new generation of people coming up who are not exclusive coffee drinkers.”

Abraham Palmer, a researcher at the University of Chicago who has researched how caffeine affects people differently, does not see much to worry about in the growth of caffeinated foods. The food merely acts as a different delivery vehicle for the drug, he said, and it is a lot harder to scarf down half a dozen Wired Waffles than it is to drink several cups of Starbucks coffee.

“Caffeine is a well understood drug billions of people around the world use it,” Palmer said. “It’s hard for me to understand why these newer formulations are causing such alarm. . . . I fear that maybe this is much ado about nothing.”

Still, he agreed with Griffiths that companies should, at a minimum, disclose the amount of caffeine in their products.

The Grocery Manufacturers Association, which represents the largest food and beverage companies, has said it intends to work with the FDA to make sure the products on grocery shelves are “safe, wholesome, quality products.” But the group is not making any anti-caffeine promises.”Caffeine has been a part of the human diet for centuries. It is a naturally occurring substance found in leaves, seeds or fruits of more than 60 plants, many of which are staples in our diets,” the group said in a statement.

The nonprofit Center for Science in the Public Interest urged the FDA in November to crack down on caffeinated snack foods, saying they could lead to “troublesome or serious health problems,” especially if consumed along with more traditional caffeine products.

“I fear that we’ll see caffeine, or coffee, being added to ever more improbable drinks and snacks, putting children, unsuspecting pregnant women, and others at risk,” the group’s executive director, Michael Jacobson, wrote at the time. “How soon before we have caffeinated burgers, burritos, or breakfast cereals?”

The group also wrote to companies such as PepsiCo and Kraft, which produces caffeinated MiO Energy water-flavoring drops, arguing that caffeine “is totally inappropriate to be included in foods consumed by children.”

The nonprofit center acknowledged that the companies had not marketed products such as Cracker Jack’d directly to kids but said that “it’s hard to imagine that the products will not be attractive to children.”

With the big food companies attracting most of the attention, small-time purveyors such as Roger Sullivan have continued with business as usual.

Sullivan said he and his wife dreamed up Wired Waffles after the economic crash in 2008 prompted them to close their coffee distribution business. Their fledgling caffeinated waffle company has produced about $30,000 in sales since the fall, mostly online. Sullivan said he supports more detailed labeling requirements for caffeine and has been transparent about the caffeine content of his waffles and syrup.

But despite the FDA’s concerns, Sullivan does not plan to stop selling anytime soon.

“That’s not going to happen,” he said. “If we waited on the government to figure things out, we’d be out of business.”


U.S. FDA warns Amazon's Whole Foods Market for misbranding food products

Dec 22 (Reuters) - The U.S. Food and Drug Administration (FDA) said on Tuesday it has issued a warning letter to Amazon.com Inc's Whole Foods Market for not labeling some products for the presence of food allergens, which led to a series of product recalls.

The supermarket chain, which was bought by Amazon in 2017 for $13.7 billion, has recalled more than 30 food products in the last year as the presence of major food allergens was not listed on product labels, the agency said.

The products were mainly from the deli and bakery sections of the store, the FDA said. (http://bit.ly/3nN1fSU)

Whole Foods is responsible for investigating and determining the causes of the violations identified and for preventing their recurrence, the FDA said in the letter issued to the company on Dec. 16.

The agency said the company should respond within 15 working days from receipt of the letter, listing out in writing the actions it is taking to address the violations.

"We are working closely with the FDA to ensure all practices and procedures in our stores meet if not exceed food safety requirements," Whole Foods said in an emailed statement. (Reporting by Manojna Maddipatla in Bengaluru Editing by Krishna Chandra Eluri)


FDA Investigation Links 16 Dog Food Brands To Canine Heart Disease

(CBSDFW.COM) &mdash Last year, the U.S. Food and Drug Administration begun investigating reports of canine dilated cardiomyopathy (DCM) in dogs eating “certain pet foods,” now the FDA is warning pet owners of 16 dog food brands that are closely linked to canine heart disease.

A recent 90 percent spike of DCM reports to the FDA in 2018 initiated this investigation. There were three reports in 2017 and 320 reported in 2018.

There have been 197 reports so far in 2019.

The commonality of the 16 brands is that many are dry foods labeled “grain-free,” and contain a high proportion of peas, lentils, other legume seeds and/or potatoes as main ingredients.

Here is the list of the brands and the number of reported DCM cases related:

  • Acana: 67
  • Zignature: 64
  • Taste of the Wild: 53
  • 4Health: 32
  • Earthborn Holistic: 32
  • Blue Buffalo: 31
  • Nature’s Domain: 29
  • Fromm: 24
  • Merrick: 16
  • California Natural: 15
  • Natural Balance: 15
  • Orijen: 12
  • Nature’s Variety: 11
  • NutriSource: 10
  • Nutro: 10
  • Rachael Ray Nutrish: 10

The FDA stated that many of the case reports included dog breeds not previously known to have a genetic predisposition to the disease. But the majority of case reports were from golden retrievers, Labrador retrievers and Great Danes.

In a statement released by the FDA, they acknowledged the severity of the illness and assured pet owners that they’re using a “range of science-based investigative tools” to learn more about DCM and its link to certain ingredients.

“We understand the concern that pet owners have about these reports: the illnesses can be severe, even fatal, and many cases report eating ‘grain-free’ labeled pet food,” the statement said.

Pet owners are advised to contact their veterinarian as soon as possible if their dog is showing possible signs of DCM or other heart conditions, including decreased energy, cough, difficulty breathing and episodes of collapse.

This is an ongoing investigation and updates will be provided by the FDA as information develops.