FDA To Investigate Safety Of Inhalable Caffeine

February 20th, 2012

ABC News

By: Mark Greenblatt

The Food and Drug Administration will launch a safety investigation of a new product that allows consumers to inhale caffeine through a lipstick-sized portable device, rather than drinking it.

AeroShot delivers 100 milligrams of caffeine per use, and comes in bright colored packages that describe it as “pure energy,” and “breathable energy anytime, anyplace.”

The manufacturer, Breathable Foods Inc., put it on the market in New York, Massachusetts, and in France late last month.

“You could easily overdose or succumb to toxicity associated with the caffeine ingestion,” Dr. Bruce Goldberger told ABC News. “You could mix it with alcohol in a social setting and also I’m troubled by its availability, potentially at home where young children can get a hold of it.”

Sen. Charles Schumer of New York said he shares those concerns.

“A new product like AeroShot raises questions that need to be answered before allowing consumers, especially teens and kids, to use and abuse it,” he said. “The AeroShot caffeine-inhaler is being marketed as a party enhancer; it can facilitate excessive drinking and its effects have never been examined by independent regulators to determine their impact on the human body and in combination with alcohol, especially for adolescents.”

The inventor of AeroShot, Harvard biomedical professor David Edwards, says his product is as safe as a cup of coffee, which provides roughly the equivalent dose of caffeine.

“I think that we are absolutely welcoming a dialogue with the FDA,” he said. “As I say, this is a new way of delivering food in your mouth, and we’re confident that as they look at the product that they will confirm what we hold, that the product is both safe and follows FDA regulations.”

Edwards was able to bring Aeroshot to the market without an FDA review being required because it is sold as a dietary supplement. ABC News asked Edwards if he or his company had done any studies of the health effects of AeroShot on children or teenagers.

“The answer is no, we did not do tests on children,” he said, explaining that children and teenagers are not part of his target market. “We need to be really clear what a company responsibly does to test the safety of their product, and we’ve followed those safety regulations.”

Edwards says his product delivers a lower dose of caffeine than many energy drinks or caffeine pills currently on the market, and says it comes in a controlled, smaller dose of caffeine.

Edwards says demand for the product is eclipsing anything he could have ever anticipated, and increasing.

ABC News found the product on store shelves throughout New York and around college campuses. We visited three delis near Columbia University — two sold us their shelf stock, while the third store was already sold out.

“I would try it during something like finals week,” said Thalia Dergham, a Columbia University student. Dergham said, though, that she would likely not be a regular consumer of the product outside of high stress times.

Other students were not so willing.

“It looks intense,” said Kristin Simmons, a Columbia University art history and visual arts major. “It looks like one of those monster Red Bull drinks.”

After announcing its review, the FDA is now likely to examine the health effects of inhaling the caffeine on at-risk populations, along with looking into the potential health effects of use when combined with alcohol.

“FDA will review information brought to the agency’s attention about this product,” the agency said in a statement. “As with any complaint or concern we receive about FDA-regulated products, we will consider whether a violation of the Federal Food, Drug, and Cosmetic Act has occurred and, if so, whether regulatory action is warranted in light of FDA’s enforcement priorities and resources.”

The product’s manufacturer has come under fire for a round of advertisements that seem to show its use by younger men and women who are out at nightclubs, where alcohol may be present.

ABC News asked the inventor of the product about those ads. Edwards said the product itself is safe and fundamentally sound, but there is ongoing discussion within his company about how to market it and where to sell it.

“Speaking as an innovator, you’re not developing a product thinking of targeting people that it’s going to hurt. And so on the contrary, the motivation of this product was to actually create a healthier and more accessible way of having caffeine, when you need it, as opposed to overdoing yourself often when you don’t need it.”

For The Full Report Go To ABC News

Marketing of Sugary Drinks to Kids and Teens: As Strong as Ever

November 2, 2011

The Atlantic

By Kelly Brownell

Today’s children will be the first generation in the history of the country to lead shorter lives than their parents did. There are several contributors to this dim picture, but obesity leads the list.

Many things are being done to help prevent obesity in children and teens. One of the most visible is the effort by cities, states, and even entire countries to wage war on beverages with added sugar. What was once a simple landscape with only a few flagship beverages like Coke, Pepsi, and 7 Up has morphed into entire new categories of drinks with sugar — sweetened teas, vitamin waters, sports drinks, and energy drinks are examples. Collectively, these beverages are referred to as soda, soft drinks, pop, sugar-sweetened beverages, and sugary drinks — all terms referring to drinks high in sugar and containing little or no nutrition. In the 1990s, consumption of sugary drinks overtook milk consumption in the U.S., a trend that makes health experts cringe.

There is a long list of reasons why these beverages are bad actors:

They are the single greatest source of added sugar in the American diet and add little or no nutrition.
The body does not seem to recognize calories very well when they are delivered in liquids, hence sugary drinks appear to fool the body’s feelings of being full.
There is very clear evidence linking consumption of these beverages with elevated risk for obesity and diabetes.
There is massive marketing.

The health consequences of consuming sugary drinks are well known. It is not surprising, therefore, that groups such as the American Medical Association, the American Academy of Pediatrics, the Institute of Medicine, the Centers for Disease Control and Prevention, the World Health Organization, and other groups have said that consumption is too high and needs to come down.

What has been missing from this picture is a detailed analysis of how the industry markets these products to the most vulnerable segment of our population: children. It is important to know this in order to help establish government policies on whether children should be protected from this influence, and also test whether the industry is holding true to its promises to market less to this age group.

The beverage industry, dominated by Coca-Cola and PepsiCo, is represented by a trade association called the American Beverage Association (ABA). The beverage companies have made a number of promises that it will market less to children. Coca-Cola, for example, claims they “…will not place any of [their] brands’ marketing in television, radio, and print programming that is primarily directed to children under the age of 12…” Some industry critics believe that the chief aim of such promises is to court public trust and to convince legislators that government intervention is not necessary. Objective information is needed to see whether industry promises are kept and whether, in fact, children are exposed to less marketing of products that may cause harm.

Our group at the Rudd Center for Food Policy and Obesity at Yale University has just released the most extensive analysis ever of the marketing of sugary drinks to children and teenagers. This new report found that children are exposed to more — not less — advertising for sugary drinks than they were several years ago, and that the companies are finding new and sophisticated ways to reach youth.

Our study looked at 14 beverage companies and examined the nutritional quality of nearly 600 products, including full-calorie soda, energy drinks, fruit drinks, flavored water, sports drinks, and iced teas, as well as diet energy drinks and diet children’s fruit drinks. Some key findings:

Click here for the full report from The Atlantic.

The Dark Side Of Energy Drinks

October 7th, 2011

Natural News

By: Tony Isaacs

Energy drinks have become a modern day phenomenon, with tens of millions now being consumed daily. What’s not to like about having more energy and alertness, particularly if it comes from beverages which often tout herbal and other “natural” ingredients? As it turns out, there is a very great deal not to like – including unhealthy ingredients and potentially dangerous health consequences.

Some of the more common unwelcome side effects of energy drinks include elevated heart rates, hypertension, anxiety, headaches and interrupted sleep patterns. Earlier this year, a report in the medical journal Pediatrics warned against energy drinks and cited potential harms including heart palpitations, seizures, strokes and even sudden death.

Late last year, poison control centers started tracking energy drink overdoses and side effects nationwide. 677 cases occurred from October through December. The chart’s list of reported energy drink-related symptoms included seizures, hallucinations, rapid heart rate, chest pain, high blood pressure and irritability.

The two most common ingredients found in energy drinks are sugar and caffeine; both of which provide temporary stimulation but can result in actual long term energy loss due to stressing the adrenal glands and causing adrenal fatigue.

Just one of a huge number of health risks caused by processed sugar is the risk of diabetes, a disease which has reached epidemic proportions in the U.S. Very large amounts of sugar can ultimately overwhelm the pancreas, the organ which generates insulin to offset sugar intake. If the pancreas becomes “worn out” by being overworked from too much sugar, diabetes can begin.

Some energy drinks contain up to 7 times as much caffeine as a cup of coffee. While small amounts of caffeine are not generally considered dangerous, too much can over stimulate the central nervous system and can dangerously elevate blood pressure and heart rate. Caffeine is also addictive and withdrawal symptoms include headaches and irritability. Caffeine also causes a loss in valuable B vitamins which are needed for “normal” energy creation.

When sugar is not used, dangerous artificial sweeteners are employed. Perhaps the most dangerous is aspartame; though increasingly, the sugar substitute of choice has become sucralose. Sucralose is a chlorinated organic compound, a chemical group which includes several compounds known to be harmful to animals and plants and which has been linked to birth defects and other prenatal conditions. The body does not recognize artificial sweeteners like sucralose as food, but instead essentially processes them as toxins.

Other potentially dangerous ingredients commonly found in energy drinks include:

*Sodium benzoate. Last year a study conducted by an expert in molecular biology and biotechnology linked the common energy drink preservative sodium benzoate to cell damage and an increase in the production of free radicals. Even more concerning, sodium benzoate in combination with vitamin C causes the potent carcinogen benzene.

*Phenylalanine. Though an essential amino acid, phenylalanine is also a neurotoxin and is one of the three main ingredients which make up aspartame. Too much can excite the neurons in the brain to the point of cellular death.

*Guarana. Guarana (or guaranine) comes from the seeds of the guarana plant, which contain up to 3 to 4 times the caffeine as coffee beans.

*Ephedra. Ephedra has been described as a drug that increases heart rate and blood pressure at low doses and causes strokes, seizures, and possibly even death at high doses.

There are far safer options for achieving greater energy than energy drinks, such as super foods powders for example. The very best long term option is an active lifestyle combined with adequate sleep, avoidance of energy robbing toxins and stress and a healthy nutrient-dense diet.

Click here for the full report from Natural News

Experts Warn About Energy Drinks

February 14th, 2011

Reuters

By: Frederik Joelving

With Americans chugging energy drinks like never before, fears are growing among doctors that the ingredients might be putting some consumers at risk.

The beverages contain a hodgepodge of caffeine, sugar and dietary supplements such as vitamins and herbal extracts, whose effects aren’t well understood.

In a new report out Monday, Florida pediatricians describe cases of seizures, delusions, heart problems and kidney or liver damage in people who had downed one or more non-alcoholic energy drinks — including brands like Red Bull, Spike Shooter and Redline.

“Across the world there are signs that for some people who consume these drinks, there are side effects,” said Dr. Steven E. Lipshultz, who heads the department of pediatrics at the University of Miami Leonard M. Miller School of Medicine.

“The incidence is low, but in certain groups that pediatricians care for there may be higher risks,” he added.

The report, which calls for regulatory action and more research, comes only months after a U.S. crackdown on alcoholic caffeinated beverages such as Phusion Projects’ Four Loko.

U.S. sales of non-alcoholic energy drinks are expected to hit $9 billion this year, with children and young adults accounting for half the market,

Because the beverages are classified as nutritional supplements, they have received much less scrutiny and are under fewer restrictions than both foods and drugs.

Manufacturers claim their products will enhance both mental and physical performance. Red Bull’s website, for instance, says energy drink will increase concentration and reaction speed, and improve vigilance and emotional status.

“Red Bull’s effects are appreciated throughout the world by top athletes, busy professionals, active students and drivers on long journeys,” the website claims.

In 2010 alone, the company told Reuters Health, it sold in excess of 4 billion cans and bottles of the drink, which is now available in more than160 countries.

But according to the Florida researchers, who reviewed the medical literature on the topic, the industry’s claims of benefit are questionable.

“We couldn’t find any evidence at all of any therapeutic effects,” Lipshultz said.

He began to take an interest in energy drinks a few years ago, when four kids from South Florida were brought to the hospital after swallowing a vitamin concoction their teacher had bottled.

“They all came in feeling tingling all over,” Lipshultz said. “This prompted me to say, we’ve got to really learn about this.”

Click here for the full report from Reuters

Kentucky Man Claims Caffeine Insanity in Wife’s Death

September 20, 2010

Yahoo News

By Brett Barrouquer

A Kentucky man accused of strangling his wife is poised to claim excessive caffeine from sodas, energy drinks and diet pills left him so mentally unstable he couldn’t have knowingly killed her, his lawyer has notified a court.

Woody Will Smith, 33, is scheduled for trial starting Monday on a murder charge in the May 2009 death of Amanda Hornsby-Smith, 28.

Defense attorney Shannon Sexton filed notice with the Newport court of plans to argue his client ingested so much caffeine in the days leading up to the killing that it rendered him temporarily insane — unable even to form the intent of committing a crime.

Sexton declined requests for comment on the defense strategy he indicated he would pursue in filings before the court. Jury selection was scheduled to start at 9:30 a.m. EDT Monday. Opening statements were expected to begin around 1:30 p.m. EDT.

A legal strategy invoking caffeine intoxication is unusual but has succeeded at least once before, in a case involving a man cleared in 2009 of charges of running down and injuring two people with a car in Washington state.

Dr. Roland Griffiths, a professor of behavioral biology at Johns Hopkins University has noted in an unrelated study that there is a diagnosis for “caffeine intoxication,” which includes nervousness, excitement, insomnia and possibly rambling speech.

Prosecutors, meanwhile, said their own expert may testify there was no evidence Smith had consumed dietpills or energy drinks as he claimed before his wife died.

Prosecutor Michelle Snodgrass said Smith tested negative for amphetamine-type substances shortly after the killing.

Police say Smith used an extension cord to strangle his wife on May 4, 2009, then used the same cord to bind her feet together. Smith then used another cord to tie his wife’s hands.

If convicted of murder, Smith could be sentenced to life in prison.

Smith told Dr. Robert Noelker, a psychologist from Williamstown hired by the defendant, he remembers taking his children to school that morning.

But Smith remembers little else about the ensuing hours.

In the weeks preceding May 4, 2009, Woody Smith told Noelker, he hadn’t been sleeping, in part out of fear his wife would take their two children and leave him.

“The next several hours of Mr. Smith’s life, were described to me as if he were in a daze,” Noelker wrote in a report.

After sleeping intermittently, Smith had nap with one child he picked up from school at midday at a school near their home in Dayton, Ky., across the Ohio River from Cincinnati. After picking up the second child later that day, Smith said he went to his mother and stepfather’s house.

He described feeling “out of control,” weeping to the point of being unable to communicate. Smith eventually confided in his stepfather, Noelker wrote, “I think my wife is dead.”

Reports and case records say during that time, he was drinking five or six soft drinks and energy drinks a day, along with taking diet pills; it all added up to more than 400 milligrams of caffeine a day.

The Diagnostic and Statistical Manual of Mental Disorders — published by the American Psychiatric Association showing standard criteria for the classification of mental disorders — defines overdose as more than 300 mg. That’s about three cups of coffee.

Noelker said he determined Smith was open to “brief psychosis” brought on by sleep deprivation, which was caused by the heavy ingestion of diet pills and caffeine in the weeks leading up to his wife’s death.

“It is my opinion that this disorder was the direct result of psychosis due to severe insomnia,” Noelker wrote in a report filed in Smith’s case. Noelker is expected to be called as a defense witness.

The defense strategy recalls the case of Daniel Noble, a budget analyst at the University of Idaho Foundation who awoke Dec. 7, 2009, after a restless night and multiple weeks of working long hours on the foundation’s budget.

Attorney Mark Moorer of Moscow, Idaho, won a dismissal of charges against the 31-year-old analyst, who had been accused by authorities of running down and injuring two pedestrians with a car in Pullman, Wash. Each man survived with a broken leg.

Moorer said Noble awoke in pajamas and slippers in near-freezing weather, went to a Starbucks and downed two large coffees before driving eight miles to Pullman where the pedestrians were hit.

Medical tests in the Noble case resulted in a diagnosis of a rare form of bipolar disorder — triggered by heavy consumption of caffeine, Moorer said.

That evidence went before a judge, who dismissed the charges after concluding Noble was unable to form the mental intent to commit a crime.

“We referred to it as a temporary insanity defense,” Moorer said. “If you sat down and talked with him now, you’d think he’s as normal as you and I.”

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