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New York State Is Investigating Energy Drink Makers

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  1. Calliope
    The New York attorney general has subpoenaed three large makers of so-called energy drinks as part of an investigation into whether the companies are misleading consumers about how much caffeine the drinks contain and the health risks they could pose.

    The attorney general, Eric T. Schneiderman, is also looking at whether the companies — Monster Beverage, PepsiCo and Living Essentials — violated federal law in promoting the drinks as dietary supplements rather than as foods, which are regulated more strictly.

    State authorities are also concerned about whether all of the ingredients that go into the beverages are properly disclosed, according to an official briefed on the investigation who spoke on the condition of anonymity.

    The state investigators are also examining whether some additives, like black tea extract and guarana, may contain additional caffeine that is not reflected when the drinks are labeled.
    The subpoenas were issued in July, and the official said more companies could face requests for information as the investigation progresses.

    Besides Monster’s drink, the beverages under state scrutiny are AMP from Pepsi and 5-hour Energy drink, which is made by Living Essentials.

    Living Essentials reported that a state attorney general inquiry was under way last month during a bond offering, but a spokeswoman declined to comment further on Tuesday. Spokesmen for Monster and Pepsi also declined to discuss the subpoenas.

    The investigation was reported on Tuesday by The Wall Street Journal.

    In a statement, the American Beverage Association said it could not comment on the details of the investigation by Mr. Schneiderman. The trade association statement noted that ingredients and labeling for energy drinks were regulated by the Food and Drug Administration and that caffeine levels from additives were fully disclosed. It also said that the industry had voluntarily restricted marketing to children and the sale of energy drinks in schools.

    In 2010, the F.D.A. issued warning letters to four companies that made energy drinks combining alcohol and caffeine — Charge Beverages, New Century Brewing, Phusion Projects and United Brands — citing a health risk. Despite concerns by public health experts, the F.D.A. has not taken on makers of more traditional energy drinks, which are often carbonated and provide a quick, caffeine-fueled boost.

    Energy drinks have surged in popularity in recent years, especially among high school and college students. They have been a source of growth for beverage companies even as demand for more traditional drinks like soda has cooled. Coca-Cola considered a buyout of Monster earlier this year, but with a market capitalization of more than $10 billion, a deal for Monster would have been expensive, and Coke ultimately passed.

    Health advocates are concerned about the use of energy drinks among adolescents, particularly when they are consumed alongside alcohol, said Amelia M. Arria, an epidemiologist who serves as director of the Center on Young Adult Health and Development at the University of Maryland School of Public Health.

    “A person who co-ingests an energy drink and alcohol doesn’t understand how drunk they are,” Ms. Arria said. “Caffeine keeps you awake so you can keep drinking, and high levels of caffeine can mask intoxication.”
    “In my opinion, some of the marketing messages go overboard about the health benefits of these drinks,” Ms. Arria added. “The term ‘energy drink’ is misleading. Energy should come from calories — this is more about stimulation.”

    Studies have shown almost 30 percent of college students consume energy drinks regularly, Ms. Arria said. The high concentrations of caffeine they contain can produce cardiovascular complications, especially in young people or those who are sensitive to caffeine, she said.

    A November 2011 report by the Drug Abuse Warning Network, produced under the auspices of the Department of Health and Human Services, showed a tenfold increase in emergency room visits linked to energy drinks from 2005 to 2008.

    “Consumption of energy drinks is a rising public health problem because medical and behavioral consequences can result from excessive caffeine intake,” the report concluded. “A growing body of scientific evidence documents harmful effects, particularly for children, adolescents and young adults.”

    About half the emergency room trips were made by patients 18 to 25 who had also used alcohol or other drugs, according to the Drug Abuse Warning Network report.

    The amount of caffeine differs widely among drinks but can range from about 80 milligrams to more than 500 milligrams. By comparison, a 12-ounce cola contains about 50 milligrams of caffeine, while a 5-ounce coffee has about 100 milligrams.

    In its statement, the American Beverage Association said “most mainstream energy drinks contain about half the caffeine of a similar-size cup of coffeehouse coffee. And the caffeine content our members voluntarily display on their packages reflects total caffeine amounts, including those that come from other sources, such as additives.”

    Shares of Monster Beverage fell 55 cents, to $59.48, on Tuesday, while Pepsi fell 5 cents, to $73.12. Living Essentials is not publicly traded.

    NYTimes
    NELSON D. SCHWARTZ

    www.nytimes.com/2012/08/29/business/new-york-state-is-investigating-energy-drinks.html

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  1. Rob Cypher
    Caffeinated Drink Cited in Reports of 13 Deaths; FDA Wants Answers

    Federal officials have received reports of 13 deaths over the last four years that cited the possible involvement of 5-Hour Energy, a highly caffeinated energy shot, according to Food and Drug Administration records and an interview with an agency official.

    The disclosure of the reports is the second time in recent weeks that F.D.A. filings citing energy drinks and deaths have emerged. Last month, the agency acknowledged it had received five fatality filings mentioning another popular energy drink, Monster Energy.

    Since 2009, 5-Hour Energy has been mentioned in some 90 filings with the F.D.A., including more than 30 that involved serious or life-threatening injuries like heart attacks, convulsions and, in one case, a spontaneous abortion, a summary of F.D.A. records reviewed by The New York Times showed.

    The filing of an incident report with the F.D.A. does not mean that a product was responsible for a death or an injury or contributed in any way to it. Such reports can be fragmentary in nature and difficult to investigate.

    The distributor of 5-Hour Energy, Living Essentials of Farmington Hills, Mich., did not respond to written questions about the filings, and its top executive declined to be interviewed. Living Essentials is a unit of the product’s producer, Innovation Ventures.

    However, in a statement, Living Essentials said the product was safe when used as directed and that it was “unaware of any deaths proven to be caused by the consumption of 5-Hour Energy.”

    Since the public disclosure of reports about Monster Energy, its producer, Monster Beverage of Corona, Calif., has repeatedly said that its products are safe, adding that they were not the cause of any of the health problems reported to the F.D.A.

    Shares of Monster Beverage, which traded above $80 earlier this year, closed Wednesday at $44.74.

    The fast-growing energy drink industry is facing increasing scrutiny over issues like labeling disclosures and possible health risks. Some lawmakers are calling on the F.D.A. to increase its regulation of the products and the New York State attorney general is investigating the practices of several producers.

    Unlike Red Bull, Monster Energy and some other energy drinks that look like beverages, 5-Hour Energy is sold in a two-ounce bottle referred to as a shot. The company does not disclose the amount of caffeine in each bottle, but a recent article published by Consumer Reports placed that level at about 215 milligrams.

    An eight-ounce cup of coffee, depending on how it is made, can contain from 100 to 150 milligrams of caffeine.

    The F.D.A. has stated that it does not have sufficient scientific evidence to justify changing how it regulates caffeine or other ingredients in energy products. The issue of how to do so is complicated by the fact that some high-caffeine drinks, like Red Bull, are sold under agency rules governing beverages, while others, like 5-Hour Energy and Monster Energy, are marketed as dietary supplements. The categories have differing ingredient rules and reporting requirements.

    In an interview Wednesday, Daniel Fabricant, the director of the agency’s division of dietary supplement programs, said the agency was looking into the death reports that cited 5-Hour Energy. He said that while medical information in such reports could rule out a link with the product, other reports could contain insufficient information to determine what role, if any, a supplement might have played.

    Mr. Fabricant said that the 13 fatality reports that mentioned 5-Hour Energy had all been submitted to the F.D.A. by Living Essentials. Since late 2008, producers of dietary supplements are required to notify the F.D.A. when they become aware of a death or serious injury that may be related to their product.

    Currently, the agency does not publicly disclose adverse event filings about dietary supplements like 5-Hour Energy. Companies that market energy drinks as beverages are not required to make such reports to the agency, although they can do so voluntarily, Mr. Fabricant said.

    Along with caffeine, 5-Hour Energy contains other ingredients, like very high levels of certain B vitamins and a substance called taurine.

    Reached by telephone, the chief executive of the Living Essentials, Manoj Bhargava, declined to discuss the filings and said he believed an article about the reports would cast the company in a negative light.

    “I am not interested in making any comment,” Mr. Bhargava said.

    Subsequently, the company issued a statement that said, among other things, that it took “reports of any potential adverse event tied to our products very seriously,” adding that the company complied “with all of our reporting requirements” to the F.D.A.

    The company also stated that it marketed 5-Hour Energy to “hardworking adults who need an extra boost of energy.” The product’s label recommends that it not be used by woman who are pregnant or by children under 12 years of age.

    The number of reports filed with the F.D.A. that mention 5-Hour Energy appears particularly striking. In 2010, for example, the F.D.A. received a total of 17 fatality reports that mentioned a dietary supplement or a weight loss product, two broad categories that cover more than 50,000 products, according to Mr. Fabricant, the F.D.A. official.

    He added that it was difficult to put the volume of 5-Hour Energy filings into context because he believed that some supplement manufacturers were probably not following the mandated reporting rules and that consumers and doctors might also be unaware that they can file incident reports with the agency. Last year, the F.D.A. received only 2,000 reports about fatalities or serious injuries that cited dietary supplements and weight loss products, he said.

    Another federal agency, the Substance Abuse and Mental Health Services Administration, reported late last year that more than 13,000 emergency room visits in 2009 were associated with energy drinks alone.

    Along with Living Essentials, The Times sent queries last week to several producers asking whether they had received reports linking fatalities or serious injuries to their products.

    Representatives for two of those companies — Red Bull and Coca-Cola, which sells NOS and Full Throttle — said they were unaware of any such reports. A representative for PepsiCo, which makes Amp, also said it was unaware of any such reports.

    In addition to Red Bull, NOS, Full Throttle and Amp are also marketed as beverages, rather than as dietary supplements.

    http://www.nytimes.com/2012/11/15/b...tml?partner=rss&emc=rss&smid=tw-nytimes&_r=1&
  2. Calliope
    Energy Drinks Promise Edge, but Experts Say Proof Is Scant
    January 1, 2013[IMGL="white"]http://www.drugs-forum.com/forum/attachment.php?attachmentid=31066&stc=1&d=1358544663[/IMGL]

    Energy drinks are the fastest-growing part of the beverage industry, with sales in the United States reaching more than $10 billion in 2012 — more than Americans spent on iced tea or sports beverages like Gatorade.

    Their rising popularity represents a generational shift in what people drink, and reflects a successful campaign to convince consumers, particularly teenagers, that the drinks provide a mental and physical edge.

    The drinks are now under scrutiny by the Food and Drug Administration after reports of deaths and serious injuries that may be linked to their high caffeine levels. But however that review ends, one thing is clear, interviews with researchers and a review of scientific studies show: the energy drink industry is based on a brew of ingredients that, apart from caffeine, have little, if any benefit for consumers.

    “If you had a cup of coffee you are going to affect metabolism in the same way,” said Dr. Robert W. Pettitt, an associate professor at Minnesota State University in Mankato, who has studied the drinks.

    Energy drink companies have promoted their products not as caffeine-fueled concoctions but as specially engineered blends that provide something more. For example, producers claim that “Red Bull gives you wings,” that Rockstar Energy is “scientifically formulated” and Monster Energy is a “killer energy brew.” Representative Edward J. Markey of Massachusetts, a Democrat, has asked the government to investigate the industry’s marketing claims.

    Promoting a message beyond caffeine has enabled the beverage makers to charge premium prices. A 16-ounce energy drink that sells for $2.99 a can contains about the same amount of caffeine as a tablet of NoDoz that costs 30 cents. Even Starbucks coffee is cheap by comparison; a 12-ounce cup that costs $1.85 has even more caffeine.

    As with earlier elixirs, a dearth of evidence underlies such claims. Only a few human studies of energy drinks or the ingredients in them have been performed and they point to a similar conclusion, researchers say — that the beverages are mainly about caffeine.

    Caffeine is called the world’s most widely used drug. A stimulant, it increases alertness, awareness and, if taken at the right time, improves athletic performance, studies show. Energy drink users feel its kick faster because the beverages are typically swallowed quickly or are sold as concentrates.

    “These are caffeine delivery systems,” said Dr. Roland Griffiths, a researcher at Johns Hopkins University who has studied energy drinks. “They don’t want to say this is equivalent to a NoDoz because that is not a very sexy sales message.”

    A scientist at the University of Wisconsin became puzzled as he researched an ingredient used in energy drinks like Red Bull, 5-Hour Energy and Monster Energy. The researcher, Dr. Craig A. Goodman, could not find any trials in humans of the additive, a substance with the tongue-twisting name of glucuronolactone that is related to glucose, a sugar. But Dr. Goodman, who had studied other energy drink ingredients, eventually found two 40-year-old studies from Japan that had examined it.

    In the experiments, scientists injected large doses of the substance into laboratory rats. Afterward, the rats swam better. “I have no idea what it does in energy drinks,” Dr. Goodman said.

    Energy drink manufacturers say it is their proprietary formulas, rather than specific ingredients, that provide users with physical and mental benefits. But that has not prevented them from implying otherwise.

    Consider the case of taurine, an additive used in most energy products.

    On its Web site, the producer of Red Bull, for example, states that “more than 2,500 reports have been published about taurine and its physiological effects,” including acting as a “detoxifying agent.” In addition, that company, Red Bull of Austria, points to a 2009 safety study by a European regulatory group that gave it a clean bill of health.

    But Red Bull’s Web site does not mention reports by that same group, the European Food Safety Authority, which concluded that claims about the benefits in energy drinks lacked scientific support. Based on those findings, the European Commission has refused to approve claims that taurine helps maintain mental function and heart health and reduces muscle fatigue.

    Taurine, an amino acidlike substance that got its name because it was first found in the bile of bulls, does play a role in bodily functions, and recent research suggests it might help prevent heart attacks in women with high cholesterol. However, most people get more than adequate amounts from foods like meat, experts said. And researchers added that those with heart problems who may need supplements would find far better sources than energy drinks.

    A spokeswoman for Red Bull did not respond directly to the European marketing claims report but said that the company did “not make claims for individual ingredients but rather for the product in its entirety.”

    To woo consumers, companies have also used another tactic — including huge amounts of well-known nutrients that make for eye-catching numbers on labels.

    For example, a two-ounce bottle of 5-Hour Energy contains 500 micrograms of Vitamin B12, or 8,333 percent of the recommended daily allowance. The energy shot also has 20 times the recommended intake of Vitamin B6.

    B-group vitamins serve many functions, such as in the digestion of food. But several experts said that healthy people get adequate amounts of them from food and that huge added dosages do not provide benefits.

    “They are not going to increase energy levels,” said Paul R. Thomas, a scientific adviser with the National Institutes of Health Office of Dietary Supplements.

    Elaine Lutz, a spokeswoman for the distributor of 5-Hour Energy, Living Essentials of Farmington Hills, Mich., said the amounts of B vitamins used were safe and effective. “The body is going to use what it needs and it is going to excrete what it does not absorb,” said Ms. Lutz.

    The sugar found in some drinks does provide a quick source of energy. But as for glucuronolactone, the additive that made rats swim better, the authors of a recent report in a scientific journal, Nutrition Reviews, said they were clueless as to why it was used in the products or what it did.

    “Certainly, this is one ingredient for which evidence-based studies are needed to justify its popularity,” wrote the researchers. That same review, which examined all published energy drink studies, also concluded that there was an “overwhelming lack of evidence to substantiate claims” that drink ingredients, apart from caffeine and sugar, provided any benefits.

    The roots of the energy drink phenomenon — and the claims surrounding ingredient mixes — can be traced to Japan. Those origins appear tied to the emergence of supposed cure-alls after World War II, a time when drugs there were in short supply.

    In the late 1940s, Taisho Pharmaceuticals, a Japanese drug maker, began selling taurine extract, apparently drawn to it by accounts citing its wartime use by the Japanese Imperial Navy to reduce fatigue among sailors and sharpen their vision at night, a history of the drug company states. “A formula that is so effective in treating unexplained fevers, neuralgia, fatigue, whooping cough and other conditions for which there is no drug is very rare indeed,” an advertisement for the extract declared.

    But around 1960, Taisho executives decided to use taurine in a new product, one that helped start the energy drink industry — Lipovitan D.

    Lipovitan D, which was sold in a small vial, contained 50 milligrams of caffeine, 1,000 milligrams of taurine, various B vitamins and flavorings. The product, which was sold cold in drugstores, was a huge success during Japan’s economic boom years, particularly with overworked office employees.

    However, 50 years and 34 billion bottles later, Taisho officials acknowledged they had not run a single clinical study involving Lipovitan D.

    “Taurine is added to Lipovitan D not so much for specific medicinal benefits but for its multifaceted functions,” said Dr. Takanori Kouchiwa, a Taisho executive.

    It was also in the 1960s that a product appeared in Thailand that was similar to Lipovitan D in its ingredient mix. It was called Krating Daeng (pronounced grating deng), or Red Bull. An Austrian businessman named Dietrich Mateschitz reportedly discovered it when trying to cure a case of jet lag and, in 1987, he and the drink’s Thai creator founded Red Bull.

    Red Bull quickly became popular in Europe with truck drivers and students and as a mixer for alcoholic drinks. It arrived in the United States in the late 1990s and soon inspired hundreds of competitors. In 2002, for example, Monster Energy was marketed in a 16-ounce can, twice as large as Red Bull’s 8-ounce can and with twice as much caffeine.

    Over the years, some producers have financed scientific studies to try to bolster performance claims. A British researcher, Dr. Chris Alford, said that Red Bull approached him about a decade ago while he was doing work on the ability of stimulants to reduce fatigue in drivers.

    In 2001, Dr. Alford, a psychologist at the University of the West of England in Bristol who has received financing from Red Bull, published a study that found test participants given the energy drink had better reaction times, were more alert and showed increased physical endurance than test subjects given a placebo like flavored water. But studies like Dr. Alford’s, researchers say, only underscore caffeine’s known benefits. And more recent attempts to tease out the impacts of drink ingredients have produced mixed results.

    Last August, Scottish researchers reported that 1,000 milligrams of taurine taken as a supplement appeared to improve the performance of middle-distance runners. But other taurine studies have been negative or inconclusive. “We found it difficult to make any conclusions about what taurine was doing,” said a graduate researcher at Tufts University, Grace Giles, who headed a study that ran participants through a battery of mental reaction and memory tests.

    Dr. Goodman, the University of Wisconsin researcher, said he believed there was a reason for such equivocal results. The scientist, who works at the school’s college of veterinary medicine, said that laboratory animals, like mice or rats, must be given huge dosages of taurine to see an effect.

    “You can force a mouse to drink a lot of taurine,” said Dr. Goodman. “With humans, it is harder to do.”

    What may qualify as the strangest trial in the annals of energy drink studies was financed by Living Essentials, the distributor of 5-Hour Energy. The office of a proctologist in a small Maine town apparently served as a setting for the 2007 study, the results of which were never published. But its findings and other details about it, like its location, emerged in a 2008 lawsuit filed by the maker of Monster Energy against Living Essentials.

    The study found that test subjects given 5-Hour Energy experienced “energy” for about 40 minutes longer than when given Red Bull or Monster Energy, though it was not clear from court papers whether that difference reflected the energy shot’s higher levels of caffeine.

    But another finding from that study sheds an interesting light on one of 5-Hour Energy’s central claims — that the energy shot, unlike competitors’, produces “No Crash Later.”

    According to the study, 24 percent of test participants who received 5-Hour Energy had reactions similar to a “moderately severe crash that left them extremely tired and in need of rest, another drink or some other action,” lawsuit filings show.

    Ms. Lutz, the Living Essentials spokeswoman, said the bold “No Crash Later” statement on product labels was followed by a special mark. That mark, which also appears on the back label, explains in fine print that “no crash means no sugar crash.”

    That is hardly surprising, because 5-Hour Energy does not contain sugar.

    Asked whether consumers mistakenly believe that the shot does not produce a caffeine-related crash, Ms. Lutz said that the use of the special mark and its explanation were clear. “I don’t believe that it is misleading,” said Ms. Lutz, who added that the advertising division of the Council of Better Business Bureaus had approved the “No Crash Later” claim.

    She added that another study showing the benefits of 5-Hour Energy was undergoing “peer review” for possible publication in a scientific journal. But she declined to say why the results of the study, which was apparently conducted five years ago, had not yet appeared. That study found a benefit when 5-Hour Energy was compared to a placebo like flavored water, she said.

    Whatever the case, the energy drink boom has come full circle in Asia, the region where it started. Over the last decade, sales of Lipovitan D have fallen and its maker, Taisho Pharmaceuticals, has tried various strategies to revitalize the brand. Among them: bringing out Lipovitan Junior, a caffeine-free version for children.

    In Thailand, Krating Daeng has suffered a similar fate. Its producer has tried to freshen up that brand by proclaiming that the Vitamin B12 in it “helps the functions of the nervous system and brain.”

    Last year, the Foundation for Consumers in Thailand, an advocacy group, started a publicity campaign against energy drinks like Krating Daeng, arguing that producers were promoting unfounded health claims to push caffeine.

    “This product just needed a way to add value to extend its life cycle,” said Patchara Klaewkla, an official at the foundation. “This product has been in the market for a long time.”

    Hiroko Tabuchi contributed reporting from Tokyo and Poypiti Amatatham from Bangkok.

    NYTimes

    By BARRY MEIER

    http://www.nytimes.com/2013/01/18/business/lawmakers-seek-data-on-energy-drinks.html
  3. Calliope
    Officials Seek Energy Drink Information
    January 17, 2013

    [IMGL="black"]http://www.drugs-forum.com/forum/attachment.php?attachmentid=31072&stc=1&d=1358550030[/IMGL]
    Three Democratic lawmakers sent letters to 14 marketers of highly caffeinated energy drinks on Thursday requesting information about the products’ ingredients and any company studies showing their risks and benefits to children and young people.

    In recent months, the Food and Drug Administration has begun examining the safety of energy drinks after reports of deaths and injuries potentially associated with the products. The number of annual emergency room visits involving the drinks doubled from 2007 to 2011, according to a federal report released last week.

    In addition, claims by drink producers that their proprietary formulations give consumers a physical and mental edge are coming under scrutiny. There is little scientific evidence, researchers say, that the drinks provide anything more than a high dose of caffeine similar to that in a cup of strong coffee.

    The letters were sent by Senator Richard J. Durbin of Illinois, Senator Richard Blumenthal of Connecticut and Representative Edward J. Markey of Massachusetts to companies including Monster Beverage, Rockstar, Red Bull and Living Essentials, the distributor of 5-Hour Energy, a small, concentrated energy “shot” drink. Letters were also sent to PepsiCo, which sells Amp; Coca-Cola, which sells NOS; and Dr Pepper Snapple, which sells Venom Energy.

    Among other questions in the letters, the lawmakers asked the companies to specify the total amount of caffeine in their energy drinks. Products like 5-Hour Energy that are marketed as supplements do not list the amount of caffeine used, and producers take it from a variety of sources, including synthetic caffeine, the guarana plant and tea extracts.

    They asked why each company chose to market its energy product as a beverage or a dietary supplement. The two categories have separate rules about ingredient disclosures and reporting of potential health risks.

    The lawmakers also requested any studies that the marketers have run or underwritten that examine the effects of energy drink use on children or young adults.

    The few studies cited by energy drink companies to support their marketing claims have taken place among adults and have compared the effects of energy drinks with those of a placebo like flavored water.

    Other public officials, including the attorney general of New York State and the city attorney of San Francisco, are looking into drink makers’ marketing claims.

    NYTimes
    By BARRY MEIER

    http://www.nytimes.com/2013/01/02/h...found-to-back-up-claims-by-energy-drinks.html
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