Since 2009, FDA has received hundreds of safety incident filings, with as many as 90 linked to one liquid energy product alone: 5-Hour Energy, distributed by Living Essentials (Farmington Hills, MI). The incidents cited range from convulsions and heart attacks to a case of spontaneous abortion, according to The New York Times, and they’ve brought a flood of negative attention to the category from government agencies, watchdog groups, and anxious consumers.
The ink spilled on energy drinks could fill a superstore beverage section, and the heated discussion that’s followed has compelled lawmakers to petition FDA to increase its oversight of the category. Most vocal among the Washington critics are Senators Richard Durbin (D-IL) and Richard Blumenthal (D-CT). In October 2012, they sent a letter to Margaret Hamburg, FDA commissioner, noting in particular their concerns about marketing practices that target youth, lax regulations regarding caffeine, and the ambiguous boundary separating energy beverages from supplements.
Of course, whether energy beverages are in fact beverages and not just supplements administered by straw is a question lawyers will litigate long after a new product has seized Capitol Hill’s notice. But on the fundamental question of safety, it’s important to remember that a link between an adverse health event and energy beverage consumption does not necessarily a causal relationship make.
Indeed, FDA has yet to move aggressively on energy beverages because it doesn’t believe it has sufficient evidence to do so. Nevertheless, the agency plans to work with outside groups, including the Institute of Medicine, to “strengthen our understanding” of the products, with a focus on “such matters as the vulnerability of certain populations to stimulants and the incidence and consequences of excessive consumption of ‘energy drinks,’ especially by young people,” Michele Mital, FDA’s acting associate commissioner for legislation, wrote in a response to Senator Durbin.
In the meantime, energy drink manufacturers must operate in a tentative regulatory environment. But that doesn’t mean they can’t make changes to improve the reputation of their products and, perhaps more crucially, their potential to maintain a clean safety record. Clearly, the place to start is an ingredient review.
Caffeine in the Crosshairs
Which ingredient to start with? With the one ingredient most decisive in establishing energy drinks’ success—and the one most liable for the current controversy: caffeine. From South America to Arabia, today and throughout history, millions have relied on caffeine for mental stimulation and physical acuity.
How caffeine provides these benefits is well-trod territory. Researchers have determined that it attaches to receptors that normally bind the neurotransmitter adenosine. Adenosine’s job is to signal the central nervous system (CNS)—via those receptors—that it’s time to slow things down and go to sleep. But if adenosine can’t communicate with the CNS because its receptors are already binding caffeine, the “get to bed” message remains unheard and the body stays awake.
Further, caffeine may be one of the world’s most widely used “performance-enhancing drugs,” sparing muscle glycogen by shunting the body toward metabolism of fat for energy, and also possibly lowering the threshold for neuronal activation and making it easier to recruit muscles into exercise, thus tricking the brain into thinking a workout isn’t as hard as it really is.
Menacing headlines notwithstanding, the case for the safety of caffeine itself, when used responsibly, is largely settled. “Studies on the safety of caffeine in the form of coffee are abundant,” says Jeff Wuagneux, CEO, RFI Ingredients (Blauvelt, NY), “and people have been consuming caffeine from natural sources for centuries without serious safety issues.”
Tea, chocolate, guarana fruit, yerba mate, the aforementioned coffee: All claim caffeine as a naturally occurring constituent, and none has raised serious safety concerns when consumed in reasonable amounts. (The LD50, or median lethal dose required to kill half the members of a test group, for caffeine is widely accepted as 150 to 200 mg per kilogram of body mass—or, says Wuagneux, “roughly 80 to 100 cups of coffee for an average adult.” Even a java addict would admit: That’s hardly a reasonable amount.)
Beverages have historically been a convenient delivery medium for caffeine, and for good reason. As Nichole De Block, marketing director, Nutraceuticals International Group (Paramus, NJ), says, “Many people depend on caffeine to start their day. It boosts energy and causes you to feel more alert and awake. These effects seem to wear off after a couple of hours, so consumers look for energy drinks that provide them with the extra ‘oomph’ to get them through their day.”
What they don’t look for—or shouldn’t—are drinks that pack into a single shot or can caffeine levels far in excess of what’s safe. As De Block observes, “Scientific and public concern has developed due to the increasing numbers of energy drinks entering the market with caffeine concentrations well above those of mainstream energy drinks, which contain, on average, 10 mg per oz.” Combine this with many consumers’ predilection for drinking several energy beverages in one fell swoop and the “adverse events” that FDA has logged start making regrettable sense.
For the record, FDA currently limits the amount of caffeine in soft drinks to 0.02% or less of the product—roughly 71 mg caffeine per 12-oz soda. However, as Senator Durbin noted in his letter to Commissioner Hamburg, a 2011 Drug Abuse Warning Network report by the Substance Abuse and Mental Health Services Administration (SAMHSA) found energy drink caffeine levels ranging from 80 to 500 mg per serving—considerably higher than the 0.02% ceiling for soft drinks.
Steven Kessler, a cofounder of Steaz, (Doylsetown, PA), a producer of energy beverages and shots, believes that “serving size is an important aspect of the energy drink sector,” and that “the responsibility falls on the company to accurately designate serving sizes.” Realistically designating them helps, too.
“It certainly could send the wrong message,” Kessler points out, “if a company labeled its 20-oz can as one serving. Consumers would obviously think they were getting a reasonable portion, but they would be getting massive amounts of caffeine. This is where responsibility comes in.” For example, one 2.5-oz Steaz energy shot equals one serving and delivers 150 mg of caffeine, Kessler says; one serving of the company’s energy drink weighs in at 8 oz, but even at 12 oz, a full can still contains a sensible 100 mg of caffeine.
And consumers can read these levels right on the product package, as Steaz chairman Jay Garnett says the company has always disclosed caffeine content voluntarily. Meanwhile, although U.S. regulations require that companies list added caffeine in the ingredient statement, “the actual amount of caffeine—or any other ingredient, for that matter—does not need to be listed on the label, leaving consumers uninformed in regard to the amount they are consuming,” De Block says.
Organizations like the Center for Science in the Public Interest (CSPI; Washington, DC) have long advocated mandatory disclosure of added—not naturally occurring—caffeine contents, and the current energy beverage controversy may aid their efforts. That would please De Block, who supports such labeling, too, even if energy beverage ingredients are part of a proprietary blend. “I think all consumers should be aware not only of what ingredients they are ingesting but of how much they are ingesting,” she says. “We have a right to know how much of something is in a product.”
Kessler agrees, seeing only upsides to his company’s dose disclosure policy. “First of all, it shows transparency to the consumer,” he says. “Secondly, if levels of ingredients like caffeine are reasonable, it proves responsibility to the consumer. Lastly, an informed consumer is a more loyal, trusting consumer.”
A Natural Evolution
And that’s just the kind of consumer—loyal, trusting, responsible—that energy beverage manufacturers would be wise to court. Not only are such consumers less likely to overindulge during an all-night arm-wrestling match at the Sig Tau house; they’ll also help extend the category beyond its traditional base.
As De Block explains, “Athletes initially were the primary consumers of energy drinks, but as the market grew and expanded, athletes were no longer the primary target. Today, the majority of energy drinks are targeted at teenagers and young adults 18 to 34 years old, due to this generation’s on-the-go lifestyle and receptiveness to advertisements for these types of products.”
The youth demographic has been good to the category, but it has its limits. As Wuagneux says, “The youthful consumer wants to stay up late and get that immediate spike in energy, while the older consumer wants longer-lasting but less-intense energy and the ability to sleep. They also would like ingredients that keep them focused. The older consumer likely does not want addictive ingredients, and they usually want less sugar for fewer calories.” In other words, they may be as thirsty for energy as the frat-house crowd; they’d simply rather that energy come in a natural form and a more conservative dose.
Steaz’s Kessler has seen this shift firsthand. His company’s typical consumers are “health-conscious individuals who want extra energy and focus, but with the added benefits of all-natural, organic superfruits and caffeine.” Meeting their demands, he says, “reassures consumers that what they’re fueling their bodies with came from all-natural sources. Therefore, they’re not just keeping their bodies safe, but are doing something good for them, too. This will ultimately attract a wider base of consumers who are interested in living naturally.”
Of course, that assumes we can all agree on what naturalreally means. And in the case of energy ingredients, that’s a tall order. Outside of inputs like flavors and colors, FDA is largely mum on the term’s meaning, while USDA limits its opinion to the matter of natural meat and poultry. Thus, industry has filled in the blank with a working definition that encompasses “ingredients that are not synthesized or highly processed,” Wuagneux says. So according to this loose definition, “Artificial FD&C colors are often used in energy beverages, but are not natural,” he continues. “A sweetener like highly processed high-fructose corn syrup is not natural, even though it is naturally derived. Aspartame is not natural, but stevia extract is. And anhydrous caffeine is not natural, but extracts of caffeine-containing herbs are.”
This appears to check out with consumer opinion, too. As Steaz’s Garnett says, “We’ve found that the natural ingredients consumers love are guarana berries, green tea, and rainforest-grown yerba mate.” Studies apparently show that “these superfruits give a boost without the crash, and fuel bodies in a more natural way,” he adds.
His company feels comfortable using yerba mate as a natural source of caffeine because of its long history of safe use by South American cultures, and because of the scientific research supporting it. Going by the botanical name Ilex paraguariensis, the plant contains the purine alkaloids caffeine, theobromine, and theophylline, Garnett says, and its safety record is strong enough for FDA to designate it GRAS, or Generally Recognized as Safe. In fact, he continues, “Evidence suggests that use of yerba mate in energy beverages is not only safe, but provides numerous health benefits, including vitamins, minerals, amino acids, and antioxidants.”
While the company combines yerba mate with açaí, guarana, and other natural ingredients, “there isn’t anything chemically that happens to ‘synergize’” them, Garnett says. “However, the combination of all three helps to provide a balanced, sustained energy boost.” And as for levels, low to moderate amounts prove effective. Brewed and consumed like tea—as is common practice in South America—yerba mate can contain as much as 85 mg of caffeine per serving, or close to a cup of coffee. Mixed with other caffeine sources like green tea and guarana, he says, it “will create practical and safe levels of caffeine in beverages of any size, depending on the amount used.”
Also taking a cue from South America, De Block’s company offers a natural, plant-derived caffeine ingredient called chá de bugre. “Chá de bugre is brewed in large drums at times of festival in Brazil, and the people consume it to sustain their energy through the night,” she explains. Energy beverage manufacturers use the ingredient as a safe, all-natural stimulant that De Block says carries none of the “negative side effects commonly associated with stimulants like caffeine or ephedra.”
“It is known to contain naturally occurring caffeine, potassium, allantoin, and allantoic acid,” she says of the plant. And while De Block says that the latter two compounds may account for chá de bugre’s traditional use in wound healing—as well as its purported fat-burning properties—research hints that the combination of caffeine and plant sterols is what gives it its safe, mild energy. De Block’s company works with a Brazilian manufacturer to produce an exclusive 10:1 concentration of the ingredient that it notes should not be confused with the low-grade leaf powder commonly exported from Brazil.
Also, remember: caffeine isn’t the only game when it comes to energizing our bodies or our beverages. Wuagneux’s company offers a product called Chocamine cocoa extract that provides a natural, caffeine-free source of theobromine, the main methylxanthine in cocoa.
Theobromine, Wuagneux explains, is “similar to caffeine, with a few important differences.” For one, a 2011 study published in the Handbook of Experimental Pharmacology (Smit HJ), found that it yields a milder stimulating effect, producing energy without caffeine’s characteristic jitters. And because it has a longer half-life than caffeine—according to both the Smit paper and a 1996 study in the European Journal of Clinical Pharmacology (Mumford, GK)—it provides a more sustained dose of energy. Also like caffeine, theobromine inhibits adenosine receptors; however, it binds the A2A receptors associated with caffeine’s addictive qualities much more weakly, suggesting that it may be less habit forming.
The branded, self-affirmed GRAS ingredient is made from Theobroma cacao—a.k.a. chocolate—and “patented as a specific composition of cocoa and its key phytochemicals,” Wuagneux says. “This type of product will have appeal among older consumers because it is not simply ‘more caffeine.’ It’s also a very experiential ingredient. Much of the population actually feels something when they eat dark chocolate, whether it’s improved energy, enhanced ability to focus, or improvement in mood and well being.”
At use levels of 500 to 1,000 mg per serving, it could make a valuable addition to energy shakes and smoothies.
Then there’s D-ribose, the naturally occurring stereoisomer of the monosaccharide ribose. Ribose is the backbone of adenosine triphosphate (ATP), “the source for all cellular energy,” according to Tom VonderBrink, president, Bioenergy Life Sciences Inc. (Minneapolis). “Ribose is the starting point and the rate-limiting compound in the synthesis of these fundamental cellular compounds, and the availability of ribose determines the rate at which they can be made by our cells and tissues.”
VonderBrink’s company produces Bioenergy Ribose, a branded ingredient identical to the ribose in our cells but produced using natural bacterial fermentation. It’s not a stimulant, he notes, “and it does not produce the ebbs and flows to energy levels experienced with stimulant-based products.” He says it merely regulates the body’s natural energy synthesis process, helping reduce energy loss during stress and “minimizing any physiological consequences of a supply-versus-demand energy mismatch,” he explains.
VonderBrink points to more than 100 studies vouching for the ingredient’s benefits. “Clinical studies continue to show that supplementing with Bioenergy Ribose can significantly improve exercise tolerance during intermediate and strenuous bouts of exercise, shorten recovery time, reduce cramping and soreness, and reduce fatigue in people suffering from energy depletion,” he says. With over 30 issued or pending patents and the distinction of being the only ribose to receive a no-questions letter from FDA along with its GRAS affirmation, the product, VonderBrink says, “helps the body create and maintain energy naturally, and appeals to a broad range of consumers.”
Another supplier, Beneo (Manheim, Germany), says its functional carbohydrate isomaltulose Palatinose, derived from sugar beet, provides a more prolonged type of energy. Beneo says this is because Palatinose provides energy over a longer period of time in the form of glucose, the essential energy source for mental and physical performance. Thanks to a steady release of glucose, blood glucose and insulin levels are said to remain consistent, avoiding the “crash” which consumers may associate with more traditional forms of energy drinks. Thus, says Beneo, drinks using Palatinose are able to provide a combination of carbohydrate energy and increased alertness.
Supplier Cargill (Minneapolis) takes a different approach. This January, the company reported on a study published in Nutritional Neuroscience on sucromalt, a slowly digestible carbohydrate. Researchers said sucromalt may better maintain feelings of mental and physical energy compared to glucose. (Cargill markets its Xtend sucromalt brand, calling it a source of “steadier” energy delivery that doesn’t cause blood glucose spikes because it is slowly digestible.)
Cargill said this could give consumers more ingredient options. “Despite the growth of super-caffeinated products, it is clear that a growing sector of the population wants more options,” said Xtend line manager Deborah Schulz.
And at the 2012 Health Ingredients Europe trade show, supplier Naturex (Avignon, France) unveiled what it called a new, healthier energy drink concept—Lift, a fruit-flavored carbonated drink formulated with ginger and ginseng. Both botanicals are associated with energy boosting and are part of Naturex’s NAT healthy range of botanical extracts. (NAT also includes other energy-boosting ingredients like maca, rhodiola, guarana, yerba mate, and rosehip.)
“The global energy drink market was worth a massive €26.5 billion a year in 2011, according to research by Zenith International. But there are still large numbers of people who are not currently engaging with the energy drinks market because they feel they can’t identify with existing brands and don’t like the chemical-sounding ingredients found in many energy drinks,” said Antoine Dauby, marketing director.
He continued, “Our new Lift concept addresses these barriers to purchase directly by creating an alternative to traditional energy drinks, using only natural ingredients that will appeal to female consumers and more mature demographic groups. We believe Lift will act as a platform to inspire beverage companies to create innovative energy drink brands that score more highly on naturalness and healthiness than current energy drinks, thereby attracting new consumers to the category.”
More than Just Energy
But energy alone may not broaden the base for the energy beverage category. Marketers can include ingredients for cognitive health, memory, focus, performance, and mood enhancement, too.
“Even if products do contain caffeine, companies may instead choose to emphasize the product’s other attributes besides just the rush of energy it provides,” says Justin Prochnow, attorney and shareholder at Greenberg Traurig LLP (Denver).
De Block says formulators might consider including saffron, which contains crocetin and crocin, two compounds that, according to the University of Pittsburgh Medical Center, may improve memory and cognitive processing. “Memory and cognitive decline are common disorders in the elderly,” De Block says, “and saffron is a relatively mild intervention that may be effective.” Her company’s Saffr’Activ is a branded, all-natural extract of the red stigmas of the Crocus sativus, or saffron, plant. “It is used as a natural approach to reducing the feelings of stress, anxiety, and oxidant stress—especially in athletes—and also for cognitive function for good mental health.”
For its part, Steaz adds 400 μg of folic acid to its energy beverages for the vitamin’s health benefits, “including preventing certain birth defects if consumed prior to conception; prevention of colon, cervical, esophageal, stomach, and pancreatic cancer; and aiding in protection from cell damage and healthy development of cells,” Kessler says. The beverages also contain vitamin B12, which can help reduce fatigue and lethargy, regulate the nervous system, maintain healthy digestion, protect against cancers, and build healthy skin, hair, and nails, he adds.
But whatever ingredients you use, Wuagneux counsels caution. “In the current regulatory environment,” he says, be mindful of the claims you make. Energy beverages can’t “treat” illnesses or reverse aging, and it’s best not to make promises that a product can’t keep—especially considering that Representative Edward J. Markey, of Massachusetts, has asked the FTC to investigate energy beverage marketing claims.
It’s also important to remember that just because an ingredient is natural doesn’t mean it’s safe. “Again,” Kessler says, “it goes back to transparency, responsibility, and reasonability on the part of the manufacturer. For example, caffeine could come from all-natural sources, but if the portion size is massive, it may not be safe.”
He, and others, think that the industry can regulate itself—if itlooks at the long term. “At the end of the day,” he says, “consumer health, well being, and safety are the most important aspects of this business; the goal of energy drink companies should be to satisfy those three aspects in addition to enriching the lives of consumers.” We’ll drink to that.
Food Chemicals Codex Revises Caffeine Standards
As reported in January, the U.S. Pharmacopeial Convention (USP) has put forth a revised Food Chemicals Codex (FCC) monograph for caffeine. (The FCC is a compendium of food ingredient quality standards.) The new monograph includes a “more discriminating” liquid chromatography test for measuring the identity and quantity of caffeine content.
USP says the new analytical method is based on an equivalent method recently published in the caffeine monograph of the USP 35–NF 30, which is USP’s compendia for pharmaceutical and excipient standards. USP is now calling for public comment on the proposed caffeine standard. The deadline to comment is March 31, 2013.
In a press release, USP stated, “With the potential for closer regulatory scrutiny of products high in caffeine content following alleged adverse events and consumer group petitions, companies will need to be confident that they know with greater precision what they are incorporating into their products—and in what quantity.”
USP’s senior director of food standards, Markus Lipp, told Nutritional Outlook that the monograph update is part of USP’s continual, routine process of ensuring standards reflect the latest technology. “We did receive specific feedback from some of our international FCC users that the current method in the monograph was not specific and unique enough for caffeine and could be disturbed by other components,” he says.
Are monographs eventually needed for botanical ingredients that naturally contain caffeine, such as guarana or yerba mate? “The complexity of quality standards for plant-derived ingredients such as guarana and yerba mate that are comprised of many different chemical compounds is even higher than for a rather well-defined chemical such as caffeine,” says Lipp.