Dietary Supplements, Cognitive Health, Relaxation/Sleep: What Goes Up...

September 16, 2011
Lynda Searby

In addition to staying mindful of regulations, manufacturers need to decide which side of the generational divide they are targeting if anti-energy products are to amount to anything more than a fragmented niche.

In the last few years, a whole new niche has sprung up around products for stress, relaxation, and sleeplessness. These so called “anti-energy” products-the antithesis of energy beverages-have attracted more than their share of media attention, not all of it positive.

Sensationalist stories have created the impression that party-goers and stressed executives everywhere are knocking back gallons of “sedating soda,” but the sales figures tell a different story.

Julian Mellentin, director of New Nutrition Business, a provider of analysis and insight into the global nutrition business, gives his estimate of the size of the market for anti-energy products.

“It’s a legitimate niche, but at the moment the size of the market is grossly exaggerated,” he told Nutritional Outlook. “Last year we looked into the market and interviewed all the players, and even a really generous estimate would only value the U.S. market at less than $50 million per year. In fact, one player actually told us the market was only worth $10 million in 2009.”

In other words, there are products for stress, relaxation, and sleeplessness on sale, but to refer to this area as a “market” is probably something of an overstatement. As David Jago, Mintel International’s director of trend and innovation, puts it: “There certainly appears to be a trend towards products that help the consumer with stress/relaxation/sleeplessness…but it’s a very difficult market to quantify, since claims vary from the very generic-for example, a tea that helps to relax and unwind-to much more specific products with functional ingredients that are claimed to aid relaxation/sleep.”
 

Latent Demand

However, just because there aren’t that many products on sale at the moment doesn’t mean there is no demand for them. On the contrary, according to Mitch Skop, senior director of new product development with New Jersey–based Pharmachem Laboratories, “This niche is appreciated by millions of consumers who are exhibiting various levels of stress, related anxiety, and related sleep disturbances.”

“This is for two reasons,” he continues, “the worldwide economy, in many countries, is still sputtering, causing many people to become worried and fixated on keeping themselves and their families secure...Another cause of physical stress is over-caffeination. Many people are consuming caffeine beverages throughout the day in their desire to remain alert and infused with energy. The energy and alertness provided by caffeine is stimulatory, which can have a negative effect on the nervous system.”

But regardless of how concerned consumers are about sleep/relaxation, it seems that the major food and beverage companies don’t want to gamble on anti-energy products.

In fact, New Nutrition Business’s research has identified a disparity between consumer health concerns and the R&D priorities of the major food and nutrition companies.

“Our survey found companies’ development focus is on digestive health, energy, cognitive health, and weight management-stress/relaxation didn’t figure, but it does figure in the top-six consumer health concerns identified by Health Focus International, which has proved to be a reliable barometer of consumer concerns in the past,” explains Mellentin.

The absence of any heavyweights, says Mellentin, is thwarting market development, as the niche is made up of lots of small, entrepreneurial firms, none of whom have the resources to educate consumers about the benefits of their products.

Mintel’s Jago agrees: “The market would undoubtedly benefit from the entrance of a major brand.”

 
Legal Lows

The vast majority of anti-energy products on the U.S. market are classified as dietary supplements, allowing their creators to describe how the product supports the structure/function of a particular organ, system, or condition by using claims such as “promotes/supports relaxation” or “supports against stress.”

As defined by the Federal Food, Drug and Cosmetic Act, a dietary supplement does not include a product represented for use as a conventional food (e.g., a brownie). However, a recent New York Times article has sparked concerns that conventional products with ingredients that have not been determined to be GRAS (Generally Recognized as Safe) for intended uses are being marketed as dietary supplements with the intent of escaping FDA’s radar. Products that have come in for criticism include Lazy Cakes “Relaxation Brownies,” since renamed “Lazy Larry,” which contains melatonin, a hormone that does not have GRAS status nor is an approved food additive.

Following the publication of the Times article, the Council for Responsible Nutrition (CRN; Washington, DC) called on FDA to “take action against conventional foods mislabeled as dietary supplements.”

Steve Mister, CRN’s president and CEO, stated: “Conventional food products, including cakes and brownies, that are fortified with a dietary ingredient, such as melatonin, are not dietary supplements despite being labeled that way; they are mislabeled conventional foods. [And] for a conventional food product to include a dietary ingredient, a company must either seek approval as a food additive or achieve GRAS status for the ingredient...CRN has reached out to the agency [FDA] and encouraged it to take swift action against these products.”

And FDA did finally take action in late July, issuing Lazy Cakes a warning letter informing that melatonin is not approved for use in food.

Melatonin was also at the center of controversy in January last year, when FDA sent a warning letter to Innovative Beverage Group Inc., the creator of Drank, a drink with 2 mg of melatonin in each can. The letter stated that “Any substance intentionally added to a conventional food, such as the beverage product ‘Drank,’ must be used in accordance with a food additive regulation, unless the substance is the subject of a prior sanction or is GRAS among qualified experts for use in foods...There is no food additive regulation in effect that provides for the safe use of melatonin, and we are not aware of any information to indicate that melatonin is the subject of a prior sanction. Likewise we are not aware of any basis to conclude that melatonin is GRAS for use in conventional foods.”

Drank is now sold as a dietary supplement, rather than a beverage, to legitimize the inclusion of melatonin, and is by no means the only brand doing this: the carbonated citrus drink Unwind, which is billed as the “ultimate relaxation beverage” and counts among its ingredients valerian root, melatonin, and passion flower; and Marley’s Mellow Mood citrus drink, which contains melatonin, along with various botanicals, and sports a prominent “dietary supplement” flash on the front of the can.

Marketers should be wary of this approach. In its warning letter, FDA shot down Lazy Cakes’ attempt to rebrand itself as a dietary supplement. For all intents and purposes, the agency said, the product is defined as a food because it made reference to the word cake, purported to use “the same ingredients your mother uses to make brownies,” and advertised itself as a brownie, a food item, through packaging. By contrast, the agency pointed out, a dietary supplement cannot be “represented for use as a conventional food or as a sole item of a meal or the diet.”

Following the Lazy Cakes warning letter, Mister stated: “We applaud FDA for its enforcement action against Lazy Cakes. CRN has reached out to the agency over the last several months, requesting that it examine whether this product is legitimately labeled as a dietary supplement. We’re glad the agency is listening. While some members of Congress have suggested that FDA needs additional power to address products such as this one, this enforcement action underscores the fact that FDA currently has the necessary tools for enforcement and is capable of using them.”

 
Beyond Dietary Supplements

Amid this controversy, there are signs that anti-energy products are moving beyond dietary supplements and into other delivery methods. If done responsibly and according to law, there could be potential here.

“Initially, stress products were mainly found within the supplements category, and still are. But there is growing demand for other delivery methods, like food and drink. For example, our anti-stress ingredient Serenzo has been successfully incorporated into an ‘energy and focus’ beverage marketed in the United States,” says Karen Jaunatre of ingredient supplier Bio Serae Laboratoires (Bram, France).

Examples of recently launched conventional food and beverage products include Mind Essential’s Relax marionberry-flavored water, which relies on flower essences for its purported stress-reduction effect; and BigQuark’s BeautySleep, launched at the start of 2010 and combining antiaging compounds with cell-protecting antioxidants, while also being positioned as an aid to sleeping well. Two new relaxation shot-style drinks were launched in summer 2010 by RelaxZen. Day Flight Instant Calm and Night Flight Sleep Soundly are specifically targeted at those traveling by air, and contain vitamins B6 and B12, passion flower and acai extracts, L-theanine, and GABA (gamma-aminobutyric acid). Another relaxation drink launched last year in the United States was Simmer, a canned beverage from Coca-Cola Bottling Company Consolidated and BYB Brands. This features ingredients such as passion flower, hops, chamomile, L-theanine, rose hips, and vitamins B3, B6, and B12. Taking the relaxation concept beyond beverages is Bach’s Rescue Gum, a homeopathic gum said to offer “natural stress relief” and containing the combination of five flower essences discovered by Dr. Bach.
 

Recipe for Success

Not all anti-stress products launched have been entirely successful, however: Dreamerz, for example, first launched in 2007 as an 8-oz milk drink containing Pharmachem’s Lactium-a hydrolysate of milk proteins-and melatonin.

According to Mellentin, although the product was “somewhat effective,” the problem was that people who have the biggest issues with sleep are older-usually 60-plus-and “do not want to drink 8 oz of liquid before bed.” Dreamerz subsequently launched the product in a “chocolate pillow” format.

The Dreamerz example highlights one of the main issues players in this market face-determining who their target audience is and identifying the right format and positioning for this demographic.

Broadly speaking, Mellentin says there are two potential target audiences for anti-energy products: 20-somethings who “are staying up too late and tanking themselves up with energy drinks,” and the baby boomers who he believes are genuinely interested in relaxation products.

“They are a completely different demographic, and a lot of the problem is that brands have positioning and imagery which are attractive to 20-somethings but are a turnoff to 50-somethings.”

While relaxation beverages might appeal to younger consumers, players in this space risk the wrath of critics who believe marketing melatonin-laced sodas at high school and college students is not entirely appropriate.

In Mellentin’s view, in any case, it is the older target audience that offers the greatest potential. One brand reportedly doing well with this consumer group is Dreamwater, a 2.5-oz zero-calorie shot drink based on a blend of melatonin, 5-HTP, and GABA. Since March, Dreamwater has faced competition from Snooz’n, an almost identical product.

 

From Herbals to Hormones

As the earlier product examples demonstrate, the ingredients being used in anti-energy products range from herbals and hormones to milk protein complexes and amino acids.

L-theanine, an amino acid found in green tea, is one of the most en vogue sleep and relaxation ingredients. Several suppliers have GRAS status for their L-theanine ingredients, including Blue California (Rancho Santa Margarita, CA) with L-TeaActive, Taiyo International (Minneapolis) with Suntheanine, and Ethical Naturals (San Anselmo, CA) with its AlphaWave ingredients.

Pharmachem’s Lactium is another ingredient with GRAS status. According to Pharmachem, Lactium has been the subject of several published clinical studies that have shown it to be safe, without side effects, and effective at regulating the major symptoms of stress on the digestive and cardiovascular systems (including blood pressure), as well as enhancing social, emotional, and intellectual capabilities. Most recently, Lactium was shown to improve various aspects of sleep disorders in a clinical study published in The Open Sleep Journal.

Bio Serae Laboratoires has developed Serenzo, an ingredient made from citrus for stress-relief support. “Serenzo helps reduce the inflammation induced by stress and consequently contributes to slow down the vicious circle of stress, and thus limits the stress response,” says Jaunatre.

Nutraceuticals International LLC (Elmwood Park, NJ), meanwhile, is offering saffron extract for a stress positioning. “Studies have said it aids in light depression and mood. We used two forms: liquid and dry form. A daily intake is 30 mg a day. After only eight days, the results of clinical trials show an improvement in mood,” says marketing director Nichole De Block.

From Next Pharmaceuticals (Salinas, CA) comes Seditol, an ingredient designed to promote relaxation and sleep while reducing the fatigue associated with poor sleep. It comprises a patented extract from Magnolia officinalis bark and a proprietary extract from Ziziphus spinosa seed and works by binding to brain receptors that promote relaxation and sleep, the company says.

An up-and-coming ingredient is GABA, which is one of the most popular relaxation-inducing ingredients in Japan, the home of functional foods.

“This ingredient, which is becoming widely used in Japan, is claimed to improve mental focus, balance, and clarity, while reducing stress and increasing relaxation, and has started to feature in product sectors such as tea drinks, soft drinks, and dairy products,” says Mia Naprta, market analyst with Leatherhead Food Research.
 

Waking Up to Future Potential

It is clear that the consumer interest and ingredients are there, but anti-energy products are a long way from catching up with their caffeine-laden competitors in terms of both volume and credibility. Perhaps the key to making a success of anti-energy products lies in shifting the focus onto the older generation of sleep seekers, and building concepts around these end-users.