The probiotics industry faces unique challenges simply because of the nature of the ingredients. They're alive, after all.

"Safe, natural probiotics are highly sensitive organisms, which can be easily weakened or destroyed by a variety of environmental factors during manufacture and storage," said Tim Gamble, president, Nutraceutix.

Shelf-stability hinges on three key factors: heat, moisture and chemical stability. And managing these is crucial to both manufacturers and suppliers, who must deliver live and functional probiotics down the supply chain, said Reza Kamarei, vice president, science and technology, Sabinsa Corp.

 Advances in technologyacross all delivery systemsare helping to give products longer shelf lives and consumers more security in their purchases.

"We've been putting a lot of effort both into the way we produce the probiotics and the way we dry them, and the excipients with which we store them," said Lars Bredmose, marketing director, Chr. Hansen. The result: Chr. Hansen pills and powders have jumped from one to two years in shelf life.

Developments in stability have also provided opportunities to pair probiotics with other ingredients. In May, Chr. Hansen released a chewable tablet combining Lactobacillus L. casei 431® and vitamin C for immune health.

To combat probiotics' inherit instability, Capsugel focuses on providing flexible and targeted delivery through low-moisture capsules. "Technological challenges are associated with ensuring the viability of probiotic bacteria during processing and storage of the product," explained Missy Lowery, Capsugel marketing manager, "as well as during the transition through the stomach and finally into the intestine, where probiotics work the best."

In late 2010, Capsugel released DRcaps, a vegetarian, acid-protected product that delays the capsule's opening. Because the hydroxypropylmethylcellulose (HPMC) product disintegrates slowlyin vitro, unpublished studies reveal the contents release fully at an intestinal pH of 6.8the capsule is better protected from stomach acid.

The low-moisture HPMC capsule has 4 to 6 percent moisture content in 50-percent relative humidity, which discourages the probiotics from activating in the package and before reaching the intestines.

Sabinsa has also been experimenting in its dietary supplement dosage forms, Kamarei said. Recently, the company developed a patent-pending bi-layer probiotic tablet. In this particular product, Sabinsa combines a layer of the probiotic microorganism (LactoSpore®) with a layer of prebiotic fiber (Fenumannan®). LactoSpore currently has a shelf life of two years at room temperature.

And longer shelf lives have a two-fold benefit. First, consumers can trust that their products are safe and effectiveimproving customer acceptance and business. But a longer life also translates to more opportunity, as Kamarei explained, "LactoSpore's two-year shelf life provides plenty of R&D opportunity for the industry to not be worried about the survivability of the probiotic while they prepare prototype of the product and test its stability at various conditions."

Advances in stability have also catapulted due to encapsulation processes that strengthen delicate strains. Similarly, the use of spore-forming probiotics and new, highly resistant strains have allowed the probiotics industry to penetrate the functional foods market.

Applying Functionality

"Probiotics" is almost synonymous with "yogurt," at least to the American consumer. But the industry is continually launching new products that transcend the traditional yogurt cup.

In the case of Sabinsa's LactoSpore, the frozen yogurt cup is the new probiotic hotspot. This August, the company announced its partnership with WellSpring Industry to provide probiotics for Tutti Frutti Frozen Yogurt, the world's largest self-serve frozen yogurt brand.

In late 2011, Chr. Hansen launched Lactobacillus paracasei 431^®, a probiotic developed to survive in low pH environments such as juice. And these environments present their own challengesnamely molds, yeast and cross contaminationthanks to pasteurization. For the project, Chr. Hansen used Swedish processing and food safety expert Tetra Pak to develop a safe inoculation system.

Bredmose said the probiotics addition improves both functionality and taste. "It takes a bit of the edge off of the sharp citrus flavors, and it can even mask some of the earthy notes of vegetable juice like carrot juice," he said.

Bredmose noted that including probiotics in products such as yogurt and juice do well for a reason: consumers already associate them with health. He explained, "It all comes down to products that consumers consider healthy and where they expect only natural ingredientsthose are good for probiotics."

Though refrigerated functional foods still dominate the probiotics marketplace, Ganeden is finding success with more novel launches, including pizza, muffins, instant coffee and chai tea. For these products, Ganeden uses its primary probiotic strain, GanedenBC30^TM, which can be baked, boiled, mixed and frozen.

And recently, the company has noticed a demand surge in convenience foodsa category that previously fell short in sales. "We're starting to see a revitalized interest in the confections category, so maybe consumers are ready for it," said Mike Bush, vice president of business development, Ganeden Biotech.

Bredmose expects probiotics to break into the skyrocketing Greek yogurt market. "The next step of major Greek yogurt brands like Chobani and Oikos could be to add further health benefits to those products with probiotics," he said.

Piggybacking off of the yogurt variety's success would be huge for probiotics manufacturers. Mintel reports Greek yogurt is "one of the fastest-growing foods ever to hit the U.S. market." Greek yogurt generally twice as expensive as regularrepresented nearly one-quarter of yogurt sales last year, according to market analyst SymphonyIRI.

Another dairy product ready for probiotics is kefir. This fermented milk drink is already common in the Middle East and Eastern Europe, but it hasn't quite caught on in America.

Kefir is a living culture containing both bacteria and yeast, and these grains ferment milk into a yogurt-like, tangy drink. Consequently, Bredmose said the American population has had trouble acquiring its strong taste. But, he noted, "If they hit the spot on the taste profile, I think kefir could be a very interesting story to sell together with probiotic health benefits."

And American consumers could learn from their international counterparts. Bredmose said while stateside recognition is growing, European and Asian consumers have long since known about the benefits of probiotics.

Bredmose said 60 to 70 percent of European customers understand the term probiotic, and the number goes up in Asian countries, especially Japan, Vietnam, South Korea and China.

"In Asia, Yakult has been promoting since 1956," he explained. "It's an ancient product that has literally spanned generations, and it's really part of their culture to eat probiotics with breakfast and afternoon tea. It becomes a habit that captures the attention of everyone."

And it's these habits that manufacturers should play into in the United States. Bush hopes Ganeden can to do just that. For probiotics to truly become mainstream, Bush said companies should focus on including probiotics into everyday, ordinary products that don't require forming new habits. "That way, your average consumer can get the benefits without having to insert a random product they have no experience with," Bush explained.

Ganeden recently partnered with Prairie Mills to offer oatmeal with probiotics, and Bush said consumers love it. Breakfast is a habitual meal for many people, so adding the probiotics simply complements an established routine. This truly resonates with consumers, Bush said. And considering manufacturers must appeal to all consumersnot just the supplement-savvythese piggybacking products may be key to boosting sales.

"We all agree that probiotics are needed every day," Bush said. "The goal of the probiotic industry in general is to have options that consumers can consume on a regular basis."

Global Guidelines: Regulations in Probiotics

Around the world, probiotics suppliers and manufacturers are being forced to respond to regulations regarding safety and claims.

In July 2011, FDA released a new dietary ingredient (NDI) draft guidance, which is unclear whether microorganisms like probiotics qualify as dietary ingredients. This, coupled with strict and burdensome filing demands, places a heavy burden on probiotics supply-chain players.

The guidelines are simply too vague, Bush said. And many in the industry fear the guidelines will stifle innovation. Luckily, FDA has decided to revise the draft, though it is unclear when.

"It means something different to every different type of company, and the entire supplement industry is trying to figure out how it affects them," Bush said. "In the meantime, we're hoping that the revised guidelines will be more reasonable and industry-friendly."

International manufacturers are fighting their own health claims battles. In 2007, the European Food Safety Authority (EFSA) released regulations requiring that any functional ingredient making health claims must meet scientific demands set by the authority. Probiotics still has a long way to go before passing the requirements, Bredmose said.

"It's not that the current science is not good science, but this requirement that has been set forth by the EFSA have been extremely high levelalmost pharmaceutical level, even though we are talking about food products here," Bredmose said.

As a result, companies are now performing phase two and three clinical studies which involve thousands of people. "But those take years," he explained, "and we are in the unfortunate situation that the regulations have kicked in without the required data."

Manufacturers are not allowed to make any health claims on functional ingredients after December without the required verification. But it should eventually improve the industry, Bredmose noted.

"Producers of probiotics have been asked to up their science and supply even more evidence of efficacy," he said. "Forcing the industry to make these investments is really going to advance the market, and we'll provide even more credible evidence of probiotic health benefits."

Attend the SupplySide West Probiotics Workshop on Friday, Nov. 7, 2012 from 8:30 to 11:30am to learn more about regulatory challenges and scientific advancements with speakers  Ulrich Adam, director, Hill+Knowlton Strategies; and Ivan Wasserman, partner, Manatt, Phelps & Phillips LLP.