Pre and Probiotics: Science, Regulations, and Economic Forecasts

November 11, 2011
Alan Richman

Buffeted by lawsuits, regulations, and enforcement actions, probiotics suppliers continue to affirm the safety, efficacy, and value of their products.

Prior to this July, most responsible probiotics suppliers and manufacturers eagerly looked forward to regulators announcing definitive guidelines about their category. Now they’ve gotten what they wished for-and they’re not happy. The proposed rules are much less favorable than probiotics supporters would have hoped.

In July, FDA published New Dietary Ingredient (NDI) draft guidance. According to some observers, the effect on the probiotics sector could be devastating.

Food and drug attorney Marc Ullman, a partner in New York, NY–based Ullman, Shapiro & Ullman, has stated, “Companies that manufacture probiotics need to be particularly concerned with the NDI guidance as it appears to pose a fatal threat to this product category. In particular, the guidance takes the position that ‘not all bacterial microorganisms are dietary ingredients, and a microorganism that is not a dietary ingredient cannot be a NDI.… Bacteria that have never been consumed as food are unlikely to be dietary ingredients’” (Section IV, C, Question 4).

The draft guidance document also states, “FDA considers each strain of a bacterial or yeast species to be a separate ingredient” (Section VI, A, Question 17). Ullman remarked, “It seems that the agency is taking the position that any new strain of bacteria used in a probiotic is not a dietary ingredient. If this is correct, this would effectively ban innovation in this area and virtually wipe out this product category.”

Time to Panic?

So what are probiotics suppliers supposed to do-drop everything, lock the front door, and go home? No way! As this was being written, FDA’s draft guidance was precisely that-a draft to be analyzed, discussed, and amended. There is no guarantee that the first version will be the final decree.

On the other hand, the guidance is important in that it reveals the strategic thinking of the regulators. As such, no one can blame those in the probiotics sector for being at least a little nervous. This is particularly true because the new NDI guidance is not the only front on which probiotics companies find themselves besieged. In recent months, there also have been costly lawsuits.

In late 2010, Dannon reached a settlement with the FTC and 39 state’s attorneys general over claims that, the government alleged, exaggerated the health benefits of Dannon’s Activia yogurt and DanActive dairy drink. The company, based in White Plains, NY, agreed to pay the states $21 million and subsequently agreed to pay consumers up to $45 million in damages to settle a class action over the same issue. In a report published by The Cleveland Plain Dealer, local attorney John Climaco, one of the leaders of the legal team bringing the suit, called it the largest settlement ever obtained in a food product case.

While agreeing to the settlement with the FTC, Dannon admitted no wrongdoing. The company said it “cooperated fully” with the FTC’s probe, and that the settlement “allows Dannon to continue to advertise the core benefits of its products, that Activia helps to regulate the digestive system and DanActive helps to support the immune system.”

Under terms of the class action settlement, Dannon was required to remove the words clinically and scientifically proven from labels and advertisements of Activia yogurt, and to substitute the words clinical studies show, or something similar. Dannon also had to acknowledge that Activia and DanActive yogurts are food, not treatments or cures for any medical disorder or disease.

Also, the company agreed to remove the word immunity from DanActive labels and ads, as well as include a qualifier to the claim the yogurt “helps strengthen your body’s defenses” or “helps support the immune system.” The qualifier states that this is only true “when [DanActive is] eaten regularly as part of a balanced diet and healthy lifestyle.”

Once again, Dannon officials admitted no wrongdoing but said they accepted the settlement to avoid the distraction and expense of prolonged litigation.

What Can We Learn?

If there is a take-home lesson from these separate “assaults” on probiotics, it may be that regulators are paying close attention not only to what is in these products but to the claims being made on their behalf.

Mike Bush, vice president of business development for Ganeden Biotech (Cleveland, OH) and a member of the board of the International Probiotic Association (IPA), says it is vital to recognize that “the regulators are serious, and industry has to follow the rules.… If you get a warning, act quickly to correct the situation,” he advises.

Bush, who describes a strain called BC30 (Bacillus coagulans GBI-30, 6086) as Ganeden’s leading “high-survivability probiotic,” says regulatory worries don’t cease on American shores. If anything, he indicates, the European Food Safety Authority (EFSA) is even harsher in its treatment of supplements sporting live microorganisms. (Read more about EFSA’s effects on probiotics on page 52.)

In October 2009, The Independent, a London-based newspaper, wrote, “Of 180 claims for probiotic ingredients, the EU’s food agency, EFSA, threw out every one.”

As Bush sees it, there is a Catch-22 at work here: EFSA insists on seeing results-oriented data based on use of probiotics in healthy individuals. But when subjects are already healthy, results may be less extreme and therefore no basis for claims. The Ganeden executive says studies have been done showing results in people who are not healthy, but EFSA will not consider such data.

Despite the frustration, Bush says, “Ganeden is a science-based company. We won’t stop doing science, and we hope others also will stick with their research as well as supporting the efforts of the National Institutes of Health.”

Michael Shahani, COO of Nebraska Cultures (Walnut Creek, CA), says, “We would like to cooperate with members of EFSA and FDA.” Shahani, who currently serves as treasurer of the Zurich, Switzerland–based IPA, says that the organization has been somewhat successful in working with Health Canada, less so with other regulatory powerhouses.

Shahani believes rulemaking would be more relevant and helpful to consumers if the industry were allowed to provide enough input to make sure regulators had a clearer understanding of the strengths and limitations of probiotic organisms.

This past June, the IPA, together with the European Food and Feed Cultures Association (EFFCA) and the International Food Additive Council (IFAC), issued a position paper urging FDA, in NDI reviews, to evaluate the safety of probiotics at the species and not the strain level. Nonetheless, the agency didn’t heed this advice in its new NDI guidance.

Shahani says the DDS-1 strain of Lactobacillus acidophilus researched by his father Dr. Khem Shahani in the late 1950s is his company’s flagship product. DDS-1 stands for the Department of Dairy Science Number One strain, and the corporate name Nebraska Cultures honors the University of Nebraska, where the elder Shahani conducted his lab work.

Recently, says the younger Shahani, the firm introduced a new line of Legacy Blends, including four new probiotics blends called Pro-Traveler, Healthy-Defense, Kid-Kare, and Digestion-Plus. Pro-Traveler, the company says, is “helpful for combating common food-poisoning bacteria;” Healthy-Defense is “formulated to help fight yeast, fungal, and viral infections;” Kid-Kare is “designed to help replenish the strains most commonly found in healthy children and infants;” and Digestion-Plus is “designed to support a healthy colon by replenishing healthy bacteria, improving digestion, and acidifying the colon.” All four contain DDS-1 along with other strains.

Shahani describes development of condition-specific formulas like these as an industry trend, but also warns that it’s a “tricky area.” Each consumer is unique, he points out-different in diet, environmental exposure, stress level, and drug regimen. “Therefore, what may benefit one person may not be necessarily right for another.”

If any generalization can be made, however, it probably is in the mode of action by which probiotics confer their benefits. Shahani explains: When probiotic products are introduced to the intestines, they find a place to “rent.” They then thrive and grow, producing enzymes, vitamin B, and folic acid. If all goes well, they can help protect against pathogenic bacteria and even small amounts of antibiotics.

According to the IPA, clinical studies have demonstrated that probiotics can offer many health benefits, including: reduction in the occurrence and duration of rotavirus diarrhea, reduction in duration of antibiotic-associated diarrhea, alleviation of symptoms of lactose intolerance, alleviation of symptoms of food and skin allergies in children, reduction of recurrent ear and bladder infections, reduction in the incidence and/or duration of bacterial vaginosis, and improvement of halitosis.

“Eventually, any disease that’s associated with an internal system imbalance would be an opportunity for probiotic research,” adds Isabelle Champié, global marketing director, Institut Rosell-Lallemand (Montreal, QC, Canada). “Currently, research is being done in areas such as gastrointestinal disorders linked to medication intake or travel; oral care (gingivitis, halitosis); brain-gut axis, including depression; anxiety; obesity and metabolic syndrome; cardiovascular disorders; allergies and atopic dermatitis-and the list goes on.”

“We’re seeing a trend towards using specific formulations to [support] specific health conditions,” she continues. “At Institut Rosell-Lallemand, we already have several of these formulations, which we call condition-specific probiotics. While this approach is new here, it has been popular on other continents, including Europe, for some time. For example, our ProbioKid probiotics support a healthy immune system for children and our Probio’Stick helps you feel better in stressful situations. Both have shown their efficacy in clinical trials.”

Forging a Standard

IPA cites articles from the association’s newsletter, BacTalk. Current issues include a report on the organization’s latest efforts to standardize probiotic testing methodologies by product category, including dairy, supplements, single strains, mixed strains, probiotic functional foods, and beverages. Following that, its goal is to help develop a unified codex of protocols. “This will ensure that products going out to the market will not overpromise and underdeliver, and that the consumer will be confident that the probiotic products [he or she is] buying contain the amount of probiotic bacteria listed on the label.”

Once this is done, IPA also plans to establish a quality-seal program, which will be facilitated by a third-party testing laboratory. “The IPA Seal of Quality will be recognized by the consumer and backed by the scientific community and industry,” the organization says.

Why Bother?

If probiotics were merely an esoteric corner of the dietary supplement marketplace, all this concern might be considered over the top. But that is not the case. Even with some sources acknowledging a lack of solid product understanding at the consumer level, almost all recognize that staunch sales figures indicate substantial current acceptance and a great future for the category.

Case in point: If Dannon can weather a payout of $66 million, then sales of Activia and DanActive have to be significantly higher. In fact, one estimate of Dannon’s 2008 sales suggested that these two products accounted for some 40% of total sales. Overall, Group Danone, the parent company, reported worldwide sales of €17 billion in 2010. At current exchange rates, that’s about U.S. $24 billion.

A 2009 study by Agriculture and Agri-Food Canada, a government agency, reported 2008 U.S. sales of probiotics at approximately $1.527 billion. Principal author Sharan Evani also pointed out in a press release, “The U.S. market for probiotics has been slower at developing than in other regions, particularly Europe and Japan, and has only started building momentum since 2005.”

The IPA cites data from Wellesley, MA–based BCC Research showing global sales of probiotics are expected to reach $19.8 billion within four years. According to IPA, this would make probiotics the biggest-selling functional food category in the world.

Frost & Sullivan, a global growth consulting company, says the probiotics market is growing at nearly a 14% rate, with rising interest continuing for probiotic supplements.

This would confirm Evani’s finding that probiotics “are not just for dairy products.” In the press release, she cited the following novel form of delivery for live microorganisms-Nestlé’s Boost Kid Essentials Nutritionally Complete Drink, which includes a straw containing probiotics that allows them to be consumed as the drink passes through the straw. “Similarly,” she stated, “a bottle cap containing probiotics has also been developed for beverages.”

Formats and Products

More common dietary supplement formats include pills, powders, liquids, etc. And, because we are speaking of probiotics, cultures lie at the heart of it all.

Danisco, a Copenhagen-based company with U.S. headquarters in Madison, WI, offers the HOWARU line, including: HOWARU Restore, to strengthen gut health; HOWARU Protect, to reinforce the body’s natural defenses; various HOWARU Balance products in adult, senior, and kids versions; HOWARU Dophilus, in which the genome has been fully sequenced; HOWARU Bifido; and HOWARU Rhamnosus. The company also features the FloraFIT brand with what Keith Mehring, global business director for supplements, nutritionals, and immune health, calls “the widest selection of single strains in the industry.”

Cargill offers a number of probiotic cultures, including: Direct vat cultures, which can be added directly to milk with no intermediate growth step; Viable cultures, which are single strains or combinations of probiotic cultures of Bifidobacterium lactis, Lactobacillus johnsonii (formerly Lactobacillus acidophilus), Lactobacillus paracasei, and Lactobacillus rhamnosus; SBIFIDUS BATL, a range of probiotic yogurt cultures consisting of the acidifying strains Streptococcus thermophilus and Lactobacillus delbrueckii subspecies bulgaricus plus either two, three, or four different probiotic strains (see the options listed under Viable cultures); and Ultra-Gro yogurt cultures, which are traditional blends of Streptococcus thermophilus and Lactobacillus delbrueckii subspecies bulgaricus and which work well for a variety of types of yogurt. Thickening strains of Streptococcus thermophilus are also available as single strains to permit easy formula optimization.

In April of this year, the Swiss company Lonza Inc., which has U.S. offices in Allendale, NJ, announced the signing of a worldwide exclusive license agreement with Organobalance (Berlin, Germany). Lonza will develop, produce, and commercialize products containing a probiotic Lactobacillus strain that is reported to act against Helicobacter pylori (H. pylori), which has been implicated as a common cause of peptic ulcers and gastritis.

Roman Quinter, Lonza’s senior vice president and head of nutrition ingredients business, stated in a press release, “This agreement creates a basis for our company to enter the probiotic market-a market with vast growth potential-with a unique ingredient.”

Gregory Bonfilio, director of business development for Pharmachem Laboratories (Kearny, NJ), says his company has an exclusive distribution agreement with Probiotical S.p.A (Novara, Italy) that enables it to offer a full range of probiotics, primarily Lactobacillus and Bifidobacterium strains. Bonfilio says the line consists of “about 25 distinct strains in bulk form, allergen-free and made under pharmaceutical standards.” Noting that Probiotical’s facility is 100% dedicated to probiotics for human health, the Pharmachem executive adds, “Everything we sell is supported by human clinical studies.”

According to Bonfilio, leading products in the line include: BIFIVIR, a symbiotic food supplement developed to support against the occurrence, intensity, and duration of respiratory infective episodes such as cold and flu, especially during the winter season; FLORATOPIC, a probiotic food supplement representing the newest generation of natural immunomodulating probiotic treatments, aimed to reduce the severity of atopic dermatitis symptoms (as determined by the SCORAD index), thus significantly improving quality of life; and ACTICAND, a probiotic medical device with a specific antagonist activity against acute vaginal infections by Candida and their recurrence. And, he adds, Probiotical also manufactures other strains under contract, making strains that are owned or licensed by its customers.

On its website, Redmond, WA–based Nutraceutix Inc. lists more than 20 available strains of bulk probiotics. Under its Prime Biotix Factory Direct banner, it claims to be “one of the few contract manufacturers that has the proper equipment, expertise, and processes to ensure probiotic organism survival during manufacture.”

On the website, the firm also says its trademarked LiveBac processes guarantee extended shelf life for probiotics, even at room temperature. Furthermore, the BIO-tract delivery technology not only protects probiotic organisms from stomach acid on their way to the intestinal tract, but also enables custom release profiles optimized for probiotics and other active ingredients.

Assessing the potential for growth of probiotic products, Tim Gamble, senior vice president of sales and marketing, says, “Consumers, across the board, are increasing their consumption of probiotics. Consumers who are less knowledgeable about probiotics are not shying away from products containing them, perhaps simply because the term is no longer alien to them.” He attributes this to the efforts of the big marketing machines in the food space.

Turning to recent events that could deter growth, Gamble has stated, “As has been seen of late, inappropriate messaging can get these brands into trouble and, unfortunately, create the impression that there is a problem with probiotics when in fact the problem is not with probiotics but with marketing.”

His own company, he says, has seen strong growth in all areas of its probiotic business, but particularly in finished probiotic tablets/caplets that benefit from state-of-the-art processes and delivery technologies.

Protecting Probiotics

Selecting an effective, condition-specific dosage of a science-backed probiotic strain is only part of the battle when it comes to creating a probiotic formula that will truly help consumers. Keeping probiotics viable as they travel to their target site, by way of a protective delivery system, plays a big role. With this in mind, capsule specialist Capsugel (Greenwood, SC) offers numerous advanced capsule choices, each designed to offer friendly bacteria maximum protection until they reach their targeted destination-the intestines.

The company offers a series of capsules made from plant-based HPMC (hydroxypropyl methylcellulose), instead of gelatin, that are especially suited for probiotics.

“Vegetarian capsules provide a preferable low-moisture delivery system for stability, and probiotics can be encapsulated without binders or exposed to the rigors of the manufacturing process required for tablets,” says Missy Lowery, marketing manager.

The company says that as a capsule material, HPMC has a lower moisture content (4 to 6% in 50% relative humidity) compared to gelatin, which can have a moisture content as high as 12 to 14%. And if you’re dealing with moisture-sensitive probiotics, this can make all the difference.

Even more specifically, Capsugel promotes its Pre-Pro Combo, introduced in 2008. It’s a capsule-in-a-capsule design that contains probiotics in the inner capsule and prebiotics in the outer. The prebiotic capsule releases its contents first while the probiotic capsule keeps its ingredients protected from releasing its sensitive ingredients too early.

Also approaching probiotic protection from the angle of acid protection, Capsugel offers DRcaps, launched in March. DRcaps offer a slow-disintegration technology that keeps a capsule’s contents protected for at least 30 minutes at a stomach pH of 1.2. When the capsule hits a pH level of 6.8 (in the intestine), it then releases its contents. Moreover, the company says, because the capsule itself serves as the mode of protection, companies can eliminate the need to apply secondary protective coatings that are not only costly but that can also damage ingredients due to heat or microbial contamination.

A Few Words About Prebiotics

Living things don’t survive without nourishment. This is true of humans, animals, plants, and even the microorganisms that constitute the probiotics category. Enter prebiotics.

Juliana Zeiher, business development manager of Westchester, IL–based Corn Products International, says, “Prebiotics are ingredients that selectively stimulate the growth or activity of beneficial gastrointestinal microflora, thus conferring benefits to the host. In other words, prebiotics are the food for the good bacteria. Prebiotics do not feed pathogenic bacteria and tend to be effective at low doses.”

Following the same line of thought, Nebraska Cultures’ Michael Shahani cites the work of Robert Hutkins, PhD, a senior scientist at the University of Nebraska, where much valuable research has been done on microorganisms. Shahani says prebiotics are to probiotics as fertilizer is to farm crops-a key element in the process.

Frank Fox, commercial director Americas for FrieslandCampina Domo (Paramus, NJ), describes prebiotics as a “second-generation product” in comparison with probiotics.

“Probiotics are getting more and more awareness with the consumers. Prebiotics can be seen as already a next generation in the development,” he says. “These ingredients will find their way to the consumer as the consumer awareness of the benefits will increase.”

He continues, “While consumer understanding of prebiotics has lagged behind the awareness of probiotics, market surveys show that there is sustained interest in the benefits of prebiotic fermentation, particularly prebiotics that increase level of beneficial bacteria probiotic like Bifidobacteria. In addition, these ingredients can now be found in everyday foods and beverages that fit into consumers’ lifestyles.”

The company’s heat- and acid-stable Vivinal GOS prebiotic is derived from galactooligosaccharide from dairy, a result of the enzymatic conversion of lactose, or milk sugar, by the enzyme beta-galactosidase. As a prebiotic, it is selectively fermented by probiotic bacteria-especially Bifidus and Lactobacilli-encouraging these beneficial bacteria to flourish. In addition, it promotes the production of short-chain fatty acids that can aid in lowering colonic and fecal pH-all good for the gut. In fact, the company says that Vivinal GOS has been shown to inhibit the adherence of pathogens to the colonic mucosal lining, promoting health of the colonic cell wall.

 

Pain in the Gut

Suppliers and users of probiotics need to spend significant amounts of time-and money-chasing positive health claims in Europe.

By Paul Gander

References to the health benefits of probiotics (although not couched precisely in those terms) go back to Pliny in the first century BC and, before that even, the Book of Genesis.

Despite this track record, and rather more solid research over the last century, those developing and applying probiotic and prebiotic products to aid digestive health could be forgiven for-rather unscientifically perhaps-hoping for a miracle of biblical proportions. 

Lars Bredmose, marketing director for probiotic cultures at Chr. Hansen (Hoersholm, Denmark), identifies at least two areas of risk for the category. The first of these, unsurprisingly perhaps, is the European Food Safety Authority (EFSA) health claims process.

Of course, probiotics is not alone in seeing this applications procedure as a threat, nor in having suffered a severe setback with multiple negative EFSA opinions under Article 13.1 of the regulation, but Bredmose presents the risk in particularly stark terms. “If it goes on for too long, with industry being unable to convince EFSA of the benefits, then it puts the entire category at risk,” he says.

The type of clinical study required by EFSA to confirm health benefits could cost up to €5 million, according to Bredmose.

These studies need not only to work with larger cohorts in order to achieve statistical significance, but also tend to take longer to complete. “Nonetheless, we believe that in the next year or two you will start to see the first positive opinions for probiotics,” he predicts. “If it took as long as five years, that could kill the category.”

Others active in the probiotics arena see EFSA’s engagement in public consultations and meetings as evidence that it is willing to provide clearer guidance on health claims. In fact, gut and immune functions were the topic for the first such meeting last December.

“We have worked proactively to improve the environment for establishing claims, particularly in relation to emerging science,” says Julian Stowell, PhD, vice president  of scientific affairs, health and nutrition, Danisco (Copenhagen). “Our investment in science has increased substantially.”

Intellectual Property

Given these uncertainties and how much is at stake, it can be argued that the link between legal health claims and intellectual property (IP) remains as hypothetical as the claims themselves. At this time, the regulatory focus will shift towards Article 13.5 claims, and IP is an area where suppliers and users of probiotics are already very active and where companies are likely to want to flex their muscles in future.

“Under Article 13.5, claims will be for specific strains, which must be clearly characterized, safe, and proven through clinical trials,” says Valérie Delahaye, deputy manager in the health and human nutrition division of the Institut Rosell-Lallemand (Montreal, QC, Canada). “These can be proprietary claims which will be protected for five years.”

This protection refers to characterizations which are not unique. In fact, given the opportunity for patent protection, that period is likely to be longer in most cases.

Bredmose believes the second major threat to industry investments and to the future of the wider category is the focus from parts of the market on species rather than strains of bacteria.

“Of course, certain strains we have researched thoroughly for their probiotic health benefits, while different strains in the same species may have none of the same benefits,” says Bredmose. So while Chr. Hansen explains the emphasis on specific strains as an issue of consumer confidence, it is also clearly to do with recognizing and protecting the value of those strains for the company and its customers.

He notes the deliberately repeated references by the big brands such as Danone and Yakult to their specific (and in some cases renamed) strains.

“There are plenty of probiotic products, notably in supplements, where you are buying a species, with no indication of what strain it is,” says Bredmose. “By definition, there can be no reference to clinical trials, which are all focused on specific strains. These are brands which risk destroying the market by applying ineffective strains.”

In fact, lawyers’ bank accounts could end up seeing the biggest “health benefits” from probiotics, as those developing and characterizing particular strains seek to defend their investments and any resulting IP. If health claims do materialize with regard to particular strains, that will only strengthen the determination of those companies to fight their corner.

At the same time, regulators both in North America and Europe are likely to be running up their own legal bills. “Danone’s U.S. business lost a case brought by the Federal Trade Commission over the brand owner’s failure to state just how much of its product you needed to ingest to derive a particular benefit,” says Bredmose. “You’re likely to see more and more of this type of thing.”

Gut Health Supreme?

The struggle to establish health claims in the area of digestive health should not be taken as an indication that probiotics will necessarily achieve claims more quickly or easily in other areas.

“There will always be a link between probiotics and digestive health, and on a secondary level with immune health,” says Bredmose. “Even if we could build the evidence with regard to eye health, for instance, it still might never fly. And if that happened, it would be for marketing reasons.”

In fact, claims regarding immune support could be even more difficult to demonstrate than digestive health. “Here, evidence of the incidence of disease can only be supportive, and there is no real consensus on which bioparameters should be used to measure immunity,” says Delahaye.

“If we are able to prove some positive effects and risk factor reduction in cardiovascular health, it may be easier to substantiate a health claim there, where the parameters-such as LDL cholesterol levels-are far better established,” says Delahaye.

Meanwhile Danisco has been working with specific strains which target reductions in metabolic syndrome. “This is an interesting new research area which may open up new opportunities for functional foods in the future,” says Stowell.

Prebiotic Prospects

So what of the other half of the probiotic-prebiotic gut health double act? So far, there are no indications that EFSA will give the evidence of prebiotic cause-and-effect an easier ride than has been given to probiotics.

“Those researching these ingredients will have to make exactly the same scale of investment to carry out the same type of study,” says Bredmose. “So you have to look at the margins. Our probiotic ingredients are complex ones, and we sell them at a higher cost-in-use, so we can afford that investment.”

Those researching fibers might respond that, while individual applications may have more value, the overall market is significantly larger. “The advantage of fibers is that they can be more easily applied to foods and drinks,” says Delahaye. “There is no challenge on shelf life as there is with probiotics.”

On the other hand, she adds, the limiting factor for prebiotic fibers is that the dose required to generate a specific benefit and justify a health claim may be too high to be practical.

Despite the challenges, the prebiotic effects of chicory inulin and oligofructose have been the subject of over 50 clinical trials to date. Moreover, says Cathy Signoret, Cosucra’s (Warcoing, Belgium) nutritional and regulatory support manager, these products are among the very few which comply with the strictest scientific definitions of “prebiotics.”

In other words, although many fiber-based products may be fermented in the large intestine, few have demonstrated that this process is carried out by beneficial microflora, with the health benefits that result from this.

“The specificity of the bacteria which will respond to inulin is a key point in the definition,” says Signoret. “Nonetheless, we can see that flora in the colon may be more complex than was thought in the past, and of course the interactions going on in the colon are equally complex.”

Although scientific definitions may be fairly clear, says Cosucra, regulatory definitions are throwing up additional hurdles. “With probiotics and prebiotics, EFSA does not recognize modulation of the flora in favor of beneficial bacteria as a health benefit,” says Signoret. “It says that modulation to reduce pathogenic flora may be a health benefit.”

Smart Synergies

Let’s not forget that, far from being competitive products, probiotics and prebiotics are complementary-to the extent that the term synbiotics has been coined to describe their combined use in a product.

As a term, says Bredmose, synbiotic may be a difficult one to communicate to consumers. From a marketing point of view, the tendency is to phrase it as a “more is better” type of declaration, he says, such as “now with probiotics and added prebiotics.”

“But from a scientific point of view, it’s not just about a mix of fibers and probiotics,” he emphasizes. “The particular fiber used would need to reinforce the benefits of that specific strain, and demonstrating this link might require another costly clinical trial.”

According to Bredmose, research from the United States suggests that the majority of consumers are not clear about what prebiotics are, although the same is not true for fiber-or for probiotics.

Cosucra questions whether the term probiotic is any better understood and recognized by consumers than prebiotic. “The bigger brands may talk about good and bad bacteria, but not ‘probiotics,’” says Signoret. “The same is true for prebiotics. Consumers recognize and respond to communications about ‘fiber.’”

There seem to be multiple, parallel realities in which these ingredients exist: scientific, regulatory, and consumer-facing. Or rather, suppliers and end users need to learn to exist in each of these very different realities.

This article first appeared in Nutritional Outlook’s sister publication, International Food Ingredients magazine. IFI magazine is the authoritative European publication on the food ingredients market. Visit www.ingredientsnetwork.com/ifi-magazine.