02 17INS ProbioticIngreScience DI S

Vol. 7, No.
4
February 2017
naturalproductsinsider.com
US$20.75
PROBIOTIC
SCIENCE &
Innovation
The research, market and regulatory
pathways that fuel advances
in beneficial bacteria
CONTENTS
Vol. 7, No. 4 February 2017
p.3 Viewpoint:
Probiotic Powerhouses p.34
Market Opportunities for Probiotics

p.5 Supplements
The strong U.S. market for probiotics is driven
by specific demographics according to Monica
Probiotics Benefits Span Beyond the Gut Feldman, Nicholas Hall & Co.
Courtney Johnson explains that different probiotic
strains target different areas of health, and brands much
choose the right one for their formulations.
p.37
p.18 Probiotic New Dietary Ingredient

Notifications
Probiotic for Digestive Health Attorneys Ivan Wasserman and Amit Sharma,
Consulant Sudhir Ahluwalia dives into research that Amin Talati Uphadhye, look at challenges posed by the
shows probiotics help numerous health conditions from updated new dietary ingredient (NDI) draft guidance.
rotavirus to gut inflammation and travelers diarrhea.
p.40
p.23
Leaders and Trends in Intellectual
Probiotics Future in Sports Nutrition Property: Probiotics
Melissa DellaBartolomea, NutraScience Labs, explains
Probiotic patents and trademarks are on the rise,
why probiotics are catching the attention of athletes.
explains attorneys Andreas Baltatzis and Gideon
Eckhouse, KramerAmado PC.
p.25
p.44
Probiotics for IBS
Sabinsas Anurag Pande describes how probiotic therapy
can alleviate symptoms associated with Irritable bowel Fostering A Culture of Responsibility
syndrome (IBS). Andrea Wong, Ph.D., Council for Responsible
Nutrition (CRN) explains key elements of new
probiotic guidelines devloped by CRN and the
p.28 International Probiotics Association (IPA).
Use of Bacillus Probiotics to Promote p.46

Health and Wellbeing
The genus of Bacillus offers beneficial activities that
are synergistic with other probiotics, notes BIO-CAT
Microbioals Chris Penet and Steve Lamb, Ph.D.
Takeaways for Your Business
p.31 p.47
A Look at Probiotic Testing SupplySide & Vitafoods Global

Tammy Blakemore, SORA Labs, details lab insights
Storefronts Directory
for probiotic testing.
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2 INSIDER Probiotic Ingredient Science Digital Magazine February 2017

Viewpoint
Probiotic Powerhouses
At the time of writing this viewpoint, Forbes is in the middle of a
series on launching a probiotic product. Readers get a first-hand look
at what a brand goes through during this process.
Now, I just have to raise capital, figure out how to get a probiotic
manufactured, create branding and packaging, get the retailers on
board before they reset their probiotic category in eight months, figure
out an online strategy and come up with a simple but effective way of
making sure consumers understand the innovation. Plus about 80 other things, the
author, Afif Ghannoum, wrote in the second installment.
Its an interesting series, but my guess is that most of the folks reading this know at
least part of what Ghannoum is going through. The probiotic category is booming, as
Monica Feldman from the Nicholas Hall Group notes on page 34 of this Digital Magazine.
But its not an easy category to enter.
The science backing these beneficial microorganisms is solid, but that doesnt
automatically mean all probiotic products are backed by solid science. Different strains
affect the bodys gut differently and thus, impart different healthy effects. Then, the issue
of proper manufacturing must be addressed; these are living organisms after all, who
often dont survive processing, shelf life or stomach conditions. Once those are secured,
a brand needs to ensure its following the proper regulations, which can be difficult when
laws are interpreted differently by different stakeholders. It can be overwhelming.
INSIDER is here to help.
This Digital Magazine will help probiotic product brands understand the emerging
science, the testing requirements, the market data and the regulatory landscape that
make up the probiotic product category.
Forbes, as a consumer publication with a strong reputation, could have chosen any
product to follow in its series. But it chose a probiotic product. Probably because the
consumer interest is so high, along with the hurdles brands face. Id take that as a sign
that probiotic brands are on the right path to success.
As soon as this Digital Magazine posts to INSIDER, Ill be sending the link to
Ghannoum. Id love to help another start up. Perhaps hell also be able to make it to
Ingredient Marketplace this year, where many of the writers in the Digital Magazine will be
speaking at Probiotic Marketplace, a day-and-a-half event on April 18 and 19. Probiotics
Marketplace is produced with the International Probiotics Association (IPA), the premier
underwriter is Nutraceutix, and additional support is provided by BIO-CAT, Sabinsa
Corp., Unique Biotech and Viva 5 Corp.
Sandy Almendarez
Editor in Chief
(480) 281-6745
sandy.almendarez@informa.com
@sandyalmendarez

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Probiotics Benefits Span Beyond the Gut

by Courtney Johnson
INSIDER's Take
Research shows different strains of Applications for probiotic delivery Manufacturers should consider
probiotics can help with digestion, methods can vary from supplements formulation challenges from the
womens health, immunity and to functional foods and beverages. survivability of a probiotic to the
sports nutrition. tableting process.
Probiotics have exploded onto the market due to the wide range of health
benefits they offer consumers, from supporting the digestive system internally to
benefitting skin health outwardly. Knowing which strains target which areas of health can
help companies market probiotic products. It is important to explore the research on
different strains of probiotics since they affect different areas of health.
According to Global Market Insights Inc., the probiotic market size is predicted to
exceed US$64 billion by 2023. Applications for probiotic delivery methods vary,
but supplements and functional food and beverages are popular choices
for consumers to achieve a healthy gut microbiome.
Probiotics are live microorganisms comprised of bacteria and
yeast that live primarily in the gut. These microorganisms help
regulate healthy bacteria. Popular strains of probiotics include
Bifidobacterium and Lactobacillus, which can be found in the
digestive, urinary and genital systems.
Two of the most widely known and characterized bacterial
strains are Bacillus coagulans (earlier known as Lactobacillus
sporogenes) and Lactobacillus acidophilus, said Shaheen Majeed,
marketing director, Sabinsa. These two strains are found in the
According to Global
digestive, urinary and genital systems naturally as well as in fermented Market Insights Inc., the
foods, such as yogurt and dietary supplements.
probiotic market
Probiotics are measured as colony forming units (CFUs), which size is predicted to exceed
determine how much of the bacteria can divide into colonies. Another US$64 billion
standard for measuring probiotics is through viable, but non-culturable, by 2023.
cells (VBNCs). At times, a probiotic ingredient can contain up to 50
percent VBNCs. The total count of viable probiotic cells equals CFUs
plus VBNCs. Counting CFUs has been the standard measurementbut it does not count
all efficacious cells. VBNCs are not measured via plating, which only detects cells that are
happy enough to form colonies in that specific media environment, said Alexis Collins,
director of scientific affairs, Pharmachem Laboratories Inc.
IN THIS ISSUE Viewpoint p.3 Digestion p.18 Table of Contents p.2

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Its a Strain to Find the Right Probiotic

There are numerous amounts of strains targeting different areas of health, and
choosing the right strain can be dependent on the products intended health focus.
Research shows various strains of probiotics help with immunity, womens health,
digestion, sports nutrition and skin health, and many of the strains support more than
one area of health.
Probiotics play a major role in maintaining a healthy immune
system. About 70 percent of the immune system is in the gut, so
its no wonder probiotics have been shown to boost immune
support. There are 10 times the amount of microbial cells in the
intestine as there are cells in the entire body. Balancing those
species of bacteria in the gut is crucial to controlling microbes that
can cause disease. For a probiotic to be effective, it must be able to
withstand the transit through the stomach to reach to the intestines.
Lactobacillus plantarum has been shown to have an effect on About 70% of the
the immune system. A study concluded intake with the probiotic immune system
strains Lactobacillus plantarum and Lactobacillus paracasei is in the gut, so its no
reduced the risk of acquiring common cold infections.1 wonder probiotics have
Bifidobacterium bifidum demonstrated an ability to modulate the been shown to boost
immune system in the human body, and is found in the large immune support.
intestine. Pharmachems Bifidobacterium breve BR03, alone and in
combination with Lactobacillus salivarius LS01, was shown to help
patients with asthma.2
Ganeden BC30 contains Bacillus coagulans, and research supports Bacillus
coagulans to promote a healthy immune system by its ability to enhance immunological
response to common viral respiratory tract infections.3 Bacillus coagulans is a lactic
acid-forming bacterium that is dormant in its spore form, protected by an outer shell, but
becomes active when it encounters perfect conditions of temperature, pH and moisture
within the large intestine.
A study found Nebraska Cultures product ProDURA, which contains Bacillus
coagulans Unique IS-2, lowered total cholesterol and raised good cholesterol
(high-density lipoprotein [LDL] cholesterol) by raising the HDL to low-density lipoprotein
(LDL) ratio in people with high cholesterol.4
Unique Biotech offers Bacillus coagulans Unique IS2, which provided benefits to
women who were administered antibiotics for the treatment of bacterial vaginosis, the
most prevalent vaginal infection worldwide.5 The Lactobacillus genus is a group of
bacteria belonging to the lactic acid bacteria group, defined by its ability to produce
lactic acid. Lactobacillus plantarum has been shown to support womens health by
helping increase iron absorption, as women can struggle with maintaining adequate
levels of iron in their bodies. A study found women who drank an iron-supplemented
fruit drink that contained Probis Ferrosorb containing Lactobacillus plantarum 299v
helped increase iron absorption compared to a placebo group, who were administered

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Probiotic Ingredient Science Q&A
Probi USA Inc., dba Nutraceutix

Niklas Bjrum, president, Probi USA Inc.
1. What are the top trends impacting the probiotics market in 2017?
The main driver continues to be an overall focus on daily health and
well-being. Consumer awareness and the knowledge around
probiotics and their vast health benefits will continue to grow. Probiotics offer a natural and
convenient solution to include important health benefits in our daily food intake.
Also, the strong focus on product quality and scientific documentation of probiotic strains
and their health benefits will continue to grow in importance. The real, perceived efficacy
experienced by consumers of different product offerings will be an important differentiator
for brand owners and suppliers in the market.
Expect to also see for me product offerings. The traditional gastro position will remain
the base of the probiotic market, with an increasing need for effective and interesting
consumer health solutions. As the market matures, consumer demand will be more diverse.
Products targeting specific consumer groupsfor example female health, sports and
athletes, or childrenwill be offered in new exciting product formats, demanding robust
strains and effective delivery technologies.
Finally, as the market for probiotics matures, products will be found in an increased
number of sales channelsthrough mass market, pharmacy and multilevel marketing (MLM)
to online shopping, sports/athletic stores, and even the convenience trade.
2. What should manufacturers do to help differentiate themselves in an increasingly
competitive probiotics marketplace?
A strong focus on product quality and scientific documentation will be absolutely key for
manufacturers and product developers.
Customer support also will be an important differentiator. At Probi, we believe growing
with our customers and offering dedicated support in science, product development and
marketing are important differentiators.
3. What unique value proposition does Probi offer?
Probi is the only global top player in this market that focuses 100 percent on probiotics
and probiotic development. We are passionate about developing and delivering our
probiotic products, all the way from research and development (R&D), through product
development, to actually producing and packing ready-to-sell consumer products for global
delivery.
We have premium offers in all market segments, ranging from products with
comprehensive clinical dossiers showing health benefits on specific indications, to high-
quality offerings in more general health positions.
Our robust strains sustain shelf life in consumer health care as well as different food formats.
Probi/Nutraceutix is a true a one stop shop for any company wanting to improve their
success in probiotics!

Ingredients
an iron-supplemented fruit drink without Lactobacillus plantarum 299v, according to

Niklas Larsson, research director, Probi.6 In conclusion, the study found intake of
probiotics can increase iron absorption by approximately 50 percent from a fruit drink
that was already high in iron bioavailability.
In terms of digestive health, Larsson noted a study found an oat beverage called
Profermin containing Lactobacillus plantarum 299v helped patients with ulcerative colitis
(UC).7 Other studies point to reduced symptoms of irritable bowel syndrome (IBS),
including a study that found patients who took Lactobacillus plantarum for four weeks
had greater relief from symptoms of IBS than the placebo group.8 Newer research found
Lactobacillus plantarum helped improve symptoms of stress, including one study
showing reduced symptoms of stress related to its effect on the gut-brain axis.
It found patients who had oral supplementation with Lactobacillus plantarum
had reduced cortisol levels in their saliva during induced stress.9
Research on probiotics for

athletes revealed positive effects
in reducing inflammation and
improving post-workout recovery.
Research on probiotics for athletes or people who exercise revealed

positive effects in reducing inflammation and improving post-workout recovery.
A study involving 16 resistance-trained men had each participant consume probiotic
capsules containing 5 billion live cells of Pharmachems Bifidobacterium breve BR03 and S.
thermophilus FP4 each, and a different group received a placebo, prior to the performance
(21 days) of a muscle-damaging exercise of the elbow flexors. The study found the group
who took probiotics had reduced baseline inflammation and improved inflammatory
response to exercise, suggesting probiotics may assist in recovery after exercise.10
Another strain of Lactobacillus, Lactobacillus acidophilus, has been shown to produce
natural enzymes, for instance lactase, which helps with the digestion of milk,11 according
to Michael Shahani, chief operations officer, Nebraska Cultures.
Beyond what probiotics can do internally, they also can provide outward benefits.
Lactobacillus salivarius LS01 was found to help atopic dermatitis (AD), a common
inflammatory skin disease characterized by eczema, in adults. After 16 weeks, 38 patients
who were treated with Lactobacillus salivarius LS01 showed improvement of AD at the
end of the treatment compared to the placebo group.12
Considering the numerous probiotic strains, its no easy task picking one to formulate
with as they all offer benefits that can tackle prevention of diseases and help treat
conditions. Several probiotic-based foods, beverages and supplements contain bacteria

The Right Probiotic
In the dynamic market for probiotics, new opportunities
are developing beyond traditional gut healthfrom
sports nutrition to allergies to healthy inflammatory
response, and more. At Pharmachem, we can guide you
in selecting a clinically substantiated strain for your
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and ability to survive the gastric system through our
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Ingredients
and/or yeasts, but their health benefits are determined by the kind of microorganisms
they contain (identified by their genus, species and strain level, as potential of different
bacterial strains differs, even within the same species) and the sort of benefits they
provide, Majeed said.
Proper Delivery Methods of Probiotics

Since probiotics are living organisms, proper handling and treatment of the organisms
is essential during the production process. Manufacturers should consider everything
from the survivability of the probiotic to the tableting process.
When choosing a method of delivering probiotics, manufacturers should be aware of
the challenges that can negatively influence the integrity and effectiveness of the
ingredients, said Missy Lowery, senior marketing manager, Capsugel. They need to be
mindful of how to maintain the stability of probiotics and target delivery of the ingredients
in the intestines where they work best.
Cross contamination can also occur between strains during the production process, so
manufacturers should be wary. Because spore-forming Bacillus are naturally more hearty
than Lactobacillus, an additional challenge facing manufacturers is that of cross
contamination, said Richard Kramer, microbiologist at BIO-CAT Microbials. However, with
proper cleaning and sterilization protocols, cross-contamination can be easily avoided.
Stability of a probiotic can be a great challenge during the manufacturing process,
since not all probiotics are room temperature stable, Majeed said. Stability of probiotics
is one of the greatest challenges faced by manufacturers while incorporating probiotics in
any dosage form, as not all probiotics are room temperature stable, and many have
limited stability which requires specific handling to stay viable. Hence, this issue has
plagued the industry for years. Another point is calculating appropriate
overages to ensure effective dosages in the end product.
The four elements that are detrimental to the stability of probiotic The four elements
bacteria are moisture, heat, oxygen and light, Shahani added. In that are detrimental to
processing or using probiotics in functional foods, these four elements the stability of probiotic
must be eliminated or at least reduced as much as possible. In addition, bacteria are
most lactic acid bacteria will slowly die off over time at room temperature,
and even at refrigerated temperature, although at a much slower rate. Moisture
Shahani noted some products claiming to have probiotics failed
because the proper technology was not used to keep the bacteria alive,
resulting in the bacteria dying before the expiration date of the product.
He recommended keeping products as dry and as cool as possible, Heat
since there is no way yet to ensure stability.
In addition, it is imperative to consider the pressure and heat from the Oxygen
tableting process, as it is harsh and can compromise the stability of a
probiotic, Lowery said. Transportation and storage issuessuch as
length of time, temperature fluctuation, and exposure to moisturecan
put probiotics in yogurt products and other packaging like sticks and Light
sachets at risk for early activation.

Ingredients
Probiotics can be acid-sensitive, so ensuring they transition through the stomach

moisture and acid without early activation and degradation is key. Encapsulation helps
preserve the bacteria as it offers more protection from moisture, as well as delaying
release until the probiotics make their way through the intestines into the stomach,
according to Lowery.
Lowery recommended vegetarian capsules as they are made from hydroxypropyl
methylcellulose (HPMC), which delay and target release of solutions and offer moisture
protection for probiotics. Because HPMC is low in moisture content (4 to 6 percent
moisture at 50 percent relative humidity compared to 12 to 14 percent for gelatin), the
HPMC polymer can help shield ingredients from moisture in the package that
can trigger premature activation before ingestion.
Newer research is exploring

the effects of probiotics on
neurological health.
There Are Great Opportunities for Further Research

Research on probiotics and the different strains can help manufacturers
decide the proper formulation for their products, and new research is constantly being
conducted. Interestingly, newer research is exploring the effects of probiotics on
neurological health. New research is now asking provocative questions involving
neurological and mental health and even allergen sensitivities and how the microbiome
impacts them, Kramer said. This, combined with the fact we are beginning to unravel
how these organisms all work together, make this a very exciting time to be involved in
anything related to probiotics.
There is also still more research to be done on probiotics effects on sports nutrition,
as Collins expressed belief that more benefits for athletes and fitness enthusiasts are
still yet to be revealed from probiotics. Specific areas of interest for the sports nutrition
market are immune support, protein absorption enhancement and inflammation
management.
Sports nutrition isnt the only category where there are still unknown mechanisms to
probiotics, as there are other areas not yet known to science, according to Peter
Agostino, vice president of product development, Viva5 Corp. New applications for
probiotics in human health are being discovered all the time, Collins added. When so
much of the human body is composed of these bacteria, it makes sense that they will
impact so many different aspects of health.

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Ingredients
References:
1. Berggren A et al. Randomised, double-blind and placebo-controlled study using new probiotic lactobacilli for strengthening
the body immune defence against viral infections. Eur J Nutr. 2011;50(3):203-210.
2. Drago et al. Immunomodulatory Effects of Lactobacillus salivarius LS01 and Bifidobacterium breve BR03, Alone and
in Combination, on Peripheral Blood Mononuclear Cells of Allergic Asthmatics. Allergy Asthma Immunol Res. 2015
Jul;7(4):409-13.
3. Kimmel M et al. A Controlled Clinical Trial to Evaluate the Effect of GanedenBC30 on Immunological Markers.
Methods and Findings in Experimental and Clinical Pharmacology. 2010;32(2):129-132.
4. Sudha R et al. Effects of Supplementation of Probiotic Bacillus coagulans (ATCC PTA-11748) on Hypercholesterolemia
Subjects: A Clinical Study. International Journal of Probiotics and Prebiotics. May 2011;6(2):89-94.
5. Sudha R et al. Clinical Study of Bacillus coagulans Unique IS2 (ATCC PTA-11748) in the Treatment of Patients
with Bacterial Vaginosis. Indian Journal of Microbiology. 2012;52(3):396-9.
6. Hoppe M et al.Probiotic strain Lactobacillus plantarum 299v increases iron absorption from an iron-supplemented
fruit drink: a double-isotope cross-over single-blind study in women of reproductive age. Br J Nutr. 2015;114(8):1195-202.
7. Krag A et al. Profermin is Efficacious in Patients with Active Ulcerative Colitis-A Randomized Controlled Trial.
Inflamm Bowel Dis. 2013;19(12):2584-92.
8. Ducrott P, Sawant P, Jayanthi V. Clinical trial: Lactobacillus plantarum 299v (DSM 9843) improves
symptoms of irritable bowel syndrome. World J Gastroenterol. 2012;18(30):4012-4018.
9. Andersson H et al. Oral administration of Lactobacillus plantarum 299v reduces cortisol levels in human saliva
during examination induced stress: A randomized, double-blind controlled trial. International Journal of Microbiology. 2016.
Article ID 8469018.
10. Jager R et al. Probiotic Streptococcus thermophilus FP4 and Bifidobacterium breve BR03 Supplementation Attenuates
Performance and Range-of-Motion Decrements Following Muscle Damaging Exercise.Nutrients. 2016;8(10):642; DOI:10.3390/
nu810064.
11. Pakdaman et al. The effects of the DDS-1 strain of lactobacillus on symptomatic relief for lactose intolerance - a randomized,
double-blind, placebo-controlled, crossover clinical trial. Nutrition Journal. 2016;15:56. DOI:10.1186/s12937-016-0172-y
12. Drago L et al. Effects of Lactobacillus salivarius LS01 (DSM 22775) treatment on adult atopic dermatitis: a randomized
placebo-controlled study. Int J Immunopathol Pharmacol. 2011 Oct-Dec;24(4):1037-48.

Digestion
Probiotics for Digestive Health

by Sudhir Ahluwalia
INSIDER's Take
Probiotics help create a healthier Plenty of research shows probiotics Brands that offer probiotic products
gut microorganism to aid digestion, help numerous health conditions from need to ensure manufacturing
immunity and general wellbeing. rotavirus to gut inflammation and techniques dont destroy the healthy
travelers diarrhea. bacteria.
According to Robert Hutkins, professor of food science, University of Nebraska,

Lincoln, our gut microbiota contains tens of trillions of microorganisms from more than
1,000 different species having a cumulative genetic base of more than 3 million genes.
He also stated that the gut microbiota could weigh up to 2 kg (4.4 pounds). The
microorganisms are found in the stomach, and small and large intestines.
Everyones gut has a unique set of microbiota; less than 30 percent of the gut
microbiota is common among humans. The microorganism composition keeps changing
throughout the life of an individual. It is influenced by the food we eat and the
environment we are exposed to. The microbiome composition in the aged person is
different from that found in the youth.
At childbirth, the gut is microbiota free. As the child makes its way down and out of the
birth canal, the first set of microorganisms acquired by the infant are from the mothers
vagina. Some claim caesarian birth infants who are not exposed to the mothers vaginal
microbiota could be more prone to ailments than those born vaginally.
The gut microorganism aids in digestion of food and helps protect the body
from external infections. It assists the digestion process, helping release
nutrition from the food and making it available to the body. A healthy and
balanced gut microbiota is critical to a healthy gut and a healthy body.
Misbalances in the gut microbiota can lead to diarrhea,
constipation, inflammatory bowel and other gut ailments. Even
diabetes and allergies have been connected to the state of the gut
microbiome, according to the International Scientific Association for
Probiotics and Prebiotics (ISAPP).
Probiotics are a group of beneficial microorganisms found in the gut.
The World Health Organization (WHO) said probiotics, when taken in
adequate quantities, confer a health benefit to the host. They help Misbalances in the
maintain a healthy balance in the gut microbiota as well as assist in gut microbiota
building the bodys immune system, according to a 2015 book, The can lead to
Good Gut by Justin and Erica Sonnenburg. diarrhea
constipation
Gut microbiota balance is affected by poor diet, infections, antibiotic
inflammatory bowel
treatments and other external factors. To restore this balance, physicians
and other gut ailments.
regularly recommend supplements containing live probiotic bacteria. The
IN THIS ISSUE Ingredients p.5 Sports Nutrition p.23 Table of Contents p.2

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Digestion
most common probiotic bacteria belong to two generaLactobacillus and

Bifidobacterium. Other genera included in this group are Enterococcus and
Streptococcus, to name a few.
The protective role of probiotics in digestion is now well established. A 2012 meta-
analysis of 74 studies, 84 trials and 10,351 patients showed probiotics are beneficial
adjuncts in treatment and prevention of gastrointestinal (GI) diseases.1
Numerous studies conducted by scientists from across the world have shown
probiotics to be beneficial in cases of acute diarrhea caused by pathogens such as
Salmonella,2 and rotavirus in children.3 Those of us who travel internationally do often
become victim to what is popularly called travelers diarrhea. Probiotics have been
found helpful in providing relief in such cases.4 However, most studies have
been conducted with probiotics in non-food form.
Different species and strains of

probiotics as well as different
ways of preparation can have
varying impact on individuals.
The role of probiotics in alleviating Helicobacteria pylori infection of the

gut, common in developing countries,5 inflammation of the bowels and
constipation are other digestive system ailments that have been studied. Initial results
indicate probiotics are helpful in these cases, although conclusive evidence has not yet
been secured.
The European Food Safety Authority (EFSA) has approved the use of a group of
probiotic bacteria genera and species in yogurt cultures. Canadian, Italian and European
regulators have accepted that probiotics help in maintaining a healthy gut.
EFSA recommends a level of 1 billion colony forming units (CFUs) per serving of
probiotics in food. Clinical recommendation for those affected by digestive ailments is
placed at 5 billion CFUs for children and 10 to 20 billion CFUs for adults.6 One to 2 billion
CFUs per day is the recommended dose for healthy adults.
The non-strain specific species of permitted probiotics in Canada are Bifidobacterium
(adolescentis, animalis, bifidum, breve and longum) and Lactobacillus (acidophilus, casei,
fermentum, gasseri, johnsonii, paracasei, plantarum, rhamnosus and salivarius).
Different species and strains of probiotics as well as different ways of preparation can
have varying impact on individuals. Some may feel bloated and even gassier after
consuming a particular probiotic product.

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Probiotics
Marketplace
April 18 9am-5:30pm April 19 9-11:00am
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to making the most of the market opportunity. This day-and-a-half event will deliver
insights on:
Science and formulation considerations
Issues to consider for an effective go-to-market strategy
Market opportunities based off of consumer buying patterns and trends
Legal issues affecting the probiotics space
AND MORE
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Digestion
Dietary supplements, pharmaceutical products, medical foods, infant formula,

fermented foods such as fresh yogurt, fermented milk, aged cheese, kimchi, craft beer,
miso, fermented vegetables like sauerkraut or pickles, sourdough bread, etc., contain
probiotic bacteria.
Fresh Yogurt Fermented Milk Aged Cheese Kimchi
Craft Beer Miso Pickles Sourdough Bread
In some of these products, the bacteria are killed during processing. This happens in
the process of baking or when the product is exposed to heat. In the case of aged
cheese, bacteria die with time.
Probiotic bacteria are effective only when they are alive and consumed in adequate
quantity. Consumers therefore need to look at the label of products at the time of
purchase. It is best to consume the product within the indicated shelf life of the probiotic
bacteria. The number of live CFUs in the product should also be consistent to the daily
need of an individual.
Gut bacteria are passed out of the body daily in the stool. To benefit from probiotic
bacteria, a daily serving must be consumed. A dose of 10 billion CFUs is often seen in
probiotic supplements and pharmaceutical products.
Sudhir Ahluwalia is a business consultant. He has been management consulting head of Tata Consultancy
Services, an IT outsourcing company in Asia, business advisor to multiple companies, columnist and author of an
upcoming book on herbs, Holy Herbs. He has also been a member of the Indian Forest Service.
References
1. Meyre D et al. Comment on: Valette et al. Melanocortin-4 receptor mutations and polymorphisms do not affect weight loss
after bariatric surgery. PLOS ONE 2012; 7(11):E48221. PLoS One. 2014 Mar 31;9(3):e93324. DOI: 10.1371/journal.
pone.0093324.
2. Rokana N. Modulation of intestinal barrier function to ameliorate Salmonella infection in mice by oral administration of
fermented milks produced with Lactobacillus plantarum MTCC 5690 - a probiotic strain of Indian gut origin. J Med Microbiol.
2016 Dec;65(12):1482-1493. DOI: 10.1099/jmm.0.000366.
3. Das S, Gupta P, Das R. Efficacy and Safety of Saccharomyces boulardii in Acute Rotavirus Diarrhea: Double Blind Randomized
Controlled Trial from a Developing Country. J Trop Pediatr. 2016 Dec;62(6):464-470. Epub 2016 Jun 9.
4. Hilton E et al. Efficacy of Lactobacillus GG as a Diarrheal Preventive in Travelers. J Travel Med. 1997 Mar 1;4(1):41-43.
5. Hassan S, udomov M. Probiotics as Dietary Supplements for Eradication of Helicobacter pylori Infection in Children: A Role
Beyond Infection. Children (Basel). 2016 Nov 10;3(4). pii: E27
6. Kligler B, Cohrssen A. Probiotics. Am Fam Physician. 2008 Nov 1;78(9):1073-8.

Sports Nutrition
Probiotics Future in Sports Nutrition

by Melissa DellaBartolomea
INSIDER's Take
Research has shown probiotics help Other studies reveal probiotics ability Use of probiotics in sports nutrition is
athletes decrease their risk of getting to increase recovery from exercise and in its infancy, but is projected to grow
sick, even during times of suppressed help maintain performance. if brands focus on manufacturing
immunity. efficacious products.
In the ever-evolving nutraceutical marketplace, consumers are constantly

searching for the next great dietary supplement product. In turn, supplement industry
insiders are constantly looking for ways to provide consumers with the next great
product. While several supplement categories have experienced growth in recent years,
there are few categories that have earned (and continue to earn) more attention than
probiotics and sports nutrition.
The nutraceutical industry has started to exploreand embracethe crossroads
where probiotics and sports nutrition meet. Researchers and opportunity seekers have
made it clear that probiotics may play a leading role in shaping the sports nutrition
supplements of tomorrow. While there are dozens of different avenues being explored,
certain opportunities have undeniable long-term potential.
Improving Performance by Boosting Immunity

Research has shown that in the hours after intense exercise, the body will often
experience a physiological phenomenon known as the window of immunosuppression.
As its name suggests, its during this window of suppressed immune activity that athletes
are more susceptible to certain types of upper respiratory infections (URTIs) like the
common cold (Nutr Rev. 2008 Jun;66(6):310-20).
Researchers examined the effects of a patented lactobacillus strain, Lactobacillus
helveticus Lafti L10 (from Lallemand Human Health), when administered orally.
(Appl Physiol Nutr Metab. 2016 Jul;41(7):782-9) During this 2016 study, researchers
hypothesized that athletes who received doses of L. helveticus Lafti would be less prone
to URTIs because gut health is linked, at least in part, to overall immune health.
(Exerc Immunol Rev. 2011;17:6-63)
Researchers found the addition of oral probiotic supplements was not able to
significantly affect or reduce the total number of URTIs that occurred. However, the addition
of probiotics did have a significant effect on the intensity and duration of symptoms. Those
who were administered probiotics experienced milder symptoms for a shorter time.
Studies like this one demonstrate the potential for probiotics and the human immune
system to serve as defining factors for the next generation of sports nutrition products.
Though indirect, supporting athletic performance and ability by means of the bodys
ability to defend and heal itself could, at least in theory, help athletes avoid unwanted
sickness or down time.
IN THIS ISSUE Digestion p.18 Irritable Bowel Syndrome p.25 Table of Contents p.2

Sports Nutrition
Improving Performance by Supporting Muscle Repair

By means of a more direct approach, researchers have also explored links between
probiotics and the bodys ability to grow and repair muscle. In a 2016 study, researchers
from Cleveland-based Ganeden wanted to study the effects (if any) of Ganeden BC30,
also known as Bacillus coagulant GBI-30, 6086, on athletes who were supplementing
their routines with casein-based protein. (PeerJ. 2016 Jul 21;4:e2276)
Over the course of two weeks, researchers administered 20 g of casein or 20 g of
casein plus the probiotic (a 1 billion colony forming unit [CFU] dose) to the recreationally
trained male participants. At the end of the crossover and diet-controlled
supplementation period, researchers measured and analyzed athletic performance and
muscle damage following a bout of damaging exercise.
What they found was that in the probiotic/protein group, there was a significant
increase in recovery speed when compared to the protein control group at both the
24- and 72-hour marks. These perceived differences were confirmed by the increase in
creatine kinase (CK) levels between the two groups (protein group: +266.8 percent,
P=0.0002; probiotic/protein group: +137.7 percent, P=0.01).
The researchers were also able to record significant reduction in performance within the
protein group (Wingate Peak Power; 39.8 watts, 5.3 percent, P=0.03) whereas participants
in the probiotic/protein group maintained performance (+10.1 watts, +1.7 percent).
These studies (and others like it) have demonstrated clear links between certain
aspects of athletic performance and the introduction of probiotic strains alongside
traditional sports nutrition supplements.
The Road Ahead: Probiotics & Sports Nutrition

The potential for probiotics to redefine the world of sports nutrition and supplementation
is there. Regardless of how many breakthroughs researchers can discover and validate, the
industry needs to clear key hurdles from a manufacturing standpoint.
While the production and manufacturing of probiotics has come a long way, the
production journey is not always a smooth one.
Along with constantly searching for better ways to enhance the shelf stability and
bioavailability of probiotic organisms, issues relating to the actual cultivation of a specific
strain (or strains) in the amounts necessary to complete a production run can prove both
challenging and time consuming.
The nutraceutical industry will continue to push forward and unlock potential
opportunities that exist for probiotics within the realm of sports nutrition. The speed at
which these opportunities are unlocked is going to depend, almost entirely, on the ability
to master the art of cultivating, storing and manufacturing probiotics.
Melissa DellaBartolomea is a content marketing specialist for NutraScience Labs. Based in Farmingdale, New
York, NutraScience Labs is dedicated to providing companies and brand owners with excellent customer service
and a full suite of dietary supplement manufacturing capabilities

Irritable Bowel Syndrome
Probiotics for IBS

by Anurag Pande, Ph.D
INSIDER's Take
Probiotics can be used to maintain Some bacteria can be formulated into In a recent study, certain bacteria
digestive health, and probiotic therapy food products to increase consumer were found to help alleviate IBS
may be optimal with specific bacteria. compliance. patients symptoms.
While using the word probiotics to describe beneficial bacteria that impart
health benefits is relatively new, these bacteria themselves have been around for
millenniapeople recognized the health benefits of bacteria in fermented foods as far
back as 6000 B.C. and possibly even earlier. Almost all major civilizations have a history
of using beneficial bacteria in foods such as sour milk, kimchi, yogurt and sauerkraut.
lie Metchnikoff, a Russian scientist, is often credited as the father of modern
probiotics. His studies related to normalizing bowel movements and health by replacing
the putrefactive bacteria with lactic acid, which created the foundation of probiotic use in
the management of gut health. In his book The Prolongation of Life: Optimistic Studies,
he noted the potential of lactic acid bacteria (LAB) in increasing the life cycle.
Today, probiotics have carved a space as functional foods and health supplements.
The probiotic industry has achieved a 6-percent, five-year compound annual growth rate
(CAGR), and is expected to reach US$36 billion globally in 2018, according to BCC
Research. Sales growth in the last few years has paralleled our understanding on the
human microbiomethe collection of microorganisms living in association with the
human bodyand the effect of probiotics on the microbiome.
The Human Microbiome Project was initiated in 2008 by the U.S. National Institutes
of Health (NIH) to identify and characterize the microorganisms living in the human
body, both those healthy and diseased. While the biomass of the bacterial cells residing
in the human body may form only 1 to 3 percent of the mass of a human body, these
cells can outnumber the human cells by 10 times. These cells play an important role in
the maintenance of our health, and changes in the microbiome are often related to
disease conditions.
Almost all major civilizations have a history

of using beneficial bacteria in foods
Sour Milk Kimchi Yogurt Sauerkraut
IN THIS ISSUE Sports Nutrition p.23 Bacillus Probiotics p.28 Table of Contents p.2

Probiotics are used by people for a variety of reasons including maintaining a healthy
gut, supplementing the gut microbiota with healthy bacteria, alleviating symptoms related
to gastric disturbances such as travelers diarrhea, constipation, abdominal discomfort
and other gut health-related conditions.
One of the most intriguing gut health conditions is irritable bowel syndrome (IBS),
which affects millions around the world, in both developed and developing countries. It
presents a gut condition, the causes of which are multifactorial in naturealterations in
gut motility, micro inflammation and visceral hypersensitivity, resulting in abdominal
discomfort, bowel dismotility such as diarrhea, inflammation, latent or potential celiac
disease and neurotransmitter imbalance. Some of these factors lend themselves to
probiotic therapy to alleviate conditions related to IBS. However, the choice of
species and strain must be carefully considered.
Although probiotics are often thought of as being equivalent, different species and
different strains (even in the same species) may not have the same benefits. One of the
important aspects of probiotic therapy is the survival of bacteria. Harsh conditions
encountered during the formulation, long shelf storage and low pH in the stomach may all
negatively affect the therapeutic benefit of a bacteria. Spore-forming lactic
acid producing bacteria (SFLAB) overcome these hurdles and offer an
alternative to provide probiotic therapy in a clinically effective dosage.
Spore-forming bacteria have brought a revolutionary change in
probiotic delivery, allowing formulations such as soft chews, gummies
and chewables to deliver adequate number of bacteria in the dietary
supplements in forms that increase consumer compliance. Moreover, with FDA GRAS
status, spore forming probiotics are now available to be formulated in a variety of food
format products such as chocolates, protein shakes, dry yogurts, ice creams and
confectionary items.
Probiotics Marketplace
TM
Anurag Pande, Ph.D., will be offering more information on the

latest science in health categories including digestive support
at Probiotics Marketplace, a day-and-a-half event on April 18
and 19 as part of Ingredient Marketplace in Orlando. Probiotics
Marketplace is produced with the International Probiotics
Association (IPA), the premier underwriter is Nutraceutix, and
additional support is provided by BIO-CAT, Sabinsa Corp.,
Unique Biotech and Viva 5 Corp. For more information, visit
marketplace.supplysideshow.com.

In a clinical setting, the spore forming Bacillus coagulans MTCC 5856 (as LactoSpore,
from Sabinsa) was used as an adjuvant to standard therapy in patients suffering from IBS
type D. Probiotic dosage of 2 billion colony forming units (CFUs)/serving was administered
once daily to IBS patients for 12 weeks in a randomized, double-blind, placebo-controlled
clinical trial (Nutr J. 2016 Feb 27;15:21). Results showed improvement in clinical symptoms of
bloating, vomiting, abdominal pain, diarrhea and stool frequency. The researchers concluded
B. coagulans MTCC 5856 can be safely consumed by IBS patients to alleviate numerous
symptoms and as a potential agent in management of diarrhea-predominant IBS.
The success of B. coagulans MTCC 5856

has provided a good case study for use
of spore-forming bacteria in Canadian
health supplements.
The study is significant from the perspective of using a spore forming bacteria in
management of IBS. Such bacteria, including B. coagulans MTCC 5856, provide a
greater flexibility in choosing the delivery system, require lower overages with better
survival rate both throughout manufacturing conditions as well as in the acidic condition
in the gut. It also has a long shelf life at room temperature.
The success of B. coagulans MTCC 5856 has also provided a good case study for
use of spore-forming bacteria in Canadian health supplements, where B. coagulans is
not part of the probiotic monograph.
To introduce B. coagulans MTCC 5856 in the Canadian market as a Natural Health
Product (NHP), human clinical safety studies were conducted to prove its safety, antibiotic
resistance and stability. A four-week, double-blind, placebo-controlled, parallel study in
40 Canadian subjects was planned and designed in consultation with Health Canada (J
Clin Toxicol. 2016;6(1)). The study results, along with a host of toxicity and viability studies,
were submitted to Canada Health to support the use of this strain as a probiotic in
Canada. Acceptance by Health Canada opened the doors to use of LactoSpore in
Canadian health supplements. The clinical study on the IBS patients was also reviewed
by Health Canada, resulting in B. coagulans MTCC 5856 being approved for use as a
health supplement to relieve the abdominal pain associated with IBS, now allowing
people suffering from IBS to use B. coagulans MTCC 5856 to manage gut health.
Anurag Pande, Ph.D., has been with Sabinsas sister company, Sami Labs, since 2004 in a research capacity,
and spent several years at Sabinsa Japans Tokyo office as senior technical manager. Today, Dr. Pande works
from Sabinsas corporate headquarters in East Windsor, New Jersey. Pande holds a doctorate in phytochemistry
from RML Awadh University, Faizabad, India, and has both a masters and a bachelors from Lucknow University,
India. He is the author of several trade and peer reviewed publications. In his current capacity, Pande helps with
technical marketing, delivers talks on various health benefits, provides regulatory support of Sabinsas portfolio of
ingredients, as well as closely working with customers to help them develop new products and formulations.

Bacillus Probiotics
Use of Bacillus Probiotics to Promote

Health and Wellbeing by Christopher Penet and Steve Lamb, Ph.D.
INSIDER's Take
Manufacturers, formulators and consumers Consumers are educating themselves Clinical trials have shown Bacillus
can have difficulty adapting to the and introducing good bacteria into their subtilis MB40 improves digestive
vocabulary transition from bad to good daily regimens, with a preference for health and has the potential to benefit
bacteria and to the rapidly changing food products. other areas such as improving heart
developments in the probiotic industry. health.
Probiotics offerings and available information about beneficial bacteria change

almost daily, making it difficult for manufacturers, formulators and consumers to keep up
with the latest recommendations. Its important for these parties to know which claims
are scientifically validated and which strains are safe. Add understanding and interpreting
the emerging rules from a regulatory perspective, and the category can be
overwhelming. One can only wonder how consumers can make informed decisions. It
wasnt all that long ago that the word bacteria was an omen of danger, illness or
worse. Bacteria associated with foodborne illness, methicillin-resistant
Staphylococcus aureus (MRSA), Clostridium difficile (C. diff), cholera and so
on, dominated the messaging to consumers from news sources. Those
bad bacteria still exist, but for the last 25 years or so, the concept of
good bacteria has entered the consumers vocabulary. Discussions
over coffee and in grocery store aisles are about introducing these
good bacteria to their families and their daily regimen.
That dialogue started when consumers began to learn that the
yogurt or cheese they had been consuming was beneficial to their
overall health, thanks largely to probiotic content. They then began to
learn and understand that they could introduce even more of these good
bacteria by purchasing highly concentrated forms of probiotics in capsules.
Media outlets began touting the health benefits, and initial studies began to
Discussions build a scientific case that these good bacteria might impact their overall
over coffee and in grocery
store aisles are about health and immunity.
introducing these The flow of information continues; data is constantly being developed and
good bacteria possibilities touted. However, the consumer now must also contend with
to their families and other questions: Does my capsule actually contain the levels stated? Is one
their daily regimen. strain better than two? Two better than four? What strain produces benefits
for my irritable bowel syndrome (IBS)? My immunity? Inflammation?
It is becoming increasingly obvious that many types of probiotics can
address these issues, and research must continue to develop. The science
addressing these questions must be validated, and clinical trials need to
IN THIS ISSUE Irritable Bowel Syndrome p.25 Lab Insights p.31 Table of Contents p.2

Bacillus Probiotics
address specific issues and follow protocols that result in clearly defined results.
Research must continue to explore the strains that address various ailments.
The genus of bacteria known as Bacillus offers beneficial bacteria that is synergistic
with the common strains of lactobacilli and bifidobacteria, and has a natural stability and
a range of metabolites (including enzymes) that they produce. These properties make
Bacillus a valuable addition to the toolbox of probiotics that can potentially address health
issues. One strain of this genus, Bacillus subtilis MB40 (from BIO-CAT Microbials) has
been shown in clinical trials to improve digestive health. It also holds promise in other
areas such as heart health and pathogen reduction through competitive inhibition.
MB40 has been successfully tested in two clinical trials for safety, digestive health
and improvement in overall wellbeing. In an unpublished trial of 29 individuals, no adverse
effects were reported after 30 days of consuming MB40. Patients reported more than
70 initial digestive ailments when starting the trial, but those were reduced to fewer than
20 ailments after 30 days. In 21 of the 29 study subjects, decreases in serum triglycerides
from initial readings to conclusion of the trial were measured. This indicated the potential
for MB40 to aid in improving key factors in cardiac health.
In this trial, glucose levels were unchanged in any of the patients, suggesting the
potential for MB40 to aid in controlled breakdown of carbohydrates and the reduction of
blood glucose level spikes. MB40 also produced a wide variety of enzymes in vitro. The
scope of enzymes produced may indicate MB40s ability to aid in digestion for patients
sensitive to certain food groups such as specific proteins or carbohydrates. The data
from this trial is currently in process to be published in a peer-reviewed journal.
A second, larger ongoing clinical trial (100 individuals in a double-blind study) has
assessed bloating as a primary endpoint coupled with nine secondary outcomes. This
trial is scheduled to conclude in March 2017, but early results showed no adverse effects
were reported, and all patients who completed the trial reported significant decreases in
bloating, overall improvement in digestive health and decreases in symptoms.
Probiotics Marketplace
TM
Chris Penet and Steve Lamb, Ph.D., will be offering more

information on the latest science in health categories
including digestive support at Probiotics Marketplace, a
day-and-a-half event on April 18 and 19 as part of
Ingredient Marketplace in Orlando. Probiotics Marketplace
is produced with the International Probiotics Association
(IPA), the premier underwriter is Nutraceutix, and additional
support is provided by BIO-CAT, Sabinsa Corp., Unique
Biotech and Viva 5 Corp. For more information, visit
marketplace.supplysideshow.com.

Bacillus Probiotics
Future research will also focus on probiotic and enzyme combination in functional
foods. Imagine pairing the best long distance runners (probiotics) that can compete with
bad bacteria and produce metabolites that enhance health with the best sprinters
(enzymes) that work to break down organic materials immediately in the digestive tract to
provide nutrition to the body and feed the probiotics. And imagine a probiotic that can
modulate triglycerides combined with a lipase enzyme that can break down dietary
triglycerides so effectively that the triglyceride cannot be reformed in the blood system.
These realities are being researched and will become part of the dialogue as to how
health can be enhanced with probiotics in the future.
Chris Penet is vice president at BIO-CAT, where he oversees the strategic planning, research and
regulatory departments. Prior to BIO-CAT, he had a 20-year tenure with Genencor International (now
DuPont), holding several positions including global industry manager for the Food and Specialty
Enzymes business unit. Penet earned his masters degree in food science from the University of
Georgia and holds several patents in enzyme applications. He serves on the Virginia Biotechnology
Association Board of Directors, the Strategic Planning Committee for the Enzyme Technical Association
and is a member of the Biotechnology Division of the Institute of Food Technologists.
Steve Lamb, Ph.D., earned his doctorate degree in microbial biochemistry from the University of
Wisconsin in 1974. For the past 40 years, he has worked in research and development for various
companies in the chemical, pharmaceutical and food industries. Lamb worked at Genencor International
(now DuPont) for more than 12 years, optimizing production processes for enzyme-producing microbes.
For the last seven years at BIO-CAT Microbials, he has worked to develop proprietary Bacillus-based
solutions for crop and animal agriculture, bio-remediation and waste treatment applications.

Lab Insights
A Look at Probiotic Testing

by Tammy Blakemore
INSIDER's Take
Determining the correct assay to The equipment that tests probiotics Probiotics can introduce an unwanted
establish probiotic colony forming units is specialized and requires detailed spread of bacteria to an environment,
(CFUs) is complicated and requires sterilization and possible care for so labs need to take extra precaution to
consideration of strain type(s). freeze-dried products. control contamination.
Good bacteria in probiotics are defined by the World Health Organization (WHO)
as live microorganisms which when administered in adequate amounts, confer a health
benefit on the host. When testing live organisms, manufacturers must go beyond
showing how many mg or the quantity included in the product. Measureable quantity
comes from knowing the total viable count or colony forming units (CFUs) of the probiotic
material. The health benefit comes from the live bacteria, so counting the CFUs is critical
to determining the potency of the product.
In January 2017, the Council for Responsible Nutrition (CRN) and the International
Probiotics Association (IPA) finalized Best Practice Guidelines for Probiotics, and
presented a Citizen Petition to FDA to reword the 21CFR101, subpart C to require
quantitative amounts of probiotics be listed in CFUs instead of mg weights.
Since the industry has officially decided CFUs will be the quantifier for potency, how
do we then decide which test method is the best? Probiotic manufacturers have
methods that are specific to their raw materials; the dairy industry has methods
available from several sources, including the International Dairy Federation; and the
Food Chemical Codex (FCC) recently added several probiotic monographs to their
compendia, as well. But, most of these available testing methods are for single-strain
raw materials and are complex pour plate methods, which could have 20 to 30 percent
results variability in terms of repeatability and reproducibility. Having methods from
compendia sources such as the FCC helps level the playing field where the same strain
type can be compared regardless of the manufacturer.
Unfortunately, a blended strain product may not have one ideal testing method, and
deciding on a method may be complicated. A good starting point is to review the
individual strain methods and look for overlapping testing. Additionally, the testing lab
may need to attempt several probiotic methods and perform method development before
exact testing can be determined.
If determining the method wasnt complicated enough, performing the testing presents
challenges. All probiotic methods require specialized equipment, specific agars and
broths to perform the testing. And, these methods require sterilized glassware with
multiple dilutions and incubation time to get to a final countable area of 25 to 300 colonies
per plate. Each specific method could have steps for heating using an ultrasonic bath or
IN THIS ISSUE Bacillus Probiotics p.28 Market Data p.34 Table of Contents p.2

Lab Insights
stomacher to break the spores of probiotics with spore forming bacteria. For other
probiotic material, stomaching and rehydration steps may be needed for freeze-dried
probiotics. Its important to realize not every testing lab is set up for this type of
specialized testing.
Another challenge is to control the microbiology lab environment. Typically, in a
microbiology lab, the samples being tested have low plate counts. The air and
environment remain clean and are monitored for contamination. When a lab decides to
start testing probiotic material, this introduces a known contaminant to this clean
environment. Even though probiotics are good bacteria, they could pollute a clean
environment, and precautions must be taken to ensure other samples are not exposed to
these high plate count bacteria. Since probiotics are designed to have high counts in the
millions, or even billions, of CFU/g, proper sample handling, cleaning of all surfaces and
using ultraviolet light or other air cleaning techniques after plating are important. The air
quality must be kept at the highest standard to ensure a clean environment for other
routine microbiology testing. Because of these challenges, working with probiotics in a
separate section of the lab and at separate plating times is often required to
avoid contamination of other samples in the lab.
Even though probiotics are good

bacteria, they could pollute a clean
environment, and precautions must
be taken to ensure other samples
are not exposed.
Additional tests need to be considered for probiotic material, and the

FCC monograph lists nucleic acid-based identification using polymerase
chain reaction (PCR) or other genetic identification methods. It also lists other specific
tests including standard microbiology panels and non-lactic acid bacteria. These
standard microbiology tests include: Coliforms, E. coli, Listeria, Salmonella, Enterococci
and Staph. It is important to note total plate counts (TPC) or aerobic plate counts (APC)
and yeast and mold testing are not included in the FCC testing methods for probiotic
material. These standard plate counts would show high growth due to the good bacteria
that make up probiotics. Sometimes customers will inadvertently order APC, not realizing
that products containing probiotics will always show counts on these types of general
growth media.
As technology continues to advance, testing choices will evolve. Recent studies have
been conducted on rapid count methods including flow cytometry. The Federation
Internatioanle du Lait (FIL) and International Dairy Federation (IDF) worked on a joint study

Lab Insights
using flow cytometry technology quantitative methods. This study demonstrated the large
testing variability can be reduced, along with showing impressive precision and accuracy.
This technology-based testing shortens the results reporting time by removing the
incubation steps that the pour plate methods use. In the future, flow cytometry methods
and other equipment-based methods may give alternative ways to quantify lactic acid
bacteria and probiotics. In the meantime, before these equipment methods are realized,
the industry will continue to use agars, media and large dilutions schemes to quantify the
CFUs for probiotic potencies.
What does this mean for probiotic product testing? It means manufacturers must be
careful which lab they choose to test their products. They need to research and ask the
right questions when deciding who will be tasked with determining the quality of
products. Choosing a lab that is accustomed to handling probiotic material and
performing specialized testing can take the stress out of making sure a product meets
the label claim today and in the future as alternate methods continue to evolve.
Tammy Blakemore is general manager at SORA Labs, a third-party dietary supplement testing lab that specializes
in enzyme testing.

Market Data
Market Opportunities
for Probiotics Supplements by Monica Feldman
INSIDER's Take
The market for probiotic supplements New successful probiotic products At-home microbiome testing could be
is strong in the United States, up 17 focus on specific demographics, the next evolution that drives probiotic
percent in 2015 from 2011s retail include other types of ingredients or products as consumers focus on
market. use fun delivery systems. personalized nutrition.
Probiotics supplements remain a strong growth driver within the supplements

industry in the United States and across the world. The retail market value of probiotics
supplements sold in pharmacies and mass channelsexcluding online, multilevel and
the natural health shopsin the United States reached US$920 million MSP
(manufacturer selling price) in 2015, up 17 percent from 2011, according to estimates
from the database DB6 of Nicholas Hall Group of Companies. The United States held
the largest share in value sales at 33 percent thanks to increased consumer awareness
of probiotics and a highly visible presence at the points of sale at pharmacies and
natural health food stores.
United States - Probiotics OTC* Sales

3,000
2,500
2,000
$ Millions MSP
1,500
1,000
500
-
2011 2012 2013 2014 2015
USA Rest of the World
* Over-the-counter
Source: Nicholas Hall Group of Companies
The high degree of liberalization of the probiotic supplement market in the United States
results in a fragmented marketplace where only a few top brands, such as Culturelle,
ReNew Life, Align, Phillips Colon Health and Digestive Advantage, accounted for a
combined value share of 33 percent in 2015. An intense competitive landscape promotes
strong investment not only in the innovation of strains, but also in formulation, delivery forms
and packaging that companies are using to stand apart from the competition.
IN THIS ISSUE Lab Insights p.31 New Dietary Ingredients p.37 Table of Contents p.2

Market Data
Innovation in the United States focuses on specific need by type of consumer

considering age, gender, stage of life, lifestyle or medical condition. This segmentation
creates new possibilities of revenue generation that benefits firms in a highly competitive
environment. Pediatric probiotics, for example, has become a hot area of innovation as
highlighted by launches since 2015 that claim to boost the immune system, or to promote
digestive regularity in children. Moreover, novel delivery forms such as chewables,
gummies and fizzy drinks are making it more palatable and fun for children
but also adultsto take their probiotic supplement.
Novel delivery forms are making

it more palatable and fun for
childrenbut also adultsto
take their probiotic supplement.
Probiotic supplements marketed at women represent another area of

market expansion that centers on the particular needs of feminine care using
either a systemic or topical approach. For example, the combination of probiotics with
cranberry extract is being touted as a good option to promote urinary health. Alternatively,
skin care is becoming a sizzling area of interest as novel systemic probiotic options claim to
help maintain healthy skin or, in any case, help treat conditions such as acne or eczema.
Alternatively, more options in probiotics are coming to market that cater to the specific
health needs of older adults, especially for digestive health and improved immunity.
Other interesting developments point to the launch of combinations with functional
ingredients such as omega fatty acids to promote heart health, lactase to enhance
digestion, vitamin B to promote energy, and vitamin C to boost immunity. In fact, new
products are going even further in innovation with the launch of probiotic wellness
options for the athlete, or as support for weight loss as a combination with green tea leaf.
Time-release probiotic supplements are gaining attention with their promise of
sustained release during a specific period of time, including nighttime formulations that
are popping up in the marketplace claiming to provide benefits of gut restoration while
the person sleeps.
From the perspective of marketing and positioning, more firms are highlighting the
number of colony forming units, or CFUs, on the packaging to show consumers the
importance on the quantity of probiotics contained in the serving of a supplement. This is
a key development to counteract the competition arising from packaged foods and
beverages such as yogurt, kefir and kombucha that typically boast probiotic content,
albeit at a much lower count when compared to probiotic supplements.

Market Data
Probiotic Marketplace
TM
Monica Feldman will be offering more information on

market opportunities, including examining consumer
buying patterns and trends, at Probiotics Marketplace, a
day-and-a-half event on April 18 and 19 as part of
Ingredient Marketplace in Orlando. Probiotics Marketplace
is produced with the International Probiotics Association
(IPA), the premier underwriter is Nutraceutix, and
additional support is provided by BIO-CAT, Sabinsa Corp.,
Unique Biotech and Viva 5 Corp. For more information,
visit marketplace.supplysideshow.com.
Physician brands continue to gain momentum among consumers who seek the
endorsement of the health care professional, especially given the conflicting information
available by the media about the quality and proven health claims of supplements.
Interestingly, physician brands are leaving their confined sales at the office to extend into
other channels such as the internet via vendors such as Amazon or direct-to-consumer
(DTC) online. In fact, DTC brands are challenging the traditional pattern of shopping for
probiotics away from the pharmacy. Firms selling premium or exclusive probiotics, or
those designing clever social media campaigns to reach out and sell to consumers have
become successful in generating sales from an emergent generation of consumers highly
connected to digital platforms for shopping.
Looking ahead, the advent of at-home microbiome testing is generating curiosity and
disrupting the marketplace. uBiome, for example, offers DNA-sequenced microbiome
screening to help consumers understand the status of their health as related to their
lifestyle, other people, and time progression. Obviously, this development can open a
door for the personalization of probiotic supplementation that can potentially generate
another channel of revenue for firms. Projections from Nicholas Hall Group of Companies
reveal probiotic supplements will reach a retail value of US$1.3 billion in 2020, up
44 percent from 2015.
Monica Feldman is the global director of client services at Nicholas Hall & Co. Her past 25 years of experience
include executive marketing positions and consulting work at leading multinational companies, consulting firms
and trade organizations. She has been a speaker at major consumer health events, and is regularly quoted in
leading trade press. Feldman is an active international advocate in business trade expansion for the life sciences
and wellness industries. She works with other thought leaders and members of academia to further opportunities
in consumer health. Monica holds a masters of business administration in international marketing and finance
from DePaul University in Chicago and is a member of the Advisory Council at the Buck Institute for Research on Ageing.

New Dietary Ingredients
Probiotic New Dietary

Ingredient Notifications
A gut check full of challenges and opportunities
by Ivan Wasserman and Amit Sharma
INSIDER's Take
The updated new dietary ingredient The chemical alteration provision Notifying FDA is a complex process, but
draft guidance poses concerns for brings questions of fermentation, since a quality, comprehensive submission is
probiotic supplement brands due to the a change in medium may not change likely to be accepted by FDA, bringing
unique nature of beneficial bacteria. the composition of the probiotic. competitive advantage.
In August 2016, FDA released its revised draft guidance Dietary Supplements:
New Dietary Ingredient Notifications and Related Issues: Guidance for Industry. The draft
guidance is intended to help companies decide whether a substance is a new dietary
ingredient (NDI), to outline the process for deciding if something requires a new dietary
ingredient notification (NDIN), and to provide an overview of the procedures for
submitting an NDIN.
While the draft guidance applies to all dietary ingredients, such as vitamins, minerals,
botanicals, amino acids and more, some provisions are particularly important for
probiotic ingredients. Understanding the document, including the best strategies to
submitting NDINs if needed, will be key to business going forward.
The International Probiotics Association (IPA), a probiotic industry trade association,
submitted comments to FDA on the draft guidance. IPA applauded FDA for proposals
such as allowing master files and creating an official list a grandfathered ingredients.
IPA offered to provide FDA with a list of genera and species known to have a long, safe
history of use in foods, and then establish criteria that would bring a strain belonging to
these genera and species to be listed.
However, IPA expressed concerns about parts of the draft guidance that would have
particular ramifications, given the unique nature of probiotic ingredients.
Challenge: Chemical Alteration

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), an NDIN is
not needed for an NDI that is present in the food supply and that has not been
chemical altered. The draft guidance provided examples of processes that FDA believes
results in chemical alteration, including: Using a fermentation medium different from the
one used to make conventional foods in the food supply. Example: use of a defined
commercial growth medium to produce a microorganism previously made by fermenting
milk into dairy products like yogurt or cheese. As IPA noted in its comments, during the
manufacturing process, several ingredients comprise the fermentation media to provide
essential nutrients for propagation of the live microorganism and substituting one source
IN THIS ISSUE Market Data p.34 Intellectual Property p.40 Table of Contents p.2

of these ingredients with another does not chemically alter or change the genetic
composition or identification of a probiotic strain. It simply provides the same building
blocks of nutrients required for the cells to grow. Consider a change in diet; modifying a
persons diet does not render a change in genetic composition or identity of that person.
Challenge: Each Species a Separate Ingredient
The draft guidance also said: FDA considers each strain of a bacterial or yeast
species to be a separate ingredient. That has been FDAs longstanding position. IPA
supports individually identifying each strain and evaluating its safety, as well as
determining whether the notification requirement should be made at the strain level.
However, once the identification and safety evaluations have been conducted, IPAs
position is that if the strain belongs to those genera and species that have long history of
useeither in dietary supplements prior to DSHEA in the United States, or in foods,
anywhere in the world at any timethey should be exempt from the notification
requirement, unless genetically modified.
While those are only some of the concerns IPA has about the draft guidance, when
the final guidance is released, the probiotic sector, like all sectors, will be affected. FDA
can choose to regulate probiotics like they do all other dietary ingredients, which will
likely lead to substantial regulatory hurdles (including the filing of repetitive NDINs by
probiotic companies), or FDA may recognize the unique nature of probiotic ingredients
and modify the guidance accordingly.
Opportunities
The NDIN requirement is law. The draft guidance represents FDAs attempt to inform
the industry on how it thinks the law should be interpreted. Regardless of the document
being finalized, the law requires NDINs be submitted. Will FDA enforce more actions for
not filing an NDIN? Only time will tell.
Probiotic Marketplace
TM
Ivan Wasserman will be offering more information on legal

issues affecting the probiotics space, including new dietary
ingredients (NDIs) and product claims at Probiotics
Marketplace, a day-and-a-half event on April 18 and 19 as
part of Ingredient Marketplace in Orlando. Probiotics
Marketplace is produced with the International Probiotics
Association (IPA), the premier underwriter is Nutraceutix,
and additional support is provided by BIO-CAT, Sabinsa
Corp., Viva5 Corp. and Unique Biotech. For more
information, visit marketplace.supplysideshow.com.

If a company determines an ingredient requires an NDIN, why not file one? While filing
an NDIN that will not be rejected by FDA is easier said than done, it may not be as
difficult as some believe. For those willing to go through the process, it may not only give
a company peace of mind that it will not be subject to FDA enforcement, it could give it a
competitive advantage.
Submitting an NDIN is an intensive process that requires the submission of all types of
data. However, the draft guidelines provide a roadmap on what they should contain.
While it is true a large percentage of NDINs are rejected by FDA (since DSHEA was
passed, three out of every four NDINs have been objected to by FDA), a closer look
shows many of them lacked essential information. High-quality, data-rich submissions
certainly have a higher than average acceptance rate.
Filing an FDA-accepted NDIN for a probiotic ingredient can be a door opener. It can
reassure potential customers about the safety and compliance of the ingredient and,
therefore, its finished products. And even if FDA rejects the notification in the first round, it
may highlight gaps in an ingredients safety dossier that ultimately will help protect the
company once the gaps are filled.
Probiotics as dietary ingredients pose unique opportunities and challenges generally,
so it is not surprising many of their NDI-related issues are complex. Carefully following
FDAs, IPAs and other stakeholders statements and actions in this area will be critical to
the probiotic industrys future. Stay informed and get involved.
Ivan Wasserman is a partner in the Washington DC office of Amin Talati Upadhye LLP. Wassermans practice
covers health, wellness, beauty and other consumer products, and he represents companies of all sizes.
Frequently cited by the media as a legal authority, Wasserman advocates for clients subject to the jurisdictions
of FDA and FTC. He also regularly represents companies before the National Advertising Division (NAD) and the
Electronic Retailing Self-Regulation Program (ERSP). He has been included in Best Lawyers in America from
2007 to 2017.
With a background in both biology and chemistry, Amit Sharma advises on laws and related legal strategies for
companies in the food, beverage, supplement, drug and cosmetic industries. Sharma, as associate at Amin Talati
Upadhye, primarily helps clients with compliance and disputes before FDA, FTC, USDA, NAD and U.S. Customs.
Amit also reviews product labels and packaging for compliance and advises on claim substantiation for websites
and other advertising platforms such as social media, print, radio, television and Internet.

Intellectual Property
Leaders and Trends in Intellectual

Property: Probiotics by Andreas Baltatzis and Gideon Eckhouse
INSIDER's Take
Probiotic patents and trademarks are Globally, more than 10,000 patents Since 2011, 600 probiotic supplement
on the rise, showing innovation as cover inventions associated with trademark applications and registrations
new products are increasing in the probiotic innovation. have been filed compared to fewer
supplement market. than 300 registrations before 2011.
Every day seems to bring exciting research about the important role of probiotics
in human health. Consumers are seeking probiotics not only for digestive health, but also
for improved immunity, womens health, brain function, oral health and better skin.
Patent Filing Trends: Rapid Growth

Patents protect inventions, and trademarks protect brands.
Innovation in probiotics has dramatically increased in the past 20 years. As new
connections are made between probiotics and health and wellbeing, the rate of
applications filed continues to increase, and has now reached more than 10,000 patent
applications throughout the world. The increasing rate of filing shows inventions
continue to be discovered.
Applications Filed Per Year

1600
1400
1200
1000
800
600
400
200
0
96 97 98 99 00 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15
19 19 19 19 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20
The Leaders: Patent Applications

Given the large number and wide range of applications for probiotics, including
supplements, food and beverage products, pharmaceuticals, nutraceuticals and
cosmetics, a wide variety of companies are represented as leaders of application
assignments. Moreover, a number of companies have established large portfolios
indicating a dedication to research and development (R&D) of new innovations.
IN THIS ISSUE New Dietary Ingredients p.37 Self-Regulation p.44 Table of Contents p.2

Application Leaders
Sanzhu Fuer Pharmaceutical
Shaanxi Univ. of Sci. and Tech.
Mars
Hu Anran
Zhejiang Univ.
Bright Dairy & Food
Jiangnan Univ.
Jinshanmei Biotechnology
Alimentary Health
Beijing Dabeinong Tech.
MJN US Holdings
Nanchang Univ.
CHR Hansen
Procter & Gamble
DuPont/DuPont Nutrition Biosciences
Healming Health Science
LOreal
Nestec/Nestle
0 50 100 150 200 250 300 350
Global Filing Trends: Probiotics Worldwide

While most applications have been filed in the leading patent offices of the United
States, Europe and China, a great deal of interest in probiotic innovation flows throughout
the world. Most applications have been published by the World Intellectual Property
Organization (WIPO). WIPO administers the Patent Cooperation Treaty (PCT) system. The
PCT system allows for a single patent application to be filed that applies to countries
throughout the world. An applicant who files in their own country first must generally file
globally (including a PCT) within one year of the earliest application.
2000
Number of Applications per Authority

1500
1000
500
0
ia il n ia da lia ina e es PO
Ind az pa ss na tr a ffic t at WI
Br Ja Ru Ca s Ch O S
Au nt ted
a te Un
i
a nP
ro pe
Eu

Since 2011, 600 nutritional supplement

trademark applications and registrations
have been filed with the term probiotic
in the listing of goods and services.
New Brands: Trademark Applications in Probiotics

Trademarks provide protection of brand names and logos for companies and individuals
who sell a product. Every trademark application and registration must list the goods and
services with which the mark is used. This ensures that the scope of the trademark rights is
limited to the products and services with which the brand is actually marketed.
Since 2011, 600 nutritional supplements trademark applications and registrations have
been filed with the term probiotic in the listing of goods and services. Before 2011,
fewer than 300 registrations fit these parameters. Regarding applications, 1,469 were
filed since 2011 that included probiotics in the listing of goods compared to 594
applications filed before 2011.
Probiotic Trademark Registrations and Applications

1600
1400
1200
1000
800
600
400
200
0
Registrations since Registrations Applications since Applications
2011 before 2011 2011 before 2011

A review of the occurrence of common terms found in probiotic trademarks show very
few keywords occurred with any significant frequency. This suggests probiotic product
manufacturers are creative in branding their products. While it might be beneficial to
include in a product name the common terms for their ingredients (e.g., acidophilus or
lactobacillus), such names are generally not available for trademark protection.
144
Common Terms in Probiotic Trademarks
91
80 70
67
26
19 19 14 14
14 13 12 12 9
Probiotic Bio Health Nature/ Nutrition/ Gut Food Green Digest/ Pure Micro Doctor Organic Lacto Supplement
Natural Nutrient Digestive
Attorney Andreas Baltatzis is a director at KramerAmado PC, a boutique law firm specializing in intellectual
property (IP). He represents a number of innovative nutritional supplement and nutraceutical companies that
improve peoples lives every day. Baltatzis also helps companies prepare and implement IP strategies by
obtaining patents and trademarks that protect their innovations and cash flow, as well as advising clients on
successfully launching new products and brands.
Gideon Eckhouse is a senior associate at KramerAmado, with more than 10 years of experience in patents and
trademarks. He assists innovative nutritional supplement and nutraceutical companies protect their IP throughout
the world. Eckhouse counsels and implements global trademark strategies for new brand launches. Additionally,
he prepares and prosecutes patent portfolios protecting new products coming to market.

Self-Regulation
Fostering a Culture of Responsibility

by Andrea Wong, Ph.D
INSIDER's Take
The Council for Responsible Nutrition A key element of the guidelines is the The guidelines offer direction into
(CRN) and the International Probiotics recommendation to label the number storage and stability testing to help
Association (IPA) released guidelines of colony forming units (CFUs) at the manufacturers consider formulation,
for probiotic product brands to end of shelf life. packaging and storage environments.
increase transparency.
Probiotics are a popular and rapidly growing sector of the dietary supplement
industry. Traditionally recognized for benefits in digestive health and immune function,
probiotics are now being researched for potential value in many areas including oral, skin
and brain health. The extent of research is reflected by a recent search of the term
probiotics on PubMed, yielding more than 15,000 results.
Part of being a responsible industry is employing self-regulatory initiatives that provide
a roadmap for companies to ensure all products abide by high-quality and reliable
standards and to facilitate transparency and consistency for consumers. In 2015, the
Council for Responsible Nutrition (CRN) and the International Probiotics Association (IPA)
identified a need to develop best practices guidelines for the growing probiotic sector,
and together, the associations established a task force of more than 60 leaders,
representing nearly 40 companies that manufacture or market probiotic ingredients or
products, to take on this initiative. After working diligently for more than a year to develop
science-based recommendations that reflect best practices for key aspects of probiotics
manufacturing and labeling, the associations released final best practices guidelines for
probiotic-containing dietary supplements and functional foods, of which a key element is
the recommendation to label probiotic products in colony forming units (CFUs).
CFU is the scientifically accepted unit of measure for probiotics and is commonly
used on probiotic product labels globally. In fact, many studies conducted to assess the
safety or benefits of probiotics report probiotic quantity in CFUs. Current U.S. regulations,
however, require dietary ingredients (other than some vitamins) be labeled by weight
(e.g., milligrams). While weight may be appropriate for quantifying many ingredients, it
does not provide meaningful information regarding probiotics because weight does not
indicate the viability of the microorganisms in the product throughout shelf life. Labeling
products in CFUs is more representative of the number of viable microorganisms in the
product and gives consumers the most accurate information.
Other means of quantifying probiotics are available or in development, and the CRN-IPA
task force took them under consideration when developing the guidelines. Consistency
in units of measure across scientific research and product labeling is important to help
consumers and health care professionals identify products that provide probiotics in
quantities shown to be beneficial. Given the overarching acceptance and usage by the
scientific community, and the goal of the industry to provide consumers and health care
IN THIS ISSUE Intellectual Property p.40 Takeaways p.46 Table of Contents p.2

Self-Regulation
professionals with information that is accurate and easy to understand, the task force
concluded CFUs are currently the most appropriate unit of measure to use on labels.
The guidelines recommend to label probiotic quantity in CFUs, promoting consistent,
science-based practices. The guidelines also clarify that the quantity of probiotics on a
label should reflect the number of viable microorganisms at the end of the stated shelf
life, rather than at time of manufacture.
In conjunction with the release of the best practices guidelines, which call for CFU labeling,
IPA recently submitted a citizens petition to FDA requesting that the dietary supplement
labeling regulations (21CFR101.36) be amended to require the quantitative amount of
probiotic ingredients in a dietary supplement to be presented in CFUs instead of by weight.
The probiotic guidelines are another meaningful

self-regulatory initiative that will elevate the trust
and confidence consumers have in products.
Another challenge associated with probiotic labeling is declaring quantity when a

product contains two or more strains. While there are some valid methods for quantifying
individual species in a blend, reliable methodology to enumerate individual strains of the
same species within a blend is not available at this time. Therefore, the guidelines
recommend that for probiotic products containing multiple strains, the total count of the
blend in CFUs be labeled. When technically feasible, the quantity of each genus or
species in the blend should be declared as well. Regardless of the level to which quantity
is labeled, the guidelines recommend that the firm identify on the label the genus, species
and strain of each probiotic microorganism contained in the product.
In addition to labeling, the guidelines address stability testing and storage. Benefiting
manufacturers, retailers and consumers alike, establishing a process for these key
aspects of probiotic manufacturing and handling ensure a product contains the labeled
amount through the end of the stated shelf life, and encourages manufacturers to
consider formulations, packaging and storage environments.
The goal of these guidelines is to increase the transparency of the probiotic market and
ensure products best serve consumers. As regulations are updated and the industry evolves
with technological changes, so will these guidelines. A demonstration of commitment to
consistency and high-quality products, the guidelines are another meaningful self-regulatory
initiative that will elevate the trust and confidence consumers have in products.
Andrea Wong, Ph.D., is the vice president, scientific and regulatory affairs of the Council for Responsible Nutrition
(CRN), a trade association for the dietary supplement and functional food industry.

Takeaways
Takeaways for Your Business

Probiotics supplements remain a strong driver of growth within the supplements
industry in the United States and across the world. The retail market value of probiotics
supplements in the United States reached US$920 MSP (manufacturer selling price) in
2015, up 17 percent from 2011, according to the Nicholas Hall Group.
Probiotics have exploded in the market due to the wide range of health benefits
they offer consumers, from digestion to womens health, immunity and sports nutrition.
The most common probiotic bacteria belong to two generaLactobacillus and
Bifidobacterium. Other common genera are Enterococcus and Streptococcus, to
name a few.
The class of bacteria known as Bacillus offers benefits that are synergistic with other
probiotics, but they also have a stability and a range of metabolites (including enzymes)
they can produce.
The protective role of probiotics in digestion is well established, but probiotic benefits
have spanned beyond digestion.
The nutraceutical industry has started to exploreand embracethe crossroads
where probiotics and sports nutrition meet. Researchers and opportunity seekers have
made it clear probiotics may play a leading role in shaping the sports nutrition
supplements of tomorrow.
An important aspect of probiotic therapy is whether the bacteria survives. The
therapeutic benefits of bacteria can be negatively affected if there are harsh conditions
during formulation or long shelf storage. Spore-forming bacteria have revolutionized
probiotic delivery by allowing formulations of food, including soft chews, gummies and
chewables, to deliver bacteria, as well as dietary supplement forms that increase
consumer usage.
To address these concerns and others, the Council for Responsible Nutrition (CRN)
and the International Probiotics Association (IPA) developed science-based
recommendations that reflect best practices for key aspects of probiotics manufacturing
and labeling. A key element is the recommendation to label probiotic products in colony
forming units (CFUs).
However, deciding which test method to determine CFUs can be difficult. A blended
strain product may not have one ideal testing method. A good starting point is to review
the individual strain methods and look for overlapping testing. Additionally, the testing lab
may need to attempt several probiotic methods and perform method development before
exact testing can be determined.
Despite difficulties with manufacturing, innovation in probiotics has dramatically
increased in the past 20 years. However, FDAs thinking on current probiotic regulation
in the United States could pose threats to probiotic product innovation.
IN THIS ISSUE Self-Regulation p.44 SupplySide Storefront p.47 Table of Contents p.2

D I R E C T O R Y
Looking for ingredients, suppliers and solutions
in the probiotic space?
Check out these SupplySide and Vitafoods Global Storefronts to get more information
such as whitepapers, presentations, contacts and other content from suppliers offering
results for probiotic manufacturers and marketers.
PROBIOTICS CATEGORY SPONSOR
Agropur Ingredients
(608)781-2345
Probi USA, Inc., dba Nutraceutix
ingredients@agropur.com
425-883-9518 x329 tgamble@nutraceutix.com
BIO-CAT & BIO-CAT Microbials Deerland Enzymes Inc. Ingredients By Nature

(770)919-8907 (909)230-6200
info@bio-cat.com info@deerlandenzymes.com jbrewster@
ingredientsbynature.com
JBSL-USA Inc. MTC Industries Inc. Sabinsa Corp.

(925)938-2732 (631)274-4818 (732)777-1111
v_hackel@jbsl-net.com lisa@mtcindustries.com shaheen@sabinsa.com
Stratum Nutrition Vesta Nutra

(417)310-2286 317-895-9000/888-558-3782
aknell@esmingredients.com sales@vestapharm.com
IN THIS ISSUE Takeaways p.46 INSIDERS Contact p.48 Table of Contents p.2

Contacts
Natural Products INSIDER EDITORIAL

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is the leading information source for marketers,
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supplements, healthy foods and cosmeceuticals. Rachel Adams .......................................... rachel.adams.us@informa.com
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Vol. 7, No.

Market Opportunities for Probiotics

p.18 Probiotic New Dietary Ingredient

Use of Bacillus Probiotics to Promote p.46

A Look at Probiotic Testing SupplySide & Vitafoods Global

2 INSIDER Probiotic Ingredient Science Digital Magazine February 2017

3 INSIDER Probiotic Ingredient Science Digital Magazine February 2017

You are no longer limited by the traditional probiotic rules.

Probiotics Benefits Span Beyond the Gut

IN THIS ISSUE Viewpoint p.3 Digestion p.18 Table of Contents p.2

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World-class Scientific and Sales Support Proprietary Stabilization Technology

Probiotics is all we do. Our founder, acclaimed microbiologist

Visit us at Engredea, booth 456

Its a Strain to Find the Right Probiotic

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Patented Improvements for Any Probiotic

Better for Researchers.

Expert Contract Manufacturing of:

Probiotic Ingredient Science Q&A

Probi USA Inc., dba Nutraceutix

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an iron-supplemented fruit drink without Lactobacillus plantarum 299v, according to

Research on probiotics for

Research on probiotics for athletes or people who exercise revealed

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We Make Ingredients Work!

Contact the Solutions Team: ask@pharmachemlabs.com | 1-800-526-0609 | pharmachemlabs.com

Proper Delivery Methods of Probiotics

12 INSIDER Probiotic Ingredient Science Digital Magazine February 2017

Probiotics can be acid-sensitive, so ensuring they transition through the stomach

Newer research is exploring

There Are Great Opportunities for Further Research

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Probiotics for Digestive Health

According to Robert Hutkins, professor of food science, University of Nebraska,

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Do a keyword search for

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