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WHITE PAPER

THE “JUST IN TIME” EVOLUTION OF NUTRACEUTICAL CRANBERRY

2007

U.S & Global Supplement Trends:

If you’re reading this White Paper there’s a certainty that you have considerable interest in the world of

natural health care. It’s also most likely a certainty that you are affiliated with one or another company

who acts as a developer and marketer of dietary supplements. It’s well known that the current

marketplace for supplements has its own history and chronology of events which have led to the

prevailing trends unfolding within the industry at large. Tipping point legislation, embodied by the Dietary

Supplement Health and Education Act (DSHEA) in 1994; has served to shape the industry not only in

terms of its rules, but its raison d’etre. Supplement sales have reached $21.3 billion in the US and $66.6

billion globally and now account for 28% and 32% of total Nutrition Industry sales respectively. Herbal

sales comprise a significant portion of dietary supplement sales, approximately $4.5 billion overall.

However, over the last 9 years their trend has slowed considerably with only a select number of favored

herbals in growth mode, cranberry being one of them.

A growing number of consumers worldwide have jumped on the natural supplement bandwagon to help

maintain their health and well-being, but require that the Natural Products Industry police itself and strive

to elevate the level of its clinical support and product quality. The bar labeled “safety & efficacy” has been

elevated to unprecedented levels.

An Industry “Herbally” Challenged:

Greater awareness of the natural end-benefits found in a multitude of different dietary supplements has

yielded increased retail distribution and consumer usage. Consumers instinctively believe that “natural is

better”. During the period from 1994-1998, herbal products exploded into the natural food and FDM retail

marketplaces and were welcomed as a new source of incremental sales. Consumers were drawn towards

the world of herbals and to products containing such ingredients as Ginseng, Garlic, St. Johns Wort, Saw

Palmetto, Echinacea and Ginkgo as a means of promoting good health and well-being. Herbals were

clearly on the fast track and seemed invincible to a category slow down.

However there are always two sides to every coin. A broad and inconsistent range of quality, coupled with

an increased incidence of contrary side-effects, resulted in their being questioned and subsequently

doubted for their safety and efficacy by industry watch dog groups and the media at large. The overall

effects of these actions have been two-prong. First, a flattening of the overall growth curve for herbals in

1

Industry Segment USA GLOBAL

Dietary Supplements

 

21,310 66,550

Natural & Organic Food

20,840 47,730

Natural & Organic Personal Care

& Household Products

6,560 18,210

Functional Food

25,660 77,890

Total Nutrition Industry $ 75,370 $ 210,380

SOURCE: Nutrition Business Journal; 2006, Represents All Trade Classes

various retail sales channels, while at the same time a concerted effort by many responsible

manufacturing entities to prove the safety and curative worth of these products clinically.

The industry has struggled with a negative consumer “trust factor”. Many want to supplement their health

with natural medicinals, but there’s that little voice inside each consumer that says, “Do these really work?

Will they truly make a difference? Will they act as promised or for that matter do me harm? Should

monies I’ve budgeted towards wellness be spent this way or should I go at it differently?”

Consumer trust is gained as a by-product of the Corporate drive towards excellence. Reputable

companies in the industry willing to elevate and sustain the caliber of their products while dedicating the

necessary time and resources towards clinical affirmation are the new breed of industry leaders. Although

this process is far from over, there has been significant improvement in the quality of natural medicines

available to the general public as well as an accelerating drive to substantiate them scientifically. It’s

believed that natural medicines are now on the cusp of another upward trend due in part to greater

satisfaction with their users worldwide.

Cranberry...A Rising Star in Herbal Sales:

In addition to its historical place at the Thanksgiving table and its consumption as a great tasting and

refreshing juice drink consumed casually, the cranberry fruit is currently used by millions for its overall

health benefits. Here are some interesting facts on cranberries (Source: Cape Cod Cranberry Growers

Association, 2006):

Cranberries are one of only three commercially grown fruits native to North America. The other

wetlands and uplands. These supporting wetlands and uplands provide open space, wildlife

habitat and groundwater recharge in an area otherwise stressed from urbanization.

On average, every planted acre of cranberries is supported by three to four acres of surrounding

cultivated on 39,000 acres in just five

states: Massachusetts, Wisconsin,

New Jersey, Oregon and

Washington. Another 8,000 acres are

cultivated in the provinces of British

Columbia and Quebec, Canada.

Delaware, Maine, Michigan, New

York, Rhode Island, as well as the

Canadian provinces of New

Brunswick, Nova Scotia, Ontario and

Prince Edward Island also produce

cranberries. Recently, cranberries

have been produced in Chile, South

America.

Most of the world’s cranberries are

growers in North America, 500 are in Massachusetts. Approximately 70 percent of these growers

are small family farms with less than 20 acres of bog. The cranberry is Massachusetts' number

one agricultural commodity crop and employees about 5,500 people.

Of the approximately 1,000 cranberry

2

Sales of cranberry nutraceutical products are rapidly accelerating at retail. Whereas just a few years ago

distribution for these products were sparse, it’s not uncommon these days to see an expansive on-shelf

choice of various cranberry products covering a wide array of quality and cost. Not too long ago, the

cranberry category was absent from top 10 herbal sales, while today it’s poised to be #1 with Garlic

currently trending downwards at almost 14%. The chart below illustrates current herbal standings in FDM

outlets:

The Cranberry herbal category is currently +20.6% in FDM outlets across the U.S. So the question is why

the sharp increase of sales within the world of nutraceuticals? To answer this question, it’s important to

understand the direction from “where” this trend has evolved. Cranberry is a category whose basis

historically is in food consumption. Not too long ago, those who wished to gain the healing benefits of this

special fruit did so by either ingesting the whole natural fruit or its juice. As awareness of the health

benefits of cranberry has broadened over the last 10 years, (in tandem with the escalation of supplement

sales) the desire to gain the health benefits inherent in this super food in the form of herbal

supplementation was a natural segue for a multitude of consumers. This certainly is not difficult to

understand given the large amounts of fruit or juice that need to be consumed to equal the benefits

supplied by products that deliver cranberry’s essential elements effectively in supplement form. There are

a preponderance of women consumers globally who now recognize the benefits of cranberry for the

maintenance of good urinary tract health, and prefer its benefits be delivered in nutraceutical form, void

of the excessive calories, sugar and costs incurred in the digestion of its food and juice forms.

3

Rank Dollar Sales Dollar Sales

% Chg YA

Dollar Sales

Chg YA

TTL HERBS $56,378,800 (3.5) ($2,065,620)

1

Cranberry $5,340.377 20.6 $911,330

2 Garlic

3

4

5

6

7

8

9

10

$4,932,349 (17.5) ($1,043,734)Soy Products $4,783,063 (39.5) ($3,125,757)Ginkgo $4,321,837 9.7 $383,007Saw Palmetto $4,050,406 (6.6) ($287,843)Ginseng 2,668,179 (4.9) ($136,058)Milk Thistle $2,178,631 2.4 $50,887St. Johns Wort $2,039,054 (2.6) ($54,426)Black Cohosh $1,990,570 2.3 $44.065Echinacea $1,746,090 (11.8) ($233,316)

SOURCE: IRI. Latest 13 weeks ending May 27, 2007. No Wal-Mart

Cranberry bares fruit for Good Urinary Tract Health:

The strong growth in cranberry nutraceutical sales is directly related to a high

prevalence of urinary tract infections (UTI’s) predominantly effecting women. The following are key

statistics: (

Source: National Kidney Foundation and the NIH).

year

Urinary tract infections are responsible for nearly 10 million doctor visits each

Over $1 billion dollars are spent per year on UTI’s.

One in five women will have at least one UTI in her lifetime.

percent of those will have yet another. Of this last group, 80 percent will

have recurrences.

Nearly 20 percent of women who have a UTI will have another, and 30

of which 30 million are unreported and involve self medication.

Total number of cases involving UTI’s are approximately 40 million per year,

UTI’s are the 2nd leading cause of lost work days for women.

More than 1.5 million hospitalizations are related to UTI’s

Indigenous peoples have used cranberry preparations to treat urinary tract infections and other illness for

centuries. Modern medical research has revealed the chemical and physiological effects cranberries have

on the urinary tract and in its natural ability to inhibit the growth of E. Coli bacteria responsible for urinary

tract infections (UTI’s). It’s important to understand the natural mechanism of action of cranberry. The E.

Coli bacteria are never “destroyed” by the cranberries, but “physiologically changed”, thereby disallowing

their attachment within the urinary tract. In contrast to the use of pharmaceutical medication, these

harmful bacteria are essentially whisked away, all within the flow of natural bodily processes.

Cran-Max® and the Evolution of Nutraceutical Cranberry:

Nutraceutical supplements are in fact medicines of the natural kind. As with any medicine, they must

deliver an end-benefit as promised. The process by which a phyto-medicine is developed and prepared

during manufacture is crucial to its efficacy. The innate goodness of plant medicines must be hermetically

sealed and delivered with optimum efficiency in the body. If a phyto-remedy is compromised by natural

bodily process it will not deliver on its consumer promise. In the case of cranberry, it’s imperative that its

synergistic healing elements remain intact and in greatest abundance while being delivered most

efficiently to their targets. Cran-Max has been developed to deliver on both counts. Nothing within the

cranberry fruit is ever tampered with or wasted. The “whole fruit and nothing but the fruit” is utilized within

a unique 20-step manufacturing process outlined below.

4

Juice

Pressing

Cranberry

Fiber

Cran-Max

Shipping

See

Seed

Planting

Cranberry

Pomace

Berry

Harvest

Cranberry

Dehydration

Dried CB

Pomace

Cranberry

Milling

Cranberry

Juice

Cranberry

Screening

Cranberry

Concentration

Cold Press

Extraction

Wet Blending &

Milling Homogenization

Filtration

Thin Film

Dehydration

Milling &

Packaging

Blending

Screening

Cranberry

Bio-Shield

The Benefits of Cranberry Magnified:

Cran-Max is a highly concentrated herbal supplement. A high multiple of whole fresh cranberries are

required to produce finished product for sale. It takes 34 pounds of raw cranberry material to

produce a single pound of Cran-Max® natural cranberry. While most other cranberry

products on the market require a daily “multi-dose” regimen, Cran-Max is delivered in a “oneper-

day” dose.

It’s highly concentrated content is significant when addressing the issue of

quality. The natural synergistic elements of cranberry are untampered and

condensed in Cran-Max resulting in a highly active and magnified dosage

making it extremely convenient for the consumer to use and reap its

benefits.

Testing has shown that its highly concentrated character makes it appealing

to those who want the benefits of cranberry without the excessive ingestion of either raw

fruit or juice. A recent study has shown that the anthocyanin content in a daily dose of

Cran-Max (500/mg) is equivalent to 7 eight-ounce glasses of Ocean Spray Cranberry

Juice Cocktail.

Nothing wasted. Everything Gained:

The efficacy of any nutraceutical remedy is dependent on its ability to survive the intrinsic acidic

conditions of the GI tract. It’s common for the innate goodness inherent in any natural medicine to be

neutralized during this process and its potential health related benefits lost.

Cran-Max contains Bio-Shield® Technology which serves to “protect” the active healing elements found in

cranberry, allowing them free and unhindered passage through the digestive tract to specific target

receptor sites throughout the body. Bio-Shield is analogous to a protective vehicle, enveloping and

safeguarding its important cargo within an impenetrable casing, delivering its payload intact and with

optimum efficacy to its final site of action. Cran-Max® uses the patented Bio-Shield system to deliver its

bioactives through the digestive tract’s acidic medium without deterioration.

Cran-Max is prepared as part of this unique, manufacturing process where “the whole fruit and nothing

but the fruit”, (solids, seeds, skins and concentrated juices) are first highly concentrated, leaving the fruit’s

natural and synergistic elements intact, then infused into the patented Bio-Shield carrier where these

actives (anthocyanins) are escorted through the stomach acids to the lower intestines where they are

released in controlled fashion, absorbed by the body over a 12-16 hour time period.

5

CB CB

CB CB

34 lbs.

CM

0

20

40

60

80

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16

ANTHOCYANIN RELEASE

quantity released (mg)

Release time (hours)

More specifically, the key benefit of Bio-Shield technology is to maintain the integrity of the anthocyanin to

glucose bond which allows anthocyanins to be passed into the lower gastrointestinal tract intact and

readily absorbed into the body from a non-acidic aqueous medium. It’s the role of the

Bio-Shield “envelope”, comprised of natural plant fibers, derivatives of the natural

fruit itself, that is credited with this activity. The genius of Bio-Shield and what makes

Cran-Max truly unique is that nothing is wasted and everything gained in the

process. Nothing is ever introduced into the manufacturing process that interferes

with the intrinsic natural value or goodness of what nature has intended. Given

the guarantee of a high concentration of fruit actives coupled with Bio-Shield

protection, consumers are assured an optimum delivery of the nutritional benefits

related to the cranberry fruit, even greater then ingesting such foods in their raw

form.

Clinical Affirmation of Branded Cranberry:

The developers of Cran-Max have made strong efforts to clinically affirm their product. Several studies have been

conducted and others are underway to prove product efficacy. An overview of these studies follow:

Results of Completed Cran-Max Studies*:

BOHBOT.

Results of a randomized, double-blind study on the prevention of recurrent cystitis with GynDelta. Dr Jean-Marc

prophylaxis against urinary tract infection in women. L. Strothers. June 2002. Can J Urol 2002 June: 9(3):

1558-62.

A randomized trial to evaluate effectiveness and cost effectiveness of naturopathic cranberry products as

Recurring Infections on the Urinary Tract. L.Hejzlar, Orology Clinic of PPCHC, SANUS in Hradec Kralove: J.

Poduska, Urology Clinic of UNV, Prague.

The Effect of Prophylactic Administration of Cranberry Extract (Swiss Cran-Max™ 7500mg) on the Occurrence if

1999.

Initial Pilot Study. Jan Poduska, MD, Department of Urology, Central Military Hospital, Prague, Czech Republic,

Dr. Ronald Wheeler Cran-Max Study. Outcome Study, Dr. Ronald Wheeler.

Preliminary Results and Abstracts of Cran-Max® Studies Under Way*:

Report. Yosef Binyamini, Yuval Bar-Yosef, Mario Sofer, Haim Matzkin and Yaakov Ben Haim.; Children's Urology

Unit, Urologic Department, Tel Aviv Medical Center

Preventive Treatment With Cranberry Extract Of Vesico-Ureteral Reflux (VUR) 14 In Children - Preliminary

amongst female soldiers.; Abstract of the trial procedure

Effectiveness of cranberry extracts as primary prevention of urinary tract 15 infections and evaluation of costeffectiveness,

Veteran Affairs, Boston Healthcare System.

Evaluation of Cran-Max for the Prevention of UTI in Spinal Cord Injured 17 Patients with Neurogenic Bladders.

Treatment of urinary tract infection.

Can Cran-Max® Be Used To Treat Current Urinary Tract Infections. 18 McMaster University. Dr. Anil Kapoor.

Independent Laboratory Results for BioShield®*:

Proposed Mechanism of BioShield bound Anthocyanins, Integrated Biomolecule 22 Corporation. Tucson, Arizona

Controlled Delivery of Components from CranMax-an In vitro Study, 25 Doddabele Madhavi, Ph.D,

BioActives, Inc., Worcester, MA

6

*Clinical Study abstracts available upon request

Bio-Shield® Matrix

Cranberry

Concentrate

Bio-Shield® Matrix

This White Paper has been written to provide an overview of the cranberry category, and highlights

Cran-Max as one of its unique entries. It seeks to shine light on the importance of cranberry within a

rapidly growing herbal marketplace, and to make a case for Cran-Max as a solution to a problem as

old as the supplement industry itself: product consistency, quality and efficacy. The question all

nutraceutical manufacturers are responsible to answer is whether their products are safe and

efficacious and whether there is sufficient clinical evidence to confirm these claims.

In summation, the development of Cran-Max parallels important trends unfolding within the

nutraceutical industry, and has come into existence due to a strong desire on the part of its

developers to elevate cranberry to a higher level within the world of nutraceuticals. Cran-Max delivers

the essential elements of cranberry in a natural, consistent and untampered fashion to consumers at

large.

 

CONCENTRATION PROTECTION

DISPERSION ABSORPTION

two are blueberries and concord grapes.

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