Natural Products New Zealand An overview

Natural Products New Zealand
An overview
Peter Lehrke
Director, Natural Products NZ
January 2016
NPNZ
• We are the industry association in NZ for
natural products including dietary
supplements and skincare plus more
• We represent over 80% of the industry
• $1.4bn contribution to economy (+40%)
• 70% of NZ export earnings are from
biologically based industries
NPNZ
Mission Statement
To increase the profile of New Zealand as a source of
quality natural products and to foster the development of
a sustainable natural products sector through
collaboration
Represent our industry to the legislators
Act as the voice of the industry – with positive messaging
and appropriate comment on negative reports
Work with the industry to assist export and achieve
growth
Niche Products for Export
Foods For Health
Peter Lehrke
Product Development Consultant
www.pharmatech.co.nz
Objectives:
• The story of colostrum as a niche export
• Health benefits of colostrum
• Colostrum marketing challenges
• Opportunities and dangers
• Risk Mitigation
What is colostrum?
• First milk, produced by the mammary gland by all
mammals after birth
• Nutrition for neonates – passive immunity
• Thick cream coloured milky liquid
• Until 1980’s it was deemed a low value stock food
• More produced than needed by calf
• How could this be utilised?
How can this be a health food?
• Classified as a food, but “pharma” properties
• Rich source of:
– Antibodies (IgG)
– Growth factors
– Peptides
– Bioactive carbohydrates
• Anecdotal evidence of efficacy in humans
– Immunity, gut health, sports performance
– Science started to be collected on colostrum
Substantial published scientific study on colostrum
• PUBMED (June 2013) – 7116 hits for “colostrum”
• PUBMED (Jan 2016) – 7768 hits for “colostrum”
Focused mainly on the areas of:
• Immunity - antibodies
• Gut health – immune and growth factors
• Diabetes – type 2
• Weight management – lean muscle mass
• Sports performance – endurance, training
Bioactives reduce each hour after calving
120
115
110
IgG in colostrum (mg/ml)
105
100
95
90
85
80
75
70
0
2
4
6
8
Hours after calving
10
12
14
There is a lot of good science in the Journals
Effect of heat stress
Intestinal villus height
Playford et al. 1999. Gut
Prosser, Stelwagen et al 2004. J. Appl. Physiol.
Intestinal permeability
Playford et al. 2001. Clin. Sci.
But…….
Internet claims for colostrum include:
• Antiviral / antifungal / antibacterial / antioxidant
• Eliminates viruses, bacteria and pathogens
• Increases Growth Factors / Enhances Lean Muscle Mass
• Regulates Cholesterol Levels / aids digestion and bowel function
• Enhances the Immune System / protects against pathogens
And…….
Weight loss / Diabetes / Fibromyalgia / Multiple sclerosis /
rheumatoid arthritis / Alleviates diarrhea / accelerates healing
What is credible and what is not?
Health Benefits of bovine colostrum
• Influenza prevention
• Reduced incidence of URTIs
• Treatment & prevention of diarrhoea
• Treatment of ulcerative distal colitis
• Protective effect on GIT lining
Bovine colostrum bioavailability
• Common question: can colostrum
survive the GIT (acid digestion)?
• Kelly3 and Roos4 both demonstrated
antibody survival through the GIT
• Faecal stool measurements showed between
4-19% of active immunoglobulins
• Colostrum antibodies do survive the entire length of
the GIT
Influenza prevention
• Study in 2007 found colostrum to be
3 times more effective than ‘flu vaccine5
• 4 groups – control, vaccinated, colostrum
(400mg/daily) and colostrum + vaccination
• ‘Flu episodes after 3 months, respectively: 41, 57, 13
and 14
Upper respiratory tract infection prevention
• Colostrum reduces the incidence of URTI in
healthy children & adults6, 7
• PRIDE study7 in India investigated effect of colostrum (up
to 3g/day) in 605 children with recurrent URTIs – a
common & major cause of morbidity
• After 3 months URTI episodes reduced by 91.2%
• Important considering antibiotic resistance
Diarrhoea
• Diarrhoea is a major cause of death in children <5yrs
in developing countries
• Colostrum is beneficial for the treatment of infectious
diarrhoea and recurrent diarrhoea associated with
antibiotic treatment & overuse7
• Indian PRIDE study found 3 months of colostrum
supplementation reduced diarrhoeal episodes by
86.6%
Gastro-intestinal Health
• Treatment of ulcerative colitis
• When colostrum was administered via enema there
was a significant reduction in the mean symptom score
compared to the control group
• Colostrum group histological score improved in 62.5%
of subjects8
Gastro-intestinal Health
• Mitigates the effects of common drugs on intestinal
epithelial surface (Playford)
• Chronic administration of NSAIDs can result in gastric &
intestinal damage and increased intestinal permeability3,
7, 9
• Colostrum administered with indomethacin resulted in
no significant increase in intestinal permeability
• Group without colostrum had significant increased
intestinal permeability 9
Colostrum market - 2011
Value to New Zealand economy
Colostrum spray dried powder manufacture
Raw material wholesale price (2011)
Wholesale raw material market size
500 tonne
$65,000 / tonne
$32.5 million
Most is incorporated into health foods and supplements
Add costs of formulation, manufacture, packing, marketing, distribution
Using and average scale up factor of x5 from raw material cost to retail price
Total market value (2011)
$125 million
Most of this was export revenue, and 70% to China
Some New Zealand Brands
Impact of China Media 2012
In 2012 China ministry of health put out a confusing announcement
Intention – to clarify that colostrum is not an approved ingredient for
infant formula
Result – media speculation that colostrum is harmful to infants
• “Colostrum banned”
• “Colostrum is abnormal milk”
• “Colostrum can cause baby big head”
Resulted in sales of colostrum in China to drop substantially
In 2013 Fonterra stopped selling colostrum powder
Now we have a shortfall
Despite the China crash there is still good demand for colostrum
Short fall in supply taken up by USA colostrum manufacturers
Now we IMPORT most of the colostrum powder going into NZ brands
Premium price is paid for good quality New Zealand colostrum:
• Quality is high
• Pasture grazed cows
• New Zealand’s reputation for dairy and for health foods
• Providence – source is important
• Great opportunity for Taranaki
However ….......
The past has taught us a few things:
1.
2.
3.
4.
5.
6.
7.
8.
9.
New Zealand origin is an important value driver
Providence – provide evidence of the province
Good science needs to be marketed well
Quality is product value – differentiation is market value
Management of supply chain is critical
Innovate or die
Danger is the brother of opportunity
When things go pear shaped – hang in there
Risk mitigation strategy is essential
Other Taranaki Opportunities
Other specialised dairy – Tatua example
Organics
Goats milk / sheep milk
Specialty cheeses
Boutique breweries and vineyards
Skincare and cosmetics
Nutraceuticals and supplements
www.meno-me.co.nz
EstroG-100
Dietary supplement
Web based e-commerce
Website developed by Kiwa
Digital marketing – Apex Digital
Distribution – from Taranaki
Changing Regulatory Environment
•
•
•
•
•
•
The New Zealand Natural Health Products Bill
New regulatory scheme for low risk natural health products
Many Dietary Supplements will fall into this category
Final Consultation – closes 5th February
Permitted substances list open for comment until 31 May
Expected to take effect from June 2016
Visit Medsafe website for more information:
Sources:
http://tinyurl.com/z5mbn8e
http://tinyurl.com/hnq67j3
Risk Management
Good Manufacturing Practice
Personnel, Premises, Equipment, Production process, Materials, Quality Control
Risk Assessment
Establish the objective (quality, health, safety, environment, financial…)
Identify hazards (things that threaten achievement of the objective)
Determine consequence & likelihood
Assess the risk
Options
Compare current risk against acceptable risk (safe)
Decide which controls are appropriate
Outputs
Inform business planning processes e.g. budget, project schedule…
May also be required for compliance with regulatory or other standards
Further information or assistance
Kevin Lehrke: 027376966 or email [email protected]
NPNZ Summit 2016
Into the Future
The Rutherford Hotel, Nelson
16 – 18 March
The Age of Disruption is here! The technological, social,
demographic, economic and legislative landscapes in which we
operate are constantly changing, so don’t wait for things to return
to normal because this is the new normal.
Early bird rate ends 29 January:
$525 members / $725 non-members
More information and to Register:
www.naturalproductsnz.org/summit-2016
Thank You
Peter Lehrke – Product Development Consultant
www.pharmatech.co.nz
1.
Pakken R et al. Review paper: ‘Growth Factors and Antimicrobial Factors of Bovine Colostrum’,
International Dairy Journal, 1997; 7:285-297
2.
Mehra R et al. Review: ‘Milk, immunoglobulins for health promotion’, International Dairy Journal,
2006
3.
Kelly CP et al. ‘Survival of anti-Clostridium difficlile boving immunoglobulin concentrate in the
human gastrointestinal tract’, Antimicrobial Agents and Chemotherapy, 1997; 41:236-241
4.
Roos N et al. ’15N-labelled immunoglobulins from bovine colostrum are partially resistant to
digestion in the human intestine’, Journal of Nutrition, 1995; 125:1238-1244
5.
Cesarone MR et al. ‘Prevention of Influenzea Episodes with Colostrum Compared with Vaccination
in Healthy and High-Risk Cardiovascular Subjects: The Epidemiologic Study in San Valentino’,
Clinical and Applied Thrombosis / Hemastasis, April 2007; 13(2):130-136
6.
Brinkworth GD et al. ‘Concentrated bovine colostrum protein supplementation reduces the
incidence of self-reported symptoms of upper respiratory tract infection in adult males’, European
Journal of Nutrition, 2003; 42:228-232
7.
Kamlesh P et al. ‘Pedimune in Recurrent Respiratory Infection and Diarrhoea – The Indian
Experience: The PRIDE Study’, Indian Journal of Pediatrics, July 2006; 73:585-591
References continued
•
8. Kan Z et al. ‘Use of the ‘nutraceutical’ bovine colostrum, for the treatment of distal colitis:
results from an initial study’, Alimentary Pharmacology & Therapeutics, 2002; 16:1917-1922
•
9. Playford RJ et al. ‘Co-administration of the health food supplement, bovie colostrum, reduces
the acute non-steroidal anti-inflammatory drug-induces increase in intestinal permeability’ Clinical
Science, 2001; 100:627-633
•
10. “Combining growth factors, stem cells, and gene therapy for the ageing brain”
Behrstock, S., Svendsen CN. Ann. N.Y. Acad. Sci. 1019: 5-14 (2004)
•
11. “Isolation of colony stimulating factor from human milk” Sinha, S. K., Yunis, A A.
Biochem Biophys Res Commun.,114(2): 797-803(1983)
•
12. Published in Science Network, Australia (11 February 2008 (Dr Mark Cregan,
University of Western Australia)
13.
Uruakpa, F. O. Et al. “Colostrum and its benefits – a review” Nutrition Research 22 (2002)
14.
“Peptide immunotherapy”, Dr. Andrew M Keech, 2009, AKS Publishing, USA
15.
The Open Nutraceutical Journal, 2013, 6, 35-44 35 Open Access “Development of a
combined bovine colostrum and immune stimulatory carbohydrate nutraceutical for
enhancement of endogenous stem cell activity”. Gill Webster and Peter Lehrke