Presentation from the 2016 Annual UNPA Member Retreat (www.unpa.com)

1. ©2015 Waters Corporation 1
Excellence Beyond Compliance
A new path forward for the dietary supplement
industry?
James Traub
Sr. Business Development Manager
Waters Corporation
2016 Annual UNPA Member Retreat

2. ©2015 Waters Corporation 2
Waters Corporation
 Manufacturer of analytical testing
solutions
 Global footprint
– Business in 100+ countries
– 6,000+ employees
 Deep understanding of the
regulated laboratory environment
 Approx 11% of revenues invested
back into R&D
– Market leader in developing
innovative technologies and industry-
specific testing solutions

3. ©2015 Waters Corporation 3
Laboratory-Dependent Organizations
Chromatography
Mass Spectrometry
Sample Prep
Sample Management
Data Management
Stability Management
On-site Training
External Training
Standards & Reagents
Proficiency Testing
Lab Analytics
Botanical Extraction

4. ©2015 Waters Corporation 4
These views and opinions are my own and
do not necessarily reflect the view of
Waters Corp.
Disclaimer

5. ©2015 Waters Corporation 5
My Background
16 years of my childhood were here in Kona
My father is a Naturopathic Physician here
Grew up taking herbal and homeopathic medicines
10 years experience working in the dietary supplement industry
•Metagenics, ChromaDex, Gaia Herbs
Very passionate and interested in the future the herbal medicines
and dietary supplements in the US

6. ©2015 Waters Corporation 6
Question: Is ‘buyer beware’ a sustainable future for our
industry?

7. ©2015 Waters Corporation 7
“When consumers take an herbal
product, they should be able to do so
with full knowledge of what is in that
product, and confidence that every
precaution was taken to ensure its
authenticity and purity…”
Negative Viewpoints

8. ©2015 Waters Corporation 8
“When consumers take an herbal
product, they should be able to do so
with full knowledge of what is in that
product, and confidence that every
precaution was taken to ensure its
authenticity and purity…”
“When Oregonians buy a dietary supplement,
they deserve to know that the ingredients in the
products are safe and comply with the law.”
Negative Viewpoints

9. ©2015 Waters Corporation 9
Negative Viewpoints

10. ©2015 Waters Corporation 10
Operation Supplement Safety

11. ©2015 Waters Corporation 11
Apr 25 – Harvard article calling supplements ‘useless’ and
‘suspect’ published in Harvard Women’s Health Watch
newsletter
Mar 8 – US AG Loretta Lynch warns consumers about
supplement safety during consumer safety week
Jan 19 – Frontline documentary ‘Supplements and Safety’
airs
Oct 22 – Oregon AG files lawsuit against GNC for sale of
products with picamilon and BMPEA
Sept 9 – NY AG sends cease and desist letters to 13
manufacturers of devil’s claw supplements
May 28 – Nature’s Way agrees to use DNA testing for raw
materials
May 26 – NY and IN AGs write a letter to FDA
Commissioner urging him to ‘overhaul federal oversight of
the dietary supplement industry’
Apr 2 – 14 AGs call for congressional investigation into
herbal supplement industry and asks congress to provide
FDA with greater enforcement powers over industry
Mar 30 – GNC and NY AG reach an agreement deal to
include DNA testing
Mar 12 – US Trade Organizations jointly release white
paper responding to core issues of the NY AG investigation
Mar 10 – 3 other state AGs form coalition with NY AG to
‘go further in investigating the herbal industry’ and to
‘achieve reform’
Feb 2 – NY AG sends cease and desist letters to 4 major
retailers of herbal supplements
Jun 17 – Dr. Oz is grilled on capitol hill over supplement
claims he made on his TV show
Dec 13 – “Case is closed--Daily multivitamins are a waste
of money” article in Annals of Internal Medicine
Nov 3 – NY times publishes article “Herbal supplements
are often not what they seem”
- 2013 -
- 2014 -
- 2015 -
- 2016 -
Oct 8 – USPLabs stops distribution of OxyELITE Pro after
29 confirmed cases of liver failure and one death
Jun 22 – John Oliver segment criticizing weak regulation
of dietary supplements airs
A look back at the last 3 years…
Jun 22 – Barry Steinlight pleads guilty to sale of diluted
and adulterated dietary ingredients and products
Sept 11 – Barry Steinlight sentenced to 40 months in
prison for sale of diluted and adulterated ingredients and
products
Oct 9 – Cheryl Floyd sentenced to 30 months in prison for
sale of misbranded drugs (sibutramine) as dietary
supplements
Apr 1 – Kamraz Rezapour sentenced to 9 years in prison
for selling misbranded drugs as herbal dietary supplements

12. ©2015 Waters Corporation 12
Challenge #1:
Dietary supplements adulterated with dangerous and illicit
substances continue to be widely available in stores and online
Real consumer harm is occurring (hospitalization, liver failure and death)
Our industry doesn‘t seem to be capable of doing anything to remove these products
Responsible industry doesn’t feel like it is their problem to fix
Everyone is waiting for FDA to fix the problem—such a solution will likely involve
increased regulation, higher business costs and higher costs to consumers
Here’s what I see:
3 Key Challenges Facing Our Industry

13. ©2015 Waters Corporation 13
Challenge #1:
Dietary supplements adulterated with dangerous and illicit
substances continue to be widely available in stores and online
Real consumer harm is occurring (hospitalization, liver failure and death)
Our industry doesn‘t seem to be capable of doing anything to remove these products
Responsible industry doesn’t feel like it is their problem to fix
Everyone is waiting for FDA to fix the problem—such a solution will likely involve
increased regulation, higher business costs and higher costs to consumers
Challenge #2:
Many firms remain challenged to meet even the most basic of
GMP requirements
Identity testing, specifications, batch records, etc.
State AGs are taking enforcement action against individual businesses
State AGs are calling on congress to increase FDAs enforcement authority
News and media outlets continue to publish articles and videos that are critical of our
supplement industry
Responsible industry is waiting for FDA to ‘ramp up’ enforcement action against the
non-compliant (not likely to happen)
Responsible industry has created very few technical resources to help other companies
achieve GMP compliance and implement best practices
Here’s what I see:
3 Key Challenges Facing Our Industry

14. ©2015 Waters Corporation 14
Challenge #1:
Dietary supplements adulterated with dangerous and illicit
substances continue to be widely available in stores and online
Real consumer harm is occurring (hospitalization, liver failure and death)
Our industry doesn‘t seem to be capable of doing anything to remove these products
Responsible industry doesn’t feel like it is their problem to fix
Everyone is waiting for FDA to fix the problem—such a solution will likely involve
increased regulation, higher business costs and higher costs to consumers
Challenge #2:
Many firms remain challenged to meet even the most basic of
GMP requirements
State AGs are taking enforcement action against individual businesses
State AGs are calling on congress to increase FDAs enforcement authority
News and media outlets continue to publish articles and videos that are critical of the
supplement industry
Again we see industry waiting for FDA to ‘ramp up’ enforcement action against the
compliant (which won’t happen given FDA’s resources)
Industry has created very few technical resources for helping other companies achieve
GMP compliance and implement best practices
Challenge #3:
There is a major disconnect between what GMP regulations
provide for and what consumers expect from supplements
Consumers expect products to be safe
Consumers want products to be effective
BUT—businesses are focusing their efforts on achieving compliance goals that ultimately
don’t matter to the consumer
Here’s what I see:
3 Key Challenges Facing Our Industry

15. ©2015 Waters Corporation 15
What’s the end result of this situation?
 Consumers are frustrated
 Clinicians are frustrated
 Regulators are frustrated
 State AGs are frustrated
 People don’t know which supplement products and companies to trust (if any)
– Limits market size
– Limits the amount of good supplements can achieve
 The amount of bad publicity from critics isn’t being offset by positive publicity
coming from industry itself
 The dietary supplement industry continues to be viewed in a negative light:
– unwilling or unable to implement GMPs to ensure product quality,
– ‘unregulated’ since the GMP requirements make no assurance of product safety or efficacy,
– unable to regulate itself and remove the ‘bad players’ from the market

16. ©2015 Waters Corporation 16
A bend in the road is not the end of the
road…
…unless you fail to make the turn.
- Hellen Keller

17. ©2015 Waters Corporation 17
Challenge #1:
Dietary supplements adulterated with dangerous and illicit
substances continue to be widely available in stores and online
Real consumer harm is occurring (hospitalization, liver failure and death)
Our industry doesn‘t seem to be capable of doing anything to remove these products
Responsible industry doesn’t feel like it is their problem to fix
Everyone is waiting for FDA to fix the problem—such a solution will likely involve
increased regulation, higher business costs and higher costs to consumers
Challenge #2:
Many firms remain challenged to meet even the most basic of
GMP requirements
State AGs are taking enforcement action against individual businesses
State AGs are calling on congress to increase FDAs enforcement authority
News and media outlets continue to publish articles and videos that are critical of the
supplement industry
Again we see industry waiting for FDA to ‘ramp up’ enforcement action against the
compliant (which won’t happen given FDA’s resources)
Industry has created very few technical resources for helping other companies achieve
GMP compliance and implement best practices
Challenge #3:
There is a major disconnect between what GMP regulations
provide for and what consumers expect from supplements
Consumers expect products to be safe
Consumers want products to be effective
BUT—businesses are focusing their efforts on achieving compliance goals that ultimately
don’t matter to the consumer
What can be done to face these
challenges?

18. ©2015 Waters Corporation 18
Expo West 2016

19. ©2015 Waters Corporation 19
The Product Promise:
What is on the label is in the pill…
at the point of purchase…
and is absorbed efficiently and
effectively into the body…
and is supported by proven clinical evidence…
and the product is safe.
- Tom Aarts (NBJ) @ Expo West 2016
What the consumer expects:
•GMP quality
•Truthful labeling
•Stability testing
•Formulation
•Ingredient forms
•Disintegration
•Dissolution
•ADME
•Delivery form
•Prior Research
•Clinical studies
•Toxicology study
•Dosing/Directions for use
•Appropriate warnings
•Herb-drug interactions

20. ©2015 Waters Corporation 20
Dietary Supplement GMPs
From the Preamble to 21 CFR 111:

21. ©2015 Waters Corporation 21
Foods
Safe until proven otherwise
Post-market surveillance
Quality
Primary enforcement tools:
- Facility inspections
- Recalls
- Warning Letters
Cost: $
Access: Open
Drugs
Unsafe until proven otherwise
Pre-market approval
Quality, Safety AND Efficacy
Primary enforcement tools:
- Facility pre-approval
- Facility inspections
- Recalls
- Warning Letters
Cost: $$$$
Access: Controlled
VS.
US Regulatory Environment

22. ©2015 Waters Corporation 22
Regulatory Environment Consumer Expectations
≠

23. ©2015 Waters Corporation 23
Regulatory Environment
Because supplements are regulated as foods
(not drugs), GMP regulations exist primarily to
ensure that supplements are free of harmful
contaminants and contain only ingredients
which are known to be safe (NDI or GRAS).
Federal GMPs make no assurance of product
safety nor efficacy.
Consumer Expectations
Consumers, however, demand much more from
supplement products than what the GMP
regulations were designed to provide
(see The Product Promise).
Consumers tend to view supplements (esp.
herbs) as OTC-style products which have been
thoroughly researched, have accurate labels
and are safe when used as directed.
≠
Question: Are new regulations coming anytime soon?
Question: Are consumer expectations likely to change anytime soon?
NO
NO

24. ©2015 Waters Corporation 24
A Proposed Solution
Because of this mismatch between what the regulations provide for and what
consumers expect, additional standards are required to bridge the gap.
And because there is no indication that changes to the regulatory environment
are being considered, it is up to industry to establish and adopt these new
standards.
Regulatory Environment
Because supplements are regulated as foods
(not drugs), GMP regulations exist primarily to
ensure that supplements are free of harmful
contaminants and contain only ingredients
which are known to be safe (NDI or GRAS).
Federal GMPs make no assurance of product
safety nor efficacy.
Consumer Expectations
Consumers, however, demand much more from
supplement products than what the GMP
regulations were designed to provide
(see The Product Promise).
Consumers tend to view supplements (esp.
herbs) as OTC-style products which have been
thoroughly researched, have accurate labels
and are safe when used as directed.
≠

25. ©2015 Waters Corporation 25
Key Stakeholders
 Athletes
 Clinicians/Hospitals
 Consumers
 Contract Labs
 Contract Manufacturers
 Growers
 Industry Associations
 Ingredient Suppliers
 Investors
 Law Firms
 Manufacturers
 News/Media Partners
 Scientific Community
 State/Federal Agencies
 Researchers
 Retailers
 Technology Providers
 Trade Organizations
These groups all
have a vested
interest in the
products, behavior
and future growth of
the dietary
supplement industry.

26. ©2015 Waters Corporation 26
What additional standards might be
required to meet consumer and
stakeholder expectations?
Unmet
Expectations
GMP
Compliance
Unmet
Expectations
The Product
Promise
Unmet
Expectations
Supply Chain
Management
Unmet
Expectations
Compliance+
Unmet
Expectations
Stronger
Pharmaco-
vigilance
Unmet
Expectations
Honest
Advertising
Unmet
Expectations
Resp. and
Sustainable
Sourcing
Ethical Self-
regulation
GMP
Compliance
The Product
Promise
Supply Chain
Management
Compliance+
Strong
Pharmaco-
vigilance
Honest
Advertising
Resp. and
Sustainable
Sourcing
Ethical Self-
regulation
This is the new
standard our
industry needs
to aspire to
REQUIRED BY LAW, BUT
INSUFFICIENT FOR MEETING
CONSUMER EXPECTATIONS
NOT REQUIRED BY LAW, BUT
REQUIRED TO GAIN AND BUILD
CONSUMER TRUST

27. ©2015 Waters Corporation 27
Key Stakeholders
 Athletes
 Clinicians/Hospitals
 Consumers
 Contract Labs
 Contract Manufacturers
 Growers
 Industry Associations
 Ingredient Suppliers
 Investors
 Law Firms
 Manufacturers
 News/Media Partners
 Scientific Community
 State/Federal Agencies
 Researchers
 Retailers
 Technology Providers
 Trade Organizations
GMP
Compliance
Supply Chain
Management
The Product
Promise
Compliance+
Pharmaco-
vigilance
Honest
Advertising
Ingredient
Sourcing
Self-
Regulation
Key Elements of
a Responsible
Dietary Supplement
Industry

28. ©2015 Waters Corporation 28
Self-regulation…
…is a regulatory process whereby an industry-level
organization (such as a trade association or a
professional society) sets and enforces rules and
standards relating to the conduct of firms in the
industry.
Anil K. Gupta and Lawrence J. Lad, “Industry Self-Regulation: An
Economic, Organizational, and Political Analysis,” The Academy of
Management Review 8, no. 3 (1983): 417.
…is a “broad concept that includes any attempt by
an industry to moderate its conduct with the intent
of improving marketplace behavior for the ultimate
benefit of consumers.”
- FTC Commissioner Maureen Ohlhausen

29. ©2015 Waters Corporation 29
Self-regulation…
“Industries have chosen self-regulation in response to both the
absence of government regulation and the threat of excessive
government regulation.”
“It complements existing laws by imposing supplemental rules
to govern the behavior of firms.”
“Businesses use self-regulation to decrease risks to consumers,
increase public trust, and combat negative public perceptions.”
Low consumer
confidence
Lack of
adequate
government
regulation
Environmental
sustainability
Unethical
behavior
Conflict
materials
Consumer
harms
Lack of
Transparency
Deceptive
business
practices
Workers rights
Lack of
standards

30. ©2015 Waters Corporation 30
Examples of other industries which
have implemented successful self-
regulation initiatives
 Industry: Retail Apparel
 Organization: Sustainable Apparel Coalition
 Vision: The Sustainable Apparel Coalition’s vision is of an apparel, footwear, and home
textiles industry that produces no unnecessary environmental harm and has a positive
impact on the people and communities associated with its activities.
 Collaboration: The urgency and expanse of the sustainability issues facing the apparel,
footwear and home textiles industry requires collective attention on a global scale. This is
why collaboration is the heartbeat of the SAC. No company alone can shift the existing
industry paradigms. To ignite the change required to redefine the way the industry is run,
peers and competitors come together as a united front, adhering to the Coalition’s set of
core collaboration values that are designed to further impactful change across the industry.
Through SAC membership, brands, retailers and manufacturers commit to transparency and
the sharing of best practices, a full-circle collaboration that benefits all involved.
 Self-Assessment Tools: The Higg Index comprises several easy-to-access, online tools or
“modules” designed for members from every segment of the industry. By entering data
about their business’ impact areas, SAC members generate standardized performance scores
that can be shared with current and future supply chain partners around the world at the
click of a button. Scores are anonymized and aggregated, which allows businesses to
benchmark their results against the industry and serves as a powerful incentive to strive for
greater improvements and raise the sustainability bar.
http://apparelcoalition.org/

31. ©2015 Waters Corporation 31
Examples of other industries which
have implemented successful self-
regulation initiatives
 Industry: Retail Apparel
 Organization: Sustainable Apparel Coalition
 Vision: The Sustainable Apparel Coalition’s vision is of an apparel, footwear, and home
textiles industry that produces no unnecessary environmental harm and has a positive
impact on the people and communities associated with its activities.
 Collaboration: The urgency and expanse of the sustainability issues facing the apparel,
footwear and home textiles industry requires collective attention on a global scale. This is
why collaboration is the heartbeat of the SAC. No company alone can shift the existing
industry paradigms. To ignite the change required to redefine the way the industry is run,
peers and competitors come together as a united front, adhering to the Coalition’s set of
core collaboration values that are designed to further impactful change across the industry.
Through SAC membership, brands, retailers and manufacturers commit to transparency and
the sharing of best practices, a full-circle collaboration that benefits all involved.
 Self-Assessment Tools: The Higg Index comprises several easy-to-access, online tools or
“modules” designed for members from every segment of the industry. By entering data
about their business’ impact areas, SAC members generate standardized performance scores
that can be shared with current and future supply chain partners around the world at the
click of a button. Scores are anonymized and aggregated, which allows businesses to
benchmark their results against the industry and serves as a powerful incentive to strive for
greater improvements and raise the sustainability bar.
http://apparelcoalition.org/

32. ©2015 Waters Corporation 32
Examples of other industries which
have implemented successful self-
regulation initiatives
 Industry: Electronics Manufacturing
 Organization: Electronics Industry Citizenship Coalition
 About: The EICC was founded with the idea of a shared industry code of conduct on key social, environmental and
ethical issues in the electronics industry supply chain. Through a shared code of conduct pegged to international
standards and best practices, EICC members and their Tier 1 suppliers follow standards in line with international
norms that respect human rights, protect the environment and demand ethical corporate behavior that supports
social and economic development around the world.
 Code of Conduct: EICC members commit and are held accountable to a common Code of Conduct and utilize a
range of EICC training and assessment tools to support continuous improvement in the social, environmental and
ethical responsibility of their supply chains.
 Audits: The Validated Audit is a key step of a capability development model that assesses conformance to the
EICC Code of Conduct, local laws, and regulations through a management systems approach to drive sustainable
solutions.
 Stakeholder Interaction: In addition to setting and holding members accountable to core standards and
providing training and assessment tools, the EICC regularly engages in dialogue and collaborations with workers,
governments, civil society, investors and academia to gather the necessary range of perspectives and expertise to
support and drive its members toward achieving the EICC mission and values of a responsible global electronics
supply chain.
http://www.eiccoalition.org/

33. ©2015 Waters Corporation 33
Examples of other industries which
have implemented successful self-
regulation initiatives
 Industry: Electronics Manufacturing
 Organization: Electronics Industry Citizenship Coalition
 About: The EICC was founded with the idea of a shared industry code of conduct on key social, environmental and
ethical issues in the electronics industry supply chain. Through a shared code of conduct pegged to international
standards and best practices, EICC members and their Tier 1 suppliers follow standards in line with international
norms that respect human rights, protect the environment and demand ethical corporate behavior that supports
social and economic development around the world.
 Code of Conduct: EICC members commit and are held accountable to a common Code of Conduct and utilize a
range of EICC training and assessment tools to support continuous improvement in the social, environmental and
ethical responsibility of their supply chains.
 Audits: The Validated Audit is a key step of a capability development model that assesses conformance to the
EICC Code of Conduct, local laws, and regulations through a management systems approach to drive sustainable
solutions.
 Stakeholder Interaction: In addition to setting and holding members accountable to core standards and
providing training and assessment tools, the EICC regularly engages in dialogue and collaborations with workers,
governments, civil society, investors and academia to gather the necessary range of perspectives and expertise to
support and drive its members toward achieving the EICC mission and values of a responsible global electronics
supply chain.
http://www.eiccoalition.org/

34. ©2015 Waters Corporation 34
Examples of other industries which
have implemented successful self-
regulation initiatives
 Industry: Financial Analysis
 Organization: CFA Institute
 Vision: To lead the investment profession globally by promoting the highest standards of
ethics, education, and professional excellence for the ultimate benefit of society.
 Values: This is how we believe financial markets and services should operate:
– Investment professionals contribute to the ultimate benefit of society through the sustainable value
generated by efficient financial markets and by effective investment institutions.
– Good stewardship and high ethical standards are necessary for trust and confidence to be secured and for
society to be served.
– Financial markets should afford every investor the opportunity to earn a fair return.
– Financial markets are more effective when participants are knowledgeable.
– High ethical principles and professional standards are essential to positive outcomes; rules and regulations,
while necessary, are not sufficient by themselves.
 Codes and Standards: An integral part of the CFA Institute mission is to develop and
administer codes, best practice guidelines, and standards to guide the investment industry.
These standards help ensure all investment professionals place client interests first. The
foundation of our work is the Code of Ethics and Standards of Professional Conduct. We
expect all CFA members and candidates to sign the statement and adhere to this code.
https://www.cfainstitute.org

35. ©2015 Waters Corporation 35
Examples of other industries which
have implemented successful self-
regulation initiatives
 Industry: Financial Analysis
 Organization: CFA Institute
 Vision: To lead the investment profession globally by promoting the highest standards of
ethics, education, and professional excellence for the ultimate benefit of society.
 Values: This is how we believe financial markets and services should operate:
– Investment professionals contribute to the ultimate benefit of society through the sustainable value
generated by efficient financial markets and by effective investment institutions.
– Good stewardship and high ethical standards are necessary for trust and confidence to be secured and for
society to be served.
– Financial markets should afford every investor the opportunity to earn a fair return.
– Financial markets are more effective when participants are knowledgeable.
– High ethical principles and professional standards are essential to positive outcomes; rules and regulations,
while necessary, are not sufficient by themselves.
 Codes and Standards: An integral part of the CFA Institute mission is to develop and
administer codes, best practice guidelines, and standards to guide the investment industry.
These standards help ensure all investment professionals place client interests first. The
foundation of our work is the Code of Ethics and Standards of Professional Conduct. We
expect all CFA members and candidates to sign the statement and adhere to this code.
https://www.cfainstitute.org

36. ©2015 Waters Corporation 36
We can’t boil the entire ocean
– so where do we start?

37. ©2015 Waters Corporation 37
Ingredient
Suppliers
Contract
Manufacturers
Manufacturers
Labs
Retailers
Best Practices Companies (Leaders)

38. ©2015 Waters Corporation 38
Ingredient
Suppliers
Contract
Manufacturers
Manufacturers
Labs
Retailers
Best Practices Companies (Leaders)
1. Work together
2. Establish new
standards
3. Take ownership
for helping the
rest of industry
to improve
COALITION

39. ©2015 Waters Corporation 39
Best Practices Companies (Leaders)
Ingredient
Suppliers
Contract
Manufacturers
Manufacturers
Labs
Retailers
COALITION

40. ©2015 Waters Corporation 40
Ingredient
Suppliers
Contract
Manufacturers
Manufacturers
Labs
Retailers
Best Practices Companies (Leaders)
Create written Codes of
Conduct for each industry
segment to bridge the gap between
current regulations and stakeholder
expectations
Engage in technical discussions
regarding compliance and best-
practices
Develop educational assets that
can assist new/aspiring businesses
with understanding and
implementing best practices
Engage in strategic
conversations to discuss
emerging issues and adaptive
challenges facing our industry
Role of this Coalition

41. ©2015 Waters Corporation 41
Technical Aspects of Regulatory
Compliance
 Adverse Events
 Allergens
 Asset Tracking
 Batch Production Records
 Calibration
 CAPA
 Chemical Storage/Handling
 Cleaning Logs
 Cleaning Validation
 Contract Laboratories
 Contract Manufacturers
 Contractors
 Deviations
 Document Control
 Electronic Records (21 CFR 11)
 Environmental Monitoring
 Facilities Maintenance
 Facilities Management
 Facility Registration
 Food Labeling (21 CFR 101)
 Finished Product Testing
 FDA Inspections/483 Response
 FSMA
 GMP Materials Storage
 Labeling
 GMP Materials Storage
 GMP Training
 GRAS Self-Affirmation
 HACCP
 Hygiene & Sanitation
 Internal Audits
 International Export
 IQ/OQ/PQ
 Lab Notebooks
 Label Claims (Structure-Function)
 Label Compliance
 Label Control
 LACF Regulations (21 CFR 113/114)
 LIMS
 Lockout/Tagout
 Master Manufacturing Records
 Material Reviews
 Method Validation
 NDIs
 Non-GMO
 OOS Investigations
 Organic
 Pest Control
 Plant Security
 Preventive Maintenance
 Process Validation
 Product Complaints
 Product Returns
 QC Data Review
 QMS
 Quality Agreements
 Receiving Inspections
 Reference Standards
 Reprocessing
 Reserve Samples
 Sample Management
 Sampling Plans
 SOP Periodic Review
 SOP Training
 Specifications
 Stability Testing
 Test Methods
 TTB
 Utensils
 Vendor Approval
 Warehousing & Storage
 Water Supply & Testing
We expect all companies to be GMP compliant but what educational resources
has our industry created to help itself achieve this goal?

42. ©2015 Waters Corporation 42
Ingredient
Suppliers
Contract
Manufacturers
Manufacturers
Labs
Retailers
Best Practices Companies (Leaders)




Create written Codes of Conduct
for each industry segment to
bridge the gap between current
regulations and stakeholder
expectations
Engage in technical discussions
regarding compliance and best-
practices
Develop educational assets that
can assist new/aspiring businesses
with understanding and
implementing best practices
Engage in strategic
conversations to discuss
emerging issues and adaptive
challenges facing our industry
Role of this Coalition

43. ©2015 Waters Corporation 43
Ingredient
Suppliers
Contract
Manufacturers
Manufacturers
Labs
Retailers
Best Practices Companies Responsible Industry




Create written Codes of Conduct
for each industry segment to
bridge the gap between current
regulations and stakeholder
expectations
Engage in technical discussions
regarding compliance and best-
practices
Develop educational assets that
can assist new/aspiring businesses
with understanding and
implementing best practices
Engage in strategic
conversations to discuss
emerging issues and adaptive
challenges facing our industry
Role of this Coalition

44. ©2015 Waters Corporation 44
Ingredient
Suppliers
Contract
Manufacturers
Manufacturers
Labs
Retailers
Responsible Industry Aspiring Businesses (Followers)




Create written Codes of Conduct
for each industry segment to
bridge the gap between current
regulations and stakeholder
expectations
Engage in technical discussions
regarding compliance and best-
practices
Develop educational assets that
can assist new/aspiring businesses
with understanding and
implementing best practices
Engage in strategic
conversations to discuss
emerging issues and adaptive
challenges facing our industry
Role of this Coalition

45. ©2015 Waters Corporation 45
Ingredient
Suppliers
Contract
Manufacturers
Manufacturers
Labs
Retailers
Responsible Industry Aspiring Businesses (Followers)




Create written Codes of Conduct
for each industry segment to
bridge the gap between current
regulations and stakeholder
expectations
Engage in technical discussions
regarding compliance and best-
practices
Develop educational assets that
can assist new/aspiring businesses
with understanding and
implementing best practices
Engage in strategic
conversations to discuss
emerging issues and adaptive
challenges facing our industry
Role of this Coalition

46. ©2015 Waters Corporation 46
 An industry ecosystem where…
– Retailers refuse to sell adulterated
products
– Manufacturers refuse to make or
sell adulterated products
– Contract manufacturers refuse to
make adulterated products for
others
– Contract labs refuse to provide
false test results
– Ingredient suppliers refuse to
sell adulterated ingredients
 Supplement companies pursue
excellence beyond compliance to
ensure products and business
activities meet the expectations
of consumers and other key
stakeholders
 An industry where best-practice
companies take a stewardship
role and share what they’ve
learned with new and aspiring
companies, helping them to also
achieve excellence beyond
compliance quickly and cost-
effectively
Vision

47. ©2015 Waters Corporation 47
What might it mean if this vision
was realized?
 A ‘responsible’ ecosystem would be created:
– Responsible manufacturers would partner with only Responsible Labs and
Responsible CMs, and buy ingredients from only Responsible suppliers
– Responsible Retailers would buy products from only Responsible manufacturers
– Consumers could shop at Responsible retailers
 Our best and brightest companies could help establish a new
standard of excellence for the industry and develop a wealth of
training and educational assets
– Similar to ISPE
 Friendly media could begin to disseminate a positive narrative,
citing the good work being done by industry to improve industry, to
combat the negative narrative currently in place
 FDA would have more resources available to police illegal products
and truly unscrupulous businesses
– Less time, money, resources spent policing basic issues of GMP non-compliance

48. ©2015 Waters Corporation 48
 An industry ecosystem where…
– Retailers refuse to sell adulterated
products
– Manufacturers refuse to make or
sell adulterated products
– Contract manufacturers refuse to
make adulterated products for
others
– Contract labs refuse to provide
false test results
– Ingredient suppliers refuse to
sell adulterated ingredients
 Supplement companies pursue
excellence beyond compliance, to
ensure products meet the
expectations of consumers and
other key stakeholders
 An industry where best-practice
companies take a stewardship
role to share what they’ve
learned with new and aspiring
companies, helping them to
achieve excellence beyond
compliance quickly and cost-
effectively
Vision Reality
An industry where…
•Retailers knowingly sell
adulterated materials
•Manufacturers knowingly
make and sell adulterated
products
•Contract manufacturers
willing make adulterated
products for others
•Contract labs willing
provide false test results
•Ingredient suppliers
knowingly make and sell
adulterated ingredients
The industry is focused on
achieving GMP compliance instead
of fulfilling The Product Promise,
meaning products will continue to
fail to meet consumer expectations
for potency and safety.
And many companies still struggle
to achieve basic GMP compliance.
An industry where best-practice
companies operate in silos, hoping
their good deeds and actions
reflect well on the entire industry
and that the bad companies don’t
ruin it for everyone.

49. ©2015 Waters Corporation 49
Where should we go from here?

50. ©2015 Waters Corporation 50
Thank you!
James_Traub@waters.com