excellence beyond compliance: a new path forward for the dietary supplement industry?

©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


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


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


These views and opinions are my own and do not necessarily reflect the view of Waters Corp.

Disclaimer


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


Question: Is ‘buyer beware’ a sustainable future for our industry?


“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


“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


Negative Viewpoints


Operation Supplement Safety


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


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









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











GMP requirements



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’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


A bend in the road is not the end of the road…

…unless you fail to make the turn. - Hellen Keller










GMP requirements



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?


Expo West 2016


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


Dietary Supplement GMPs

From the Preamble to 21 CFR 111:


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


Regulatory Environment

Consumer Expectations

≠



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.


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


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.


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.


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.

≠


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.


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


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


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


The Product Promise

Compliance+

Pharmaco-vigilance

Honest Advertising

Ingredient Sourcing

Self-Regulation

Key Elements of a Responsible

Dietary Supplement Industry


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


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


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/



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/



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/



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


We can’t boil the entire ocean – so where do we start?


Ingredient Suppliers

Contract Manufacturers

Manufacturers

Labs

Retailers

Best Practices Companies (Leaders)




Manufacturers

Labs

Retailers


1. Work together

2. Establish new standards

3. Take ownership for helping the rest of industry to improve

COALITION





Manufacturers

Labs

Retailers

COALITION




Manufacturers

Labs

Retailers


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


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?




Manufacturers

Labs

Retailers










Manufacturers

Labs

Retailers

Best Practices Companies Responsible Industry









Manufacturers

Labs

Retailers

Responsible Industry Aspiring Businesses (Followers)







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


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


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.


Where should we go from here?


Thank you!

[email protected]

excellence beyond compliance: a new path forward for the dietary supplement industry?

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