© Mannatech, Inc. 2006 Cornerstone Training 1.Something That is Fundamentally Important. 2.The...

© Mannatech, Inc. 2006© Mannatech, Inc. 2006

Cornerstone TrainingCornerstone Training

1.1. Something That is Fundamentally Important.Something That is Fundamentally Important.2.2. The First Stone of a New Building.The First Stone of a New Building.3.3. The Basics or Beginning from which to Build.The Basics or Beginning from which to Build.

What is a Cornerstone:What is a Cornerstone:

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• The Basics in 5 Sixty-Minute ModulesThe Basics in 5 Sixty-Minute Modules • Mannatech-Approved Method for Mannatech-Approved Method for

Associates to Train AssociatesAssociates to Train Associates• A Duplicatable Way to Create a Culture A Duplicatable Way to Create a Culture

of Trainingof Training

What is Cornerstone Training?What is Cornerstone Training?

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What is Cornerstone Training? The Basics in 5 Sixty-Minute Modules

What is Cornerstone Training? The Basics in 5 Sixty-Minute Modules

As You Grow & Need To Know3


What is Cornerstone Training?Mannatech-Approved Method for

Associates to Train Associates

What is Cornerstone Training?Mannatech-Approved Method for

Associates to Train Associates

• On the WebOn the Web• On MannatalkOn Mannatalk• One on oneOne on one• In Home MeetingsIn Home Meetings• Training MeetingsTraining Meetings• Area or Regional EventsArea or Regional Events

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• Watch ItWatch It• Learn ItLearn It

• Improve ItImprove It• Do ItDo It

Let’s Get StartedLet’s Get Started

What is Cornerstone Training?A Duplicatable Way to Create a Culture of TrainingWhat is Cornerstone Training?A Duplicatable Way to Create a Culture of Training

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• What is Compliance, and why is it important?• Use of trademarks, logos and patents• Product Claims - what you can say• Use of promotional and Third-party Materials• Maintaining a Compliant Business

ComplianceCompliance

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What is Compliance?What is Compliance?

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… you are conducting an ethical business in accordance with Mannatech’s Policies and Procedures and acting within the boundaries set by DSHEA (Dietary Supplement Health Education Act).

To Be Compliant Means…To Be Compliant Means…1994 Congress Responds to Consumer Demand1994 Congress Responds to Consumer Demand

DSHEADSHEADietary Supplement Health and Education Act of 1994Dietary Supplement Health and Education Act of 1994

1994 Congress Responds to Consumer Demand1994 Congress Responds to Consumer DemandDSHEADSHEA

Dietary Supplement Health and Education Act of 1994Dietary Supplement Health and Education Act of 1994

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Why Do We Need Compliance?Why Do We Need Compliance?

“As Mannatech Associates, we are on a Mission with Purpose:To ‘share the gift’ and to be good stewards of the gifts we’ve been given to share.”

Sam Caster, Founder, Chairman and CEO

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We Need Compliance…We Need Compliance…

•To preserve the future of Mannatech and our mission of Sharing the Gifts of Hope, Health and Opportunity

•To be good stewards of our products

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Where Do I Go for Compliance Information?

Where Do I Go for Compliance Information?

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Compliance ReferencesCompliance References

• Associate Policies and Procedures

• Associate Code of Ethics

• Compliance Guide

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Associate Policiesand Procedures

Associate Policiesand Procedures

•The Policies and Procedures serve as a guide for Associates to successfully build and maintain their businesses as Independent Distributors.

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Associate Code of EthicsAssociate Code of Ethics

• The Code of Ethics serves as a guide so that Associates may act independently but in alignment with the organization and its values.

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Compliance GuideCompliance Guide

• Handy, pocket-sized reference guide

• A quick reference to help you make informed decisions

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Trademarks, Logos and Patents

Trademarks, Logos and Patents

Patents filed protecting proprietary rights

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Product ClaimsProduct Guide

Product ClaimsProduct Guide

• Contains– Product and Ingredient

information– Label Information– Product Claims– Good Manufacturing

Practices (GMPs)– Safety and Quality

Information

Remember, acceptable claims vary by country, so be sure to look at the product information sheets for your country of operation!

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• According to the Federal Trade Commission, a product claim is a statement that clearly and fairly describes an attribute of the product that can be substantiated and is not deceptive.

• Example: Advanced AmbrotoseTM is designed to support effective cell-to-communication.*

• Testimonials are not substantiation!

Product ClaimsWhat is a Proper Claim?

Product ClaimsWhat is a Proper Claim?

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

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As a general rule, avoid the words As a general rule, avoid the words

diagnose, cure, treat , prevent, illness, disease, diagnose, cure, treat , prevent, illness, disease, conditions, mitigateconditions, mitigate

when discussing Mannatech’s products.when discussing Mannatech’s products.

Product ClaimsWhat You Can Say?Product ClaimsWhat You Can Say?

WRONGWAY

WRONGWAY

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• Mannatech’s products are designed to optimize general health and well-being.

• Mannatech’s products provide the raw materials for the body to use to promote optimal cellular communication.

• If you are facing a challenge in life, you can benefit from better nutrition.

Product ClaimsAppropriate General Statements


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• Better nutrition can improve your quality of life.

• Good nutrition supports good health.

• The body knows how to maintain health and has healing mechanisms.

• The better cells communicate, the healthier they will be.

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• Scientists have known for years that the body has the ability to maintain itself. The challenge is to provide the body what it needs to maintain health and help it repair and regenerate.

• The cell is where health begins.

• Healthy cells help make healthy tissues that help make healthy organs that help make healthy systems that help make healthy bodies.



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What if someone asks me about the products and a specific disease or condition?

Nutritional supplements are designed to improve your quality of life, regardless of your state of health.

Product ClaimsSpecific Disease Conditions

Product ClaimsSpecific Disease Conditions

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• Mannatech Promotional Materials- Marketing materials produced by Mannatech that have been reviewed for compliance

• Mannatech Educational Materials- 403B “Label-exempt” material

• Generic Materials (Third party)- Materials that do not reference, explicitly or implicitly, the company, products or business opportunity

Definition of MaterialsDefinition of Materials

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• Mannatech produced and/or approved materials that use Mannatech’s brand.

• Can be used in connection with the products or business opportunities.

Definition of MaterialsMannatech Promotional Materials

Definition of MaterialsMannatech Promotional Materials

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• Federal Trade Commission (FTC)

• Food and Drug Administration (FDA)

• Dietary Supplement Health and Education Act (DSHEA)

Educational MaterialsGoverning Bodies and ActEducational MaterialsGoverning Bodies and Act

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• Federal Food, Drug, and Cosmetic Act21 U.S.C. §321(m) provides

– “The term labeling means all labels and other written, printed or graphic matter upon any article or any of its containers or wrappers, or (2) accompanying such article.”

Educational MaterialsUnited States

Educational MaterialsUnited States

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How to Recognize “Labeling”How to Recognize “Labeling”• Specifies a company,

e.g. Mannatech• Specifies a brand name,

e.g. Advanced AmbrotoseTM

• Contains a “Structure-Function Claim”, e.g. “supports immune health”

• Contains mandatory disclaimer: “This statement has not been evaluated by the FDA. This product is not intended to treat, diagnose, cure or mitigate any disease.”

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How to Recognize “Labeling”How to Recognize “Labeling”

• Specifies a company,e.g. Mannatech

• Specifies a brand name, e.g. CardioBalance®

• Contains a “Structure-Function Claim”, e.g. “Heart Care Formula”


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How to Recognize “Labeling”How to Recognize “Labeling”

• Specifies a company,e.g. Mannatech

• Specifies a brand name, e.g. ImmunoSTART®

• Contains a “Structure-Function Claim”, e.g. “Formulated to provide immune system support”


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• Suggestions of “treatment, diagnosis, cure, or mitigation of disease” could remove the products from the dietary supplement category into the drug category, rendering the product(s) an unapproved new drug and requiring withdrawal from the market.

•“Secondary health hazards”—consumers relying on “drug-type claims” and discontinuing use of conventional drug therapy, causing their condition to worsen.

Two Dangers of Drug ClaimsTwo Dangers of Drug Claims

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• A publication, including an article, a chapter in a book, or an official abstract of a peer-reviewed scientific publication that appears in an article and was prepared by the author or the editor of the publication which is reprinted in its entirety, shall not be defined as “labeling” when used in connection with the sale of a dietary supplement to consumers when it:

1. is not false or misleading. 2. does not promote a particular manufacturer or brand of a dietary

supplement.3. is displayed or presented, or is displayed or presented with other such

items on the same subject matter, so as to present a balanced view of the available scientific information on a dietary supplement.

4. if displayed in an establishment, is physically separate from the dietary supplements and

5. does not have appended to it any information by sticker or any other method.

“403B Label-Exempt” MaterialsDietary Supplement Labeling

“403B Label-Exempt” MaterialsDietary Supplement Labeling

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• Not false or misleading. • Doesn’t promote a particular

manufacturer or brand of a dietary supplement.

• It is displayed or presented, or is displayed or presented with other such items on the same subject matter, so as to present a balanced view of the available scientific information on a dietary supplement.

• If displayed in an establishment, it is physically separate from the dietary supplements.

• Does not have appended to it any information by sticker or any other method.

“403B Label-Exempt” Materials(U.S. Only)

“403B Label-Exempt” Materials(U.S. Only)

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• Something is “generic” if it cannot be linked back to the company or the products in any way.

• For example, a material is not “generic” if it contains:- Company name- Company logos- Company trademarks- Copyrighted materials and graphics- Pictures of corporate representatives, employees, officers or directors

Associate Policies & Procedures Section 2.10

Generic MaterialsGeneric Materials

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NO!! - Why not?NO!! - Why not?

Is the Product Shown Below Generic?

Is the Product Shown Below Generic?

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• Not reviewed by Mannatech for compliance.

• Ask if unsure! “Has this material been reviewed by best qualified legal counsel as label-exempt?”

• Use only for your own educational purposes.

• Never attach Mannatech’s name or product names to Third Party material or it will be considered “labeling.

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The Use of Generic MaterialThe Use of Generic Material


• “The Miracle Cancer Cure”

• The book does not endorse or otherwise mention any particular supplement brand.

• The author/publisher does not sell the herbal supplement and does not have any material connection to any marketers of the herb.

• As non-commercial speech, the book itself would not be subject to the FTC's jurisdiction over advertising.

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Identifying Generic MaterialIdentifying Generic Material


• If a marketer of the herb referred to the book in advertising materials (for instance, by quoting the title and using excerpts to describe the anti-cancer benefits of his/her product), such references would likely be considered advertising or even labeling.

• The advertiser and marketer would be responsible for substantiating any claims about the advertiser's product that are conveyed by these references.

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Identifying Generic MaterialIdentifying Generic Material


• GlycoScience.org—peer-reviewed educational site

• Company-sponsored events

– ALL vendors selling printed materials and other media at company-sponsored events are required to ensure that their materials are compliant with all applicable laws.

– Always ask: “Has this material been reviewed by qualified legal counsel as label-exempt 403B compliant?”

• Bookstores, online vendors, etc.

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Where Can I GetEducational Materials?

Where Can I GetEducational Materials?


Opportunity Meetings and Educational Meetings

Opportunity Meetings and Educational Meetings

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• This is a meeting open to the general public.

• Attendees may give their own testimonials.

• Mannatech-approved educational materials can be made available, but must be placed separately from products.

• Educational materials CANNOT be discussed at the meeting.

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What is anOpportunity Meeting?

What is anOpportunity Meeting?


Guidelines for Hosting Opportunity MeetingsGuidelines for Hosting Opportunity Meetings

– Separately display any Mannatech-approved educational materials.

– State the required disclaimer if questioned about the relationship between good nutrition and a specific condition.

– Mention that educational materials are available only if questioned about a specific disease condition during the meeting.

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DO:


Guidelines for Hosting Opportunity MeetingsGuidelines for Hosting Opportunity Meetings

– discussing Mannatech-approved educational materials containing medical/physiological information (including GlycoScience.org)

– discussing the effects of product ingredients beyond the labeling claims.

– attaching educational materials to product, product information, or business cards.

AVOID:


• Meeting leaders must begin by stating:

– Mannatech nutritional products are designed to promote health and general well-being.

– An opportunity is being given for individuals to come forward and tell the audience about their personal experiences with the products.

– Individuals who come forward must relate only their own experience or the experience of family members who live in the same household.

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TestimonialsSharing Life Stories

TestimonialsSharing Life Stories


Before and After a Testimonial Before and After a Testimonial •“Bookend” each testimonial

section with the disclaimer that Mannatech products are not intended to treat, cure, mitigate or prevent any disease or health condition.

• Don’t give your personal testimonial if you are the meeting host.

• Don’t summarize a testimonial after it is given.

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• When you are talking to someone one on one, tell them your own personal experience with the products.

• DO NOT write that experience down or record it and use it to promote the products - it becomes “labeling” under the law and, depending on what you record, it is quite possibly illegal.

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Always RememberAlways Remember


•An educational meeting is designed to An educational meeting is designed to discuss the scientific underpinnings of discuss the scientific underpinnings of Mannatech’s products. Recruiting may Mannatech’s products. Recruiting may not occur during or immediately after the not occur during or immediately after the meeting.meeting.

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What is anEducational Meeting?

What is anEducational Meeting?


• Use only MannapagesUse only MannapagesTMTM or Mannatech-licensed or Mannatech-licensed Web-sites to promote Mannatech products.Web-sites to promote Mannatech products.

• Do not create or maintain a website using Do not create or maintain a website using Mannatech’s logo, trademarks, copyrights, Mannatech’s logo, trademarks, copyrights, product names or pictures or any testimonials.product names or pictures or any testimonials.

• Do not add a hyperlink to the corporate website, Do not add a hyperlink to the corporate website, your MannaPage, GlycoScience.org or to other your MannaPage, GlycoScience.org or to other sites containing testimonials from your Web-site.sites containing testimonials from your Web-site.

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Web-sitesCompliance and the Internet

Web-sitesCompliance and the Internet


• Mannatech products are not intended to diagnose, treat, cure or prevent any disease.

• Use only Mannatech-produced materials to promote the company and its products.

• Never encourage someone to forego traditional medical treatment in lieu of Mannatech products.

• NEVER use disease protocols.

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Closing Thought:Be a Good StewardClosing Thought:

Be a Good Steward

© Mannatech, Inc. 2006 Cornerstone Training 1.Something That is Fundamentally Important. 2.The...

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