2. Welcome to Our October Webinar For Nature’s Sunshine Consultants
Keeping You Safe – A Conversation with Nature’s Sunshine’s Attorney
October 20, 2011

3. My Contact Information
Scott Terry P F E S. Provo, UT 84606

4. This webinar will be recorded and can be viewed on www.nspwebinars.com
A phone recording of this webinar is available by calling
PIN
(This is not a toll-free call)

6. New Corporate Headquarters August 2012

7. New Corporate Headquarters August 2012

8. Education Week! November 14-21 11 am & 6 pm Live Mountain Time;
Recordings will be provided as well
Six free webinars
Product discounts & specials
Lots of fun giveaways on live sessions

9. Enter your questions, we’ll address them when we conclude
What topics would you like to see discussed on our future consultant webinars?

10. Jamon Jarvis
Executive VP-General Counsel, Chief Compliance Officer

11. Claims, Pains & Regulations: An Introduction to the Regulation of Dietary Supplements
Jamon Jarvis
General Counsel & CCO
Nature’s Sunshine Products, Inc.

12. Purpose Cover the Basics Why Do “They” Care? Why Should We Care?
Who Regulates
Define the Terms
Claims
Why Do “They” Care?
Why Should We Care?
Practical Application
Questions?

13. Who are the Regulators? FDA FTC
Regulates over $1 trillion worth of consumer products
Approximately 25 cents of every dollar spent by consumers
Promote and protect the public health
Guiding principles: Products must be safe, clean, wholesome, produced and stored in sanitary conditions, and truthfully labeled
Priorities include dietary ingredient/supplement safety
The Nation’s Consumer Protection Agency
Act to prevent fraud, deception and unfair business practices
Joins with FDA on dietary ingredient/supplement consumer issues

14. Dietary Supplement Health and Education Act of 1994 (DSHEA)
DSHEA Definition
The Dietary Supplements Health and Education Act of 1994 (DSHEA) amended previous statutes to encompass dietary supplement-specific provisions including the definition of a “dietary supplement”, product safety, nutritional statements and claims, ingredient and nutritional labeling, good manufacturing procedures, the classification of “new” dietary ingredients, and third-party literature/ informational materials (i.e. articles, fact sheets, etc.).

15. Dietary Supplement Health and Education Act of 1994 (DSHEA)
Background and Overview
Why?
Defines a dietary supplement
Reverses burden of safety
The role of “third-party” materials

16. Dietary Supplement Health and Education Act of 1994 (DSHEA)
Key Requirements
New Dietary Ingredients
FDA Disclaimer created
Structure/Function Statements

17. Claims and Substantiation
What Can I Say?

18. Permitted Claims Structure/Function Claims Nutrient Content Claims
Structure/Function claims describe the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans
Function v. Dysfunction
Nutrient Content Claims
Describe the level of nutrient or dietary substance in a product (using terms such as “free,” “high” and “low”)
Compare the level of a nutrient in a food to that of another food (using terms such as “more,” “reduced” and “lite”)

19. Permitted Health Claims (Continued)
Describe a relationship between a dietary supplement ingredient and a reduction in the risk of disease or health related condition (can be used if certain criteria are met)
Health claims based on authoritative statement of a scientific body of the U.S. Government, after FDA’s review of scientific evidence
Qualified health claims supported by credible evidence and accompanied by a non-misleading disclaimer

20. Permitted Health Claim Example
Calcium, Vitamin D, and Osteoporosis:
Adequate calcium and vitamin D throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis.
Complete List:

21. Disease Claims Generally Not Permitted -
Dietary supplements, in general, are not permitted to be marketed as a treatment, prevention or cure for a disease or condition
Dysfunction v. Function
Very limited exceptions

22. What is a Structure/Function Claim?
DSHEA
Describes role of nutrient or ingredient intended to affect the normal structure or function in humans
Characterize the documented mechanism by which a nutrient or ingredient acts to maintain such structure or function
Describes general well-being from consumption of nutrient or ingredient
Function v. Dysfunction

23. When is a Structure/Function Claim Allowed?
Manufacturer has substantiation that statement is truthful and not misleading
What qualifies as substantiation?
NSP’s Responsibility
Mandatory disclaimer included
“This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

24. Permissible Structure/Function Claim Examples
Pain associated with non-disease states, e.g., muscle pain following exercise
Supports a normal, healthy attitude during PMS
Helps support cartilage and joint function

25. Testimonials
Distributor product testimonials – restrict claims to those similar (if not identical) to the claims contained on the product label and brochures
Testimonials from doctors and scientists – no difference
To be considered substantiation, must meet same standards
If not proven via scientific research contemplated by the substantiation requirements, don’t say it in testimonials
Can testimonials be used?
Yes, if they do not make drug/disease claims
If they are not false or misleading
If they express product attributes such as taste, quality or nutritional content

26. Third-Party Literature
Cannot be false or misleading
Does not promote a particular manufacturer or brand of dietary supplement
Does not have appended to it any information by sticker or any other method
Can be a publication, including an article, a chapter in a book, or an official abstract of a peer-reviewed scientific publication
Reprinted in its entirety
Can be used in connection with the sale of a dietary supplement to consumers

27. Practical Examples (Indications and acceptable/unacceptable claims)
Wrong
Right
Blood Pressure – Lowers
Cholesterol – Lowers
Blood Sugar (Diabetes) - Controls
Joints - Pain
Sleeplessness – Insomnia
Stomach – Duodenal lesions/Bleeding
Blood Pressure – Maintains normal range
Cholesterol – Maintains normal range
Blood Sugar - Maintains normal levels
Joints – Joint function/cartilage
Sleeplessness – Occasional
Stomach – Upset/Sour

28. Practical Examples (Indications and acceptable/unacceptable claims)
Wrong
Right
Acne – Cystic
Pain – Analgesic
Sex- Restores Potency
Heartburn – Relief of
Inflammation – Anti-Inflammatory
Memory – Alzheimer’s/Dementia
Calcium – Osteoporosis
Immune - Wasting/AIDS
Acne – Non-cystic
Pain – Muscle (after exercise)
Sex – Sexual Desire
Heartburn – Occasional
Inflammation – Inflammation Response
Memory– Mild (Aging)
Calcium – Helps Build Strong Bones
Immune – Supports the immune system

29. Practical Examples (Indications and acceptable/unacceptable claims)
Wrong
Right
Eyes – Glaucoma
Constipation - Chronic Constipation
Weight Loss – Obesity
Hair Loss – Alopecia
Mood - Herbal Prozac/Depression
Flu Season
Eyes – Presbyopia (Focus/aging)
Constipation – Occasional - Laxative
Weight Loss – Appetite Suppressant
Hair Loss - With Aging
Mood – Relaxed Feeling
Seasonal Changes

30. Key Take-Aways
NSP’s Policy: Actively market and promote NSP’s products within the current regulatory and legal framework, pushing for legislative change where appropriate.
Any disease claim, with rare exception, regarding a dietary supplement is prohibited.
Health Claims, structure/function claims, testimonials and third party literature can be valuable sales and marketing tools when used within regulatory limits.
Unauthorized, unsubstantiated claims can lead to regulatory problems for the Company and its distributors.
Education and corporate vigilance protects the Company and its distributors.

31. Thank You Jamon!

32. Questions & Answers

33. Next consultant webinar is scheduled for Tuesday, November 22nd
Thanks Everyone!
Next consultant webinar is scheduled for Tuesday, November 22nd