1. Product Benefit Claims The nutraMetrix ® product line features great products with great benefits Unfortunately, the law does not permit you to say anything you want about their benefits These restrictions apply, even if the statements are true We need to teach the staff how to talk about the products and product regimens

2. Identify Legal “Category” of nutraMetrix ® Product Line Food = No Drug = No Dietary Supplement = Yes

3. Product Benefit Claims Product benefit claims for dietary supplements are regulated by the Dietary Supplement Health and Education Act of 1994 (“DSHEA”). - - DSHEA permits a special kind of product claim - These product claims are called Structure/Function Statements - - DSHEA permits a special kind of product claim - These product claims are called Structure/Function Statements

4. DSHEA Definition of a Structure/Function Claim A statement may be made for a dietary supplement if: The statement claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the United States, describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, or describes general well-being from consumption of a nutrient or dietary ingredient. 21 U.S.C. §343(r) (6) (A)

5. DSHEA Prohibits Disease Claims Under DSHEA, a statement made for a dietary supplement may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases. 21 U.S.C. §343(r) (6) (A) Read more about this on FDA’s website: http://www.cfsan.fda.gov/~dms/dietsupp.html

6. Let’s practice some examples* * Don’t cheat by reading ahead in your course materials. Please follow on the screen. Let’s practice some examples* * Don’t cheat by reading ahead in your course materials. Please follow on the screen.

7. The statements made in this presentation have not been evaluated by the Food and Drug Administration. nutraMetrix products are not intended to diagnose, treat, cure or prevent any disease.

8. Disease vs. Structure/Function nutrametrix ® TriActive lowers cholesterol nutrametrix ® TriActive supports cholesterol levels within the normal range

9. Disease vs Structure/Function nutrametrix ® Glucosatrin soothes the pain of arthritis nutrametrix ® Glucosatrin maintains joint flexibility

10. Disease vs. Structure/Function nutrametrix ® Blood Sugar Support supplement controls diabetes nutrametrix ® Blood Sugar Support supplement promotes healthy blood glucose levels

11. Consequences of Making Illegal Product Claims Punishment Provisions 21 U.S.C. 333 – Civil Penalties and/or – Imprisonment

12. Risk Management Strategies Stick to Market America’s (nutraMetrix ® ) product literature and sales aids (refer to Career Manual) Rely on good science Focus on ingredients – not product benefit claims Doctor/Patient relationship deference

13. For More Information Structure/Function Claims, Small Entity Compliance Guide http://www.cfsan.fda.gov/~dms/sclmguid.html