“TOO GOOD TO BE TRUE”

1. “TOO GOOD TO BE TRUE” Guiding Dietary Supplement Consumers Away from Risk and Toward Safety Presented by: The Council for Responsible Nutrition (CRN)

2. ABOUT CRN AssociationFactsOne Association—The Council for Responsible Nutrition (CRN) Amount with CRN Staff ……………………………………………..……………….20 Voting Members…………….…………………………...........128 International Members …………………………………………..3 Associate members ……………..…………….……………….68 Annual budget ………………..……………………….$7.0 million Years in existence ..…………..…………………….…….……46 Also contains: scientific, regulatory, international, mediarelations and government relations expertise not found anywhere else.

3. COMPANIES & BRANDS WE REPRESENT (JUST A SAMPLE)

4. WHERE IS THE SUPPLEMENT CONSUMER PURCHASING SUPPLEMENTS? % of supplement users

5. WHY WE’RE HERE TODAY • Tainted products masquerading as dietary supplements put consumers at risk • There are high risk categories and other red flags can serve as indicators for retailers and consumers • Learn ways to identify tainted products and talking to consumers about products they purchase

6. TAINTED PRODUCTS DEFINED • Products illegally marketed as dietary supplements • FDA has identified three “high-risk” areas where adulteration is most prevalent • Tainted products can fall under other categories, too SEXUAL ENHANCEMENT WEIGHT LOSS BODY BUILDING

7. TAINTED PRODUCTS MAY CONTAIN: Ingredients which may or may not be declared on the label Active ingredients found in FDA-approved drugs Active ingredients found in withdrawn drugs Analogs of active ingredients Controlled substances Other compounds that do not qualify as dietary ingredients

8. CASE STUDY #1: SARMs “They are fully intended to give you the results you need without any of the nasty side effects… They also decrease body fat, increase lean muscle mass and improve your wellbeing!” • A.K.A. Selective Androgen Receptor Modulators • Can be listed as “ostarine” or “andarine” #protein #gym #weightlifting #gymmotivation #vegan

9. CASE STUDY #2: SIBUTRAMINE & PHENOLPHTHALEIN • “Zero XTreme” • “Green Lean Body Capsule” • “Adipotrim”

10. CASE STUDY #3: SILDENAFIL • “Leopard Secret Miracle Honey” • “Panther Power Platinum 11000” • “Red Stallion Extra Strong” OH MY!

11. CASE STUDY #4: PHENIBUT • Can be listed as “Beta-phenyl-y-aminobutyric acid HCI” or “Phenyl-GABA” (Phenyl-gamma aminobutyric acid)

12. CASE STUDY #5: CBD • 2018 Farm Bill does not affect or modify FDA jurisdiction or position on CBD use in food and supplements • FDA considers CBD an illegal ingredient in foods and supplements • Lack of oversight leaves regulatory gap and vulnerable consumer base

13. HOW CAN YOU ENSURE CBD PRODUCTS ON YOUR SHELVES ARE SAFE FOR CONSUMERS? • Facility is registered with FDA • Company is GMP compliant • Making appropriate marketing claims • Labels are compliant with current supplement/food regulation • Have a system in place for adverse event recordkeeping and reporting • Structure/Function Claims • CBD containing supplements are treated as new dietary ingredients, subject to notification

14. FDA’S ROLE • FDA has authority to take enforcement action, but the agency has limited resources… • And illegal activity is conducted by fly-by-night operations

15. INDUSTRY’S ROLE • Legislation • Self-regulation • Consumer education • Retailer Relations

16. RETAILER’S ROLE • Vetting of both products and vendors • Use of third-party certification programs • Proactively monitor FDA’s website • Increase education and awareness of consumers’ supplement use and potential safety concerns KNOW WHAT’S IN YOUR PRODUCTS

17. KEY TAKEAWAYS • Risk of tainted products is minimal, but it exists • Extra caution around bodybuilding, weight loss, and sexual enhancement products • When it comes to consumer safety, we all have a role to play

18. RESOURCES • FDA • www.fda.gov/drugs/buying-using-medicine-safely/medication-health-fraud • www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=tainted_supplements_cder • www.fda.gov/food/dietary-supplement-products-ingredients/dietary-supplement-ingredient-advisory-list • CRN • www.crnusa.org • www.BeLabelWise.org • www.crnusa.org/SARMs • www.SupplementOWL.org • Dietary Supplement Quality Collaborative • www.dsqcollaborative.org

19. THANK YOU! Nancy Weindruch nweindruch@crnusa.org Holly Vogtman hvogtman@crnusa.org