Learn to reduce your risk if you use dietary supplements Presented by Amy Eichner, PhD for USA Swimming, Dec 6 2017
Introduction PERFORMANCE VERSUS SAFETY 2
What we hear all the time Is my supplement safe? Which supplements can I take? Is this supplement legal in sport? Will this make me test positive? Is this a USADA approved supplement? How can I get my supplement tested by USADA? Which products are approved in sport? Can you just check this label and tell me if this product is ok? Are there any banned substances in this product? Is this product banned? 3
Some dietary supplements can: Give you more than you bargained for Positive doping tests Health problems Give you nothing at all Divert your attention away from things that are effective like assessing your sleep/rest schedule, organizing your training better, planning a better diet 4
Video 5
Learning Objectives Describe why current regulations do not protect athletes from tainted supplements Describe at least one recent regulatory change that affects supplement safety Provide examples of cases (case studies) where supplement contamination cause health problems or positive doping test in an athlete or military member List at least 5 red flags that suggests a supplement is risky Name at least 3 resources for identifying risky products/companies, or identifying prohibited substances 6
Learning Objective: KNOW WHY REGULATIONS DON T PROTECT ATHLETES 7
Why don t current regulations protect athletes? FDA doesn t approve supplements before they are sold Quality decisions left to manufacturer-conflict of interest Recalls are voluntary, and often ineffective Supplement companies argue incessantly with FDA over the legality of dangerous ingredients Many supplement companies are beyond the reach of the FDA (internet, overseas, etc). 8
Why don t current regulations protect athletes? FDA doesn t approve supplements before they are sold Things you might hear: if Product X was so bad it wouldn t be on shelves if it was that dangerous, someone would have done something The truth is the FDA doesn t even know about a product until enough people have been hurt or made sick that there is a signal in the adverse event report statistics. Recalls by the company are voluntary, and not always effective 9
FDA battling sibutramine for 10 years Sibutramine cancelled as weight loss drug because of severe health problems. Never got FDA approval because it was TOO DANGEROUS. 287 recalled sibutramine products from 2007-2017 Products go on shelves faster than the FDA can do anything. 10
A year in the making 11
Why don t current regulations protect athletes? Quality decisions left to manufacturer-conflict of interest Manufacturers must ensure compliance with the law, but Quality programs are expensive to run so companies take short cuts to save money Some companies don t understand the testing and confirmations they are supposed to do Some companies don t report adverse events like they are supposed to 12
Why don t current regulations protect athletes? Supplement companies argue incessantly with FDA over the legality of dangerous ingredients 2013 13
Why don t current regulations protect athletes? Many supplement companies are beyond the reach of the FDA (internet, overseas, etc). No address or contact information anywhere on the website. No street address. 14
Why don t current regulations protect athletes? 15
Why don t current regulations protect athletes? FDA doesn t approve supplements before they are sold Quality decisions left to manufacturer-conflict of interest Recalls occur slowly and may be ineffective Supplement companies argue incessantly with FDA over the legality of dangerous ingredients Many supplement companies are beyond the reach of the FDA (internet, overseas, etc). 16
Learning Objective: HOW TO STAY ON TOP OF REGULATORY CHANGES 17
Recent Regulatory Updates Food Safety Modernization Act (FSMA) Signed into law 2011 Amends the FD&C Act by requiring food facilities to register with the FDA. Dietary Supplement manufacturers are considered food facilities This lead to increased transparency and inspections post 2011. Designer Anabolic Steroid Control Act (DASCA) Signed into law 2014 Added a number of steroids for the controlled substances act 18
Subscribe to industry publications Subscribe to Nutrition Outlook, or any one of the several legal blogs on supplements and regulations. 19
For a Summary video. https://www.youtube.com/watch?time_continue=63&v=7hiviim-35w 20
Learning Objective: KNOW A FEW CASE STUDIES DEMONSTRATING THE CONSEQUENCES OF SUPPLEMENT CONTAMINATION 21
Dietary Supplement with Glycerol 22
Low risk may not be low risk 23
Healthy Life Chemistry 24
Press release/advisories 25
You cannot rely on the label Athletes put way too much stock in the label. NO ONE can look at the label and tell if a product is safe. Examining the label is a purely theoretical exercise. 26
Learning Objective: LEARN TO IDENTIFY RED FLAGS 27
28
Supp411 Red Flags 29
Learning Objective KNOW WHERE TO GO FOR INFORMATION 30
Resources Resource Supplement411 and High Risk List USADA Facebook, LinkedIN, Twitter USADA Athlete Express GlobalDRO (drug reference online) Operation Supplement Safety (OPSS) FDA Report a Problem FDA Tainted Supplements Third party certification websites Need Anti-Doping information about supplements Get updates through social media/advisories Ask a question via email Look up the status of a medication or substance Health risks of supplements from a military perspective Report supplements you find for sale that are concerning Search for hundreds of tainted products Stay in the know! 31
Resources Call us on 719 782 2000 option 2 32
Conclusions: Describe why current regulations do not protect athletes from tainted supplements Describe at least one recent regulatory change that affects supplement safety Provide examples of cases (case studies) where supplement contamination cause health problems or positive doping test in an athlete or military member List at least 5 red flags that suggests a supplement is risky Name at least 3 resources for identifying risky products/companies, or identifying prohibited substances 33