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Dietary Supplements Information for Coaches- USA Swimming August 19, 2015
Dietary SupplementsInformation for Coaches- USA
Swimming
August 19, 2015
USADA’s Mission
Learning Objectives
• Describe the FDA’s role in regulating supplements
• Describe what is, and what is not a dietary supplement
• Describe USADAs stance on dietary supplements and the strict liability principal
• Know the four steps to reduce your risk and the limits of each step
• Have answers to THE most common question from athletes: Is my supplement safe?
www.usada.org4
FDA role in regulating supplements
Postmarket
www.usada.org5
No review or approval prior to being sold.
The FDA does not even know about the existence of a dietary supplement until someone brings it to their attention.
The FDA MAY investigate IF (and that’s a big IF) they get enough adverse event reports about a particular product.
Even when products are recalled by the FDA they often stay on store shelves.
The fact that a product is on a store shelf means absolutely nothing.
In real life…
• Athletes and parents may assume that the FDA has a more active role, or that if a product is available for sale then it must be okay.
• As a coach, it helps to be able to explain why this is not the case.
www.usada.org6
Definition of Supplement- by law
There are four things that have to come together that makes something a supplement
www.usada.org7
These are NOT dietary supplements
• Skin patches
• Sprays intended to be absorbed through mucosa of the mouth
• Topical creams
• Injections of any type
• Sports drinks that offer hydration as the major effect (Gatorade, powerade)
• Meal replacement shakes
www.usada.org8
Deer antler spray
• Conflicting directions for use:– Swish in mouth before swallowing
Borderline:
As long as the company intends for the product to be swallowed (ingested) the FDA seems to accept sprays that say swish before swallowing. Gray area.
No clear guidance from the FDA about whether deer antler sprays are dietary supplements.
www.usada.org9
USADAs position on dietary supplements
Use at your own risk!
Strict liability—YOU are responsible for
what is in your system
In the scheme of things
Probably Ok
• Basic vitamins, minerals, fish oil etc.= probably okay, low risk.
• BUT no guarantees! Purity First Vitamin B product was found by the FDA to contain methasterone.
High Risk Products
• Body building
• Weight-loss
• Energy/preworkout
• Sexual enhancement
• Anything that promises to deliver the same effects as something on the prohibited list
– Boost hormones
– Boost growth factor
– Boost EPO
– Increase testosterone naturally
www.usada.org11
www.usada.org12
Reduce your risk in four steps
• Ask a Sports RD
• Look for third party testing/certification
• Look for known warnings/issues– High Risk List
– FDA.gov Tainted Supplements
• Review the label for red flags
www.usada.org13
Reduce your risk: Third party testing
• Neither WADA nor USADA – certify or approve supplements.
– Endorse any company that conducts this service.
• It is up to you to review and understand what each program covers
• They all have pros and cons
• No testing program can test for every possible doping substance.
www.usada.org14
Third party testing-common logos
• Don’t just rely on the logo on the label. Go to the website!
• All of these programs have an official list of certified products and batches that you can verify
• These companies are out of business as soon as an athlete tests positive from a certified product, but they can still make mistakes.
www.usada.org15
Third Party Testing
• We have a whole section on third party testing on the website
www.usada.org16
FDA.gov
www.usada.org18
http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=tainted_supplements_cder
Knowing the unknowable
• Is my supplement safe?
• Does my supplement contain banned substances?
• Will my supplement make me test positive?
www.usada.org19
It is unknowable because….
• No one double checks the contents against the label before it is sold.
• But companies are required to list everything on the label right?
• Yes, by law, but that doesn’t mean they do it. It is a leap of faith on our part to assume they got the label right.
• But this is a really good company, they are super careful and honest.
• That’s great but their ingredient supplier may have changed where they get an ingredient from, or they could have made a mistake in the manufacturing.
www.usada.org20
It is unknowable because….
• OR, you could buy a counterfeit version of a supplement (yes this has happened!)
• Okay can you just look at the label and tell me if you see any prohibited substances?
• Sure, but that may not have any bearing on what is in the bottle.
www.usada.org21
The weakest link
Making a decision about a product by reviewing the label is a hypothetical exercise.
www.usada.org22
www.usada.org23
Questions?
