INFORMED-SPORT

Inadvertent Doping – Managing the Risk

Science
for a safer world
 SOME FACTS:
SUPPLEMENTS ARE A RISK TO SPORT

Sports supplements present an ongoing and very real threat in

terms of an athlete committing an anti-doping rules violation

“44% of UK Anti-Doping positive tests in the 2012

testing year were caused by prohibited
substances contained in supplements”
 SOME FACTS:
SUPPLEMENTS ARE A RISK TO SPORT

Out of 2,631 tests conducted at the Sochi Winter

Olympics, seven positives had been reported and all
had involved supplements.

Jeff Benz,
Arbitrator Court of Arbitration for Sport (CAS)
2014 Tackling Doping in Sport Conference
 WADA STRICT LIABILITY
The principle of strict liability is applied in
situations where urine/blood samples collected
from an athlete have produced adverse
analytical results.

“It is each Athlete’s personal duty to ensure that

no Prohibited Substance enters his or her
body. Athletes are responsible for any
Prohibited Substance or its Metabolites or
Markers found to be present in their Samples.
Accordingly, it is not necessary that intent,
Fault, negligence or knowing Use on the
Athlete’s part be demonstrated in order to
establish an anti-doping rule violation “
 World Anti-Doping Code
NO FAULT or NEGLIGENCE

The 2015 World Anti-Doping Code also recognises

the risks associated with sports nutrition products.

Contaminated Products
In cases where the Athlete or other Person can
establish No Significant Fault or Negligence and
that the detected Prohibited Substance came
from a Contaminated Product, then the period of
Ineligibility shall be, at a minimum, a reprimand
and no period of Ineligibility, and at a maximum,
two years Ineligibility, depending on the Athlete’s
or other Person’s degree of Fault (10.5.1.2.)
 THE SPORTING LANDSCAPE

Rhys Williams (Wales):

“I am utterly devastated about the
news of this anti-doping rule violation,
which has come as a great shock to
me. From the outset, I would strongly
like to state that I have not knowingly
taken any banned substance.”

Anabolic steroid

Evi Sachenbacher-Stehle (Germany):

"This is the worst nightmare you could
imagine. I can't explain how the doping
test could be positive. I can only expressly
assure everyone concerned that I at no
time consciously took forbidden
substances and I will be doing everything
to have this cleared up completely."

Methylhexanamine
 THE SPORTING LANDSCAPE
Marin Cilic (Croatia): “What
has happened to me is a
nightmare, your life is not any
more in your hands and you
are there in the position where
your career can completely
turn around.
“I could have been out for two
years and what would happen
after that? My life, my career is
at stake - I knew I had not tried
to cheat.“
Nikethamide
Asafa Powell Tai Cheau Xuen
(Jamaica): (Malaysia)
"I want to be clear in “I don’t think there was
saying to my family, ever any intention to
friends and, most of all, use these to cheat. But
my fans worldwide that we cannot make an
I have never knowingly exception to the rule
or wilfully taken any simply because we are
supplements or sympathetic. We have a
substances that break job to do, to protect the
any rules.“ clean athlete.” (OCA)
Oxilofrine Sibutramine
THE CONSUMER LANDSCAPE
THE CONSUMER LANDSCAPE
THE CONSUMER LANDSCAPE
THE CONSUMER LANDSCAPE
THE CONSUMER LANDSCAPE
Inadvertent Doping ‘Athletes curse’

• There is a problem!

• Sources of contamination

• Risk management – there is a solution!

 CONTAMINATION RESEARCH
2001-2004: 634 supplement products, 13 countries, mixed
formulations
14.8% (94 products) contained undeclared WADA banned
steroids

30
25
20
15
10
5
0

IOC survey, results from Geyer et al, WADA Lab Germany

 SUMMARY OF RESEARCH
• 289 samples from companies also selling steroids and/or pro-
hormones: 21.1% positive

• But 345 samples from non-steroid and/or prohormone selling

companies: 9.6% positive

• Highlighted cross contamination issue

- raw materials

- production equipment (e.g. contract manufacturers)

• Wide-reaching consequences
 CONTAMINATION RESEARCH

2007: HFL study involved analysis of 58 supplements

(purchased via stores/internet in USA)

25% contained prohibited steroids

11% contained prohibited stimulants

2008: HFL study involved analysis of 152 supplements
(purchased via stores/internet in UK)

10.5% contained steroids and/or stimulants

Both these surveys focused on products that did not

undergo regular banned substance testing
 2013 EUROPEAN PRODUCT SURVEY
• 2013: 24 top* brands selected from 12 European countries

• 114 products purchased (internet/stores) and tested

• Energy products, protein products, other

• Powders, tablets, capsules, liquids, bars

• Some products claimed they had been tested for banned

substances or were ‘doping free’

• No products on Informed-Sport programme were included

* Source Euromonitor 2013

EUROPEAN PRODUCT SURVEY
10% contained steroids and/or stimulants

Chance of contamination:
 2013 EUROPEAN
PRODUCT SURVEY

Anabolic Agents Stimulants

• Methylhexanamine 3
• Androstenedione
• Sibutramine
• Androstadienedione 2
Product claims:
• DHEA 1 “…. Products are testing for doping
substances by an independent
• Androstenediol laboratory…..”1
“….Rigorous controls ensure that all
• Testosterone products are completely doping free
and safe for use at any level of
competition….” 2 3
• Norandrostenedione “…. Analyses conducted by an
independent laboratory show that
• Nandrolone products do not contain DHEA,
testosterone, nandrolone…..” 1
 SOURCES OF CONTAMINATION

Raw materials
• Contamination at source?
• Imported raw materials – levels of QA?
• Botanical products – natural steroids,
stimulants?

Manufacturing Process
• Cleaning processes and cross
contamination
• Detection levels
• Machine history
 2010-2011 MANUFACTURING SITE
RESEARCH

1 European, 1 US manufacturing
site:
 Swabs taken from key areas: goods
in/storage, manufacturing lines,
packing/storage
None of the sites handled banned
substances at the time of the visit
 2010-2011 LGC REVIEW OF
MANUFACTURING SITES
European site:
• 41 swabs
• 20 showed evidence for contamination (49%)
• Testosterone, DHEA, ephedrine/
pseudoephedrine, methylhexanamine

American site:
• 20 swabs
• 17 showed evidence for contamination (85%!)
• DHEA, androstenediol, androstenedione,
methamphetamine
 WHAT ARE LEVELS OF
‘CONTAMINANT’?

Generally, level of contamination in supplements is low

Part per billion level (ppb)

e.g. 10 nanogram per gram of product!
mg/ml = part per thousand
µg/ml = parts per million
ng/ml = parts per billion

1US Dollar bill = 1g

1/1000 = 1mg
1/1,000,000 = 1µg
1/1,000,000,000 = 1ng

Banned substance testing in products

is 50,000 times more sensitive than GMP regulation testing
 How low does contamination need to be
to cause positive test?
ADMINISTRATION STUDIES (MSSE, April 2009 and April
2010)*:

• 20 volunteers (11 female, 9 male)

• Administered creatine (5g) spiked with 5, 2.5 and 1 microgram
of 19 nor-androstenedione
• (3 separate trials)
• Urine samples collected over 24-hour period
• Analysed for nandrolone metabolites (WADA threshold 2 ng/ml)
* Funded by LGC, UK Anti Doping, Lucozade Sport and Loughborough University
 How low does contamination need to be to
cause positive test?
 5 microgram study: 75% of volunteers failed
 2.5 microgram study: 25% of volunteers failed

 1 microgram study: 0 volunteers failed

Note: Contamination at 10ng/g x serving of 250g, or 250 ml = 2.5 microgram dose

 IS ANTI-DOPING COMMUNITY AND
SPORT DOING ENOUGH?

Do NADOs, IFs and NFs recognise

the risks associated with
supplements and warn their
athletes/stakeholders?

Do all NADOs, IFs and NFs advise

athletes/stakeholders how best to
manage the risk?
 IS SPORT/ANTI-DOPING COMMUNITY DOING ENOUGH
TO TACKLE INADVERTENT DOPING?

The message and approach is inconsistent:

 Some NADOs/ADOs recommend testing supplements for substances

banned in sport – but how rigorous is the testing that is recommended?

 Some sports and sports clubs recommend athletes do not use

supplements, but have highly-visible commercial deals with supplement
brands

 Some sports and sports clubs insist that only batches used by elite
athletes must be tested – what about the general consumer, especially
teenage consumer?

NEED FOR HARMONIZATION AND MINIMUM STANDARDS

FOR TESTING
 IS SPORT/ANTI-DOPING COMMUNITY DOING
ENOUGH?
Is it effective just telling athletes not to
take supplements?

Not effective: ignores the reality of wide

supplements use across the globe
- large majority of elite athletes take supplements
- large majority of people who do physical activity use
supplements
- industry continues to grow and is dominated by very
effective marketing/branding
- lack of regulation allows label and advertising
claims
 NEED FOR RISK MANAGEMENT

International Olympic Committee (IOC)

“Athletes contemplating the use of supplements and
sports foods should consider their efficacy, their cost,
the risk to health and performance and the potential for
a positive doping test.”
IOC Consensus Statement on
Sports Nutrition 2010
 RISK MANAGEMENT
Athletes remain totally responsible for what they consume

Strict liability - you are responsible for any substance found in

your body, regardless of how it got there.

“Assess the need, assess the risk”

 Choose a product with proven efficacy

 Ensure product made to high quality standards
 Ensure product has been tested for banned contaminants
by a recognised sports anti-doping lab

Reference Informed-Sport certification programme.....

 INFORMED-SPORT ALLOWS ATHLETES TO
IDENTIFY HIGH QUALITY PRODUCTS

• Many reputable companies now undertake extensive testing

of their products to ensure they are not contaminated
• LGC has been working with such companies since 2002
• Tested more than 50,000 supplement samples since that
time, 10,000+ tests in 2014
• Test for a range of substances prohibited in sport by WADA
• Help companies ensure their products can be TRUSTED by
athletes
 WHAT IS INFORMED-SPORT?
Informed-Sport is a global risk management programme that tests
sports nutrition products for substances prohibited in sport by the World
Anti-Doping Agency (WADA)
Informed-Sport is based on two fundamental pillars of quality
assurance:

1. Rigorous pre-registration audit

2. Testing EVERY batch pre-release to market
using ISO17025 accredited methodology
 LGC - A HISTORY OF ANTI-DOPING
• World-class sports anti-doping laboratory
• State-of-the-art facilities in UK and USA
• 50 year’s expertise in doping control for sport:
- horse racing/greyhound racing authorities
- athletes (WADA-accredited lab 2004-2007)
• Largest commercial supplement and feed anti-doping testing/research lab
- ISO17025 accredited feed testing since 1990’s
- ISO17025 accredited supplement testing since 2002
- Informed-Sport supplement testing programme since 2008
• Part of global scientific group LGC since Dec. 2010
 LGC Testing Footprint

• LGC has tested for approx. 300 customers in the last year

• Test for brands in 24 countries (Australia, Belgium, Canada, France,

Germany, Guernsey, Hong Kong, Hungary, India, Japan, Jersey,
Luxembourg, Malta, Netherlands, New Zealand, Norway, Poland,
Singapore, South Africa, Sweden, Switzerland, UK, USA)
 INFORMED-SPORT
Supplement testing and voluntary certification programme supported by
organisations such as:

 UK Anti-Doping (UKAD), Spanish Anti-Doping Agency (AEPSAD),

NADA Austria, Dutch Anti-Doping Authority, Swiss Anti-Doping, Anti-
Doping Norway, South Africa Institute for Drug-Free Sport (SAIDS),

 UK Athletics, English FA, RFU, European PGA, LTA, England &

Wales Cricket Board, British Athletes Commission (BAC), English
Institute of Sport (EIS) British Swimming, Norwegian Olympic
Committee, Australian Institute of Sport (AIS)

 Ministry of Defence (MOD): mandatory for British

armed forces to use only supplements registered
on Informed-Sport
 INFORMED-SPORT
Registration Process
Part A: Product Assessment Questionnaire

• Assess quality control process from supply of raw

materials and manufacturing of products to packaging and
distribution

Part B: Pre-Registration Sample Analysis

• Minimum of 5 samples per product to be registered

• (3 samples from one batch, 2 samples from 2 further
batches)
 INFORMED-SPORT
Product Assessment Questionnaire
Designed to assess both production and quality
procedures employed by the manufacturer:

• Products to be registered (including all ingredients)

• Assessment of critical control points.
• Traceability of finished products and raw materials.
• External / internal audits and inspections.
• Review of all raw ingredients / materials used within the
production facility.
• Review of equipment and cleaning procedures employed.
• Review of manufacturing process.
• Review of selection processes for Third Party Manufacturers and
Raw Material suppliers.
• Review of packaging and distribution procedures
 INFORMED-SPORT

Post Registration:
• Test samples from EVERY batch of product, PRIOR to
release for sale
• Secure storage of each batch tested
• “Blind” product testing – 4 x year (tailing off to 1 per year)
• Notify over 200 sports bodies, sports dieticians and
nutritionists to alert them to new products in the
programme
• Includes governing bodies for football, tennis, athletics,
golf rugby, cricket, etc.
INFORMED-SPORT WEBSITE
INFORMED-SPORT WEBSITE
 UK Anti-Doping – Supplements Policy

In the UK, LGC has taken the initiative to create a

scheme to support athletes in assessing the risk. The
Informed-Sport programme is designed to evaluate
supplement manufacturers for their process integrity
and screening of supplements and raw ingredients for
the presence of substances that are on the WADA
Prohibited List. For further information, visit
the Informed-Sport website.
UKAD believes this risk minimisation service to be a
positive step and welcomes the approach being taken
by industry and the LGC Informed-Sport programme.
Spanish NADO – Supplements Policy
The Football Association
English RFU
Australian Institute of Sport (AIS)
‘Sport Supplement Framework’
Ministry of Defense (MOD)
Informed-Sport

Service policy is clear that the taking of steroids,

other than those prescribed for medical reasons, is
not compatible with service life and soldiers caught
using such drugs face disciplinary action and
potentially dismissal from the Army.

In order to protect soldiers from the pitfalls of

inadvertently taking steroids in dietary or sports
supplements the MOD has adopted the
Informed Sport programme as a method for
users to check the provenance or possible
contamination of supplements.

Soldiers contemplating the use of supplements are

advised to only use those listed on the Informed
Sport website (see link top right).

Head of Army Health Promotion, Brigadier John

Donnelly added: “Simply telling service men not to
use supplements is unrealistic, we must therefore
educate them at all levels on the potential
consequences of supplement use in order that they
are able to make informed choices. Furthermore,
we must promote the message ‘Be Safe’.”
 RISK MANAGEMENT

 No certification programme can offer ‘100% guarantee’ that products

will not contain any banned substance

 Only test small portion, detection limits are not infinite

 WADA list is open ended – cannot test for ‘every’ banned substance –
and designed for testing urine and blood, not supplements samples

 BUT regularly tested products, made by reputable companies,

are considerably safer compared to non-tested
products – provided the testing programme
is ‘fit for purpose’!
 SUMMARY
 Contamination is an issue that affects sport and the sports supplements
industry.

 This is recognised by sport and the anti-doping community, but more

needs to be done: minimum standards and harmonization

 Athletes at all levels use sports supplements but they need to be aware
of the risk of inadvertent doping

 Informed-Sport provides the most rigorous and widely-trusted risk

management programme available, with more than 300 products
registered worldwide

 Informed-Sport promotes clean sport on a global level

Thank you and any questions?
Terence.ORorke@lgcgroup.com

Science
for a safer world