Contents

Contents
Section 1: Scene-Setting The Problem
1.

Which supplements are likely to be contaminated?

2.

The WADA Prohibited List

3.

Why do athletes take supplements?

4.

Steroids and Stimulants

5.

World Anti Doping Agency (WADA) attitude to supplements

6.

HFLs testing experience

7.

HFLs positive findings experience

8.

A Solution - Informed-Sport

Section 2: Quality
9.

Sources of contamination

10.

Variation between and within batches

11.

GMP Good Manufacturing Practice

12.

The WADA Test

13.

ISO 17025

Section 3: Laboratory Testing The Solution

14.

Standard lab testing and limits of detection

15.

Banned substance screening

16.

10 ng/g?

17.

Why mass spectrometry?

18.

Limitations/lack of guarantees

19.

Why so few capable labs?

20.

GMP

21.

DSHEA

22.

FDA

Page 1

Section 4: Regulations

Introduction

Introduction
It is clear that inadvertent contamination of supplements by steroids and stimulants is an
issue that demands the attention of a wide range of interested parties, including:

Athletes (from School Age to Elite)

Sports Bodies of all types
Leagues
Teams
Coaches
Dieticians
Parents
Supplement companies
Third Party Manufacturers
National Anti Doping Organisations
World Anti Doping Agency (WADA)
Whilst many reputable supplement companies will undoubtedly undertake extensive
testing of product within a Quality Assurance programme, the requirements of banned
substance testing (in relation to WADAs Prohibited List) introduce particular challenges
that lie well outside traditional testing of foodstuffs and pharmaceuticals.

Page 3

These challenges need to be understood. This book is intended to introduce the topic of
banned substance testing, and then to explain the issues that must be addressed.

Which Supplements are Likely to be

Contaminated?

Chapter 1: Scene-Setting The Problem

1.

Which Supplements are Likely to be Contaminated?

Summary
It is clear that ALL forms of supplementation should be considered as potential sources
of a positive drugs test for elite athletes, as a direct result of inadvertent contamination of
raw materials and/or cross-contamination within the manufacturing process.
The major focus when addressing the issue of supplements that may be contaminated with
substances prohibited by WADA (see Section 2) is a sub-set of products commonly referred
to as Sport Supplements. The definition of a sport supplement is, however, somewhat
vague. More specifically, the term Dietary Supplement has a definition based in US law,
from within the Dietary Supplement Health and Educations Act (DSHEA) of 1994:

A Dietary Supplement is a product that contains substances like vitamins,

minerals, foods, botanicals, amino acids and is intended to supplement the
usual intake of these substances. Dietary supplements are found in pill, tablet,
capsule, powder or liquid form and are meant to be taken by mouth.
Many foodstuffs would meet this criterion - beyond those that are classically viewed as
supplements e.g. some brands of margarine, specialised yoghurt drinks and even bread!
It might be imagined that sport supplements are those dietary supplements that
supplement the usual intake of substances that would enhance sporting performance.
Whilst this might have a useful meaning within the gym market (building muscle,
increasing endurance), it also applies to the more general issues of weight gain, weight
loss, suppleness, fitness and general wellbeing.
In the context of contamination of products with substances on the WADA Prohibited List,
it is perhaps useful to identify the sub-set of supplements in which WADA banned
substances have been identified in the past as contaminants (i.e. their presence was not
declared on the label). These include the following generic types:

testosterone boosters
weight loss products
creatine
muscle regulator products

but also:
vitamin C
multivitamins
magnesium
skimmed milk products

Contamination identified in the latter examples in particular is typically due to inadvertent

cross-contamination within the manufacturing process see Section 7.

Page 5

The WADA Prohibited List

2.

The WADA Prohibited List

Summary
It is neither possible nor appropriate to test supplements for everything on the WADA
Prohibited List. Instead, laboratories that test supplements should focus on a subset of
substances that are banned by WADA, using experience to identify those substances that
are of significant concern.
From time to time, the World Anti Doping Agency will update a published list of
substances that are considered to be prohibited within elite sport. Blood and/or urine
samples are taken from professional sports people on a regular basis, and these samples
are subjected to testing by a limited number of WADA-accredited laboratories across the
world (currently 33, listed on the WADA web site: www.wada-ama.org). Any evidence for
the presence of a prohibited substance will violate the WADA Code. The WADA Prohibited
List is available for download from the above website.
The WADA Prohibited List specifies generic categories of substances (e.g. Anabolic
Androgenic Steroids), and then provides a list of specific examples from each category
(e.g. 1-androstenedione). Sections on Anabolic Agents and Hormones and related
Substances finish with a general statement relating to other such substances that are
not specified:
other substances with a similar chemical structure or similar biological
effect(s)
It is clear that the WADA Prohibited List is therefore open-ended, and it is not a definitive
list of prohibited substances. There is potentially an infinite list of substances that would
meet the generic criteria that are selected by WADA, and their accredited laboratories are
challenged to identify any new substances that are subjects of cheating (e.g. the now
infamous tetrahydrogestrinone or THG).

Page 7

It is therefore not possible to test supplements for everything on the WADA Prohibited
List. Neither is it appropriate, referring as it does to substances that must not be found
in blood and urine, rather than what is eaten or drunk. The human body works on
whatever enters the body to break it down, extract what is good and get rid of what is of
no value the process of metabolism. The WADA list will therefore include metabolised
(broken down) forms of any steroids and stimulants. When testing supplements it is
therefore important to test for the parent substances that could generate a positive
WADA test after metabolism. Also, the most likely source of contamination is from
materials inadvertently introduced by the raw material supplier or in manufacture. A
worthwhile testing programme identifies and targets those compounds most likely to
arise in these circumstances, for example DHEA (dehydroepiandrosterone) which is still
available over the counter in the US. The list of substances for supplement testing is
therefore subtly different from the WADA Prohibited List.

Why do Athletes
take Supplements?

3.

Why Do Athletes Take Supplements?

Summary
Some supplements have undoubted benefits, proven in clinical trials, and will improve the
performance and recovery of an individual. Indeed, many athletes will argue that they
MUST take supplements in order to compete conscious that their competitors are likely
to be taking the same.
However, note that these products are marketed alongside many with claims that cannot be
scientifically proven (but laws are being introduced in some countries to address this issue).
Given the vast array of supplements on the market, athletes run the very real risk of taking
supplements that are ineffective but with impressive claims and which may be
contaminated with banned substances.stances.
There is no doubt that certain supplements have proven efficacy in the field of sport. Such
supplements may, for example:
add bulk
reduce weight
develop muscle increase endurance
re-hydrate improve suppleness aid recovery
overcome a mineral deficiency
If performance may be enhanced in this way, using substances that are not prohibited,
then athletes will inevitably take supplements. This is despite the advice of WADA and
almost all National Anti Doping Organisations, who state that supplements are not
necessary in order to compete at even the highest level.
Contrast this with the quoted diet of an elite athlete in Pro American Football:
Breakfast
50 mg coenzyme Q10
400 IUs vitamin E
1,800 mg essential fatty acids (EFA)
Protein powder shake
1,000 mg glucosamine

2,000 mg vitamin C
5 g creatine monohydrate
1,000 mg beta-hydroxy-beta-methylbutyrate
800 mg chondroitin sulphate

Mid Morning
8 g glutamine
2 mg copper sabacate

200 mg chromium polynicotinate

Lunch
2,000 mg vitamin C
1,000 mg HMB
1,000 mg glucosamine
Whey powder

1,800 mg EFA
800 mg chondroitin sulphate
Protein shake

450mg magnesium asparate

One Hour Before Bed

30mg zinc monomethionine
Just Before Bed
Protein shake

Page 9

Dinner
Same as Breakfast

Steroids and Stimulants

4.

Steroids and Stimulants

The Issue
Research has shown that steroids and stimulants banned by WADA have been found as
contaminants within some supplement products. Both steroids and stimulants have an
undoubted impact on individual performance as such, most are prohibited for use by
elite athletes.
Definition: Anabolic Steroid

A group of synthetic hormones that promote the storage of protein and the
growth of tissue, sometimes used by athletes to increase muscle size and
strength.
Anabolic steroids are related to the male hormone, testosterone. They can be synthesised
and taken as tablets, in powder form, or by intramuscular injection to improve muscle
growth, strength, and endurance. Many can be acquired on prescription for the treatment
of a number of diseases including anaemia, breast cancer, and post-surgical muscle
wasting. Anabolic steroids are responsible for much of the drug abuse in sport.
An estimated 200,000 users in the UK take steroids for non-medical purposes i.e. to
enhance their appearance or strength. Several routes of administration can be used
simultaneously - a process called Stacking. Abusers believe that stacking enhances the
effects of the drugs. Until relatively recently, the abuse of anabolic steroids was confined
mainly to athletes and adult body-builders. Now there seems to be a significant increase
in the number of young people, both male and female, taking these compounds.
Some estimates place anabolic steroid abuse among young males in American high
schools as high as 10 per cent; some are participants in competitive sports but many are
not. Users of anabolic steroids may also feel stronger, more aggressive, and more
confident. Many law enforcers are seriously concerned that increased aggression
associated with steroids (known as Roid rage) is leading more young people to commit
violent crimes.

Page 11

However, the use of steroids, especially among teenagers, is not without risk. Steroids can
seriously affect skeletal growth. Numerous investigators report that steroid abuse in
males may reduce the size of the testes and reduce sperm production, as well as lead to
the development of enlarged breasts. In females, the steroids may cause the development
of secondary male characteristics such as growth of facial hair, enlargement of the
clitoris, disruption of the menstrual cycle, and reduced breast size. Other side effects
include psychological damage, liver damage and heart disorders.

Steroids and Stimulants

Definition: Stimulant

An agent, especially a chemical agent such as caffeine, that temporarily

arouses or accelerates physiological or organic activity.
Or:

A stimulant is a general term used to describe a substance that can

temporarily quicken a functional activity or the activity of an organ in the
body
Stimulants are relatively common compounds ranging from caffeine, which can be found
in drinks such as coffee, as well as over-the-counter medicines, through to recreational
drugs such as amphetamine, cocaine, etc. Caffeine is widely available in many foodstuffs,
affecting the central nervous system and temporarily raising alertness.

Page 13

Ephedrine and pseudoephedrine are chemicals found in the Ephedra plant type. These
have been used for many years as stimulants, as well decongestants, appetite
suppressants, etc. The use of ephedrine has been prohibited in the USA since 2004,
following a number of high profile deaths after the consumption of the herbal weight loss
product ephedra.

World Anti Doping Agency (WADA)

Attitude to Supplements

5.

World Anti Doping Agency (WADA) Attitude to Supplements

Summary
WADA advise elite athletes that they should not take supplements recommending
instead that a balanced diet will provide all of the necessary nutrition.
However, it is clear that many supplements are indeed beneficial to performance, and
many athletes take a variety of such supplements.
WADA has effectively banned WADA-accredited labs from offering services to assist
supplement companies from introducing effective quality control procedures to avoid
inadvertent contamination.

WADA (and the International Olympic Committee IOC) takes a clear stance on the use of
supplements in any sporting context, arguing strongly that athletes need not take such
supplements in order to compete at the highest level. Instead, they should maintain a
balanced diet.
The stance of WADA (responsible for world-wide doping control since 2004) is carried over
from the IOC (previously responsible for doping control activity across the Olympic
community). The IOC funded a piece of research at its laboratory in Cologne (then
accredited by the IOC, now by WADA) to investigate the range of undeclared substances
that supplements may contain and to assess whether these posed a risk to drug-free
sport. The Cologne lab purchased 634 products from standard retail channels in 13
different countries. The products were analysed for the presence of steroids or prohormones (which the body will metabolise into steroids).
Out of the 634 products analysed, 15% were found to be contaminated with steroids/
pro-hormones:

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It may also be that WADAs expressed view is somewhat influenced by a concern that the
condition of strict liability might be compromised.

Page 15

(from Geyer H, Parr MK, Mareck U, Reinhart U, Schrader Y, Schanzer W.

Analysis of non-hormonal nutritional supplements for anabolic-androgenic
steroids results of an international study. Int J Sports Med. 2004; 25, 124-129)

World Anti Doping Agency (WADA)

Attitude to Supplements

Strict liability refers to a ruling that athletes are singularly responsible for anything that
is found within that athletes body. So, whether it was a coach, a dietician, a parent or
whoever that recommended an element of a diet, it is the athlete that is ultimately
punished by WADA for a doping violation.
Now, consider what would happen if WADA were in any way to endorse supplementation
within a diet, and (perhaps worse) consider that a WADA lab might have screened the
never a
supplement for the presence of inadvertent contamination by banned substances (n
100% guarantee of safety in this regard). If that supplement is then proven to have been
responsible for a positive drugs test, then the WADA disciplinary system is clearly
compromised: a lab accredited by WADA will have identified the positive urine test, and a
WADA lab will have approved the supplement. The athlete will strongly argue mitigating
circumstances, and it is possible that the prosecution will fail and certainly be
compromised. The principles of strict liability are therefore fundamentally undermined.
As a result, WADA has now taken strong action to prevent any of their accredited labs from
undertaking quality control activity for supplement companies via the latest issue of the
International Standard for Laboratories:
WADA International Standard for Laboratories Version 5.0 January 2008
Appendix B: Laboratory Code of Ethics
The Laboratory will not engage in analysing commercial material or
preparations (e.g. dietary supplements) unless specifically requested by an
Anti-Doping Organisation as part of a doping case investigation.
The Laboratory will not provide results, documentation or advice that, in
any way, suggests endorsement of products or services.
The National Anti Doping Organisations (NADOs) that take responsibility for doping
control in each country follow WADAs lead, cascading the stance on supplements to a
local level.

Page 17

However, it is clear that a number of supplements do have proven efficacy i.e. if an athlete
takes them, they can compete at a higher level. As a consequence, it is widely recognised
that the majority of athletes will take one form of supplement or another, whether it be a
multivitamin, a protein drink, or whatever. Indeed, athletes typically take a broad range of
supplements morning, noon and night (see Section 3).

6.

HFLs Supplement Testing Experience

Summary
HFL undertook an analysis of 58 supplements purchased through standard retail outlets
in the USA in 2007 and found that 25% contained low levels of steroid contaminants, and
11% were contaminated with stimulants.
Companies that work regularly with HFL show a significantly reduced incidence of
contamination typically around 1 or 2%. In addition, these products can be withheld from
the market.
HFL has been working closely with the supplement industry since 2002, partnering with
manufacturers and suppliers to offer quality assurance services and advice to
organisations around the world. In 2007 alone, HFL analysed over 2,600 samples,
summarised below:
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These samples included both finished products, and raw ingredients of various forms.
Of the finished products analysed, 1.9% were found to contain low levels of steroid and/or
stimulant contaminants that appear on the WADA Prohibited List. The contaminants had
been inadvertently incorporated into the product.
The highest incidence of contamination was found in tablet products, followed by capsules
and powders. No contamination was detected in the liquid/ gel or bar products analysed:
Edh^i^kZWn;dgbjaVi^dc;^cVaEgdYjXi

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HFL also undertook a key piece of research in 2007 to review and update the research
undertaken by the Cologne lab (presented in Section 5).
Within the USA, 58 products commonly used by professional sports people were
purchased from standard retail channels. These were analysed for the presence of
steroids and stimulants that appear on the WADA Prohibited list. 25% were found to be
contaminated with steroids, and 11% with stimulants. Table 1 outlines the findings.
STEROIDS

STIMULANTS

Negative

Negative

energy drink

Negative

Negative

hormone regulator

inconclusive

Negative

hormone regulator

Negative

Negative

hormone regulator

Contamination with androstenedione and DHEA

Negative

hormone regulator

Negative

Negative

muscle builder

Negative

Negative

muscle builder

Negative

Negative

muscle builder

Test failed

Negative

muscle builder

Negative

Negative

muscle builder

Negative

Negative

muscle builder

Negative

Negative

muscle builder

Negative

Negative

muscle builder

Negative

Negative

muscle builder

Inconclusive

Contamination with ephedrine

muscle builder

Negative

Negative

muscle builder

Negative

Negative

muscle builder

Contamination with androstenedione, DHEA,

and some 1,4 androstadienedione

Negative

muscle builder

Negative

Negative

muscle builder

Negative

Negative

post work out/recovery

Negative

Negative

post work out/recovery

Negative

Negative

post work out/recovery

Negative

Negative

pre workout

Negative

Negative

pre workout

Negative

Negative

pre workout

Negative

Negative

pre workout

Negative

Negative

pre workout

Negative

Negative

Protein

Negative

Negative

Protein

Negative

Negative

Protein

Negative

Negative

Protein

Negative

Negative

Protein

Negative

Negative

rehydration/protein

Negative

Negative

testosterone booster

Contamination with DHEA, androstenedione, 1,4

androstadiene-dione

Test failed

testosterone booster

Contamination with androstenedione, 1,4

androstenedione, androstenediol, DHEA

Contamination with ephedrine

testosterone booster

Contamination with DHEA, androstenedione, 1,4

Negative

androstadienedione, androstenediol (trace)

Page 19

energy drink

HFLs Contamination
Findings

7.

HFLs Contamination Findings

Summary
Substances found as inadvertent contamination are non-standard with regard to routine
quality control test procedures, and demand specialised analytical techniques.

In 2007, HFL identified the following WADA prohibited contaminants in supplement

products:

androstenedione

androstenediol

dehydroepiandrosterone (DHEA)

estrenedione (19-nor-androstenedione)

estrenediol (19-nor-androstenediol)

1,4-androstadiene-dione

Ephedrine

Page 21

The most common of these contaminants were the steroids DHEA and Androstenedione.

8.

A Solution - Informed-Sport

Summary
There is a solution to this dilemma: Informed-Sport
The Informed-Sport programme allows athletes and their connections to make a choice
about the risks associated with the use of supplements. If the Informed-Sport logo is
shown on the product, it is an indicator that the product has been subjected to rigorous
batch by batch testing against internationally recognised standards (including ISO 17025
see Section 13).

Informed-Sport was created in response to a recognised need to test supplements for

inadvertent contamination with substances prohibited in sport via a cost-effective, reliable
and high integrity service.
The aim is to provide athletes, coaches, advisors, parents, etc. with an informed choice
with regard to supplements, as part of a general approach to risk management. It is
NEVER possible to provide a 100% GUARANTEE that any product is absolutely free of
contamination because no lab can test for every steroid and stimulant that exists.
However, the choice is simple
If you choose to take a supplement, ensure that what you take has been tested for
trace levels of contamination using appropriately accredited tests
The following key elements are integral to the Informed-Sport programme

Product Testing using ISO17025 accredited tests

Product Assessment Questionnaire

Pre-Registration Testing of products

Post Registration Testing of products

Logo Use and Web Directory for communication and education

Informed-Sport Registration Process

Product Testing to ISO 17025 Standards
The Informed-Sport testing specification has been developed through the analysis of over
6000 supplement samples over 6 years.
This is reinforced by research into supplement contamination levels and the analysis of
positive drug tests within professional sport on a global basis. The appropriate detection
limits are those selected to reassure the athlete that they are not taking undue risks. The
specification may be updated from time to time under the guidance of the Advisory Panel.

All testing for INFORMED-SPORT is accredited to ISO 17025 - vital to ensure that the
analyses meet expectations in terms of consistent quality and coverage of drugs.
Validated methods are required for each matrix (powders, liquids, capsules, bars, tablets)
at the specified detection limit. The integrity of the programme is built upon this standard.
Product Assessment Questionnaire
This draws on many years of experience in supplement analysis and evaluates the
integrity of the manufacturing stages from supply of raw materials, through third party
manufacturing, into packaging and storage.
Pre Registration Testing
Samples of product to be registered are drawn from a number of batches, to explore both
inter- and intra-batch variations. All tests must be negative for registration to proceed.
Post Registration Testing
Every manufactured batch of registered products will be subjected to testing and batches
only released for sale upon the issue of a negative Certificate of Analysis (i.e. where no
contamination was detected). A number of products will also be purchased by the Central
Administrator directly from standard retail outlets blind testing to reinforce the
integrity of the programme.
Logo Use and Web Directory

Page 23

All registered products are entitled to use the Informed-Sport logo. All tested products are
www.Informed-Sport.com) allowing elite
listed on the Informed-Sport web directory (w
athletes to choose products which have been screened for banned substances and to
avoid those that have not been through the Informed-Sport certification process.

Sources of Contamination

Chapter 2: Quality
9.

Sources of Contamination

Summary
Inadvertent contamination can come from a number of sources, typically crosscontamination within the manufacturing process, or contamination within raw ingredients.
Of course, deliberate contamination could be undertaken to give the user a particular
benefit albeit from a prohibited source.
A number of real-life case studies, drawn from the experiences of HFL, are useful in
demonstrating the origin of contaminated supplements:

9.1 DHEA
News reports have called DHEA "the mother of all hormones". A new book calls it
a "superhormone". On the Internet, it's billed as the "fountain of youth hormone".
Claims include

increased life expectancy

prevent cancer
prevent heart disease
alleviate the effects of Alzheimers
combat aids

DHEA is a steroid, and explicitly banned by WADA for use by elite athletes. It is
freely available over the internet, and over the counter in the USA.
HFL case study: A major US manufacturer of supplements had historically
produced DHEA product alongside a range of other mainstream sports
supplements. The manufacturer wanted to investigate the possibility of cross
contamination.
HFL was sent 14 samples from the manufacturing facility for analysis each one
blind (i.e. with no product identification), and drawn from a range of powders and
liquids. One of the samples turned out to be a sample of the DHEA product that the
company made. However, evidence of DHEA contamination was found in every
single one of the 13 other samples noting that one of these blind samples was
a tap water sample from the mens rest room!

Page 25

This is a clear example of how easy it is for contamination to spread to all areas of
a manufacturing facility, and indicates the potential for cross-contamination
between manufacturing lines within the same facility.

Sources of Contamination

With some products being particularly prone to cross-contamination, any products

supplied to elite sport people should be completely isolated within the
manufacturing process ideally in a different building.
Note that many supplements are produced by third party manufacturing facilities
i.e. sub-contractors, who manufacture products on behalf of many supplement
companies. Whilst a particular brand may not contain DHEA in their product line,
this may provide no reassurance with regard to cross-contamination. The
manufacturing facility must therefore have the highest integrity quality systems in
place. The owner of the brand must have a quality system that addresses this issue.

9.2 Tribulus Terrestris

Tribulus terrestris is a herb, with what is claimed to have fantastic benefits:
increasing energy and vitality; building muscle and strength; etc. It has been used
as a Chinese remedy for headaches, and calming the liver. For bodybuilding, it is
claimed to boost testosterone levels by up to 50%.
HFL case study: Experience drawn from testing a number of Tribulus products as
part of research and routine analysis suggests that this herb is commonly
contaminated with a range of prohibited substances, including DHEA and
androstenedione. The source of such contamination is unclear, but it is noted that
some of the suppliers of the associated raw materials used in Tribulus products do
not always implement the quality assurance programmes needed to provide the
required level of confidence required by elite sport.
Those companies that market tribulus terrestris products should ensure that their
suppliers conform to a defined quality standard which demands testing for low
levels of contamination, including banned steroids and stimulants.

9.3 Manufacturing Control

Effective testing of product and some of the raw materials can significantly
enhance the quality of the final product.

The use of third party manufacturers is common practice within the supplements
industry; whilst the products of Company X may not be associated with any
borderline substances, the third party manufacturer may also produce product
for the less reputable Company Y on the same equipment. Unless the equipment
is scrupulously cleaned between manufacturing runs, and batches are tested
using the appropriate limits of detection (see Section 14), it is inevitable that the
product range of Company Y will cross-contaminate that of Company X.

Page 27

HFL case study: A supplier of sports supplements approached HFL with a product
range to be tested. Initial contamination findings ran at a rate in excess of 30%. An
analysis of the manufacturing process (which was provided by a third party)
indicated that the quality control procedures were inadequate, in terms of both the
control of raw materials and also the management of cross contamination within
the manufacturing process.

Sources of Contamination

The supplier that had approached HFL did indeed use a range of testing
technologies within a quality control programme, drawn from the food industry and
primarily targeted at the verification of labelling. However, these measures were
inadequate for the sports supplement sector. The mere existence of quality control
procedures is not the answer. These procedures must also be appropriate.
The outcome? Discussions took place between the supplier and the third party
manufacturer in question, and a long-standing partnership was eventually
terminated. Selection of a new manufacturer followed, and the contamination
findings dropped to a negligible level.

9.4 Capsules and Tablets

Supplements in capsule and tablet form are manufactured on intricate pieces of
equipment that basically take a blend of powder or liquid bulk product and
apportion the blend into individual dosage units.
HFL case study: A manufacturer of supplements requested analysis on some
capsule samples. The results showed evidence for contamination with DHEA,
which was not used anywhere at the facility. Initial investigations involved analysis
of the bulk powder blend that had been used prior to encapsulation. These tests
showed no evidence for DHEA contamination. Further investigation was directed at
the encapsulation machine - this had recently been purchased by the
manufacturer. The equipment was, in fact, a reconditioned encapsulation machine
that was found to have been used several years previously to make DHEA products.
Analysis of dust from the filter unit showed contamination with DHEA.

Page 29

Despite the passage of time, reconditioning and thorough cleaning, this case study
underlines the significance of possible contamination that may be trapped inside
manufacturing equipment, and that could ultimately generate a positive finding for
an athlete.

Variation - Between and

Within Batches

10.

Variation Between and Within Batches

Summary
For banned substance testing the amount of product actually analysed is a tiny proportion
of the whole batch that is manufactured, and it is possible to get variation in levels of
contamination both between separate manufacturing batches, and even within a batch
itself if the product blending is inadequate.
Just because a sample passes the test does not provide a 100% guarantee that the entire
product is clean.
A batch is a quantity of a finished product or other material that is intended to have
uniform quality (within specified limits), and is produced within a single manufacturing
cycle.
Typically, a batch will weigh hundreds of kilograms, and yet the portion of this batch that
is tested for the presence of banned substances may only be a few grams (i.e. typically
less than 1 part in a million). So, it is probably not surprising that there may even be
variation in analytical results taken from different samples within the same batch i.e.
problems with homogeneity in a batch, or inconsistent mixing (albeit as measured by
extremely sensitive techniques).

Page 31

There is evidence to suggest that, at the levels of detection that are typically used within
the laboratory (see Section 14), analytical results between manufacturing batches may
vary i.e. the level of contamination may vary between batches.

GMP - Good Manufacturing

Practice

11.

GMP Good Manufacturing Practice (USA)

Summary
The GMP standard provides a reassurance with regard to the documentation of the
manufacturing process, but not a guarantee that product has even been tested for
substances that could give rise to a positive drugs test in professional sport (given the very
low levels of relevant contamination, and the specialised nature of the testing demanded).
What is GMP?
GMP refers to the Good Manufacturing Practice regulations promulgated in the USA by the
US Food and Drug Administration (FDA) under the authority of the Federal Food, Drug,
and Cosmetic Act. These regulations, which have the force of law, require that
manufacturers, processors, and packagers of drugs, blood, medical devices, and some
food, take proactive steps to ensure that their products are safe, pure, and effective. GMP
regulations require a quality approach to manufacturing, enabling companies to minimise
or eliminate instances of contamination, mix ups, and errors. This in turn, protects the
consumer from purchasing a product which is not effective or may even be dangerous.
Failure of firms to comply with GMP regulations can result in very serious consequences
including recall, seizure, fines and potentially jail for the most senior staff.
GMP regulations address issues including recordkeeping, personnel qualifications,
sanitation, cleanliness, equipment verification, process validation, and complaint
handling. However, most GMP requirements are very general and open-ended, allowing
each manufacturer to decide individually how to best implement the necessary controls.
This provides much flexibility, but also requires that the manufacturer interpret the
requirements in a manner which makes sense for each individual business.
The Regulation of Supplements
Currently, the FDA regulates dietary supplements under a different set of regulations than
those covering "conventional" foods and drug products (prescription and Over-theCounter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the
dietary supplement manufacturer is responsible for ensuring that a dietary supplement is
safe before it is marketed (see Section 21). The FDA is responsible for taking action
against any unsafe dietary supplement product after it reaches the market. Generally,
manufacturers do not need to register their products with the FDA nor get FDA approval
before producing or selling dietary supplements. Manufacturers must make sure that
product label information is truthful and not misleading.

The quality assurance of sport supplement products therefore requires highly specialised
testing.

Page 33

Is GMP an effective way of assuring that the product is free from contamination? Whilst
the requirements of GMP will undoubtedly provide a good degree of confidence in the
integrity of the manufacturing process, it would not specifically address the particular
issue of potential contamination of sports supplements by low concentrations of WADA
prohibited substances. Issues of safety are typically focused at concentrations of
contaminants at levels which are 100 10,000 times higher than those that would trigger
a positive WADA test in urine.

The WADA Test

12.

The WADA Test

Summary
The WADA analytical testing that is undertaken by its accredited laboratories is not
appropriate for supplement testing. WADA testing focuses on urine or blood samples, and
therefore takes account of residual substances after passing through the body. Supplements,
on the other hand, can take many forms (but none of them urine or blood!), and these
products are tested prior to any metabolism by an athletes body.
The WADA Test refers to the analysis of blood or urine samples taken from athletes, and the
identification of substances that are referred to in the WADA Prohibited List.
From time to time, the World Anti Doping Agency will update a published list of substances
that are considered to be prohibited within elite sport. Blood and/or urine samples are taken
from professional athletes on a regular basis, and these samples are subjected to testing by
a limited number of accredited laboratories across the world (currently 33). These labs are
www.wada-ama.org). Any evidence for the presence of a
listed on the WADA web site (w
prohibited substance will result in violation of the WADA Code. The WADA Prohibited List is
also available for download from the above web site.
The Prohibited List typically specifies generic categories of substances (e.g. Anabolic
Androgenic Steroids), and then provides a list of specific examples from within each category
(e.g. 1-androstenedione). Sections on Anabolic Agents, Hormones and related Substances
and Stimulants, etc. finish with a general statement relating to other such substances:
other substances with a similar chemical structure or similar biological effect(s)
The WADA Prohibited List is therefore open-ended it is not a definitive list of prohibited
substances. There is potentially an infinite list of substances that would meet the generic
criteria that are selected by WADA, and their accredited laboratories are challenged to
identify any new designer substances that find their way into sport (e.g. the now infamous
tetrahydrogestrinone or THG).
It is therefore not possible to test supplements for everything on the WADA Prohibited List.
Neither is it appropriate, referring as it does to substances that must not be found in blood
and urine, rather than what is eaten or drunk. The body works on whatever enters the body
to break it down, extract what is good and get rid of what is bad the process of metabolism.
For the testing of supplements, therefore, it is important to test for substances that could
generate a positive WADA test after metabolism. The list of substances for supplement
testing is therefore subtly different from the WADA Prohibited List.

In addition, it would be impossible to detect low levels of many steroid contaminants using an
administration technique as some steroids are converted to other steroids within the body;
hence the parent compound would not be identified. For example, androstenedione, DHEA
and androstenediol are all converted in the body to testosterone. Hence urine testing may
show increases in testosterone levels but the actual contaminant that caused the increase
would not be determined.

Page 35

Equally it is not possible to test a supplement by administering it to an individual and

collecting and analysing urine samples using a WADA test for urine. Steroid metabolism can
vary considerably between individuals the amounts of steroids detected in urine can be
highly variable from person to person. Low levels of steroid contaminants in a supplement
product may not necessarily give rise to a positive urine test in every individual.

ISO 17025

13.

ISO 17025

Summary
As testing for inadvertent contamination is aiming to prove the absence of a substance
(rather than its presence), it is essential that tests comply with the international standard
ISO 17025 specifying the range of substances for which there are proven (validated) tests
and the appropriate detection limit for each.
Otherwise, a negative analytical result may merely indicate that the testing method was
simply not good enough to find the substance.
Quality accredited to ISO 17025 - Why so important to the Supplement Industry?
INFORMED-SPORT is committed to the highest standards of quality, compliance and
service in all aspects of its work. All testing is conducted using methods validated to ISO
17025 (an internationally recognised analytical testing standard).
The ISO 17025 standard demands that testing is validated for each substance for each
matrix (i.e. powder, liquid, capsule, tablet, bar), at each of the specified detection limits. Only
this will ensure that the analytical methods are adequately robust suitable for challenge
in the Courts. In the absence of this standard, the analytical work is of reduced value.
The Main Objectives of ISO 17025 are to:

assure the customer that the testing constantly meets their expectations in terms
of coverage of named contaminants, in named matrices, and to specified detection
limits

deliver a quality service time and time again to a legally defensible standard

assure the customer that they are dealing with a high integrity service provider,
working to the highest professional standard

the screen has been assessed to internationally recognised standards, and has
been shown to be robust and capable of meeting the stated detection levels on a
routine basis

strict control measures are in place when every batch of samples is tested

all of these measures are subjected to external audit on an annual basis, as well
as internal audits throughout the year

Page 37

An ISO 17025 accredited screen indicates that:

Standard Lab Testing and

Limits of Detection

Chapter 3: Lab Testing - The Solution

14.

Standard Lab Testing and Limits of Detection

Summary
It is possible to put appropriate testing in place as part of a Quality Assurance/Quality
Control process, but the tests are very specialised and there are relatively few
laboratories around the world that are capable of undertaking such testing.
It should be noted that the relevant limits of detection for analysis are considerably
smaller than those conventionally addressed by quality control procedures in either the
food or pharmaceutical sectors. It is generally considered across the WADA community
that the relevant levels for detection are measured in parts per billion (i.e. nanograms per
gram or nanograms per millilitre); both the food and pharmaceutical sectors would
consider parts per million as being trace levels i.e. one thousand times less sensitive.
In terms of sensitivity, one part per billion can be viewed as roughly equivalent to
dissolving a teaspoon of a substance into an Olympic-sized swimming pool.and still
being able to detect it!
Note that the concentration levels expressed in terms of a standard unit (i.e. a gram in this
case) are actually not directly relevant here; it is the total intake within a daily dose that is
important which may vary from a few grams to perhaps over 200 grams per day. The
more one takes, the more significant are lower concentrations of contaminants. It should
also be noted that athletes do not necessarily adhere to the recommended daily doses
typically increasing recommended dosing intake to enhance the impact.
This has profound implications on quality assurance programmes, demanding
sensitivities in quality control processes that meet these exacting limits of detection. It is
highly unlikely that the manufacturing facilities used by supplement companies will have
the capability to undertake such trace analysis, concentrating instead on the verification
of label listings of specified contents. Indeed, pharmaceutical companies themselves are
generally unable to meet the requirements of testing for trace levels of substances that
appear on the WADA prohibited list.

Page 39

As a consequence, it is generally necessary to out-source the testing of raw ingredients

and finished products as part of a quality assurance programme. Coupled with this
testing, it is possible to put practices in place that will absolutely limit the opportunity for
contamination as part of a sourcing policy for raw materials, and the definition of standard
manufacturing practices.

Banned Substance Screening

15.

Banned Substance Screening

Summary
Testing methods can be developed for a specified sub-set of the WADA Prohibited List.
However, it is essential that these methods are explicitly linked to defined:
-

substances
limit of detection for each substance
type of supplement (powder, liquid, capsule, tablet or bar)

Which Substances to Look For?

As has already been discussed, the banned substances subject to testing in
supplements refers to the WADA prohibited list (see Section 2). As the WADA prohibited
list is open-ended in nature, laboratories must draw upon their experience to trim the list
to be relevant to the industry. If too large, then the accreditation costs increase
significantly (noting the importance of ISO17025 see Section 13). The tests becomes
unwieldy to screen for thousands of compounds, many of which may never go near a
supplement. If too small, and the risk of a relevant contaminant generating a positive
urine or blood test escalates. A combination of judgment and experience is therefore the
key.
Limits of Detection?
The list of substances alone is not enough; each substance must have a detection limit
separately identified. Without this, there is no threshold against which a positive or
negative finding can be declared. If the limit of detection of substance X is 1 g, then
anything less than 1g will not be detected. In the case of supplement testing, the accepted
detection limit is 100,000,000 times smaller than 1 g (see Section 16)!
Powder, Liquid, Capsule, Tablet or Bar?

Page 41

The detection limit of any given method for analysis is likely to vary according to the type
of product (matrix) that is being tested. So, each substance must have an associated
detection limit for each of the typical matrices powder, liquid, tablet or bar.

How Appropriate is the 10 ng/g

Detection Level?

16.

How Appropriate is the 10 ng/g Detection Level?

Summary
Increasingly sensitive techniques can be developed to find contamination at increasingly
tiny levels. But how relevant is it to test at such low levels?
Generally, detection limits of 10 nanograms per gram (10 ng/g) have been shown to be
appropriate to provide adequate reassurance to athletes and manufacturers.
In supplement testing the detection limit for many substances on the Prohibited List
(typically steroids) is 10 nanograms per gram (10 ng/g; or 10 parts per billion - ppb). This
is genuinely a tiny amount of contamination!
Foodstuffs more generally are submitted for analytical tests with sensitivities that are
many times higher than this, as part of their routine quality control process. Many of these
tests are measured in parts per million (ppm) at best. So, why so sensitive for
supplements?
The detection limit of 10 ng/g is driven by the fact that the anti-doping laboratories that
are accredited by WADA routinely analyse blood and urine samples with a sensitivity for
steroids at just 2 ng/ml. In setting these incredibly sensitive testing limits, WADA is not
suggesting that such levels will have any impact on the performance of an individual, but
rather that there is no place for steroids in blood and urine at this level. Finding such a
trace amount in the blood or urine may be indicative of a much higher dose taken some
days previously. So, a urine finding of some steroids at a concentration of 2 ng/ml is
enough to prosecute an athlete.
The key issue is to determine the level of contamination that could give rise to such a trace
finding in blood and/or urine. The answer can only be found by what are effectively mini
clinical trials feeding volunteers products containing various doses of steroid or
stimulant contamination, and then analysing blood and/or urine samples at various time
intervals after administration.

Page 43

HFL has conducted such trials using the nandrolone precursor, norandrostenedione, as
the contaminant. It was found that at a total dose of 10 micrograms of contaminant in
5 g of product generated a positive drugs test in urine in 100% of the volunteers. This
contamination level was the equivalent of just 0.0002%.

How Appropriate is the 10 ng/g

Detection Level?

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This research was funded by Lucozad e Sport/GSK

Given that some of the urine test results in the above study were 14 times higher than the
WADA threshold for a positive urine test, one could try to estimate the amount of
contamination that would guarantee NOT to show a positive urine test. This is likely to be
less than even 1 microgram somewhere around the 0.1 microgram level ( = 100 ng).
So, if the contamination level of steroid within a supplement is 10 ng/g, then a daily dose
of just 10 g of the supplement product could contain 1 microgram of steroid, and
potentially give rise to a positive test.

Page 45

Would this kind of contamination level have any impact on the individuals athletic
performance? Absolutely not. But the athlete may be fined and/or receive a ban an
expensive consequence of inadvertent contamination of product.

Why Mass Spectrometry?

17.

Why Mass Spectrometry?

Summary
Mass spectrometry is the method of choice in the world of doping control. If samples are
prepared in the correct way, the instrument sensitivity is exceptional. Since labs are
typically trying to prove the absence of any prohibited substance, then this sensitivity is
essential..
Further, the legal systems around the world recognise the integrity of analytical data
produced by mass spectrometry. Rules for the interpretation of data are well established,
and have benefited from regular legal scrutiny.

A mass spectrometer, in its simplest form, is made up of two parts:

1.

A method of breaking up the molecules within a sample (e.g. heating, or electrical

discharge)

2.

A mechanism for measuring the mass of the fragments, and plotting the intensity of
any mass peak against that mass (i.e. generation of a mass spectrum).

Each molecule will break up or fragment in a characteristic manner (dependent upon the
method used) commonly called the fingerprint of that molecule. The resultant
spectrum is then the accumulation of all of those characteristic fingerprints. A
combination of software and scientific experience is then used to interpret the mass
spectrum and to determine if any prohibited substance is present.

Page 47

Mass spectrometry is used in every industry where accurate measurement of trace

components is required (food, pharmaceuticals, toxicology, clinical diagnostics, forensics,
petrochemicals, etc.) and is considered the bench mark technique for absolute
identification.

Limitations / Lack of
Guarantees

18.

Limitations / Lack of Guarantees

Summary
It is not possible to provide a 100% guarantee that any supplement is totally free of
contamination. Analysis can only indicate that no contamination could be found within the
sample that was analysed, for specified substances, at defined limits of detection.
As such, banned substance testing on a portion of a batch should be taken to be an
assessment of the likelihood of contamination in the entire batch.
It becomes a matter of risk reduction better to be taking a supplement that has been
subjected to credible testing and appropriate manufacturing controls, rather than none at
all.

(i)

By necessity, the WADA listing is not specific in many cases, identifying broad
types of prohibited substances (e.g. steroids) rather than naming a definitive
list of such compounds. Given the effectively infinite possibility of modifying
the basic structures of these generic types (e.g. the designer steroid THG), it
is clearly not possible to test for all prohibited substances.

(ii)

Whatever analytical technique is applied within the analysis, there is a finite

limit of detection below which the technique will not be effective. This limit of
detection will vary from substance to substance and from lab to lab.

(iii)

Whatever statistics are used, the sampling process for supplement testing is
inherently inadequate i.e. there is always some of the product that is not
tested, and it may be this sample that contains the contaminant. This is
particularly relevant for solid product (powders, capsules, tablets, bars etc.)
where the mixing of raw materials is likely to be variable. One might
anticipate more effective mixing in the case of liquids, so that the sample
analysed will be more representative of the whole.

Page 49

It is clear that all stakeholders would like to identify a testing regimen that will guarantee
that supplements are free from any substances that could give rise to a positive test
against the WADA prohibited list. This is not possible for three key reasons:

Why so few Capable Labs for

Supplement Testing?

19.

Why So Few Capable Labs for Supplement Testing?

Summary
Detection of substances relating to the Prohibited List demands a very high level of
specialisation largely limited to those labs that are active within doping-control in sport.
The development of methods to test products for the particular substances in question,
and at the tiny detection limits that are essential for effective quality control, demands:
a.

Considerable experience in the field of doping control

b.

Considerable investment in the necessary equipment

c.

Considerable experience in testing supplements of all types

d.

Quality systems and associated procedures that assure that supplement

analyses can be defended through the legal systems anywhere in the world
(ISO 17025 is an essential standard)

The labs that are accredited by WADA will satisfy some, but not all, of the above (certainly
(a) and (b)). WADA, however, has banned its labs from undertaking quality assurance
testing on behalf of supplement companies.

Page 51

There are very few other labs that will satisfy any of these conditions.

GMP - Good Manufacturing

Practice

Chapter 4: Regulations
20.

GMP Good Manufacturing Practice (USA)

Summary
The GMP standard provides a reassurance with regard to the documentation of the
manufacturing process, but not a guarantee that product has even been tested for
substances that could give rise to a positive drugs test (given the very low levels of
relevant contamination, and the specialised nature of testing demanded).
What is GMP?
GMP refers to the Good Manufacturing Practice regulations promulgated in the USA by the
US Food and Drug Administration (FDA) under the authority of the Federal Food, Drug, and
Cosmetic Act. These regulations, which have the force of law, require that manufacturers,
processors, and packagers of drugs, blood, medical devices, and some food, take proactive
steps to ensure that their products are safe, pure, and effective. GMP regulations require a
quality approach to manufacturing, enabling companies to minimise or eliminate instances
of contamination, mix ups, and errors. This in turn, protects the consumer from purchasing
a product which is not effective or may even be dangerous. Failure of firms to comply with
GMP regulations can result in very serious consequences including recall, seizure, fines and
potentially jail for the most senior staff.
GMP regulations address issues including recordkeeping, personnel qualifications,
sanitation, cleanliness, equipment verification, process validation, and complaint handling.
However, most GMP requirements are very general and open-ended, allowing each
manufacturer to decide individually how to best implement the necessary controls. This
provides much flexibility, but also requires that the manufacturer interpret the requirements
in a manner which makes sense for each individual business.
The Regulation of Supplements
Currently, the FDA regulates dietary supplements under a different set of regulations than
those covering "conventional" foods and drug products (prescription and Over-the-Counter).
Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary
supplement manufacturer is responsible for ensuring that a dietary supplement is safe
before it is marketed. The FDA is responsible for taking action against any unsafe dietary
supplement product after it reaches the market. Generally, manufacturers do not need to
register their products with the FDA nor get FDA approval before producing or selling dietary
supplements. Manufacturers must make sure that product label information is truthful and
not misleading.
Is GMP an effective way of assuring that the product is free from contamination? Whilst the
requirements of GMP will undoubtedly provide a degree of confidence in the integrity of the
manufacturing process, it would not specifically address the particular issue of potential
contamination of sports supplements by low concentrations of WADA prohibited substances.
Issues of safety are typically focused at concentrations of contaminants at levels which are
100 10,000 times higher than those that would trigger a positive WADA test in urine.

Page 53

The quality assurance of these sports products therefore requires highly specialised testing.

DSHEA

21.

DSHEA (USA)

Summary
DSHEA represents legislation in the USA to protect the consumer against harmful
consequences of taking a supplement.
As with GMP, DSHEA is not a guarantee that product has even been tested for substances
that could give rise to a positive drugs test (given the very low levels of relevant
contamination, and the specialised nature of testing demanded).
For decades, the Food and Drug Administration regulated dietary supplements as foods,
in most circumstances, to ensure that they were safe and wholesome, and that their
labeling was truthful and not misleading. An important facet of ensuring safety was FDA's
evaluation of the safety of all new ingredients, including those used in dietary
supplements, under the 1958 Food Additive Amendments to the Federal Food, Drug, and
Cosmetic Act (FD&C Act). However, with passage of the Dietary Supplement Health and
Education Act of 1994 (DSHEA), Congress amended the FD&C Act to include several
provisions that apply only to dietary supplements and dietary ingredients of dietary
supplements. As a result of these provisions, dietary ingredients used in dietary
supplements are no longer subjected to the premarket safety evaluations required of
other new food ingredients or for new uses of old food ingredients. They must, however,
meet the requirements of other safety provisions.
Signed by President Clinton on October 25, 1994, the DSHEA acknowledges that millions
of consumers believe dietary supplements may help to augment daily diets and provide
health benefits. Congress's intent in enacting the DSHEA was to meet the concerns of
consumers and manufacturers to help ensure that safe and appropriately labeled
products remain available to those who want to use them. In the findings associated with
the DSHEA, Congress stated that there may be a positive relationship between sound
dietary practice and good health and that, although further scientific research is needed,
there may be a connection between dietary supplement use, reduced health-care
expenses, and disease prevention.

Page 55

The provisions of DSHEA define dietary supplements and dietary ingredients; establish a
new framework for assuring safety; outline guidelines for literature displayed where
supplements are sold; provide for use of claims and nutritional support statements;
require ingredient and nutrition labeling; and grant FDA the authority to establish good
manufacturing practice (GMP) regulations. The law also requires formation of an
executive level Commission on Dietary Supplement Labels and an Office of Dietary
Supplements within the National Institutes of Health.

FDA

22.

FDA (USA)

Summary
The FDA regulates dietary supplements in the USA under a different set of regulations
than those covering "conventional" foods and drug products (prescription and Over-theCounter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the
dietary supplement manufacturer is responsible for ensuring that a dietary supplement is
safe before it is marketed. The FDA is responsible for taking action against any unsafe
dietary supplement product after it reaches the market. Generally, manufacturers do not
need to register their products with the FDA nor get FDA approval before producing or
selling dietary supplements.Manufacturers must make sure that product label
information is truthful and not misleading.
The FDA's post-marketing responsibilities include monitoring safety e.g. voluntary dietary
supplement adverse event reporting and product information, such as labeling, claims,
package inserts, and accompanying literature. The Federal Trade Commission regulates
dietary supplement advertising.
What is the FDA's role in regulating dietary supplements versus the manufacturer's
responsibility for marketing them?
In October 1994, the Dietary Supplement Health and Education Act (DSHEA) was signed
into law by President Clinton. Before this time, dietary supplements were subjected to the
same regulatory requirements as were other foods. This new law, which amended the
Federal Food, Drug, and Cosmetic Act, created a new regulatory framework for the safety
and labeling of dietary supplements.
Under DSHEA, a company is responsible for determining that the dietary supplements it
manufactures or distributes are safe and that any representations or claims made about
them are substantiated by adequate evidence to show that they are not false or
misleading. This means that dietary supplements do not need approval from FDA before
they are marketed. Except in the case of a new dietary ingredient, where pre-market
review for safety data and other information is required by law, a company does not have
to provide the FDA with the evidence it relies on to substantiate safety or effectiveness
before or after it markets its products.

Page 57

Also, manufacturers do not need to register themselves nor their dietary supplement
products with the FDA before producing or selling them. Currently, there are no FDA
regulations that are specific to dietary supplements that establish a minimum standard of
practice for manufacturing dietary supplements. However, regulations on good
manufacturing practice (GMP) focus on practices that ensure the identity, purity, quality,
strength and composition of dietary supplements.

HFL Sport Science

Newmarket Road, Fordham, Cambridgeshire CB7 5WW, UK
Tel: +44 (0) 1638 720500 | Fax: +44 (0) 1638 724200
E-mail: info@hfl.co.uk | www.hfl.co.uk