What is HFL Sport Science?

HFL Sport Science is a world-renowned sports doping control and research laboratory, with over 49 years of expertise in anti-doping in sport. HFL has published over 300 scientific papers on methods for detection of trace levels of substances that are prohibited in sport and has over 450 man-years of research into doping control.

HFL's testing capability for supplements/ingredients includes the analysis of over 146 substances that are considered prohibited in sport and substances that pose a threat in respect of product contamination. These substances include anabolic agents, stimulants, beta-2-agonists, recreational drugs, masking agents, etc.

Testing methods used for a range of substances from these categories have been validated and accredited to the ISO 17025 standard in supplements/ingredients, in each of the relevant matrices: powders, bars, liquids, capsules, tablets, etc., with defined method capabilities/reporting limits. HFL has held this accreditation since 2003, granted by UKAS (United Kingdom Acceditation Service, see www.ukas.com: laboratory no. 1187).

Other prohibited substances tested for are not explicitly covered within the ISO 17025 accreditation schedule for supplements/ingredients; however, similar analytical methods and quality control procedures are employed to those used for the analysis of the accredited compounds.

As a doping control laboratory, HFL works directly with sports authorities, national anti-doping organizations and national governing bodies worldwide. Providing advice and expert support, HFL is able to represent the views of partners and assist in the shaping of future regulation.

Is HFL a WADA (World Anti-Doping Agency) accredited laboratory?

HFL was only the 34th laboratory in the world to be accredited by WADA/IOC. Experience within this elite environment has provided a unique understanding of the regulatory environment from a laboratory perspective.

WADA now prohibits any of its accredited labs from providing testing services to supplement companies. HFL voluntarily withdrew its WADA accreditation in 2007, ensuring that a high integrity service could be provided to address issues of quality assurance within the trade.

HFL remains part of the WADA community, undertaking WADA-funded research contracts into drug detection in sport.

How long has HFL been testing for prohibited substances in supplements?

HFL has been testing for prohibited substances in sport since 2002 and has tested over 30,000 product/ingredient samples during that time. HFL is currently testing over 5,000 samples per year for over 120 nutrition companies worldwide.

Is HFL an accredited laboratory?

HFL is accredited to the ISO 17025 standard for a broad range of analytical testing, including the analysis of nutritional supplements/ingredients for banned substances. HFL ahs held this accreditation for supplement/ingredient testing since 2003, grant by UKAS (United Kingdom Acceditation Service, see www.ukas.com: laboratory no. 1187). This accreditation covers all relevant matrices: powders, bars, liquids, capsules, tablets, etc., and all tests have defined method capabilities/reporting limits.

What is ISO 17025 accreditation and why is it important?

ISO 17025 is the key standard for an analytical laboratory. It provides absolute confidence that if contamination exists above the defined limit of detection, then it will be identified and called "positive".

Laboratories that do not meet this standard may call a "negative" simply because they are unable to find the contamination, NOT because it is absent. Their techniques may be wholly inadequate.

Analysis is of no value unless it meets the exacting requirements of the various regulating bodies.

HFL understands the importance of integrity, and analytical methods for supplement analysis meet the requirements of:

• ISO 17025 (international standard for analytical laboratories)
• GLP (Good Laboratory Practice)
• GMP (Good Manufacturing Practice)

Results are therefore dependable, and will withstand scrutiny in court, in any jurisdiction around the world.

Which substances does INFORMED-CHOICE screen for?

HFL's testing capability for supplements/ingredients includes the analysis of over 146 substances that are considered prohibited in sport and substances that pose a threat in respect of product contamination. These substances include drugs of abuse, anabolic agents, stimulants, beta-2-agonists, masking agents, etc.

Does INFORMED-CHOICE test for everything on the WADA Prohibited List?

The WADA Prohibited List is specifically designed for urine analysis and refers to substances found in urine (i.e. after the drug has passed through the body). The body may convert some or all of the drug to other compounds as it passes through the body.

Not all of the substances on the WADA prohibited list are able to be present in a supplement product.

Additionally, the WADA list of prohibited substances is not definitive. By necessity the list identifies classes of prohibited substances, such as anabolic agents and related substances and prohibited methods only, rather than publishing a full list of substances. When analyzing a supplement product for contaminants the Prohibited List is unable to act as a checklist for all prohibited substances against which products should be screened — supplement analysis cannot guard against contamination using untried, untested and unknown designer drugs.

Although it is not possible to test for all substances on the WADA list, HFL's experience in testing over 30,000 samples and its close relationship with the WADA community, it has been possible to identify a list that will maintain product integrity.

What are the limits of detection needed for banned substance screening in supplements?

The relevant limits of detection for analysis at the manufacturing stage are much smaller than those conventionally addressed by "standard" quality control procedures in the supplements industry.

In general, the necessary levels of detection used in anti-doping screening for athletes are measured at the part per billion level (i.e. nanogram per ml). However, the supplement manufacturing industry would generally use parts per million (i.e. microgram per ml or microgram per gram) for detection of general contaminants for quality control purposes. This means that an athlete's urine or blood test is much more sensitive and is more likely to detect the presence of a prohibited substance than when a supplement is tested during the manufacturing process using conventional methods, with parts per million detection limits.

The concentration levels expressed in terms of a standard unit (i.e. a gram or ml in this case) are not as relevant as the total intake of a supplement within a daily dose, which may vary from a few grams to perhaps over 100 grams depending on the product. For example, an athlete would consume a greater volume of the supplement taking one serving of creatine than they would in taking one vitamin tablet. The more one takes, the higher the risk of having traces of a prohibited contaminant in your system.

The levels and limits of analytical detection have profound implications on supplement quality assurance program, demanding testing sensitivities that can only be met by highly specialized analytical laboratories, working to ISO 17025 standards. It is extremely uncommon for the manufacturing facilities used by supplement companies to have the capability to undertake such trace analysis, concentrating instead on the verification of label listings of specified contents. In most cases, supplement manufacturers will test products for other contaminants such as toxic substances, heavy metals, etc. and not necessarily for those substances that may give rise to a positive drug test for a professional athlete, such as nandrolone or ephedrine.

What detection levels should supplements be tested at?

The labs that are accredited by the World Anti-Doping Agency (WADA) to screen athletes blood and urine samples use techniques that are very sensitive — with capability to detect banned substances down to 2 nanograms per milliliter of urine (i.e. 2 parts of substance in 1,000,000,000 parts of urine).

Doses (total intake) of low levels of banned substance (in the microgram range) can generate such levels in an athlete's urine. As a result, supplements need to be tested for the presence of banned substances at sensitivity levels in the nanogram per gram or nanogram per milliliter range (as an athlete may ingest many tens of grams of supplement). Such low detection levels are beyond the "normal" QC requirements of pharmaceutical and food industries.

In supplements tested through HFL and the INFORMED-CHOICE program, the Level of Detection is 10ng/g for steroids and 100ng/g for stimulants.

What list of substances should be looked for within a supplement testing program?

Since no lab can test against the whole WADA List (see here), a relevant sub-set of compounds must be defined. The list of compounds screened for in the INFORMED-CHOICE Standard uses the knowledge gained by the WADA experienced lab with the most exposure to supplement testing — HFL. From this knowledge of testing over 30,000 samples, and close relationship with the WADA community, it has been possible to identify a list that will maintain product integrity.

HFL screens for over 146 substances listed on the WADA and other prohibited substances lists.

Is there a link between WADA testing and ISO 17025?

WADA screening is specifically designed for urine and blood analysis. There is no such thing as a 'WADA test' for anything else. However, WADA testing for urine/blood is carried out to ISO 17025 standards. ISO 17025 is an international analytical capability standard - any tests that are accredited to this standard have been developed and validated in line with international requirements and are regulated by external authorities.

The testing lab used by INFORMED-CHOICE (HFL Sport Science) is a WADA-experienced lab that performs testing of supplements to the same international analytical standard (ISO 17025) that WADA urine/blood testing is carried out to.

What are the important things to look for within a testing & certification program?

1. That testing methods accredited to ISO 17025 (an international analytical testing standard)
2. That accredited methods are used for all of the relevant formulations (liquids, powders, tablets, capsules, bars, etc.)
3. That testing is performed by a credible WADA-experienced laboratory (with proven capability)
4. A thorough audit of the manufacturing and supply chain quality systems to ensure the products are manufactured to strict GMP standards.
5. That the program is committed to education and training
6. That the program is committed to underpinning research in supplements and sport

Why do supplements need to be tested?

While it's not a major issue for most people, it is clear that some supplements (our evidence suggests 10-25%) suffer from low levels of contamination from steroids and stimulants. Sports supplements are frequently blamed by elite athletes when they test positive in a urine/blood drug test. Historically, high sensitivity testing of supplements has indicated that a significant proportion of these contain traces of substances that are considered prohibited by WADA. This has somewhat reinforced the athlete's claims about the origins of their positive urine/blood tests.

Although the contamination may be present at a very low concentration, the levels may be sufficient to generate a positive drug test in elite sport — in other words; the athlete’s urine sample may show evidence of taking steroids or banned stimulants.

Only those products that have been tested using appropriately accredited methods (ISO 17025), at the appropriate detection limits for the relevant substances, should be considered suitable for regular "drug-free" use.

Is my supplement safer than others?

Athletes would like the sports authorities to find an analytical test that could guarantee that a particular supplement is free from any substances that could give rise to a positive urine test. This is not possible for a number of reasons:

• The WADA list of prohibited substances is not definitive. By necessity the list identifies classes of Prohibited Substances, such as anabolic agents and related substances and Prohibited Methods only, rather than publishing a full list of substances. When analyzing a supplement product for contaminants the Prohibited List is unable to act as a check list for all Prohibited Substances against which products should be screened — supplement analysis cannot guard against contamination using untried, untested and unknown designer drugs.
• The sampling process for supplement testing is inherently inadequate as there will always be a large part of the product that is not analyzed and it may be this part of the sample that contains the contaminant. This is particularly relevant for solid products such as powders, capsules, tablets and bars where the mixing of raw materials could potentially be variable (meaning that the contaminant may not be spread homogeneously throughout the whole product). More effective mixing is possible in the case of liquids, which means that the sample analyzed is most likely to be representative of the whole product.

However, by screening a portion of a batch of product for the presence of banned substances using a highly sensitive and specialized test, supplement manufacturers can be alerted at an early stage to any possible trace contamination in the batch, allowing them to identify and eliminate the source. By carrying out this additional quality control measure the manufacturer can provide some assurance to an athlete that they would not be taking an undue risk when using their product.

Who has responsibility for testing the supplements?

Responsibility for the quality of a product rests entirely with the manufacturer and reputable manufacturers do everything in their power to keep their supplements free of contamination. However, even trace levels of contamination are potentially important and require a sensitivity of testing beyond most quality control systems.

The INFORMED-CHOICE standard provides both manufacturers and consumers with a defined specification based on the very best scientific expertise to both manufacturers and consumers and reassurance that products bearing an INFORMED-CHOICE logo can be trusted.

Our testing indicates that contamination rates are considerably less than 1% for companies who participate in ongoing testing as part of their quality assurance program.

What are the prohibited substance lists?

These are listings of substances and technologies that are considered banned (by WADA — the World Anti-Doping Agency) and major sporting leagues for elite athletes who are subjected to regular doping control testing. The lists (updated annually by WADA and sporting leagues) contain specific substances, as well as many generic terms that define whole classes of substances and chemical or biological methods that could be used to cheat in sport.

To see the WADA Prohibited List, go to: www.wada-ama.org and click on the Prohibited List tab.

INFORMED-CHOICE tests products and/or its ingredients for over 146 prohibited substance in sport, including those listed by WADA, the NFL, MLB, NBA, NHL, PGA, LPGA, WTA and NCAA.

Are prohibited substances illegal for sale?

Although many of the substances listed on a prohibited substance list are illegal for sale (e.g. cocaine, ecstasy), there are also many that are prescription drugs or legally available for sale over the counter.

It's important to understand that just because it’s banned by sport does not mean it’s banned for sale. Legal supplements may be prohibited by sport if the governing body considers that the substance provides an unfair advantage in training or competition.

DHEA is an example of a popular supplement that is widely manufactured and sold in many specialty nutrition stores. Although this product/ingredient is legal, it is prohibited by WADA and most sporting leagues as it is considered a performance enhancing steroid.

Athlete's must do their homework and research each ingredient to ensure the product does not contain a banned substance under its chemical name or other trade names.

What is a steroid?

Steroids are a class of fat soluble compounds with a basic 17-carbon atom structure, arranged into 4 rings. Steroids can be natural or synthetic, and have specific functions in the body. Examples of natural steroids include pro-hormones (such as testosterone, androstenedione and DHEA) which the body converts to an anabolic steroid.

The most common prohibited steroids found in supplements are DHEA and androstenedione.

What is a stimulant?

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 and soda), as well as over the counter medicines, through to recreational drugs such as amphetamine, cocaine, etc. Stimulants can also be used to suppress appetite.

The most common prohibited stimulants found in supplements are ephedrine and methylephedrine.

What does cGMP Certification mean?

"cGMP" stands for Current Good Manufacturing Practice. This is a quality control guideline for the manufacturing of dietary supplements, pharmaceutical ingredients/products, foods etc.

In 2007 the FDA published the cGMP Final Rule for dietary supplements known as 21 CFR 111. Under the Final Rule, all manufacturers of dietary supplements must comply with these new regulations set by the FDA to ensure proper quality controls are in place.

Although the FDA doesn't recognize any 3rd party certification program, manufacturers of dietary supplements will work with independent organizations/agencies to obtain cGMP Certification to ensure their facility meets the new FDA cGMP guidelines. Audits are typically performed at least once per year to ensure these standards have been met.

CGMP Final Rule (from www.fda.gov):

• The U.S. Food and Drug Administration issued the final rule establishing regulations to require current good manufacturing practices (CGMPs) for dietary supplements.
• The current good manufacturing practices (cGMPs) final rule will require that proper controls are in place for dietary supplements so that they are processed in a consistent manner, and meet quality standards.
• The cGMPs apply to all domestic and foreign companies that manufacture, package, label or hold dietary supplements, including those involved with the activities of testing, quality control, packaging and labeling, and distributing them in the U.S.
• The rule establishes cGMPs for industry-wide use that are necessary to require that dietary supplements are manufactured consistently as to identity, purity, strength, and composition.
• The requirements include provisions related to:
  • the design and construction of physical plants that facilitate maintenance,
  • cleaning,
  • proper manufacturing operations,
  • quality control procedures,
  • testing final product or incoming and in-process materials,
  • handling consumer complaints, and
  • maintaining records.
• To limit any disruption for dietary supplements produced by small businesses, the rule has a staggered three-year phase-in for small businesses. The final cGMPs is effective in June 2008 for large companies. Companies with less than 500 employees have until June 2009 and companies with fewer than 20 employees have until June 2010 to comply with the regulations.

Does GMP certification prevent banned substance contamination?

No. This is often a misperception that if a company is GMP certified, the product must have been tested and free of banned substances. Although GMP certification is important, it only certifies that the manufacturer has the necessary manufacturing documentation, processes and controls in place to ensure product quality, traceability and competence.

It does not cover the presence or absence of substances such as steroids and banned stimulants.

GMP certification does not require the product to be tested for banned substances at an ISO17025 accredited laboratory such as HFL Sport Science. Because of this, inadvertent contamination from banned substances is still possible even in GMP Certified manufacturing facilities.

If a banned substance is not listed on the label, does this mean it is safe?

This is a common mistake that has resulted in the suspension of many elite athletes. Prohibited substances may appear on the label, but under a different name than what is on the list. For example, a product may contain an ingredient called geranamine. This word doesn't appear on the WADA list, but its chemical came does, methylhexaneamine. In this case an athlete could unknowingly use a supplement they believe is safe only to fail a drug test because they did not do their homework.

It is very important to research each ingredient and that can be easily done using your favorite website search engine. If you still are unsure you can contact INFORMED-CHOICE directly and we can help answer any questions you may have.

Additionally, some raw materials may have low levels of cross-contamination or naturally occurring steroidal compounds which are found in some herbal ingredients.

It's recommended to only use products that have been tested for banned substances using ISO17025 accredited methods.

Does banned substance testing mean that the supplement has proven efficacy?

Certification with Informed-Choice means that the manufacturing standards applied during production of the registered product have been rigorously assessed and that the product is not contaminated with substances considered prohibited by WADA. This kind of certification does not, however, give any indication as to how efficacious the product is. It is always recommended that athletes speak with a nutritional advisor when choosing a supplement product so that they can ensure that the chosen product is suitable from an efficacy point of view.

How can supplements be inadvertently contaminated?

In most cases the presence of a prohibited substance in a supplement product arises from inadvertent contamination. Such contamination can come from a number of sources including:

• Cross-contamination within the manufacturing process (e.g. if equipment isn't cleaned thoroughly between batches)
• Impurities within the raw material (particularly herbals)
• Cross-contamination between raw materials within the supply chain

What is required to test at levels in the nanogram per gram range?

Only highly specialized laboratories are capable of screening supplement products at such low detection levels. Rigorously developed techniques are used (e.g. liquid and gas chromatography) coupled with mass spectrometric detection.

Supplement companies typically do not have such technologies in house as part of their general Quality Control testing, so sub-contract laboratories must be used.

These sub-contract labs must have undergone accreditation by the World Anti-Doping Agency if they are to have the necessary credibility and must use ISO 17025 accredited methods. INFORMED-CHOICE uses HFL as its analytical laboratory — which meets all of these criteria.

How often are products contaminated by banned substances?

A defining piece of research was undertaken in 2004 by the Anti-Doping Laboratory in Cologne. 634 supplements were purchased from retail outlets in 13 countries and tested for the presence of steroids prohibited in sport (Geyer et al., 2004). Almost 15% of these were found to contain steroids, none of which were declared on the label. HFL Sport Science has also carried out studies — a 2007 US survey of 58 products showed that 25% were contaminated with steroids and 11% were contaminated with stimulants. A follow up study in the UK carried out by HFL in 2008 showed that of 152 products tested, 10.5% were contaminated with either steroids/stimulants.

While it's clear that a number of supplements explicitly contain banned substances (as declared on the label), it is also clear that a number of "clean" supplements may be inadvertently contaminated with substances that could lead to a positive drugs test.