The Dietary Supplements Health and Education Act (DSHEA) of 1994 stated that nutritional supplements that do not claim to diagnose, prevent, or cure disease are not subject to regulation by the Food and Drug Administration (FDA). Many supplement manufacturers have concluded that DSHEA means that there is no requirement to prove claimed benefits, to show safety with acute or chronic administration, to commit to accepted quality assurance practices, or to follow the stringent labeling regulations followed for food products.
The nutritional supplement industry represents $2 billion a year growth industry with total global revenue sales projected to be in excess of $4.5 billion by 2007. Athletes from around the world are turning to nutritional supplements as a way to get bigger, faster and stronger and to have any edge possible over their competition. However, what many do not know or are finding out the hard way is that many of the supplements on the shelves do not contain the advertised amounts of substances in them or in the worst case, have additional substances in them that are not on the label. This can be of concern if the athlete has health issues where a certain herb or manufactured supplement could interfere with medications they are taking and for the elite athlete who gets drug tested at will, it could cause them to fail a test and be suspended from their sport.
Quality assurance of dietary supplements continues to be a concern, with some companies following good manufacturing practices (GMPs) while others do not. It is hard for athletes to know what products contain, especially when you consider that contamination of a supplement can occur at so many levels in the supply and manufacturing process. Avoiding companies that produce and sell prohormones such as nandrolone and testosterone derivatives, which result in positive drug tests, may not be enough to prevent purchase of contaminated products.
Since the release of the Schanzer report commissioned by the International Olympic Committee in 1999 showing 18% of all dietary supplements may lead to a positive doping offence, there has been increasing commercial awareness of the adverse publicity companies would face if proven to be connected with contaminated products.
The problem is clearly widespread, as indicated by a study conducted by the International Olympic Committee laboratory in Cologne, Germany. Of 634 supplements purchased and tested from 13 different countries, 94 supplements (14.8% of total) contained prohibited substances. Another 10% showed that steroids may have been present but the analysis was not conclusive. This equates into a 1 in 4 risk of contamination with prohibited substances!
Products that tested positive were found to be purchased in the Netherlands (26%), Austria (23%), the United States (19%), the United Kingdom (19%), Italy (14%), Spain (14%) and Germany (12%), among others. Contamination levels of products tended to be small and highly variable among and within batches, making it difficult to identify the source of the contaminated supplement. Even though the prohibited substances that were found have not been officially published, they included the following types and/or categories:
- Branched chain amino acids
- Tribulus Terrestris
- Conjugated linoleic acid
- Protein powders
- Herbal extracts
What’s Being Done
There are several industry-driven GMPs programs in place, though many experts continue to be concerned about sources of raw materials and guarantees for each batch of product. One industry program is under the National Nutritional Foods Association (NNFA), which has certified dozens of companies and has a strategic alliance with NSF International ( www.nsf.org ). Membership in NNFA requires compliance with its GMPs, and its web site ( www.nnfa.org ) lists companies that are members. NSF International has an athlete-certification program, and can test specific products for interested athletes. Two other resources include www.consumerlab.com , which has independently tested dietary supplements and has an Athletic Banned Substances Screened Products Program and the FDA, which has also presented an outline of a GMP program on its web site at www.cfsan.fda.gov.
No matter what programs or processes are in place, athletes who compete at the elite level are randomly drug-tested which leads to continued confusion and concern about how to make decisions regarding the use and purchase of dietary supplements. It would be hard to imagine completing a long training session without the replacement of carbohydrate, fluid, and electrolytes, and the products that provide these ingredients are vital to training and competition. Any product can be contaminated and there aren’t any industry standards in place to prevent this. The good news is that the industry is moving towards the creation of preventative standards, but it will surely take time.
As a result of all of this information, not much has changed except that legislation in various countries might make the supplement manufacturers more accountable. The principle of strict liability still applies so athletes must be extremely careful when choosing nutritional supplements. It doesn’t matter if the athlete knows if a banned substance is present in their nutritional supplement or if they know their supplement has been contaminated. Presence of sufficient levels of prohibited substances will result in either a temporary suspension or permanent ban from competition.
- Geyer et al. 2000. Deutche Z Sportsmed. 51, 378-382.
- Gatorade and Sports Science Institute, 2003 Scientific Conference.
- Gatorade and Sports Science Hot Topic Article, May 2001. Dietary Supplements: Contamination may cause failed drug tests. Ronald J. Maughan, Ph.D.