The supplements industry associations had a lot to say about the recent report citing contamination of sports supplements. Industry leaders speak to Shane Starling.
Daniel Fabricant, PhD, vice president, scientific and regulatory affairs, Natural Products Association
"With respect to the recent study, I think the whole series of events is unfortunate. The study which was not a peer-reviewed study omitted a number of details, including the following: How were samples blinded to eliminate bias? If a steroid trace was indicated, did the laboratory go back to perform an analysis to confirm the presence of the analyte, which is common practice in drug testing?
"Without answers to these questions, drawing the sweeping conclusions that has led many to draw conclusions about the industry is at best sloppy and unscientific and at worst, irresponsible. Additionally although a substance may be banned by WADA, it does not necessarily prohibit its legal sale. Ingredients in common over-the-counter cold medicines and even some cancer drugs are prohibited by WADA, but can legally be sold.
"Given the time period of the tests, some of the ingredients cited in the study could legitimately be sold. Without knowing the products used in the study there are too many unknowns. With that said, how many of the professional athletes who have blamed a dietary supplement for a failed drug test in the past year alone have taken a case to court to prove that the supplement was indeed the cause of the failed drug test? Zero.
"There is an old line about if you have a case you take it to court and if you don't you take it to the 'court of public opinion'. I believe this is the crux of the issue, coupled with the fact that athletes and their respective sporting associations usually have a cleared list of supplement products, manufactured by the responsible industry that can be used. Any athlete that deviates from that path, and goes in search of a product making illicit drug claims is ultimately responsible. With that said I think we know what the problem is and really the best solution, which we have started on a small scale via TruLabel is to test products that are popular with the consumer, to show them that they can easily go to their local health food store and be assured that the product they use as a weekend warrior or their child uses for their scholastic sports is a safe product."
Andrew Shao, PhD, vice president, scientific and regulatory affairs, Council for Responsible Nutrition
"Sports nutrition supplements are legitimate and beneficial products and are particularly important to athletes, due to the physical stress from intense exercise. It is unfortunate that athletes and some testing programs can anonymously point the finger at either individual companies or the entire industry.
"We are in favor of testing programs, but those programs must be transparent. And we consider it "anonymous" when you conduct a study and then claim a percentage of products are contaminated - without naming those companies that passed or failed and without having provided necessary information on the testing methods and standards used. If in fact there are companies that are producing contaminated products, that is a problem - but it is a problem that can be solved if companies are named so FDA can take action.
"There have been other reports of not meeting label claims from other testing programs with regard to other categories of supplements; however the same problem exists. If you're not upfront about your testing program, no one has any way to determine whether you're being accurate or just looking to make a profit.
"We believe the overwhelming majority of dietary supplements, including sports nutrition products are manufactured under good manufacturing practices (GMPs) which should eliminate contamination. The instances of reported contamination are isolated to a few products out of the thousands that are in the marketplace.
"What surprises us is the credence given to reports generated by firms who claim to be protecting consumers, yet disclose little information about the products that were tested and which testing methods were used. If consumers' safety, health and wellness are the primary concerns, then the right thing to do is to release the brands/products that allegedly failed the tests, as well as the brands/products which passed, so that FDA can take action if necessary. Consumers - and FDA - need and deserve to know that there are reputable companies in the supplement industry that have consumers' best interests at heart and go to great lengths to ensure their products are contamination-free.
"The first step is figuring out whether or not this is actually a 'problem' — and the only way to do that is for the lab that tested these products to release the names of the products that failed the test and the methods of testing that were used, to see if it's possible for another lab to replicate these same results. If companies are knowingly or unknowing manufacturing products that are adulterated with banned or illegal substances, then the FDA needs to enforce the law and take those products off of the shelf.
"The recent release of the GMPs for dietary supplements will also help ensure that what's in the bottle is on the label. Beyond this, companies must continue to perform due diligence when it comes to sourcing raw materials and manufacturing their products — they must choose the right raw material suppliers and contract manufacturers to work with, to ensure the highest quality finished products possible reach consumers.
"To assist the industry with qualifying and sourcing the highest quality ingredients from the best suppliers, CRN has led a four trade association effort to develop the Standardized Information on Dietary Ingredients (SIDI) protocol. SIDI is a set of documents that provide guidelines on the type and scope of information that a supplier should provide to their customer (and manufacturers should look for) pertaining to their ingredients. SIDI represents a paradigm shift — a completely new and standardized way for ingredient suppliers to provide information on their ingredients to manufacturers.
"The most relevant and pertinent information on raw material ingredients — allergen information, manufacturing process, potential sources of contamination, and so on — can be compiled proactively by ingredient suppliers by following the SIDI protocol, and provided to their customers. This represents a substantial resource savings for both ingredient suppliers and manufacturers over the current system which involves filling out arduous product questionnaires (running 50 — 100 pages in length), each of which is different for different manufacturers."
Loren Israelsen, executive directive of the Utah-based Utah Natural Products Alliance (UNPA)
"An article that appeared in a recent USA Today has raised again the issue of sports products and the presence of banned substances. As most of you know, the issue of contaminated supplements frequently arises from the sports community, and ramps up pre-Olympics. Whether the issue is wrongful slinging of mud at our industry, or real manufacturing, buying or business practices, this issue repeatedly garners headlines and industry has had inadequate ammunition with which to respond.
"In this case, a new program called Informed-Choice (US-based -www.informed-choice.org) has managed testing on several supplements, with the actual analytical testing being done by UK-based HFL Labs, a lab which until earlier this year was an accredited WADA lab, that is, they would do testing on the blood and urine of athletes on behalf of WADA and the UK and other sports organizations and teams. A 'study' has been published by HFL, promoted by Informed-choice.com with no disclosure of passes and fails.
"According to a statement issued by CRN, HFL no longer has WADA accreditation. This is true, but to the best available knowledge, this is not due to lack of its performance as a WADA lab, but due to pressure behind the scenes in the sports community. Beginning a few years ago at least, WADA and the IOC debated whether it was a conflict of interest for WADA accredited labs to also run commercial programs, that is, offer contract analytical services. WADA ultimately decided that labs had to choose either to be WADA labs or commercial labs. HFL has been fighting this for a couple years as one of few labs on both sides of the fence, with perhaps the largest position on the commercial side. They've been running product testing for companies for several years, including a multi-year program to do work for GSK sports beverages.
"Going back to the article, now a press release, too, and program in question.
"For some time we have been aware that HFL has been trying to develop business in the US, partly to compensate for the loss of WADA business, partly to recognize the opportunity for those companies committed to supplying the sports community.
"This new program, co-ordinated by Informed-Choice, represents the launch of another sports product certification program. Programs continue to proliferate around the world, driven by concerns, real or perceived, that the sports community does not firstly, trust the quality of supplements, and secondly, does not trust in the absence of banned substances, many of which will never be tested for in commercial production, and even then, the level at which substances need to be detected to assure athletes will not test positive is far lower than would be required for regulatory purposes.
"This does not change a couple fundamental facts. If impure ingredients were to be purchased and these did contain steroid residues, then this would almost certainly result in a doping positive. Next, if inadequate equipment cleaning procedures were in place, then for instance, DHEA residue could theoretically appear in another product, which technically, since DHEA is on the WADA list, would again cause a positive. Next, if a company had process controls that didn't adequately control for batch uniformity, this problem would be compounded. Finally, there is the issue of deliberate adulteration, and it is strongly believed that some unscrupulous companies in this category 'soup-up' their products deliberately to enhance efficacy, and consumption of these products will certainly cause a doping positive.
"In order to encompass all scenarios, one must also consider the high achievement attitude of athletes and that some will deliberately consume performance enhancing products and blame supplements. It is arguable what proportion of the incidences fall into this category, and in fact, both the lack of disclosure of products and companies by the sports community, and the lack of adequate communication between industry and the sports community have compounded a difficult situation. In short, neither group trusts the other.
"Moving forward, implementation of the supplement GMPs helps this situation as do underlying practices such as enhanced value chain management specifically directed to expectations of suppliers. From formalization of cleaning procedures to establishment of specifications, tolerances etc, this represents movement in the right direction that should reduce incidence, create some more credibility with the sports community, and allow a better response to the sensationalist press generated deliberately by this release.
"Also, there appear to be some comments that are under review and challenge by industry and external experts. This includes level of validation of methods for some matrices, as well as concerns about the Informed-Choice program description as described on their website. Under no circumstances will they be "the only supplement testing program that uses a WADA-experienced lab and ISO 17025 accredited analytical methods." "This is an issue that will not go away. We must be prepared to understand the perspectives all the way around. Stay tuned…"