Third Party Certification Programs for Dietary Supplements

Transcription

1 Third Party Certification Programs for Dietary Supplements A Risk Reduction Step for Athletes. Why third party testing? Independent oversight is important in ensuring quality in any business or industry. The Food and Drug Administration (FDA) regulates dietary supplements as a special category of food through the Dietary Supplement Health and Education Act of 1994 (DSHEA). According to the regulations, dietary supplements are presumed to be safe and do not require FDA approval or review prior to being sold. In other words, the FDA doesn t check the labels, doesn t check what s in the bottle, and doesn t check to see how, or where, the supplement company is making the supplement the ingredients are coming from. In fact, the FDA does not keep a list of supplement companies in the United States so the FDA does not know how many supplement companies there are or how many supplement products are on the market at any one time. According to DSHEA, the supplement manufacturer (and not the FDA) is responsible for making sure that the supplements they sell are safe. When you buy a dietary supplement you are placing your health and safety in the hands of the supplement company. Some supplement companies have excellent quality assurance, but some companies do not. An independent third party testing company can intervene and conduct a quality review. A good third party testing company can meet with the company owners, visit the manufacturing plant, examine where the company is getting ingredients from, look at how the supplements are made, and test the ingredients and the final products for contaminants including heavy metals, pesticides, microbes, and substances prohibited in sport. Third party testing of dietary supplements is a relatively new industry, and the companies that conduct the review and testing vary widely in terms of how they approach the problem, how they test products, and how they prioritize risk. To lower costs, some companies test only for substances prohibited in sport. Third party testing agencies also have different qualifications and are constantly modifying their programs. Some supplement companies even invent a certification label, decal, or other decoration that claims the product is guaranteed to be steroid free or banned substance free, but there is absolutely no testing involved! This document discusses the different models of third party testing, the pros and cons of each model, and provides you with a list of questions to ask a third party testing company to help you make your own assessment of their program. Ultimately, you, need to decide whether a particular testing program reduces the risk to a level you are willing to accept. Definition of third party A third party is external to you the consumer and the dietary supplement company. Ideally, it is a fully independent outsider (someone who is not in or associated with the company that is making the supplement) with qualifications to assess whether a supplement is safe and manufactured according to the law and is free from prohibited substances. The company making dietary supplements voluntarily pays the third party company to conduct a review and testing of its products against certain criteria. If the products pass then the supplement 1

2 company can advertise that their products have passed the third party testing or review program. It costs money for a supplement company to register their products with most third party programs, but the trade off is that consumers might buy more of their products. Many people ask why the World Anti Doping Agency (WADA) or the U.S Anti Doping Agency (USADA) don t test and certify products. WADA labs are barred from testing and certifying dietary supplements for commercial purposes due to conflicts of interest. According to the WADA website 1 The Laboratory Code of Ethics, in the International Standard for Laboratories (Section 4.4 of Annex B), states that WADA accredited laboratories shall not engage in analyzing commercial material or preparations (e.g. dietary supplements) unless specifically requested by an Anti Doping Organization as part of a doping case investigation. The Laboratory shall not provide results, documentation or advice that, in any way, suggests endorsement of products or services. Because USADA uses WADA accredited labs, USADA cannot send supplements out for testing and certification/endorsement. Understand the limits Before proceeding, it is important to understand the limits of all third party testing programs. No matter how good they are, no one can guarantee that a dietary supplement is completely free from prohibited substances because: The Prohibited List is open ended and no third party certification body can test for every single substance that could give rise to a positive doping test. There is a continual supply of new designer drugs which are put into products but are not on the testing menu of any third party testing company. There are inherent difficulties in extracting or making sure that all of the substances in a product can be detected.this happens because of the vast differences in how the supplements are prepared (called the matrix). For instance, different methods are required to detect a steroid in an oily capsule versus a dry powder. For a third party testing company that conducts batch testing (at least one bottle from each batch is tested), the testing is only valid when the batch is consistent from bottle to bottle. Sometimes the proportions of ingredients (or adulterants) in bottles from the same batch vary, even though a company is certified to Good Manufacturing Practices 2. If a certifying body happens to choose 3 the bottle with low levels of adulterants, the test results will be clean even though other bottles in the same batch may have higher levels. Which risks are important to you? Each person ranks risks differently, and each person will have a different opinion about whether a particular risk is likely to occur, and whether the benefits outweigh the risks. 1 ama.org/en/resources/q and A/Dietary and Nutritional Supplements/, accessed April 11, Compliance with Good Manufacturing Practices (GMP) for dietary supplements is required by law. To learn more, visit the FDA webpage 3 There is a way to calculate a statistically sound sampling frequency to reduce the likelihood of this happening. The third party certifying body should provide consumers with a rationale for their sampling method, and why they believe the sampling frequency will detect problems. 2

3 The primary concern on the mind of most elite athletes is a positive doping test, and the consequences can be severe. There are also serious health risks such as organ damage, drug/supplement interactions, blood pressure changes, heart rate changes, nausea, headache, dizziness, and even death in some cases, that have been documented in people using certain dietary supplements. Many athletes may not be aware of the health risks, or they underestimate the seriousness or likelihood of these risks. Even when a dietary supplement causes only moderate or mild adverse health effects, sub optimal health may result in sub optimal performance which may mean the athlete never reaches the peak of their ability. Athletes also risk wasting their time, money, and effort using dietary supplements that don t do what they claim to. Some argue that this is no big deal and it s worth using even if there is only a chance it will help. But in doing so an athlete may neglect to do or eat things that would improve their health and performance. It is impossible to say what an athlete might have achieved had their diet and health been truly optimized. Table 1. Categories of Risk in using dietary supplements. Risk Positive anti doping test Possible Consequence Sanction, loss of results, barred from competition And possible career loss. Problems with work or school. Health problems Malnutrition, toxicity, drug/supplement interactions, physiological effects resulting in severe health problems (organ damage, changes in blood pressure etc.) or sub optimal health or performance. Waste of time, money, and effort Wasting time and money on products that don t improve health or performance. Neglects to take other actions that could actually improve their health and performance. What to look for in a Third Party Testing Company Because athletes are more likely to buy products (that say they are) guaranteed to be free from prohibited substances. There is an advertising advantage placing decals, or guarantees on supplement bottles, therefore, some supplement companies have developed their own certification programs, or their own guarantees of being free from prohibited substances. This is not truly third party this is the fox watching the henhouse. Third party testing is when an independent, outside company comes in and conducts a review or testing of processes and final products. Even if a supplement company sets up a great testing program of its own, there remains substantial conflicts of interest. A supplement company may conduct their own testing but it is very difficult to evaluate and independently verify the results of the testing program because the information is proprietary (private, with details 3

4 not shared). The consumer has no choice but to rely on the word of the supplement company. It is also very unlikely that a supplement company would have the expertise required to conduct the appropriate analytical testing for prohibited substances. Therefore, if athletes really want to do everything in their power to maximally reduce their risk (health, antidoping, and wasting time and money), they should use products that have been evaluated by an outside company that is truly independent from the supplement manufacturer. The third party certifying company should be free from conflicts of interest. Stating this, there are some conflicts of interest that are inherent in a fee for service certification company. First, in some ways it is in the interest of the third party testing company to pass a product in order to keep the supplement company as a client. After all, third party testing agencies need to stay in business too. Second, third parties often provide consulting services to the supplement company to help them meet the criteria set forth in the certification program. This is kind of like a teacher helping a student pass a test. However, by helping a supplement company through the certification process that company will ultimately make better, safer supplements. This is good for consumers. While these two conflicts of interest are unavoidable, it is trusted that they are balanced by the liability the third party testing company takes on by certifying a product. After all, if a certified supplement causes a positive anti doping test or a serious health problem this would make the third party testing company look very bad and consumers wouldn t trust them anymore. In spite of a few inherent conflicts of interest, the remaining conflicts of interest can and should be avoided to ensure products are evaluated honestly and without bias. The FDA has issued guidance on conflicts of interest for certifying bodies ( Voluntary Third Party Certification Program for Foods and Feeds 4 ; section K) which form the basis of the following recommendations: 1. The certification body should not be owned, operated, or controlled by a producer, manufacturer, processor, packer, holder, supplier, or vendor of dietary supplements. 2. The certification body should not be owned, operated, or controlled by a dietary supplement Trade Association. 3. Members of the certification body should not a. have any ownership or financial interest in any product, producer, manufacturer, processor, packer, holder, supplier or vendor of dietary supplements. b. participate in the production, manufacture, processing, packing, holding, promotion, or sale of any dietary supplements c. accept anything of value from anyone in connection with the establishment being audited other than the program/audit fee. The term anything of value includes, but is not limited to, gifts, gratuities, reimbursement of expenses, entertainment, loans, or any other form of compensation in cash or in kind. 4. The certification body should maintain records pertaining to the financial interests of the personnel involved in the certification program. 5. Fees charged or accepted should not be contingent or based upon the report made by the certification body or any personnel involved in the audit process. 6. The certification body and its auditors should be free from any other conflicts of interest that threaten impartiality. 4 accessed February 17,

5 The third party testing company should have appropriate qualifications It is essential that the third party testing company has the ability to detect problems in a supplement. They need to be able to tell if a company is manufacturing the product in a risky way, and they need to be able to tell if the product contains a banned substance. Therefore, they need to be able to evaluate the supplement company and the manufacturing process, and to conduct analytical testing of products. How can a consumer be sure that a thirdparty testing company can do all of these things? There is plenty of argument about what qualifies a company to conduct supplement testing. Some argue that experience is the most important aspect while others will say it s the length of the list of banned substances that they test for. Whatever features you eventually decide are important, it is critical that you are able to independently verify what a third party company is doing. Therefore, third party testing companies should have multiple external accreditations granted by the International Standards Organization (ISO) and/or the American National Standards Institute (ANSI) or equivalent. They should provide copies of their accreditations and fully explain the scope and limits of such accreditations. Two accreditations to look for include ISO General requirements for the competence of testing and calibration laboratories and ISO Guide 65 General requirements for bodies operating product certification systems. Does this mean that testing companies that don t have these accreditations are bad? No, they may have the ability to detect prohibited substances in and other problems with dietary supplements. The problem is that without external accreditations, consumers have no choice but to take the third party testing company at their word. This puts athletes back at square one with only marketing claims to rely on. Third party certifying companies should be able to provide you with objective evidence of their qualifications, and you should independently verify their accreditations by asking for copies and by contacting the company or organization that granted the accreditation(s). The ideal certification program The entire process of creating the dietary supplement should be designed to ensure quality. That is why it is important to do more than just test for prohibited substances. To maximally reduce the risk of consuming a tainted or unsafe product, it is recommended to have supplements tested by a third party company that conducts all of the following steps: 1. An audit to Good Manufacturing Practices 2. Full quality review of the supplement, preferably according to a standard 3. Testing for substances prohibited in sport 5

6 Table. 2 What to look for in Certification Programs for dietary supplements. Essential to avoid substances prohibited in sport The program should include.. Audit to Good Manufacturing Practices (CFR 111, or equivalent) Testing for substances prohibited in sport Rationale These steps are essential in reducing the risk of adulteration by substances prohibited in sport. These steps can only be carried out by an organization with appropriate expertise and qualifications. Other considerations Athletes are wholly reliant on a third party testing company to conduct these steps. Essential to avoid health issues Evaluation and testing of final 5 product (preferably to the ANSI/NSF 173 standard) and including label verification, testing for heavy metals/microbes, etc. These steps are important in ensuring the ingredient label is accurate and the product contains the ingredients it claims. Also ensures that an athlete is not inadvertently consuming common contaminants that threaten health, and ingredients on the label are listed properly and can be identified. Athletes are wholly reliant on a third party testing company to conduct these steps. Essential to avoid wasting time and money on products that don t do what they promise Assessment of efficacy/clinical studies Review of health claims and other advertising Toxicology Assessment These steps critically evaluate the efficacy of a supplement to determine if an athlete will actually benefit from taking the product. These steps also ensure that the product does not make inappropriate health or performance claims. The toxicology assessment will identify potential drug supplement interactions, or potential health problems associated with certain ingredients. If the steps in the first two categories (above) are properly carried out, an athlete can conduct the steps in this category themselves, or with the support of a medical professional or dietician. Athletes who cannot or do not wish to conduct these steps on their own should look for a program that incorporates these reviews and assessments into their testing program. 1. Audit to Good Manufacturing Practices. Testing alone is not enough to ensure quality products because it is impossible to test every single pill or bottle of a supplement. Batch testing (when one or two bottles from a batch is tested) is only useful when you have a consistent batch (the last bottle of the run is the same as the middle bottle which is the same as the first bottle) and this consistency is only achieved if the product was manufactured properly. Therefore, an audit to Good Manufacturing Practices (GMP) is important to make sure that the products are being made in a plant that is clean and products are manufactured using proper techniques, that the ingredients are purchased, stored and labeled properly, and that all the ingredients are added in the correct amounts and mixed properly. Manufacturing according to GMP is the law (US Code of Federal Regulations Chapter 111). 5 Testing of raw materials, both for identity and for substances prohibited in sport, is a very good thing to do because it will help a company identify poor quality or contaminated ingredients before they are used to make a supplement. Because multiple things can go wrong in the manufacturing process, it is still important to test the final product. 6

7 If the third party testing company conducts this step, they should have an accreditation to show that they are qualified to audit to GMP (CFR 111). However, sometimes third party testing companies outsource this step (they have someone else conduct the audit, or they accept a GMP certificate from the supplement company as proof). This is fine as long as the supplement company has been fully audited to good manufacturing practices by an independent third party and can prove it. If asked, the third party testing company should reveal to consumers what criteria they will use to determine whether products are made according to good manufacturing practices. While USADA considers over all quality assurance to be essential, it is important to audit the supplement company to good manufacturing practices even if you only care about the presence of prohibited substances. Products not made in compliance with good manufacturing practices may be inconsistent from batch to batch. Batch consistency is absolutely critical if you want to rely on testing for prohibited substances. Third party testing companies can only test a few bottles of a supplement. If the contents are not the same in each bottle something might be missed by selecting the wrong bottles. 2. Evaluating the supplement for overall quality Currently, the American National Standards Institute (the official U.S. representative to the International Organization for Standardization, or ISO) publishes a standard on dietary supplements that was developed with NSF (NSF/ANSI 173). The ANSI/NSF 173 standard is the only standard currently available for evaluating dietary supplements, and any testing company can use the standard if they choose. The standard encompasses many quality monographs from the U.S. Pharmacopeia (these are industry accepted methods that were developed in concert with industry and scientists alike). The standard covers things like label verification, detecting microbes and other contaminants, labeling and advertising, and other items. 3. Testing Final Product for Substances Prohibited in Sport. There is no standard that specifically addresses testing for substances prohibited in sport, however, for athletes, this is an important step. Since the Prohibited List is open ended (whole categories of substances are prohibited, such as anabolic agents, not just the substances that are specifically listed), the testing of dietary supplements for substances prohibited in sport should include as many substances as possible. Third party testing companies should have ISO17025 accreditation for this testing and the scope of the accreditation should cover as many prohibited substances, methods, and matrices as possible. The third party testing company should have a standard operating procedure that specifically lays out which substances are tested for, what methodology they use, and what the limits of detection are. Conclusion Be informed when choosing to use any dietary supplements. You can help reduce your risk of using a contaminated product by selecting one that has been evaluated by an independent third party company. Ultimately it is up to you to determine if the third party testing company reduces the risk to a level you are comfortable with. 7

8 Appendix: Questions to ask the Third Party Certification Company Conflicts of interest: Do employees, senior staff, and people on your advisory boards have any conflicts of interest? How do you manage the inherent conflict of interest in having supplement companies as feepaying clients? Can you provide a copy of your conflict of interest policy? Qualifications and program: What accreditations or qualifications does your company hold such as ISO, ANSI, or other relevant business or analytical testing standards? If you conduct the good manufacturing practice audit, who on your staff performs this task and what are their qualifications? If you conduct an audit to good manufacturing practice, do you specifically audit to U.S. federal regulations (i.e. CFR 111)? If you outsource the good manufacturing practice audit, what is your criteria for selecting a qualified auditing company? If the good manufacturing practice audit is outsourced, how do you verify that the GMP auditor does not have any conflicts of interest? If you do not conduct a GMP audit, do you require supplement companies to prove that they comply with GMP regulations? If so, what do you accept as evidence of compliance? Will the good manufacturing practice audit be a full audit that includes a site visit or partial audit (or a desk audit)? How often will the audit be repeated? Will an audit report be made available to consumers for review? How are problems (non conformities) dealt with? What are the criteria for pass/fail? What are the qualifications and scope of accreditations of your analytical testing laboratory. Can you provide copies of your accreditations? Do you use validated methodology for preparing the dietary supplement for testing? If you do not have a validated method to detect a particular substance in a particular matrix, do you develop one? Do you synthesize your own reference material or do you purchase it? How often are certified products retested or recertified? If a problem is found with a product that has been certified, what does your company do and how are consumers notified? Do you evaluate products against the NSF/ANSI 173 standard? If not, do you conduct label verification, and test for contaminants such as microbes or heavy metals? 8

9 Do you insist on the use of standard nomenclature for ingredients? For instance, if a company listed 1,3,7 trimethyl 1H purine 2,6(3H,7H) dione instead of caffeine what would you do? What role does your organization play in notifying authorities of dangerous or illegal products? Have you ever notified the Food and Drug Administration, the Drug Enforcement Agency, or the Federal Trade Commission of dangerous or illegal products? Have you ever withdrawn certification from a supplement company? Do you conduct your sampling of products in a way that is statistically sound and that will allow you to catch quality problems associated with variability in batch runs? Are products certified in a way so that tested products are clearly identified including batch number? Is there a way that consumers can be sure to only use the tested batches? Banned Substance Testing How extensive is your experience in the detection of prohibited substances in dietary supplements? Have any products that you ve tested ever caused a positive doping control test? How often to do you consult the Prohibited List for updates? How often do you modify your prohibited substance screen? What were the last 5 modifications to your prohibited substance screen, and when did you make these modifications in relation to the publication of the new WADA Prohibited List? If you add a new substance to your prohibited screen, what happens to all of the products that have already passed your certification program? Do they get retested? What proportion of substances specifically named on the Prohibited List do you test for? How do you manage the risk of testing for prohibited substances when there are many substances that could cause a positive doping test but might not be specifically named on the Prohibited List? Does your scope of accreditation cover all of the substances that you test for? What are the detection limits of your testing, and what does this mean for athletes? Do you test raw ingredients for substances prohibited in sport? 9