Third-party Dietary Supplement Certification Program Comparison
Key Elements of Third-Party Certification for Banned Substances
When considering third-party dietary supplement certification for banned substances in sport like drugs on the WADA Prohibited List or other potential drug contaminants, it is important to evaluate the key elements to understand the protection offered. Differences in lot testing frequency, testing menu, reporting levels and process, and transparency in program details and database listings can lead to significant variances in the underlying security provided. We explain what to look for in third-party certification for banned substances in sport in the comparison chart and discussion below. A pdf of the chart is available through the following link: Comparison Chart – Third Party Banned Substances Certification Programs
Key Elements of Third-Party Certification for Banned Substances – A Comparison Chart
(as of May 14, 2020)
What is Important to Consider in Banned Substance Certification?
A third-party dietary supplement certification program should include certain key elements. First, at its core, a certification program should require ongoing batch testing for banned substances in sport and/or other drugs. In general, the more drugs included in the testing menu the broader the protection offered. The best way to evaluate a testing menu is to look at the percentage of World Anti-Doping Agency (WADA) adverse analytical findings, or positive drug tests, covered by the menu over the last decade. Testing should be performed in ISO 17025 accredited laboratories using methods that are included in the ISO scope of accreditation and have been validated for testing dietary supplements or other related products.
Clearly explaining batch testing frequency and verifying that a batch has been certified is vital. It is important to realize that some certified products may carry a seal but the batch may not be tested and the protection may not apply. Make sure to ask for and consider the sampling scheme used. Always verify the batch you are using has been certified by looking up the number stamped on the package in the searchable databases. Watch out for products with ‘All’ listed in a database as only a subset of finished product lots may have been tested.
Method capabilities, represented by detection levels should be in the low parts per billion range in order to be able to find trace amounts of substances that could lead to positive drug tests for athletes or other drug-tested professionals. Use of a maximum allowable level per serving threshold for performance-enhancing drugs is inherently risky and should be avoided, except in certain circumstances where scientifically justified.
An initial review process is also part of any good third-party dietary supplement certification program. That process should include a FDA 21 C.F.R. 111 Current Good Manufacturing Practice (GMP) compliance assessment that reviews supplier qualification process, raw material and finished product quality control, adverse event reporting, recall procedures and other requirements. Random sampling is another important element to ensure consistent protection of a product or ingredient.
Most importantly, a third-party dietary supplement certification program should be transparent and clearly outline its program details and key elements. Unfortunately, not all programs share these important details. An up-to-date comparison chart for third-party dietary supplement certification programs is offered here so you can scrutinize the key elements.
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