Last week's Consumerlab.com release regarding its test results for multi-vitamin products in various formats has received widespread media pick-up. In its release, Consumerlab.com noted that over 50% of the products it tested failed its criteria and hence were not 'approved'. The criteria for approval in this case were a mix of USP standards and Proposition 65 State of California regulations governing lead levels.
Industry dialogue over these results, their presentation and appropriateness of test methods in general has continued this week. There are numerous questions that just beg to be asked.....
Last week's Consumerlab.com release regarding its test results for multi-vitamin products in various formats has received widespread media pick-up. In its release, Consumerlab.com noted that over 50% of the products it tested failed its criteria and hence were not approved. The criteria for approval in this case were a mix of USP standards and Proposition 65 State of California regulations governing lead levels.
Consumerlab.com and its results are often cited as conclusive data by media (and on Capitol Hill) by those calling for more or better regulation of dietary supplement companies. The recent results have raised alarm over the quality of vitamins in the marketplace.
The use of USP, reference to specific tests and analytical methods, use of the terms 'contaminated' 'regulations', 'Upper Levels' and RDAs' in various communications point to the need for a better collective understanding of analytical issues such as appropriate use of methods, standards, the process and the limitations of method validation. This entire discussion and the concern generated by these 'results' point quite clearly to the need for raising baseline education levels and industry's ability to ask better and more discerning questions than just merely "Did it pass or fail"?
On another related front, experts say that the amount and level of validated methods is seriously lacking and even then confounding factors such as matrices or ingredient interference make many methods inappropriate for use. Certainly, complex mixtures in proprietary proportion in one finished product format cannot be analyzed by an off the shelf method based on another product format - at least without the method being proven suitable by accepted methodology. How should methods be selected and proven appropriate or suitable for use? What questions can be asked to determine if a method is unsuitable? How do in-house methods factor in?
In a broader sense, what should companies and the industry do to prove their materials are in fact tested using validated (in-house or third party) methods? When companies go up against Consumerlab.com or other allegations of failing tests, or of not meeting regulatory criteria based on 'testing' how do they differentiate between substance and rhetoric/sensationalism?
Typically pass and fail are viewed as black and white issues, and well they should be. Lurking in the background though, are rules and practices that help to make it so. Pass and fail without this background and platform are merely words.
Returning to the recent Consumerlab.com report and results, the use of USP 24 is but one of several triggers surrounding the latest Consumerlab.com results. Although in my past life I've managed an analytical lab and both method development and validation issues, in our current industry environment there are experts better equipped to answer questions about suitability and method details, so that we can all place these results in the context in which they belong.
Read more in NPIcenter's Analytical/Testing blog.