Of all study designs, the double blind, randomized, crossover trial is classified as the gold standard, especially if carried out on the end product to be marketed. However, unlike with dietary supplement trials, placebo food or beverage products are best served in the context of the whole diet. Providing a food or beverage product that is with and without the actives while controlling for dietary intake is a difficult task. However, in order to effectively identify that the mechanism of action is bioactive-based rather than taste- or sensation-based is a vital undertaking. Additionally, if taste is the mechanism of effect, the design should be adjusted accordingly. There are already some indications and examples of what level of evidence will be required to achieve health claim approval under the new framework for P293 (Figure 3).
Click the chart to enlarge.
In anticipation of the integration of P293 into food regulation, the food standards agency commissioned reviews into a number of potential high-level claims. For example, evidence was accepted for a general-level claim on omega-3 essential fatty acids (EFAs) and heart health. What is interesting about the Australian/New Zealand system is these documents are made public, which can provide invaluable guidance to companies looking to make future claims. However, this seems slightly unfair given the time and expense to put such dossiers together, which will provide a free resource for future companies looking to make similar claims. A similar scenario exists in Europe with the publication of an approved list in Jan 2011 of health claims under article 13. (For more on the topic, see the Feb. 04, 2008, INSIDER article, “Europe 2008: Health Claim Heaven or Hell”.)
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