Case Study

Characterizing Food Additives to Determine Statistical Equivalence

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Rising consumer and regulatory concerns are putting pressure on food and beverage makers and their natural ingredient suppliers to produce safer food products. Chemically, many natural ingredients are highly complex formulations with thousands of individual components that are challenging to characterize. When companies need to change formulations to eliminate compounds of concern, they must be able to show that the new formulation has not introduced any unexpected changes in the final product. 

A food manufacturer came to Battelle for help in proving statistical equivalence of their new food product formulation for regulatory purposes. The manufacturer was phasing out an ingredient due to consumer concern and the potential for future regulation. In order to reduce the likelihood that they would need to conduct expensive regulatory studies and resubmit the product for FDA approval, the manufacturer needed to be able to prove that the new product was substantially equivalent to the old product with the exception of the removed ingredient.

The Solution

Battelle conducted a complete characterization of the new and old product formulations using a suite of contemporary chemical analysis methods combined with innovative statistical data evaluation techniques. Using Statistical Equivalency Testing, researchers were able to compare the chemical fingerprints of the different samples at the molecular level to determine product equivalence.  
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The Outcome

Our methods allowed the manufacturer to demonstrate that their new product was statistically equivalent to their original formulations—except for the removal of the ingredient of concern. The analysis showed that there were no significant or unexpected changes to the new product that would indicate regulatory concerns. 
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