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Wheeler says they’re using extracted vapor for HPHC testing, rather than testing both the vapor and the bottled liquid, because in the deficiency letters they’re seen so far, the FDA only seemed concerned with the vapor testing. Besides, says Wheeler, If the FDA really needs that liquid data, we can come back and do it later. The aerosol data gives you more information about what actually goes into the lungs. The results were comparable, Wheeler said, which validates the effectiveness of the pooled testing. Because the comparison tests are part of the master file submitted to the FDA, AVM members don’t have to repeat them to show the FDA that the process works. In the most recent round of validation testing, Labstat—AVM’s partner lab in Kitchener, Ontario—went a step further. We threw everything at this one, says Wheeler, including a wide variety of flavors and one sample spiked with formaldehyde. The preliminary results were what they had hoped for.
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