Imagine a government official approaching you outside your business one afternoon. The official demands that you empty your pockets. You refuse and ask why. “Because you appear to have contraband in your pockets.” When you ask what evidence he has he answers, “I’m not sure . . . yet.” What would you do in this case?
This example seems outrageous to Americans and their love relationship with rights to privacy and against unlawful search and seizure. But it is similar to FDA’s every day “regulatory” actions against cosmetic importers in the Los-Angeles District Office (LOS-DO). It’s true! It turns out that LOS-DO has been detaining imported cosmetics alleging they contain unsafe color additives whenever the importer fails to provide copies of color batch certificates for each of the labeled colors – even when the colors are properly declared in the ingredients statement!
Yes, you heard that right: FDA is detaining cosmetics that properly declare legal, permitted color additives alleging the cosmetics appear to be adulterated with unsafe color additives only because the importer did not prove that the cosmetics were not adulterated initially! See a problem with this? FDAImports.com did. FDA’s LOS-DO is holding shipments citing a lack of color certification documentation in the entry package as its only evidence! These FDA holds and detentions are resulting in shipment delays of weeks or months – and many of the cosmetics are holiday items, being imported for Christmas sales. FDA has simply gone wild over imported cosmetics.
To be absolutely clear, FDA does not have the authority under the law (much less the Constitution) to presume a color ingredient in a cosmetic product is not from a certified batch simply because the importer did not provide copies of FDA batch certificates at entry. Period; no way; no how. FDA has this precisely backwards; just like a government official forcing you to show him what is in your pockets to prove you do not have contraband when the official has no evidence that you even might. So why does FDA do this? What’s really going on at FDA here?
According to FDA officials, the field compliance officers have gone wild over cosmetics and colors, frustrated by their lack of ability to check whether colors in imported cosmetics are from certified batches unless they first allege that the colors are uncertified. While FDA enjoys certain newfound powers under the recent Food Safety Modernization Act, no such powers were carried over by Congress to cosmetics. In this case FDA is attempting to sneak cosmetics into its new FSMA authorities. This is only going to get worse and it is illegal. Cosmetic manufacturers and importers, take note- FDA’s gone wild… over your cosmetic colors.
