This from our good friend Benjamin England at FDAImports.com.  Ben knows his business.

For years Benjamin England of FDAImports.com LLC has argued that FDA improperly treats import alerts as automatic detentions and wildly throws around its authority when the agency finds what it calls the “appearance” of a violation of FDA law from evidence other than the examination of samples. FDA has attempted to avoid this allegation by changing the name of its import alerts from “automatic detention” to “detention without physical examination.” It matters because FDA lost several lawsuits alleging that because its “automatic detentions” are actually invalid and unenforceable regulations pretending to be guidance. Del Monte, in a recent legal victory, put the agency to the test again challenging FDA’s addition of a cantaloupe farm in Guatemala to Import Alert 99-19. FDA alleged it appeared the Guatemalan supplier’s cantaloupe contained Salmonella because FDA’s trace-back investigation of a Salmonella outbreak led to cantaloupes and, quite frankly, Del Monte sold more cantaloupes than anyone else.  Oops. That, “it appears”, would not be sufficient evidence and Del Monte told a court so.

In response, FDA withdrew the import alert listing. “Apparently” FDA did not have the stomach to rely on its epidemiology evidence when all evidence pointed to the farm operating under Good Agricultural Practices (“mere agency guidance”) and not a single cantaloupe from the farm tested positive for Salmonella.

FDA does have broad authority to detain shipments of food, dietary supplements, beverages, cosmetics, drugs and medical devices and import alerts are a reasonable way to get the word out to FDA field offices about evidence that pertains to specific products from specific processors. That authority arises from the statute, which grants FDA the power to detain and even refuse products if “it appears from the examination of samples or otherwise” that the products violate the law. But “appearance” must be more than a hunch, more than a guess, and more than “well you are the biggest supplier, so it appears you must be at fault.”

Apparently, FDA must have evidence.


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