Food and Drug Administration

According to former FDA Regulatory Counsel, Benjamin England, on October 1st, 2011, FDA will implement a new fee/examination structure that will increase the cost of importing food, food prices and the overall burden on taxpayers.  According to Benjamin England, the new FDA food import fee will ultimately function like a food import tax. Beginning the first day of the 2012 Fiscal Year, FDA will charge U.S. food importers at the rate of $224 per hour for the time and resources it takes for FDA re-examine or re-inspect any imported food shipment for which FDA has identified a questionable food safety issue.

Food and Drug Administration
Food and Drug Administration

This holds true even if it is proved that there was no food safety issue whatsoever.  Due to FDA’s unusual definition of an “examination,” U.S. food importers, most of them small businesses, will be charged for FDA time that amounts to little more than data-retrieval in FDA’s data systems and involve no physical inspection of the imported food at all. In addition to the immense burden of fees and testing that the U.S. importer will have to bear, the American taxpayer will be footing the bill for the infrastructure of the process as well.

Once FDA initiates its “re-examination” of an imported food subject to the new fee regime, the clock will start ticking against the $224 per hour rate. FDA might review documents related to the shipment or detain the shipment without any physical examination (for instance because the foreign manufacturer might be subject to an FDA Import Alert). FDA might review private laboratory test results or conduct an examination at the importer’s warehouse, just to make sure the import declaration was right. All of these activities will be performed at the hourly rate of $224. In most cases, the shipment will be released for consumption. FDA will then process the importer’s re-examination fee invoice, mail the invoice, monitor the account, send follow-up notices and then leave the small business food importer with the choice of paying the full fee or requesting that the fee to be reduced or waived.  FDA will even bill the importer for the expense of processing the invoice and the fee collection. All of the steps in this process will be at significant cost to the American Taxpayer.

FDA has stated that small businesses may appeal to the Agency for a reduction or waiver of the fee. Benjamin England, Founder and CEO of, hinted at the fact that the new fees will essentially function like a tax:

FDA’s new fees will generate significant income for the United States government, however it will be at the expense of small businesses, the economic engines of the U.S. economy, and the American Taxpayer.  The likelihood that FDA will grant waivers or reductions in fees to small businesses is slim to none. FDA would already have done the work and spent its resources, issued the invoice and would be waiting for its money. Getting a letter in exchange from the importer begging for mercy just means more resources and delay – all while the government racks up more deficits. The small businesses will not have the money in their margins to pay the fees and will have to pass it on in the form of higher prices. The average American consumer will pay for it, as they always do, in the cost of their food inching higher and higher.

Benjamin L. England is a former 17-year veteran of the FDA and served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs.  Currently he is founder and CEO of, LLC, a firm of consultants and affiliated attorneys routinely seeking removal of foreign manufacturers from FDA import alerts.

By daryl

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