© [2020], NCBFAA, Washington D.C., Monday Morning eBriefing. Originally published [07/20/2020]. www.ncbfaa.orgReprinted by permission

During NCBFAA’s July RAC meeting, FDA’s Director of Import Operations, John Verbeten, listened to the concerns of southern border brokers about the long delays and exorbitant costs faced by importers as the FDA and CBP step up inspections of hand sanitizer imports from Mexico. Brokers say they are waiting 60 to 90 days for the FDA lab analyses to be completed.

For products found to contain methanol, the FDA does not allow the option of exporting the product. Destruction is the only remedy available. With the quoted price of $30,000 to destroy the product contained in one trailer, brokers explained to Verbeten that this is not a realistic solution for importers. Brokers implored the FDA Import Director to consider alternatives, such as allowing the product to be returned to Mexico for destruction or to undergo a process to filter out the methanol.  Verbeten responded that, with the high rate of violations they are finding for hand sanitizer imports (either because of low alcohol content or because of the presence of methanol), the trade can expect an increased level of scrutiny for some time to come.

In fact, he said, FDA plans to expand their inquiry in other ports to include hand sanitizer from other countries. He also stated that, so far, 50% of the samples sent for lab analyses do not comply with FDA requirements — with the results of the other 50% still pending. Verbeten said, if the violation is due to a low alcohol content, importers do have the option to export or destroy the product. But, for product that contains excess levels of methanol, the export option is not available, though he will ask his agency about the possibility of exporting the product to be destroyed in Mexico. Verbeten was, however, candid in saying he did not know how that would work, since there are no controls in place to ensure that the product will actually be destroyed. “After all,” he said, “the Mexican supplier already sent bad product to the US once.” Verbeten did promise to look at providing clearer written guidance to the trade about the refusal process. Brokers also expressed the frustration of importers of compliant hand sanitizer who are caught up in the 60 to 90-day testing backlog. “Most importers want to import good product.

We are confident that FDA’s lab tests will ultimately show the shipment to be compliant,” commented one broker, “But waiting 60 to 90 days for the compliant product to be released is a problem for the trade. Not only will it cause unacceptable delays and market shortages, but storing all that flammable product in the southwest heat is a real concern, as well.” Brokers asked the agency to consider solutions to these delays, such as allowing importers to do their own testing in approved 3rd party labs to expedite the process.

Verbeten promised to discuss this within the agency. NCBFAA’s RAC will continue to work with the FDA to address these ongoing issues.  See also: