FDA is increasing its regulatory presence at our nation’s international mail facilities (IMFs) and will be implementing a portable screening device to “more quickly identify and assess suspect products entering through IMFs,” according to an article by FDA Commissioner Scott Gottlieb and two of his colleagues that was posted to the agency’s FDA Voice blog site on March 21st.

By adding 14 additional “investigators” (presumably the regulatory type) at the nine IMFs throughout the country, FDA will be able to screen an additional 30,000 packages per year.  While this is a noticeable improvement, it will hardly make a dent in the mountain of packages arriving at the IMFs each year which are subject to FDA oversight.  Of the 275 million incoming mail shipments each year, close to 50 million could involve FDA-regulated products, based on FDA’s own estimate that such products account for about 20 cents of every dollar of annual spending by consumers.  To that point, FDA’s article acknowledged that less than 0.06 percent of suspected drug shipments are being inspected by the agency.  This alarming figure underscores just how overwhelmed FDA is at the IMFs. And this is an ominous sign for consumers.

FDA also outlined a successful pilot at two IMFs in which an ion mobility spectrometer was used to detect undeclared drug ingredients in products marketed for weight loss and sexual enhancement.  FDA plans to expand the use of this device at two additional IMFs and hopes to eventually implement it at all nine IMFs so staff “can quickly determine whether products contain undeclared drug ingredients.”

FDA added that it is working on an opioid screening method for this device and plans to initiate a pilot study using this method in the near future. That’s great news, but this new device on the block makes me wonder what happened to CD-3.  Was it banished to the island of misfit mobile testing devices?  FDA trumpeted this groundbreaking mobile counterfeit detector in 2013, but it has apparently fallen off the agency’s radar since then (see my CD-3 post here).  Will the ion mobility spectrometer fade away into oblivion too once the limelight is gone? Only time will tell.

Ultimately, FDA believes more efficient oversight at the IMFs will be achieved by advancing the science behind “rapid, deployable, screening methods” and seeking “to shift the paradigm” of how products are screened at these locations.

While identifying and destroying more illegal products at the IMFs will certainly keep a greater number of dangerous products from reaching consumers, such an approach will be of marginal value without a corresponding emphasis on criminal investigations. FDA’s announcement will not send shivers up the spines of any criminals who exploit IMF oversight vulnerabilities to distribute counterfeit, unsafe, and unapproved products to consumers.  Criminals don’t fear FDA regulators or their ion mobility spectrometers.  What they do notice, however, are criminal prosecutions, and lots of them.

If FDA is really serious about the IMF problem, it will strategically deploy Special Agents from its Office of Criminal Investigations (OCI) to establish a meaningful law enforcement presence for the agency at all of the IMFs and aggressively pursue waves of law enforcement operations in partnership with the Department of Justice and its Consumer Protection Branch.

This problem will not be solved by science alone.  FDA must adopt a more comprehensive enforcement strategy at the IMFs that includes its own criminal investigators or this problem will continue to mount.  I find it curious that FDA’s article doesn’t mention OCI.  If FDA is not referring every shipment of illicit FDA-regulated products to OCI, it should be. Simply destroying such packages is not good enough; it’s just the cost of doing business for criminals.  FDA will continue to be viewed as a toothless tiger as long as its IMF strategy keeps OCI on the sidelines.