FDA Using Ion Mobility Spectrometers In 4 IMFs, Plans Use In 4 More

Across all 9 IMF facilities in FY 2019, FDA screened around 25,200 parcels containing more than 41,000 products, detained more than 38,000 including 1,801 identified as supplements and expects to destroy more than 17,000.

The Food and Drug Administration has extended use of ion mobility spectrometer portable screening devices to four of the nine US international mail facilities and plans to deploy the technology in four other IMFs.

Representatives from acting Commissioner Normal "Ned" Sharpless' office provided an update on the FDA's use of the devices following Sharpless' visits on 8 October to IMFs at JFK Airport in Jamaica, NY, and at Secaucus, NJ, to view work by agency investigators along with Customs and Border Protection officials to prevent overseas shipments containing illicit and potentially dangerous drugs and other products from reaching the US market.

The commissioner's office told HBW Insight that in fiscal year 2019, across all the IMF facilities the agency screened around 25,200 parcels containing more than 41,000 products. FDA officials detained more than 38,000 of the products, including 1,801 identified as dietary supplements, and the agency expects to destroy more than 17,000 subject to its administrative destruction authority.

Acting Fda commissioner sharpless: A "stunning volume of parcels come into a single international mail facility on any given day."

The FDA has exercised its administrative destruction authority, since it went into effect in May 2017 after being established in the FDA Safety and Innovation Act passed in 2012, at the JFK IMF and destroyed more than 3.7m capsules/tablets, comprising 7,136 products and 16.58 tons, of illicit and potentially dangerous drugs.

Of the products detained at JFK and later destroyed, 30 were initially identified by FDA staff as supplement products before being determined to be drugs, including erectile dysfunction and weight loss products, according to the agency.

In March 2018, FDA officials announced that a six-month pilot program demonstrated the ion mobility spectrometer portable screening device is reliable, efficient, produced valid results and supported adding the devices at additional IMFs. The program's results with the technology, which law enforcement and security agencies use to test for explosives and illegal narcotics, included finding undeclared drug ingredients in 65% of tested products that were labeled as dietary supplements at two IMFs. (Also see "Ion Spectrometer Improves FDA's Import Screening: Health And Wellness Industry News" - HBW Insight, 26 Mar, 2018.)

The commissioner's office representatives say the FDA currently is working on deploying additional devices to four of the remaining IMFs in FY 2020. Due to the small volume of parcels processed at the US Virgin Islands IMF, the agency doesn’t plan to use one there.

For FY 2019, 81% of the total of 200 samples, 161, that were field analyzed with the devices at IMFs tested positive for containing an active pharmaceutical ingredient.

More efficient IMF screening processes are needed because more than 275m "international mail" packages are received annually at the nine US facilities, most without advanced or specific identifying information. International mail is classified as small packages typically shipped from a business to a customer, or between consumers. (Also see " US House Committee Requests Proof Of FDA Progress Seizing Opioids In International Mail" - HBW Insight, 13 Jun, 2018.)

"Many of these parcels lack any package labeling, contain products labeled as dietary supplements with hidden drug ingredients, or contain drug products or medical devices that are unapproved or counterfeit," said Sharpless following his tour of the IMFs. He noted "the stunning volume of parcels that come into a single international mail facility on any given day."

In addition to New York, New Jersey and the Virgin Islands, the US operates international mail facilities in Los Angeles, San Francisco, Chicago, Miami, Honolulu and Puerto Rico.

Ion mobility spectrometer devices compare the chemical signature of an unknown substance against the signatures of known compounds in a process that takes less than 30 seconds. During the pilot, FDA loaded the device with a library of pharmaceutical compounds to test whether products marketed for weight loss and sexual enhancement contained undeclared drug compounds such as sibutramine, phenolphthalein and sildenafil, the drug ingredients most commonly found while undisclosed on labels of products marketed as dietary supplements.

The scanner’s methods are flexible and, in addition to finding undisclosed ingredients in supplements, can be used to detect active ingredients in drug products by adding new pharmaceutical libraries developed by FDA laboratories, which has developed an opioid screening method for the device.