FDA teams up with other agencies to tighten inspections of IMF shipments

03-Nov-2020 - Last updated on 03-Nov-2020 at 17:08 GMT

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The US Food and Drug Administration has signed an MOU with other federal agencies to improve the search and seizure of illegal products entering the country via International Mail Facilities.

The new Memorandum of Understanding is due to be posted on the FDA website today. It links FDA with US Customs and Border Protection (CBP), and the US Immigration and Customs Enforcement, Homeland Security Investigations (ICE-HSI) in an effort to maximize the inspection capabilities for the stream of products flowing through the IMFs.

IMFs feature higher percentage of problem products

Drugs, dietary supplements and illegal products masquerading as supplements enter the country via several channels. An FDA spokesman said the IMF packages, which are generally smaller parcels often sent by individuals overseas, have a much higher rate of violative products than other shipping channels which generally feature bigger, higher dollar value shipments.

According to an FDA press release, since April 2016, when the Agency implemented its administrative destruction authority at all nine IMFs, more than 12.9 million capsules, tablets or pieces have ben destroyed. The total weight of the destroyed products was more than 41.2 tons.

The seized and destroyed shipments included a variety of goods including illicit opioids like fentanyl and unapproved medical devices, according to an FDA spokesman. Some of them are illegal weight loss and erectile dysfunction products that masquerade as legally marketed dietary supplements. These products can contain illegal active pharmaceutical ingredients including sibutramine in the weight loss products and various analogues of sildenafil (trade name Viagra) for the sexual enhancement products.

Incidence of seizures shows upward trend

In fiscal year (FY) 2019, FDA said it screened approximately 25,200 parcels containing more than 41,000 products at its IMF facilities. More than 35,000 of those products were rejected and nearly half (more than 17,000 products) were identified as violative drugs and destroyed using FDA’s administrative destruction authority. So far in FY 2020, FDA said it has screened approximately 27,500 mail parcels, containing almost 43,000 FDA-regulated products. Of these products, more than 34,000 were refused admission and more than 24,000 were violative drug products that have been destroyed.

“Americans must have confidence that the products they receive are reliable and fully comply with US laws,” said FDA Commissioner Stephen M. Hahn, MD “The collaborative efforts we’ve announced will enable more resourceful, effective, and efficient oversight to prevent illegal and potentially harmful products from entering the United States—thereby aiding our essential mission to protect the health and safety of the American people.”