FDA and Customs cracking down on fake herbal Viagra

US Customs and Border Protection (CBP) and the Food and Drug Administration (FDA) are employing “Predictive Risk-based Evaluation” to target economically motivated adulteration of erectile dysfunction and other unauthorized supplements at US borders.

The system’s implementation has been delayed due to IT problems but is ready to go and the two agencies seek to crack down on shipments that range from the very small to the extremely large.

"CBP officers can see parcels containing these suspect shipments in quantities of anywhere from 8 to 8000 tables," said David Murphy, CBP director of field operations in Chicago.

"CBP remains vigilant, on-guard and in-sync with our federal partner, the FDA, to protect American consumers from these potentially harmful products. Our collaboration with FDA ensures the continued success of the missions of both agencies."

In a joint-statement, the agencies noted that, “In addition to counterfeit prescription drug products, CBP and FDA have seen an increase in tainted male sexual enhancement products being purchased on-line and imported into the United States.”

“Although these types of products are being marketed as ‘all natural’ or ‘100% herbal’ these products often contain undeclared pharmaceuticals such as sildenafil, vardenafil and tadalafil (the active ingredients in Viagra, Cialis and Levitra). Use of these tainted male enhancement products pose a threat to consumers because the manufacturing of most of these products is entirely unknown. In addition, these products may interact with nitrates found in some prescription drugs (such as Nitroglycerin) and may lower blood pressure to dangerous levels.”

The agencies noted the difficulty in detecting contraband in that they may look exactly like approved products but contain unapproved ingredients or, “varying amounts of the supposed active ingredient.”

"FDA has identified an emerging trend where products sold directly to consumers, frequently represented as dietary supplements or 'all natural,' contain active ingredients which are not on the label that could be harmful," said Scott MacIntire, FDA Chicago District Director.

Predictive Risk-based Evaluation” makes use of barcode scanners linked to a database to focus port inspections on particular items that may have raised some kind of red flag.