FDA Touts Results of New Prosecutorial Enforcement Muscle Worldwide

The Food and Drug Administration (FDA) is increasing and strengthening its ability to enforce criminal sanctions against conduct related to illegal FDA-regulated products across the globe, according to an October release.

The release serves as a signal from the agency of its priorities and accomplishments that span national borders and address the challenges presented by internet-based commerce. Companies with products or intellectual property subject to such illicit activities are well-served by this enforcement priority and should be encouraged that the agency is pushing beyond the borders of the United States to halt such conduct.

In the release published October 17, 2019, the agency stated that congressionally authorized authorities and resources have allowed the FDA’s law enforcement personnel to make arrests and prosecute more cases. The Criminal Investigations Office now has six U.S. field offices and special agents posted at The Hague, Washington, D.C. and London.

Of particular interest to the FDA are vaping-related products illegally shipped through international mail facilities, including more than 3.7 million illegal and potentially dangerous tablets/capsules destroyed at just the facilities in New York and New Jersey since 2012.

From October 2017 to June 2019, the agency arrested 94 individuals, obtained 88 convictions, and obtained fines and restitution totaling more than $45 million. This included the forfeiture of assets worth more than $41 million and the seizure of more than 4,200 internet domain names.

As examples, the agency cited the following:

• In 2019, the FDA led an investigation into a U.S.-based global consumer goods conglomerate that allegedly participated in an illicit nationwide scheme to increase prescriptions of its opioid addiction treatment drug Suboxone. The company agreed to pay $1.4 billion to resolve the claims.
• The FDA has also cracked down on dark web marketplaces and vendors manufacturing and selling counterfeit opioids. This effort resulted in a guilty plea by the “Drug Llama,” a California defendant who admitted to facilitating the shipment of over 50,000 counterfeit oxycodone tablets laced with fentanyl on the dark web.
• Similarly, a federal indictment charged a Massachusetts resident, “Kill Will” with the distribution of fentanyl and the sale of counterfeit oxycodone pills containing the opioid fentanyl. If convicted, he could face up to 20 years in federal prison and fines of over $1.25 million.