Deputy Assistant Attorney General Arun G. Rao Delivers Testimony at Senate Judiciary Hearing

Remarks as Prepared for Delivery

Good morning, Chair Durbin, Ranking Member Graham and members of the Committee.

My name is Arun Rao, and I am the Deputy Assistant Attorney General for the Civil Division’s Consumer Protection Branch.

There is an urgent need to combat the illegal distribution and sale of unauthorized electronic nicotine delivery systems — or e-cigarettes — and I appreciate the opportunity to appear before you today.

Safeguarding the well-being of our nation’s youth is a paramount concern for the department, especially in this area.                              

Illegal e-cigarettes are a significant public health risk to Americans.

They contribute to addiction and health issues. And they pose a dire threat to youth, who are often the primary targets of aggressive marketing campaigns.

As you are aware, illegal e-cigarettes have flooded our nation. Many of these products originated from abroad, and in particular, from China.

Tens of millions of e-cigarette applications have been filed for Food and Drug Administration (FDA) authorization.

Many manufacturers have exploited the premarket authorization process. For example, some have tried to evade FDA denial orders by making minimal alterations to a previously-denied product and then filing another application with FDA.

Some overseas manufacturers routinely misdeclare shipments at ports of entry to evade import alerts.

And retailers across the country continue to manufacture their own products in individual stores.

Taken together, these factors have made illegal e-cigarettes all too accessible, allowing young people to obtain them at brick-and-mortar retailers across the country and online.

The Justice Department performs an important role in supporting the FDA’s efforts to ensure that illegal e-cigarettes stay off the market.

When manufacturers challenge FDA orders denying their marketing applications, the Civil Division defends the FDA’s decisions in court.

We have defended the FDA in over 80 legal challenges filed by manufacturers.

While many of those matters have yet to be decided, we have prevailed in more than a dozen cases, including in unanimous decisions in seven courts of appeals.

In a case where we have received a significant adverse decision in the Fifth Circuit, the department is seeking review from the Supreme Court.

The department also plays an important role in enforcing the Tobacco Control Act.

For example, the FDA has pursued monetary penalties against over 55 manufacturers and 100 retailers and has sent warning letters to hundreds more.

Although the department cannot impose penalties itself, we are prepared to assist the FDA in collection actions to ensure compliance.

Additionally, we have partnered with the FDA in significant enforcement actions. This includes the first domestic seizure of unauthorized e-cigarettes, which included more than 45,000 illegal e-cigarettes.

We also have the authority to bring civil injunctive actions in matters referred to the department by the FDA.

These actions do not allow us to recover monetary penalties, limiting their deterrent effect in some circumstances. But they are an important tool in appropriate cases.

The department has secured injunctions against six entities, continues to litigate against another and just yesterday filed a proposed consent decree in our most recent case. 

We recognize that the illegal distribution and sale of e-cigarettes is a complex and evolving problem that poses a grave threat to public health and safety. It demands urgency. While some progress has been made, there is still much work ahead of us.

That is why earlier this week, the department and FDA announced the creation of a multi-agency Task Force with the sole purpose of addressing the threat posed by the sale of illegal e-cigarettes.

The Task Force combines the expertise of multiple law enforcement partners — including the Bureau of Alcohol, Tobacco, Firearms and Explosives, U.S. Postal Inspection Service, U.S. Marshals Service, U.S. Customs and Border Protection, as well as the Federal Trade Commission — to help combat this problem through comprehensive enforcement strategies.

From seizing unlawful products to pursuing criminal investigations and prosecutions under the Prevent All Cigarette Trafficking Act, or the “PACT Act,” we will use every tool available to bolster our efforts to halt the illegal sale of unauthorized e-cigarettes.

We also stand ready to work with Congress in its legislative efforts to address this important issue. Congress has an important role to play to ensure that the department and FDA are able to effectively pursue critical enforcement actions.

In closing, I want to express my gratitude for the opportunity to testify. I am confident that, working together, we will make additional progress in the fight against the illegal sale of unauthorized e-cigarettes and will safeguard the well-being of all Americans, and especially our youth.

Thank you.

Department of Justice
Office of Public Affairs

Source: Justice.gov