78 Leading Organizations Call for “All Hands On Deck” Federal Enforcement Strategy to Clear the Market of Unauthorized E-Cigarettes

WASHINGTON, D.C. – Today, 78 leading public health, medical, education, community and other organizations urged the U.S. Food and Drug Administration (FDA), the U.S. Department of Justice (DOJ) and the U.S. Customs and Border Protection (CBP) to utilize all the enforcement tools at their disposal to clear the market of unauthorized e-cigarette products, including flavored products that appeal to kids and put them at risk for nicotine addiction and other significant health harms. 

The FDA has authorized the sale of only 23 tobacco-flavored e-cigarette products and stated that “these are the only e-cigarette products that currently may be lawfully sold in the U.S.”

“This means that virtually the entire e-cigarette market consists of unauthorized, illegal products, including a wide variety of flavored products (largely disposables) that FDA has found to be highly appealing to youth. This is a wholesale failure to enforce the Family Smoking Prevention and Tobacco Control Act by FDA and other government enforcement agencies. There must be an intensified and coordinated, multi-agency federal effort to enforce the law against these illegal products in an effective and equitable manner,” the groups stated in a letter to the three agencies.

The groups urged the adoption of several concrete changes in tobacco enforcement policies and activities to bring this problem under control, including:

• The FDA should make more frequent use of the full range of available enforcement tools, especially stronger tools such as civil monetary penalties, no-tobacco-sale orders, product seizures, import restrictions, injunctive actions, and criminal prosecutions.
• The FDA must seek greater civil monetary penalties to create real incentives to comply with the law. To date, the FDA has been charging companies with only a single violation of the law and has been seeking the maximum penalty for a single violation – now only $20,678 – even when the company may be marketing hundreds or thousands of illegal products. The Tobacco Control Act gives the FDA explicit authority to charge a company with multiple violations, with a penalty of up to $1.2 million in a single proceeding.
• The DOJ must prioritize tobacco product enforcement and the process for bringing actions for injunctive relief must be streamlined. Because the FDA does not have its own litigation capability, it must involve the Department of Justice in seeking injunctive relief from courts against the marketing of unauthorized products. However, injunctions have been sought by the DOJ against only seven manufacturers of unauthorized e-cigarettes all since, October 2022. In addition, there has been a significant time lag of 13 to 19 months between the time the FDA sent warning letters to companies and the start of injunction proceedings in court, allowing companies to continue profiting from the sale of illegal products. 
• The CBP and the FDA must prioritize efforts to stop illegal importation of unauthorized products. These include unauthorized products manufactured in China, particularly flavored disposable e-cigarettes, that have generally been recognized as largely supplying the illegal market in recent years.
• Enforcement actions must be brought against all parties in the supply chain, including manufacturers, distributors, importers and retailers.
• The FDA must end the broad exercise of enforcement discretion and fully enforce the law against all unauthorized e-cigarettes, including those with pending marketing applications before the FDA. Ending “safe harbors” from enforcement is especially critical with regard to flavored products that appeal to youth.

The letter concludes, “The failure to adequately enforce the law against unauthorized products has real, and significant public health consequences. We urge FDA, DOJ and CBP to respond with an ‘all hands on deck’ strategy that will use all enforcement tools at their disposal to protect the public health, and particularly the health of our young people, from the flood of illegal, unauthorized e-cigarettes.”

According to the 2023 National Youth Tobacco Survey, youth e-cigarette use remains a serious public health problem in the United States, with 2.1 million middle and high school students currently using e-cigarettes. Nearly 90% of these youth e-cigarette users report using flavored products.