Durbin Criticizes FDA for Unauthorized Vape Sales

In a letter addressed to FDA Commissioner Robert Califf and Attorney General Merrick Garland, Durbin called for an explanation to Congress for why the agency is dragging its feet on enforcing federal law governing the sale of e-cigarettes.

Durbin pointed out that there are thousands of vaping products on the market that violate the law, and the Tobacco Control Act requires e-cigarette manufacturers to prove to the FDA that their products meet certain public health requirements. He argued that our federal agencies are not properly enforcing this statutory pre-market review requirement, which is related to the increase in e-cigarette use among young people.

Durbin commended the Department of Justice, which litigates on behalf of the federal food regulator, for filing six injunctions against manufacturers that were selling e-cigarettes without proper authorization last year. However, he noted that the number of vendors sidestepping the law is much larger.

Although the FDA has stated that it aims to review 99% of the 26 million authorization applications it has received, Durbin claimed that these efforts would be in vain if the agency cannot keep illegal products off the market. He stated in his letter that “Every single day in America, children pick up vaping with unauthorized products that are on store shelves only because FDA has seemingly granted these illegal e-cigarettes a free pass.”

Durbin referred to a December study from the Reagan-Udall Foundation, an independent FDA watchdog, which found that the agency lacks transparency in how it enforces the sale of vape products. The study also concluded that Justice Department procedures have made it difficult for the regulator to bring forward tobacco-related cases for litigation.

Durbin demanded that the FDA and Department of Justice explain why they have yet to hold unauthorized e-cigarette manufacturers accountable under the law, particularly those that he said are marketed to children. The senator also directed the agencies to provide information about their policies regarding enforcement of noncompliant companies.

Meanwhile, Durbin praised the FDA for its February 24 announcement that it would host a summit with the Justice Department aimed at strengthening tobacco regulation enforcement in the wake of the Reagan-Udall report.

E-cigarette sales have skyrocketed over the last decade, with flavored e-cigarette products accounting for around 41% of 2018 sales, which the commission contended are more popular among young people. The Federal Trade Commission reported that vape sales among the six largest vendors skyrocketed to over $2 billion in 2018 from just $300 million in 2015, three years prior. Conversely, tobacco-flavored vapes made up roughly 21% of sales.