Durbin puts FDA on blast over unauthorized vape sales

WASHINGTON (CN) — An explanation to Congress is needed for why the Food and Drug Administration is dragging its heels on enforcing federal law governing the sale of e-cigarettes, a top Senate Democrat said Thursday in a letter to the agency.

“There are thousands of vaping products on the market in violation of the law,” Senator Dick Durbin said in the letter addressed to FDA Commissioner Robert Califf and Attorney General Merrick Garland.

Durbin points to the Tobacco Control Act as requiring vape manufacturers to demonstrate to the FDA that their products satisfy certain public health requirements. “Yet this statutory pre-market review requirement is not properly enforced by our federal agencies,” the Illinois Democrat argued, tying the lack of enforcement to increased use of e-cigarettes among young people.

Albeit with restraint, Durbin tipped his hat to the Department of Justice, which litigates on behalf of the federal food regulator. Last year the agency filed six injunctions against manufacturers that were selling e-cigarettes without proper authorization.

But that number pales against the number of vendors sidestepping the law, the senator said.

While the FDA has said that it aims to review 99% of the 26 million authorization applications it has received, Durbin said those efforts will be in vain if the agency can’t keep illegal products off the market. “Every single day in America," his letter states, "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.”

The Senate majority whip referenced 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 commended the FDA for its Feb. 24 announcement that it would host a summit with the Justice Department aimed at strengthening tobacco regulations enforcement in the wake of the Reagan-Udall report.

“It was long overdue,” the senator said. “It is important that DOJ and FDA improve collaboration to address the barriers to enforcement that jeopardize public health, especially as it relates to our children.”

E-cigarette sales have skyrocketed over the last decade. According to a 2022 report from the Federal Trade Commission, vape sales among the six largest vendors skyrocketed to over $2 billion in 2018 from just $300 million in 2015, three years prior.

Around 41% of 2018 sales were flavored e-cigarette products, which the commission contended are more popular among young people. Conversely, tobacco-flavored vapes made up roughly 21% of sales.

Follow @BenjaminSWeiss

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