Lawmakers Blast FDA for Rise of Illegal Vapes

The agency is struggling to justify the need for additional resources to combat illegal vape products.

A bipartisan group of powerful House lawmakers are doubtful of the Food and Drug Administration’s proposal to begin collecting fees from e-cigarette companies, akin to how the agency charges fees to tobacco firms.

FDA officials say that the fees would give regulators resources to tackle the thousands of illegal vapes lining store shelves.

Lawmakers on the House Energy & Commerce Committee questioned whether the FDA’s Center for Tobacco Products (CTP), which has struggled for years to police the vaping industry, is capable of effectively using allocated funds.

The agency is caught in a Catch-22 situation. Some lawmakers are demanding that the FDA crackdown on illegal e-cigarettes before receiving more funding, but the FDA argues that it needs additional funding to boost its enforcement efforts.

CTP Director Brian King attempted to persuade lawmakers that the agency has taken significant action against vape companies selling illegal products. This includes imposing fines on retailers, seizing products at the border, and filing injunctions against manufacturers in federal courts. Lawmakers from both sides questioned if the agency was taking sufficient action.

New Jersey Rep. Frank Pallone said that while he hopes e-cigarette user fees would “make a difference,” he was skeptical of whether the FDA would be able to rein in the illegal vape market. “I hate to say it but you just make it seem hopeless to me,” he said.

Tony Abboud, executive director of the Vapor Technology Association (VTA), said the FDA’s Center for Tobacco Products (CTP) created a flawed and broken premarket tobacco product application (PMTA) process. He explained that the House committee hearing revealed that, under King’s leadership, CTP continues to approve combustible cigarettes while also denying millions of e-cigarette PMTAs at a 91:1 ratio.

“Director King’s statement that there is ‘no safe harbor’ for companies with pending applications clearly demonstrates that CTP continues to move the scientific goalpost and is not truly committed to harm reduction for Americans who smoke,” said Abboud. “Cigarette smoking continues to be the leading cause of preventable death and disease in the U.S., yet Director King calls for more money to remove less harmful products from the market.

“The CTP must acknowledge the undisputed smoking cessation benefits of e-cigarettes, authorize a diverse marketplace of flavored nicotine alternatives to cigarettes, and stop approving new cigarettes.”

House Energy and Commerce Committee Chair Cathy McMorris Rodgers said that out of more than 26 million applications for electronic nicotine delivery systems (ENDS) products and has authorized fewer than 50 products.

“However, according to recent market data, those products only account for about 10 percent of sales, showing how behind the FDA is with keeping up with the demand,” she said. “The lack of clear enforcement policy and authorized products leaves tobacco users, distributors, and convenience stores in the dark on what products they can use and sell to those that are looking for alternatives to traditional cigarettes.

“Companies need clear guidelines on what is required to meet the standard for authorization and what changes to products require new applications.”

The CTP currently collects user fees from cigarette and cigar companies. However, it requires Congressional approval to begin collecting user fees from vaping product manufacturers. The agency has been advocating for this change for some time. This change is estimated to increase CTP’s budget by approximately $114 million from its current budget of over $700 million.

Half of this additional funding would be allocated to increasing enforcement efforts, according to STAT News.

The hearing, titled “Evaluating FDA Human Foods and Tobacco Programs,” was House lawmakers’ first chance to question both King and Jim Jones, the FDA’s deputy commissioner for Human Foods. King joined the agency in July 2022. Jones joined last September.