Suggested Trump Admin improvement – End The Illegal ENDS Epidemic

Authored by Roderick Law via RealClearHealth,

As President Trump and border czar Tom Homan set about getting control of our southern border, they have an opportunity not only to clamp down on the horrors of human trafficking and drug smuggling. They can also deal a blow to the Chinese companies that make $3.5 billion a year selling contraband e-cigarettes and vapes in the U.S. and the Mexican cartels that smuggle them.

It is estimated that 98 percent of the electronic nicotine delivery systems (ENDS) sold in the nation are illegal products, and most of them are made in China. They are cheaper, more potent and manufactured with far less health and safety regulation than American products. Often, the products are flavored, packaged and branded to appeal to children and adolescents.

Last summer, the Food and Drug Administration (FDA) finally got serious about the flood of untested and possibly hazardous products that find their way from China to U.S. convenience stores. The agency launched a taskforce with the Department of Justice to crack down on vape smuggling. In October, it announced that it had seized $76 million worth of contraband vapes. In December, authorities interdicted $81.5 million worth of e-cigarettes and vapes just in Chicago.

While fighting smuggling and holding retailers accountable for selling illicit products are productive steps, the FDA has it in its power to impact demand for contraband vapes. The FDA’s Center for Tobacco Products (CTP) has had jurisdiction over e-cigarettes since 2016. To sell new tobacco products in the United States, companies must file a “premarket tobacco application” (PMTA) and receive a “marketing granted order” (MGO) from the CTP. Companies pay “user fees” to the FDA to cover the cost of the research and testing on the products.

E-cigarettes and other vapes have been marketed as a healthier alternative to smoking – delivering nicotine without tar and some other byproducts of tobacco. They have helped many smokers quit and are therefore considered a harm-reduction tool. But the CTP has approved just 34 new products out of 26.6 million applications since 2019. Nature abhors a vacuum, and so does the ENDS market. Users want selection and low prices. Retailers want product for their shelves. Illegal Chinese vapes fill the void.

On the surface, CTP seems like low-hanging fruit for Elon Musk’s Department of Government Efficiency. But efficiency isn’t the real problem. Ideology is. On nicotine, the FDA shares a prohibitionist mindset with the anti-smoking activist groups it works closely with. In fact, it shares a revolving door with those special interests. The FDA has taken it upon itself to limit the availability of harm-reducing ENDS.

The CTP allegedly does a lot of goalpost moving. In December, the U.S. Supreme Court heard arguments in a case brought by two domestic vape manufacturers who maintain the agency pulled what the 5th Circuit Court of Appeals characterized as a “regulatory switcheroo.” The companies say the agency changed standards and imposed new requirements for approval after the companies submitted their PMTAs. Asked by Justice Brett Kavanaugh why the companies were suing the FDA instead of simply resubmitting amended applications, their lawyer cited the agency’s glacial approval pace. The companies simply “can’t afford to wait that out.”

For their part, retailers have long complained that the FDA is unclear and even evasive about what products are legal for sale. The agency moved to address the issue by launching a Searchable Tobacco Products Database. But inexplicably, the database didn’t include two of the most popular products on the market, Zyn and Juul. They’re legal products. The FDA notes that the database “is not an exhaustive list of all tobacco products that can be legally marketed.” Then why bother with a database at all?

The problem of illegal, potentially dangerous Chinese vapes lining the shelves of gas stations and smoke shops can’t be fought on just one front. President Trump has promised (indirectly) to staunch the flow of products from across the Mexican border. The CTP needs to do the job Congress gave it and process applications. If it won’t, it and the FDA more broadly need a serious housecleaning.

Roderick Law is the Communications Director for the Functional Government Initiative. He is a graduate of the George Washington University, with a BS in international affairs and a MA in security policy studies.