U.S. Sen. Ron Johnson is asking the U.S. Food and Drug Administration whether the agency considered how many businesses could shut down over e-cigarette rules. Credit: Associated Press

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How many businesses will shut down as a result of the FDA's new regulations on electronic cigarettes?

U.S. Sen. Ron Johnson (R-Wis.) is asking the U.S. Food and Drug Administration whether the agency considered that question when it devised rules requiring FDA review of e-cigarettes and other products derived from tobacco.

"I write to request your assistance in understanding the consequences that this new regulation may have on small businesses and the public's health," Johnson wrote this week in a letter to FDA officials.

Johnson cited concerns of a Hartland-based vapor company whose top executive called the regulations "catastrophic" and suggested that the regulations would put tens of thousands of people out of business nationwide.

E-cigarettes and other vaping devices used to inhale nicotine have been unregulated and gaining popularity since hitting the U.S. market in 2007 — growing to a roughly $3.5 billion industry, according to analysts. Industry trade groups estimate that there are roughly 8,000 e-cigarette and specialty vape shops nationwide.

The FDA announced new rules earlier this month banning sales to minors, requiring ingredients to be included on labels and mandating a pre-market review of all such products, among other provisions.

Pre-market reviews can cost hundreds of thousands of dollars, possibly millions depending on the number of products.

"The costly impact the rule will have on e-cigarette manufacturers will stifle innovation and make it harder for e-cigarette companies to continue to offer products that serve as an alternative to smoking," Johnson wrote.

Johnson — noting that the Senate Committee on Homeland Security and Governmental Affairs is authorized to investigate the efficiency and economy of all branches of government — also questioned how the government settled on the regulations given the available data about the potential benefits and possible harms. Public health experts debate the risks that e-cigarettes present especially when compared with conventional cigarettes.

Studies have shown electronic cigarettes and e-liquids used for vaping can contain diacetyl and 2,3-pentanedione, two flavoring chemicals associated with serious and sometimes fatal lung disease.

Researchers at the Harvard T.H. Chan School of Public Health called for "urgent action" last year after their study found 39 of 51 e-liquids tested had diacetyl.

Before that, a cardiologist in Greece found diacetyl and 2,3-pentanedione in nearly 75% of the 159 samples of sweet flavored e-liquids that he tested.

An investigation by the Milwaukee Journal Sentinel last year found diacetyl is sometimes present in e-cigarettes and liquids even when manufacturers claim it's not. Manufacturers often trust their flavor suppliers and don't always test for the chemicals. When they do, the testing method often used isn't sensitive enough to detect lower levels, the investigation found.

Diacetyl was tied to deaths and serious lung disease in hundreds of workers in the microwave popcorn industry in the early and mid-2000s and more recently in coffee workers.

The chemical is also present in conventional cigarettes. Studies differ on the concentrations and public health experts argue diacetyl could play a role in lung disease in smokers.

Arguments that e-cigarettes help people quit smoking are anecdotal and not based on scientific evidence, FDA officials said in defending the regulations. The agency is involved in dozens of studies examining the potential benefits and risks of e-cigarettes.

Johnson wondered whether the agency would issue a "revised rule" if it finds sufficient data indicating that e-cigarettes are safer than conventional cigarettes.

He asked the FDA to respond to his questions by the end of the month.

Read the investigation

Read the Journal Sentinel's investigation into the dangers of the chemical diacetyl, which is commonly found in e-cigarettes and the coffee-roasting process, at jsonline.com/gaspingforaction.