The increase in e-cigarette use over the past decade has been nothing short of explosive. In a brief span, e-cig companies like Juul have overtaken industry veterans that have controlled the market for smokers focused on switching from traditional tobacco to electric alternatives.

Unfortunately, the new craze may have some drawbacks. The lucrative and somewhat novel nature of e-cigs has left the Food and Drug Administration (FDA)struggling to safely regulate the surge of new players arriving in the e-cigarette market while maintaining consumer freedom. This has led to some dangerous occurrences amid e-cig companies and users.

E-Cigarette Injuries: Burns and Explosions

A recent study published in MedPage Today found a large number of injuries associated with electronic cigarettes, such as explosion and burns. The injuries arise from unstable batteries suddenly detonating, leading to third-degree burns and shrapnel-related injuries. NBC News and The Daily Beast have all reported on the injuries, citing the cause as device defects in which lithium batteries overheat and then explode.

MedPage reports that from 2015 to 2017, over 2,035 e-cig explosion and burn injuries required hospitalization. It is also noted that this is a 40,000 percent increase from 2009  to 2015. That means that 40 times more injuries have occurred in the past 3 years than in the 6 years prior.

Dr. Anne Wagner, medical director of the University of Colorado Hospital Burn Center, told The Denver Post that almost all e-cigarette burns have required skin grafts. Multiple third-degree burns have been reported, she said. Other serious injuries include the loss of eyes and teeth, in addition to in the form of 38-year-old Tallmadge D’Elia.

Erectile Dysfunction Drugs in E-Cig Liquids

In addition to the physical risk posed by e-cig components, there is also a concern about the materials within the vape pen liquid. In an FDA surprise inspection of China-based HelloCig Electronic Technology Co., two active ingredients in erectile dysfunction drugs (sildenafil and tadalafil) were found in products, including one called “E-Cialis HelloCig E-Liquid.” This led to a warning letter against the company.

While it may seem to be an interesting discovery, the FDA has a different stance on this inclusion. The FDA cites risks of serious side effects and safety violations as a result of combining oral medication into an inhalable vape liquid. Many medications, including insulin, are being converted into inhalable liquids with only minimal oversight since the FDA did not originally anticipate this use for the vape pens.

“[Erectile dysfunction drugs] are . . . PDE-5 inhibitors, and the labeling on the e-liquids failed to disclose the substances, . . .This makes them misbranded under the Federal Food, Drug and Cosmetic Act.”

One reason for this sudden crackdown is the devastating effect these drugs could have on adolescents, one of the largest users of e-cigarettes. FDA Commissioner Scott Gottlieb has begun a crusade to tackle e-cig use in adolescents, declaring war on e-cig companies marketing to teens as in a September press announcement. Juul, in particular, was addressed for intentionally marketing to teenagers.

“Everything is on the table,” Gottlieb said in a statement. “This includes the resources of our civil and criminal enforcement tools.”

“If the companies don’t know, or if they don’t want to know, that straw purchases are occurring, . . . the FDA has both civil and criminal remedies at its disposal,” leave little to the imagination as to the severity of Gottlieb’s mission to stop “what I now believe is an epidemic of e-cigarette use among teenagers.”

The future of e-cigarettes is looking much different than it did at their inception. With the FDA commissioner pushing for regulation on one side, and consumer injuries from faulty products on the other, e-cig manufacturers are finding themselves being backed into an uncomfortable corner. It seems as though the wild west of e-cigarette companies may soon see settlements as FDA increases pressure for transparency in labeling, pre-approval of products, and a total shutdown of adolescent marketing.

“If the companies don’t know, or if they don’t want to know, that straw purchases are occurring, . . . the FDA has both civil and criminal remedies at its disposal,” leave little to the imagination as to the severity of Gottlieb’s mission to stop “what I now believe is an epidemic of e-cigarette use among teenagers.”

While some may be concerned about the freedom of a buyer’s market, Gottlieb’s position is crystal clear. The future of e-cigarettes may be one of the mandatory regulations to ensure a safe, controlled alternative to their combustible brethren.

The FDA won’t tolerate a whole generation of young people becoming addicted to nicotine as a tradeoff for enabling adults to have unfettered access to these same products,” Gottlieb said.