Product Liability

Vape maker sues FDA over new regulations

vaping e cigarette close up shutterstock 369589925 326x210 Vape maker sues FDA over new regulationsNicopure Labs LLC, a Florida manufacturer of vape products and e-liquids, is suing the U.S. Food and Drug Administration (FDA), alleging the agency is unlawfully exceeding its regulatory reach with a new rule expanding its authority to regulate the vaping market and all tobacco products.

Nicopure’s complaint comes less than a week after the FDA published the final tobacco rule May 5. The rule requires manufacturers to show the FDA that products introduced since the last tobacco rules were updated in 2007 meet federal health standards. All vaping products, including e-juice, all fall into this category. Any new products must submit an application for FDA approval before they can be marketed and sold.

In what could be a damaging blow to most vape companies, the new FDA rule also prohibits the sale of e-juice or e-liquids (flavored nicotine fluids that vaporize in the vaping device) to juveniles younger than 18 years old. The devices have become wildly popular among teenagers and much of the marketing and products target young consumers.

According to Law 360, “Nicopure said the rule will subject the overwhelming majority of the company’s products — including hundreds that are neither made nor derived from tobacco — to premarket approval, reporting, recordkeeping, inspection, labeling, manufacturing, testing and other requirements.”

The company asserts that the new regulations will severely burden its operations and cost millions of dollars. The pre-market approval requirements of the new rule will also force Nicopure to discontinue products already on the market and prevent it from introducing new ones.

Nicopure argues that all of this will ultimately “drive consumers back to cigarettes, thereby undercutting the [Tobacco Control] Act’s objectives.” The company said the new rules were arbitrary and capricious, claiming vape products provide a much safer alternative to smoking traditional cigarettes and other tobacco products.

The  company also claims the rule violates the First Amendment by barring it and other manufacturers from making truthful, non-misleading statements about their products.

“The government’s role is not to regulate for the sake of regulation; regulation must be based on sound science and robust procedure, and it must accomplish certain public health goals,” Nicopure said in a company statement.

The Department of Health and Human Services (HHS), however, says that while cigarette usage among teens has dropped in recent years, the number of young people being introduced to nicotine by way of vaping is soaring, reversing the all the strides made in keeping young people nicotine-free.

“We have more to do to help protect Americans from this dangerous addiction, and that is especially true for our youth,” HHS said.

“As cigarette smoking among those under 18 has fallen, the use of other nicotine products, and especially [vape products], has taken a drastic leap. Between 2011 and 2015, the percentage of high school students who [vape] has skyrocketed over 900 percent.”

Nicopure filed its complaint in a D.C. federal court, asking the judge to vacate the FDA’s new rule, which will go into effect in August.

Department of Health and Human Services
Law 360
U.S. Food and Drug Administration