FDA to delay enforcement of e-cigarette rules

The Trump administration is delaying the enforcement of first-ever rules for electronic cigarettes.

The Food and Drug Administration (FDA) said in a court filing this week that it would defer enforcement of all future compliance deadlines under the new rules for e-cigarette products for three months, as it asked a federal district court judge in Alabama to delay the case that Cyclops Vapor 2 LLC brought against the agency challenging the rules.

Judge Charles Coody granted the e-liquids distributor and FDA’s joint request to delay the lawsuit by three months to give the new administration time to look at the Obama-era rule. 

{mosads}Cyclops is challenging the rule the FDA finalized last May, which requires companies to go through a costly approval process for products that hit store shelves after Feb. 15, 2007, get FDA approval before making advertising or labeling claims, register manufacturing facilities with the agency and open facilities for biannual inspections.

The rule also gave the FDA the authority to require warning labels on products, restrict sales, mandate new product safety standards and create requirements for product testing.

Manufactures were given 12 months after the rules took effect in August to request an exemption from product approval requirements, 18 months to submit an application proving the product has a substantial equivalent already on the market and 24 months to submit an application for pre-market approval.

Cyclops claims the rules will keep the company from being able to introduce new e-liquids and force it to discontinue existing product.

Sen. Ron Johnson (R-Wis.) praised the Trump administration for delaying what he called a “burdensome rule.”

“This rule threatens an emerging industry, as well as former smokers who have switched to vaping,” he said in a statement. 

“While this is only a first step, I am hopeful that the administration will permanently rein in this regulation so that the e-cigarette industry can continue to provide safe products that help save lives.”

Johnson has asked both Vice President Pence and Health and Human Services Secretary Tom Price to consider repealing or suspending the rule.