The e-cigarette industry warned Thursday that the FDA's move to regulate its products will end up shutting down entire businesses and product lines, and said it's pushing for Congress to avoid that outcome with a legislative tweak to the rule.
The Food and Drug Administration issued a final rule on Thursday outlining how it will regulate e-cigarettes and other products such as cigars and hookahs. The rule has a grandfather date that says any e-cigarette product made after February 2007 must be submitted to the FDA, which will review the ingredients, product design and health risks.
But the e-cigarette industry says the 2007 date makes no sense, as there were hardly any e-cigarettes on the market back in 2007. Gregory Conley, American Vaping Association president, said the date will cause real harm to the industry.
"The FDA's refusal to modernize the February 2007 predicate date will cause a modern day prohibition of products that are recognized worldwide as far less hazardous than cigarettes," he said Thursday. He added that without a change to the law or relief from the courts, "thousands of small businesses will close in two to three years."
The agency has countered that the date was in a federal law that gave the FDA the power to regulate tobacco products, and notes that it is giving businesses three years to submit an application for products already on the market.
Tony Abboud, legislative director for the trade group Vaping Technology Association, said the industry's next move is to keep pushing for a change to the law, which is has already been seeking in a House appropriations bill.
Industry groups lobbied for the inclusion of an amendment into the latest FDA funding bill that changes the grandfather date to when the regulation is finalized, which is Thursday. The amendment was successfully included and the funding bill was sent to the House floor.
However, the administration opposes the riders added to the bill on tobacco regulations, FDA officials said during a press call Thursday.
Rep. Tom Cole, R-Okla., one of the lawmakers behind the amendment, called the rule part of President Obama's "regulatory overreach and nanny-state mentality."
While Cole approves of the ban in the rule on e-cigarette sales to minors, he said in a statement that his amendment provides regulations without harming small businesses and "treating law-abiding adults like naive children."
Meanwhile, Conley said a lawsuit against the rule could be filed in the coming weeks.
"I'd expect a lawsuit to be filed by a coalition of small- and medium-sized businesses in the next month," he said.
Abboud told the Washington Examiner that it is too early to tell whether his group will sue the FDA over the rule.
"This 500-page document came out within the last couple of hours," he said. "Everybody is trying to figure out exactly what is in here and make that determination first."
However, Abboud said that a court challenge is "certainly within the realm of possibility."