What the FDA Deeming Regulations Mean for Your Vape ShopBuckle up for some major changes ahead.
On May 5, the U.S. Food and Drug Administration finalized a rule deeming e-cigarettes, vape pens and certain other products tobacco products. That means they’re subject to the Federal Food, Drug, and Cosmetic Act — and FDA regulation. The rule goes into effect August 8, 2016.
Vape shop owners should strap in for some major changes ahead.
Among them: Sale of all vapor products to anyone under age 18 will be banned, as will free samples. Vending machine access to all vapor products, including hookah tobacco and e-cigarettes, will also be banned. Warning labels will be required on product packages and in advertisements.
Perhaps the biggest change: All vapor tobacco products that were introduced after February 15, 2007 will have to undergo the full FDA new product approval process. For products already on the market before the new rules take effect in August, pre-market product applications must be submitted by August 8, 2018. See the compliance periods here. If your shop currently produces custom vape flavors and blends, you will be required to submit each product you make to the FDA for approval.
Gregory Conley, president of the American Vaping Association, thinks the new regulations prohibiting sales to minors and requiring warning labels make sense but that the FDA has overreached with the other requirements.
In an interview with CNN he said, “The problem is the FDA is regulating with a sledgehammer instead of with a scalpel.”
He predicted that two years from now, more than 99 percent of the vapor products on the market today will disappear, not because they are unsafe “but because the small and medium sized businesses making them will not be able to afford multi-million dollar applications just to keep one single product on the market,” Conley told CNN.
On May 12, the first lawsuit challenging the deeming regulation was filed in federal court by e-liquid manufacturer Nicopure Labs. In a public announcement, the company’s general counsel and chief compliance officer, Patricia Kovacevic, said, “Today we turn to the justice system to protect our rights and the rights of our customers because we believe in its fairness.”
An effort is underway to protect existing products from the new product approval requirement. In April 2015, a bipartisan bill (HR 2058), the FDA Deeming Authority Clarification Act of 2015, was introduced by Reps. Tom Cole, a Republican from Oklahoma, and Sanford Bishop, a Democrat from Georgia. It essentially would grandfather in vape products on the market prior to August 8, 2016, exempting them from the costly and time consuming FDA approval process. You can track the bill’s progress here.
Arnaud Dumas de Rauly, president of Gaïatrend USA and treasurer of the Vapor Technology Association, said the FDA’s rule as it stands is devastating for small businesses. “The Cole-Bishop Amendment is the only immediate vehicle that can change the predicate date and save the vapor industry,” he said. He encouraged small business owners to call their representatives in Congress and express their support for the bill.
“I encourage anyone who wants to get involved to get in touch with the Vapor Technology Association through our website, as we will shortly be providing direction on the way forward,” de Rauly said.