Proposed Nicotine Rules Could Put 99 Percent of Vape Shops Out of Business

The U.S. Food and Drug Administration (FDA) is expected to unveil new rules sometime in the next two months that will require federal approval for nearly all flavored nicotine juices and e-cigarette devices sold in vape shops.

Manufacturers will have to spend between $2 million and $10 million to gather data and assemble an application for each item they want the FDA to consider for approval, the regulatory consulting company SciLucent LLC explained to The Wall Street Journal (WSJ). The Smoke-Free Alternatives Trade Association, a lobbying group representing vapor shops and companies, estimates those costs will drive 99 percent of the industry out of business.

“We call it vapocalypse,” Daniel Walsh, chief executive of PureBacco USA LLC, a Gaylord, Michigan-based maker of a liquid nicotine called Flavorz, told WSJ.

Once the FDA completes the rules, companies will have six months to register products and ingredients with the agency, and two years to complete the application process. According to WSJ, the regulations will likely cut the supply of liquid nicotine and substantially increase costs for shop owners and prices for vapors. Big Tobacco companies like Atria Group Inc. and Reynolds American Inc. will be minimally impacted by the changes, since they have their own e-cigarette brands and have the funds to afford the approval process.

E-cigarettes were introduced in 2008 and were touted as a safer alternative to smoking traditional cigarettes, and were advertised as a smoking cessation method, but their long-term effects are unknown. The devices are especially troubling to health officials, anti-tobacco groups and lawmakers due to the increasing number of children being poisoned by the liquid nicotine used in e-cigarettes. A U.S. Centers for Disease Control and Prevention (CDC) study released in April shows teen e-cigarette use tripled in 2014. Health officials and anti-tobacco groups say e-cigarettes could be a gateway to traditional cigarettes, WSJ reports.

The FDA said in a statement obtained by WSJ that the new rules will help it “learn more about these products and ultimately ensure that newly regulated products cause no worse harm to users.” The agency also said it will give small businesses time to comply with the new rules.

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