Expensive e-cig approval process clouds the industry’s future.
On May 5, the Food & Drug Administration issued a press release that detailed the organization’s new regulations on Electronic Nicotine Delivery Systems (ENDS). These include vaporizers, hookah pens, and electronic cigarettes, as well as the liquid that goes inside them. Although they don’t contain tobacco, e-cigs will soon be treated like all other tobacco products. Here are the five things you need to know about the changing vape market.
E-cig popularity is soaring, especially among kids and teens. From 2011 to 2015, e-cigarette use shot up from 1.5 percent to 16 percent among high school students and from 0.6 percent to 5.3 percent among middle school students, according to the FDA. Another of their studies found more than 3 million middle and high school students smoked e-cigarettes in 2015.
Under 18? You won’t be able to buy e-cigs as of August 8, in person or online. Anyone shopping for vapes will be required to verify their age with a valid photo ID, much like when buying cigarettes and alcohol. “As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap,” says Health & Human Services Secretary Sylvia Burwell. “All of this is creating a new generation of Americans who are at risk of addiction.”
Nearly all e-cig batteries, tanks, and e-liquid flavors on the market must now pass an expensive application for federal approval. The FDA will require manufacturers to show that the products meet its public health standard unless they were on the market before February 15, 2007. Zak Laikin, executive director of the Vapor Association of Indiana, says the cost of compliance in the proposed FDA approval process has been estimated to be several million dollars per product. “The proposed federal regulations, as they stand today, would be devastating to the industry as a whole,” Laikin says. “This will stifle innovation and restrict access to a product many consumers claim has helped them escape the well-proven hazards of combustible tobacco.”
That new application process could spell trouble for your local vape shop. Manufacturers can continue to sell their current products without approval for up to three years. This will allow them to submit applications for two years, which the FDA will review over a year’s time. Industry experts said this costly procedure could mean only the largest tobacco companies will stay in the e-cig business.
The long-term health effects of vaping are still not known. The FDA said the regulations will help them prevent misleading claims by tobacco product manufacturers and assure the evaluation of the ingredients in the products. Many varieties of e-liquid contain nicotine extracted from tobacco, though non-nicotine juices also exist. Laikin supports regulation, but explains that he believes states are better suited to regulate the industry. He says an FDA approval will be wildly more expensive than following Indiana’s new law.
Indiana will begin regulating e-liquid on July 1. The law requires e-liquid makers to obtain a permit from the alcohol and tobacco commission before bottling or selling their product. Laikin explained that the new law will provide safer products for consumers. He said Hoosiers will be assured that e-liquids sold in Indiana are produced in a clean, monitored environment, and that formulations are consistent, packaging is child-safe, and labeling is accurate. “Vape consumers may not realize that prior to this law, anyone could produce e-liquids in any environment, using any ingredient he wished to include,” Laikin says. “If a bad batch were to hit the streets and cause harm, there was no mechanism for tracking the product so that investigators could determine who was responsible or fully identify the potential impact on public health.”
As part of the state permit application, each store must enter into a five-year agreement with a security company. Mike Cline, owner of Indiana’s first vape store, Indy Vapor Shop, agrees that regulation is important because nicotine can be a dangerous product. He said that the state legislation created a monopoly, however, because only one company in the United States can currently fulfill the strict security requirement. “We welcomed regulation as an industry,” Cline says. “Regulation was needed to protect us and the consumer. Then it became very apparent that the objectives of the state and federal government were not truly to regulate for the betterment of public health, but to eliminate the industry.”
The law could also prevent Indiana vape shops from selling liquids made out of state by manufacturers that cannot comply with the requirements. Many vape shops, even those that produce their own e-liquids, sell a mix of products made by other manufacturers.
