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E-Cig Makers Could Go Up in Smoke with New FDA Regs


Richmond partner Bryan Haynes was quoted in a May 5 Law360 article about the FDA now having the authority to enforce regulations on e-cigarettes for the first time and how many feel that could “snuff out” the small companies that make up much of the industry.


Electronic cigarettes and nicotine liquids manufacturers, as well as producers of hookah, pipe tobacco and premium cigars, are going to have to spend potentially millions of dollars to go through the FDA’s approval process for products introduced into the market since early 2007. Companies that are able to complete the application process will still be left questioning how the FDA will react to their products given the lack of guidance on what would be acceptable.


Per Bryan, companies will be able to sell e-cigarettes and other products now under the FDA’s authority for two years before submitting an application, which the agency will have one year to review. If the agency hasn’t come to a decision yet by the end of year, then the product will be subject to being taken off the market.


“This shifts the burden of regulatory inertia from agency to the industry,” Bryan, who represents e-cigarette makers, said. “We have cigarette clients whose applications have been pending five years without any substantive review.”