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Tobacco Watchdog Expands Its Reach: A Primer

What Is The FDA’s Authority?

Since 2009, the Food and Drug Administration, based on authority it gained from Congress, has regulated cigarettes, smokeless, and roll-your-own tobacco. But it has been working to enact a regulation to extend its authority over all tobacco products, including e-cigarettes, cigars and pipe and hookah tobacco. That regulation was finalized in May and went into effect on Aug. 8.

What Happens Broadly for These Products?

As of Aug. 8, it became illegal to sell e-cigarettes or cigars to minors, although most states already had adopted such a prohibition. Free samples are also now prohibited. Companies are also no longer allowed to introduce new kinds of e cigarettes or cigars unless they get so-called premarket authorization from the F.D.A. By December, manufacturers must also register with the F.D.A. and submit lists of their products, including labeling and advertisements. Any products introduced since February 2007 are considered “new products” and will have to seek some kind of F.D.A. marketing approval.

What Happens to Cigars?

Certain cigars, like e-cigarettes, may be considered “new tobacco products” and have to undergo a thorough premarket review to determine if they are “beneficial to the population as a whole.” But most other cigars have either been around since before 2007 or will be able to argue they have “substantial equivalence” to cigars on the market before 2007, meaning they also would essentially be grandfathered. The cigar companies argue that even these “substantial equivalence” reviews will be expensive and they fear they will be forced to submit different applications just because a cigar differs in size. As a result, they predict many cigar manufacturers, particularly those smaller businesses that sell hand-rolled products, will be put out of business, and consumers will have less choice. The F.D.A. acknowledges that certain cigars may be removed from the market. But it estimates applications per cigar product for the less onerous substantial equivalence reviews should cost only between $1,500 and $22,787, depending on what type of application is submitted.

What Also Happens to E-Cigarettes?

Any e-cigarette introduced since 2007 – essentially all of them –must now receive retroactive market approval by going through an application process to examine whether the “product prompts young people to become addicted to nicotine, reduces a person’s interest in quitting cigarettes, and/or leads to long-term usage with other tobacco products.” Companies have until August 2018 to file their applications that must list all ingredients, components, and additives and include an analysis of the impact their products will have on public health. The F.D.A. estimates these reports will cost in the “low- to mid-hundreds of thousands of dollars,” while industry executives predict they could cost $1 million or more, perhaps putting many companies out of business. Companies then have until 2019 to get approval for e-cigarette products, or they will need to be removed from store shelves. Thousands of vape shops that now mix their own e-liquids, at a minimum, will most likely no longer be allowed to do this, and will instead have to sell preapproved products.

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