What does being "grandfathered" mean?
Any tobacco product (other than those exclusively in test markets) on the market as of Feb. 15, 2007 is considered "grandfathered." Otherwise, any products that are introduced or modified on or after that date are considered "new" tobacco products and must submit a premarket application to the FDA through one of the three available pathways.
Are there any e-cigarettes that are grandfathered and could be used as a predicate for a Substantial Equivalence application?
It's possible that an ENDS product exists that may have been on the market in the United States as of February 15, 2007 and could be used as a valid predicate. However, the burden of identifying a predicate falls to the applicant, so a manufacturer would have to prove such a product is grandfathered.
The FDA expects that most ENDS products that companies submit for market authorization will utilize the PMTA pathway, which does not require a comparison to a predicate product
How can FDA regulate products that are clearly not made or derived from tobacco, such as the coils of an e-cigarette, as a “tobacco product?”
The definition of “tobacco product” comes from the Tobacco Control Act, which was written by Congress. The definition of "tobacco product" includes any product made or derived from tobacco and intended for human consumption, including any component, part, or accessory of a tobacco product. All products that meet the definition set forth by Congress, except for accessories of newly-deemed products, are now subject to FDA regulation.
As a result of the deeming rule, the existing framework that had been in place for previously regulated products – such as traditional cigarettes – is extended to newly-regulated products. So, just as the FDA regulates rolling papers as “tobacco products” because they affect how tobacco is used, the FDA now regulates the coil in an e-cigarette because it similarly affects the product in question.
I am an importer of tobacco products – what requirements apply to me?
Importers who import finished tobacco products for sale or distribution in the U.S. are considered tobacco product manufacturers. Examples of requirements applicable to importers of newly deemed, finished tobacco products include:
- Reporting ingredients, and harmful and potentially harmful constituents;
- Submitting an application for premarket review and receiving authorization from FDA before marketing new tobacco products;
- Complying with health warning requirements on product packages and advertisements; and
- Not selling modified risk tobacco products (including those described as "light," "low," or "mild") unless authorized by FDA.
Additionally, importers who own or operate a domestic establishment engaged in the manufacture, preparation, compounding or processing of a newly regulated tobacco product need to register the establishment and submit product listing to FDA by June 30, 2017 (extended from December 31, 2016).
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I have an e-liquid line coming out next week. Will I be able to sell it next week?
New e-liquids entering the market after August 8, 2016 are in violation of the law and may be subject to enforcement if marketed without authorization.
To legally sell a new e-liquid, a manufacturer must submit an application through one of the three available premarket pathways for each tobacco product and receive marketing authorization from FDA.