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Pathways for an FDA E -Cigarette Premarket Authorization

Pathways for an FDA E -Cigarette Premarket Authorization

Pathways for an FDA E -Cigarette Premarket Authorization

FDA Pre Market Tobacco Applications

The FDA regulations recently deemed a number of products, including electronic cigarettes and e-liquids, as tobacco products. According to the Food, Drug and Cosmetic Act (FDCA), all newly deemed tobacco products that were not on the market in the U.S. before February 15, 2007 are required to obtain premarket authorization from the FDA of their products.

According to the FDA, there are three pathways for premarket authorization:

  1. Substantial Equivalence (SE)
  • A SE tobacco product has been found by FDA to either have the same characteristics as a predicate tobacco product; or has different characteristics than the predicate tobacco product, but the information submitted demonstrates that the new product does not raise different questions of public health.
  • A predicate tobacco product is one that was commercially marketed in the United States (other than in a test market) as of February 15, 2007, or a product previously found to be substantially equivalent by FDA and in compliance with the requirements of the FDCA.
  • If the new product raises different questions of public health, the product is not SE.
  1. Exemption from Substantial Equivalence
  • A tobacco product that is modified by adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive, may be considered for exemption from demonstrating SE if:
  • The product is a modification of another tobacco product and the modification is minor
  • The modifications are to a tobacco product that may be legally marketed under the FDCA
  • A SE Report is not necessary to ensure that permitting the tobacco product to be marketed would be appropriate for the protection of public health
  • The modified tobacco product is marketed by the same organization as the original product
  • An exemption is otherwise appropriate
  1. Premarket Tobacco Product Applications (PMTA)
  • Tobacco products not meeting either of the above, must submit a PMTA when seeking authorization for any new tobacco product.
  • PMTA’s must provide scientific data to demonstrate that the new tobacco product is beneficial to the population as a whole including users and non-users.
  • Must include:
  • Full reports of all information published/known/reasonably known to the applicant concerning investigations which have been made to show the health risks of such tobacco product and whether such tobacco product presents less risk than other tobacco products;
  • A full statement of the products: components; ingredients; additives; properties; principle(s) of operation; a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of the product;
  • An identifying reference to any tobacco product standard which would be applicable to any aspect of such tobacco product, and either adequate information to show that such aspect of such tobacco product fully meets such tobacco product standard or adequate information to justify any deviation from such standard;
  • Samples of the product and of components as the FDA may reasonably require;
  • Examples of the labeling proposed to be used for the product; and
  • Other information relevant to the subject matter of PMTA as the FDA may require.
  • Upon receipt of an application, the FDA will determine if the application can be accepted and then filed for substantive review.
  • If an application has a deficiency, FDA will refuse to accept it.

As the electronic cigarette and e-liquid industry is relatively young, it is anticipated that majority, if not all, of the manufacturers will need to go through the PMTA process. The FDA estimated that the new approval process will cost “several hundred thousand dollars,” but industry insiders anticipate costs to be in the millions as several thousand hours will be required to complete the PMTA. For those companies able to complete the costly and time consuming PMTA process, it is unclear how the FDA will actually view the PMTA.


If you are in the e-cigarette/e-liquid/ENDS industry and need help navigating the stringent FDA regulations, the attorneys at Brown & Charbonneau, LLP can help. Call us today at 714 406-4595 or email for more information.