Compliance with Premarket Tobacco Product Applications (PMTA) Requirements
Compliance with Premarket Tobacco Product Applications (PMTA) Requirements
FDA’s PMTA Requirements
The FDA has deemed e-cigarettes, eliquids, and devices as “tobacco products” within its authority and subject to the Tobacco Control Act (TCA). As a result, when manufacturers create a new “tobacco product” (one that was not on the market in the U.S. before February 15, 2007) or modify a tobacco product in any way, they must obtain an order from FDA authorizing the marketing of the product before the product may be introduced or delivered for introduction into interstate commerce. There are three pathways to obtaining an order from the FDA: substantial equivalence, exemption from substantial equivalence, and the premarket tobacco product application (PMTA).
The PMTA will be the path that almost all vapor products will need to follow given that the electronic cigarette and e-liquid industry is relatively young. Manufacturers of e-cigarettes, eliquids, and devices will have 24 months to submit a PMTA application. After an application has been submitted, manufacturers will have an additional 12 months to market products.
The PMTA seeks highly detailed information regarding tobacco products. It is completed online through the Center for Tobacco Products (CTP) Portal. The PMTA must include the following information:
- Full reports of all information, published or known to, or which should reasonably be 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 tobacco product’s components, ingredients, additives, properties and 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, such tobacco 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;
- Such samples of such tobacco product and of components thereof as the Secretary may reasonably require; and
- Specimens of the labeling proposed to be used for such tobacco product; and such other information relevant to the subject matter of the application as the Secretary may require.
Upon receipt of an application, the FDA will determine if it can be accepted and then filed for substantive review. FDA has proposed to refuse to accept procedures for premarket tobacco product submissions.
If the application is accepted, the FDA then will conduct a filing review to determine whether the application is complete. If the application is complete, FDA will file the application and begin substantive review.
After completing its review, FDA intends to issue an order within 180 days after receipt of the Premarket Tobacco Application that the new product may or may not be introduced or delivered for introduction to consumers.
The e-cig/e-liquid attorneys at Brown & Charbonneau, LLP are up to date on all of the relevant issues affecting the industry and can assist you with the PMTA process. To learn more about how we can help you, call us today at 714.406.4397, or e-mail to set up a consultation. For more information about the e-cigarette, e-liquid and ENDS industry, please click here
ENDS Attorney Gregory G. Brown
