Guidance from FDA About the Pre Market Tobacco Application (PMTA) Process

Guidance from FDA About the Pre Market Tobacco Application (PMTA) Process

The US Food and Drug Administration (FDA) deemed all “tobacco products” within its authority and subject to the Tobacco Control Act (TCA). FDA has made available extensive information regarding tobacco products and the new regulations.

With regard to selling newly deemed tobacco products, manufacturers those products that were not commercially marketed in the United States as of February 15, 2007, will now be required to obtain premarket authorization of their products before they can be sold. There are three pathways to obtain the authorization, but the Pre-Market Tobacco Application (PMTA) will be the path that almost all vapor products will need to follow given that the e-cigarette and e-liquid industry is relatively young.

The PMTA process requires detailed information be submitted to the FDA prior to its approval of any newly deemed tobacco product. FDA has recognized that the PMTA process has raised numerous questions concerning compliance. As such, FDA has created a detailed information page on their website to address various questions and concerns.

FDA has also been issuing guidance to help the industry understand, and comply with, all regulations and the law. In September 2011, FDA published Applications for Premarket Review of New Tobacco Products. In May 2016, FDA published guidance titled “Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems”

Note that FDA guidance documents are only recommendations, unless specific regulatory or statutory requirements are cited.

The e-cig/e-liquid attorneys at Brown & Charbonneau, LLP are up to date on all of the relevant issues affecting the industry, including the FDA’s deeming rule and related requirements, and are prepared to assist you. To learn more, 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