SFATA ISSUES STATEMENT ON FDA’S FINAL DEEMING RULE

SFATA ISSUES STATEMENT ON
FDA’S FINAL DEEMING RULE

Largest Vapor Trade Association Says New Regulations Problematic
President and Executive Director Cynthia Cabrera Available for Media Interviews

WASHINGTON, D.C., May 5, 2016 — The Smoke-Free Alternatives Trade Association (SFATA), the largest trade association representing and managing the interests of the vapor industry, today issued the following statement regarding the Food & Drug Administration’s (FDA) final deeming rule on e-cig and vapor regulations:

“As the Royal College of Physicians, one of the world’s leading medical associations, recently released its historic report endorsing vaping as a harm reduction option, stating that regulations should not inhibit the development or use of vapor products, the FDA today issued its final rule classifying vapor products as tobacco, essentially banning 99 percent of all vapor products on the market as a result of the February 15, 2007 predicate date.

“Although the FDA states it has found a vapor product on the market in 2006, it has yet to be determined whether the far more technologically advanced vapor products on the market today can be considered substantially equivalent to that product.

“Our industry has a long history of supporting sensible science-based regulations, including license requirements, as well as banning sales to minors and adopting child-resistant packaging. Today’s final rule pulls the rug out from the nine million smokers who have switched to vaping, putting them in jeopardy of returning back to smoking, which kills 480,000 Americans each year and costs the U.S. more than $300 billion in annual health care expenses.

“These new regulations create an enormously cost-prohibitive regulatory process for manufacturers to market their products to adult smokers and vapers. It also limits access to the 40 million adult smokers in the U.S. yet to make the switch to vaping and cripples a multi-billion dollar job-creating industry, the majority of which are made of small businesses.

“Since a growing body of scientific evidence confirm that vapor products are more than 95 percent less harmful than combustible cigarettes, it is essential that Congressional action be taken so vapor products can remain on the market as highly effective replacement tools for smokers. The only viable option at this time is to change the predicate with federal legislation, such as H.R. 2058 (aka Cole Bill), as well as a recent bi-partisan amendment introduced by U.S. Representatives Tom Cole (R-OK) and Sanford Bishop (D-GA) that recently passed the House Appropriations Committee, so that a more reasonable substantial equivalency pathway to market is created.”

SFATA Member-Only Conference Call Tomorrow

Following today’s release of the FDA’s deeming regulations, we understand that our members are looking for accurate information for your business.

To give SFATA members an in-depth, quality analysis of the regulations and to cut through the speculation and rumors that are already out there, we will be hosting a members-only conference call tomorrow, May 6th at Noon ET/9am PT. SFATA President and Executive Director Cynthia Cabrera will be joined on the call by our regulatory lawyers.

SFATA members have already received an email with the call in information. If you have not received that email, please contact Robert House at Robert@SFATA.org.

0 comments ↓

There are no comments yet...Kick things off by filling out the form below.

Leave a Comment