The Smoke Free Alternatives Trade Association (SFATA) and its member companies will head to Washington, D.C. for a “Day on the Hill” Nov. 4 – 5 to meet with Congressional Representatives and senior staff legislators to discuss the rapidly growing electronic cigarette industry.
“This is a critical time for SFATA, its members and the e-cig industry at large,” said Cynthia Cabrera, executive director, SFATA. “While our industry understands reasonable and appropriate regulation is needed, it is vital our young industry not be grouped with combustible cigarettes as federal guidelines are developed for these products. Excessive regulation could limit adult access to e-cigs and stifle growth and innovation in the segment.”
The US Food and Drug Administration (FDA) set an Oct. 31 deadline to issue a proposed rule (better known as the “deeming regulation”) that would expand its oversight under the authority of the 2009 Tobacco Control Act. This law gave the FDA authority over cigarettes, smokeless tobacco and roll-your-own tobacco, and has been misapplied to allow the agency to expand its oversight to additional products, such as electronic cigarettes.
The FDA has reportedly completed the drafting of its deeming regulation and submitted its proposal to the White House Office of Management and Budget (OMB) for review by OMB’s Office of Information and Regulatory Affairs (OIRA).
Once a final draft is approved by OMB, the proposed rule will be published in the Federal Register, and the industry and consumers will be given an opportunity to submit comments, which FDA is then required to review and analyze in its final rule.
Dating from 2011, FDA has expressed its intent to include electronic cigarettes under its authority. In an August 2011 letter to stakeholders, FDA stated that other tobacco products captured by its deeming regulation would be subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.”
SFATA is encouraging the FDA and elected officials to refer to research established by credible health professionals who offer scientific evidence proving that e-cigarettes are a reliable, adult alternative to combustible cigarettes.
SFATA has already begun this process by submitting a letter to OIRA, requesting the agency rigorously evaluate the information submitted by FDA.