SFATA Inaugural E-Cig Summit Sums Up Current State of E-Law with Help of Former FDA Chief Counsel, Ralph Tyler, Esq.

Stakeholders from around the world attend inaugural e-cig summit.


Las Vegas, NV -- (ReleaseWire) -- 02/04/2013 --The Smoke Free Alternatives Trade Association (SFATA) held its 2013 E-Cig Summit, Monday January 28, 2013 at The Oquendo Center in Las Vegas, Nevada. In attendance were approximately 100 stakeholders from the personal electronic vaporizing unit (“PEVU”) segment of the market place, which included manufacturers, distributors and retail sellers of electronic cigarettes as well as representatives from The U.S. Food and Drug Administration FDA (“FDA”). The purpose of the summit was to educate stakeholders on regulatory and legal issues facing the electronic cigarette industry.

“We are extremely pleased with the overwhelming support and input members of the industry shared with SFATA and each other during yesterday’s summit” says SFATA executive director Chris Venis. “The willingness this large group of stakeholders showed in their commitment to work together, in a strategic and organized manner to achieve common goals is truly remarkable.”

SFATA is aware that the FDA plans to deem electronic cigarettes as tobacco products, which will have significant and negative consequences for stakeholders. If regulated under the current Family Smoking Prevention and Tobacco Control Act (the “Act”) stakeholders may be required to spend millions of dollars per year on testing specifically designed to prevent harm caused by combustible tobacco products like combustible tobacco cigarettes, which would be inappropriate for PEVUs such as electronic cigarettes and electronic cigars.

Another, perhaps unintended consequence of applying the Act, which was never intended to govern PEVUs, would be that consumers who currently enjoy a wide variety of e-cig flavors would likely be limited to a choice of Menthol only.

Attendees were particularly interested in hearing keynote speaker Mr. Ralph Tyler, Esq. and his thoughts on whether the FDA had proper authority to deem electronic cigarettes as tobacco products and the significance and applicability of Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891 (D.C. Cir. 2010), a case which is often misunderstood and one which Mr. Tyler oversaw while serving at FDA.

Mr. Tyler is currently a partner within Venable LLP’s Litigation and Government groups, located in Baltimore, Maryland and Washington, D.C.; he is uniquely qualified to comment on such issues.

Immediately prior to joining Venable LLP, Mr. Tyler served as the Chief Counsel for the FDA where he oversaw the FDA’s legal operations, including all counseling, litigation and enforcement matters, which included the Sottera case.

Mr. Tyler’s keynote address was entitled The Immediate Threat to the E-Cig Industry of FDA Substantial Equivalence Requirements. He informed attendees that while reasonable legal minds may disagree, it remains clear that Congress never intended the Act to apply to electronic cigarettes.

He continued by clarifying that the United States Court of Appeals for the District of Columbia Circuit in the Sottera case did not determine that electronic cigarettes are to be classified as tobacco products. Rather, the issue before the court was limited to whether or not electronic cigarettes could be classified as “drugs,” “devices,” or “combination products” not whether or not e-cigarettes could be classified as tobacco products.

Mr. Tyler noted that while the Court in Sottera held that the FDA could not classify electronic cigarettes as “drugs,” “devices” or “combination products” absent therapeutic health claims, the FDA may [not shall], deem electronic cigarettes as tobacco products under the Act if, and only if, the FDA were to issue proper deeming regulations. To date, the FDA has not attempted to deem electronic cigarettes as tobacco products and as such, electronic cigarettes are not deemed as tobacco products.

Mr. Tyler and one of his Partners at Venable, Mr. Todd Harrison, Esq. who is the Chair of Venable’s FDA practice group regularly advises clients on FDA matters, stressed the importance of industry stakeholders playing an active role in SFATA and in coming together to: (1) Implement universally accepted industry standards for Good Manufacturing Practices (GMPs) and scientific testing and (2) Communicate the standards to officials within Congress as well as to those at the White House’s Office of Management and Budget.

Other presenters included Mr. Lou Maiellano, from TAZ Consulting who discussed the evolution of the e-cig industry; Mr. Kevin Altman, a consultant to CITMA (Council of Independent of Tobacco Manufacturers of America) who spoke of the positive influence strong industry trade associations can have in shaping appropriate legislation and closing remarks by Mr. Phillip Daman, Esq. of Daman and Associates, LLC, an attorney who regularly counsels stakeholders in the electronic cigarette industry on regulatory matters and issues involving the protection and use of their intellectual property.

Mr. Daman cited the importance of reaching out to local, state and federal legislators to help educate them about e-cig technology as many city, state and federal agencies misunderstand the relevant laws and technology. By way of example, Mr. Daman pointed to an opinion letter written by the Attorney General for the Commonwealth of Virginia which was requested by Christopher Peace, a Delegate within Virginia’s House of Delegates after a constituent called him subsequent to being incorrectly told by the Virginia Department of Health that the e-cigs do violate the state's ban on smoking in restaurants or other public places. Contrary to the Department of Health’s assertion, the Attorney General for the Commonwealth stated that e-cigs did not fall within the Virginia’s ban on smoking laws because they produce “vapor” not “smoke.”

See http://www.oag.state.va.us/Opinions%20and%20Legal%20Resources/Opinions/2010opns/10-029-Peace.pdf

SFATA plans to have additional workshops in 2013 so that industry stake holders may continue to collaborate on issues such as manufacturing standards, scientific testing and lobbying initiatives to ensure that the industry does not suffer harm from inappropriate regulations. Specifically, SFATA plans to return to the White House, with many of its new members, to speak with officials in the Office of Management and Budget to discuss why FDA’s efforts to regulate PEVUs under the FSPTCA are inappropriate. To learn more about SFATA please visit www.SFATA.org.

SFATA’s E-Cig Summit 2013 was held at The Oquendo Center in Las Vegas on January 28th. Attendance was free to members of the electronic cigarette industry. The next workshop is scheduled for April 2013; details will be announced soon. Individuals seeking information about future workshops can email SFATA’s Executive Director, Mr. Christopher Venis at Director@sfata.org.

The Smoke Free Alternatives Trade Association represents a wide cross section of the “Smoke Free” industry including distributors, manufacturers, retailers and consumers of Personal Electronic Vaporizing Units such as electronic cigarettes and the liquid solutions they contain. SFATA is largest organization of its kind and is dedicated to educating members of the industry on state and federal regulatory issues, providing a framework for meaningful industry standards and GMPs, furthering the advancement of peer reviewed scientific studies and serving as an advocate capable of successfully engaging government officials on behalf of its members. Through its membership, SFATA builds the networks necessary to support outreach and research endeavors paramount to the future of the industry. For more information, visit SFATA.org.