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 was created to assist the FDA in response to the Sottera case and represents the interests of the electronic cigarette industry in response to efforts by the FDA to regulate as tobacco.
Sottera Inc. v. FDA is the landmark litigation brought against the FDA in which the FDA attempted to ban the importation of electronic cigarettes under the federal Food, Drug and Cosmetic Act by characterizing them as unapproved drugs or devices.
The District of Columbia’s federal appellate court found that the FDA could not regulate e-cigarettes as a drug or device unless a company made therapeutic claims about the use of the product. In the absence of such claims, the appellate court ruled that the FDA had authority to regulate e-cigarettes under the Tobacco Act. (However, the court did not decide whether electronic cigarettes were “tobacco products”, which are defined as “product[s] made or derived from tobacco that is intended for human consumption”.)
Founded in 2011, SFATA serves as an educational and lobbying resource for manufacturers, whole-sellers, retail sellers and distributors of Personal Electronic Vaporizing Units (PEVUs) such as electronic cigarettes (e-cigs).
As the leading provider of objective, accurate information on electronic cigarettes, SFATA is dedicated to fostering communication, sharing reliable information and providing forums where SFATA members and state and federal agencies can engage in meaningful dialogue regarding public health, regulatory affairs and industry matters.
SFATA keeps members abreast of state and federal regulatory issues; serving as a powerful advocate by successfully engaging government officials on behalf of its members.
SFATA is committed to providing a framework for meaningful industry standards, Good Manufacturing Practices (GMPs) and furthering the advancement of peer reviewed scientific studies.
Through its membership, SFATA builds the networks necessary to support outreach and research endeavors paramount to the future of the electronic cigarette industry.
The Immediate Threat
Although the The FDA has not yet categorized e-cigarettes as “tobacco products” many believe it is their intention. Chapter IX of the FD&C Act subjects “tobacco products” to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and adulteration and misbranding provisions.
Chapter IX also subjects “new tobacco products” (i.e., products that are first marketed or modified after February 15, 2007) and “modified risk tobacco products” (i.e., products “sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products”) to “premarket review”.
Subjecting electronic cigarettes to pre-market review would have a devastating impact on the industry; a fact many in the electronic cigarette industry are unaware of.
The Long Term Goal
Our long-term goal is the promotion of electronic cigarettes as separate and distinct from tobacco. SFATA believes self-regulation is pivotal to the success of the industry. Self-regulation can only be achieved through the implementation of high quality standards of manufacturing and quality control. SFATA believes these standards should form the basis of a reasonable regulatory scheme for electronic cigarettes.
SFATA firmly believes a proactive approach is necessary because it is imperative for industry representatives to actively participate in a dialogue with the public as well as with the FDA.
In the aftermath of the Sottera decision, SFATA has established a strong line of communication with the FDA, and is advocating before the agency to provide a carve-out designation for electronic cigarettes – separate from tobacco regulation.
We advocate on state issues that threaten the survival and organic growth of the industry, provide informative resources, updates on state issues and programs that educate and prepare industry participants to meet compliance requirements.
We present regional events designed to promote membership while bringing together local business communities to face the challenges in their areas intelligently and cohesively.
The Bottom Line
If tobacco regulation governs electronic cigarettes, this new and innovative industry will be squelched, the marketplace will be less vibrant and consumers will lose. SFATA is working tirelessly to prevent such costly regulation from being implemented at the national and state levels.
SFATA asks for your support. Become a Member Today!