Taking a Look at The Smoke Free Alternatives Trade Association
October 22, 2013
Taking a Look at The Smoke Free Alternatives
By Cynthia Cabrera, SFATA Executive Director
The e-cig industry is a disruptor, turning the tobacco industry on its head,
empowering consumers and creating a
new multi-billion dollar industry. But, in the
long run who will be able to reap the windfall brought on by this nascent industry?
The World Health Organization, the Center for Disease Control and the Surgeon
General have for many years agreed that
tobacco use is harmful, and in particular, that
smoking tobacco cigarettes is very harmful in various ways. Despite the well-known dangers
of cigarette smoking and the public policy arguments in favor of reducing tobacco consumption such as lower health care costs, efforts to reduce tobacco consumption have not been as effective as one would expect over the past several decades. Reducing tobacco use is a significant benefit that has the potential to change our society for the better and an objective that the FDA and anti-smoking groups across the globe have been trying to achieve for decades.
I believe a major problem right now is that FDA and anti smoking groups seem to view vapers and the act of vaping as indistinguishable from smokers and smoking when the two are in reality very different things. Given the stigma smoking has earned, and the harm it causes, there is a strong push by FDA, various Attorney Generals, and legislators at the federal, state and local levels. These groups and individuals confuse smoking with vaping and attempt to regulate vaporizers in the exact same manner as cigarettes. This doesn’t make sense, and would be a huge mistake on many levels as it would unfairly stifle the industry, deny millions of adults an alternative to tobacco and stifle one of the most prolific segments of our economy. That’s bad news for an industry that’s largely comprised of small companies and entrepreneurially-minded individuals
The Smoke Free Alternatives Trade Association (SFATA) exists in part to help educate smaller and mid-sized companies as to what we consider to be acceptable advertising, manufacturing and marketing protocols and to serve as a powerful voice for them in our nation’s capital as well as in their own backyards where many of them are being unfairly treated as though they were tobacco companies.
At SFATA we are constantly engaging and educating regulatory officials and legislators at the federal, state and local level on behalf of our members. Our membership grows each month as more companies look to collaborate to achieve common goals and to obtain guidance and support as the industry expands and become more complicated.
To date, SFATA is the largest e-cig trade association and is comprised of sophisticated companies in the industry who are looking to work together to help protect common interests. Business owners and consumers of e-cigs and e-cig accessories can help in a variety of ways:
Become a member of SFATA. While different companies may not always agree on every initiative, as some affect others differently in the marketplace, its important to have an industry that speaks with a unified voice on the issues that everyone agrees are most important. SFATA is committed to engaging with government agencies and elected officials in an effective manner—to communicate industry messages that smaller and mid-size businesses would not normally able to convey. We employ FDA experts, as well as attorneys and staff who specialize in the areas that affect our industry and are able to be of the most help as they have a profound understanding of the regulatory, legal and business issues that are unique to the vaping community.
The way consumers and business owners talk about vaping needs to be different.
As a business owner, your message and your right to communicate it, is different than that of a consumer and that’s an important distinction. A consumer can talk about his or her vaping experience with impunity and in ways businesses cannot.
A consumer can advocate about what they see as any benefit vaporizers provide them with. Perhaps the availability of flavors keeps that consumer interested in using his or her personal vaporizing device rather than tobacco cigarettes? Perhaps he or she has cut down use of tobacco cigarettes and have saved money? Perhaps he or she feels better having switched to vaping from smoking. There are many compelling, important and amazing stories that vapers share about how vaping has changed their lives for the better. It’s important that consumers and consumer advocacy groups make those statements so that elected officials, government agencies and others unfamiliar with vaping understand consumers’ point of view.
Business owners have a responsibility to sell and advertise products as intended and governed by law. While it is fine for consumers to share their personal stories, business should never make or endorse health or smoking cessation claims. Doing so could, arguably, subject such a business to being regulated by the FDA as a tobacco product under the current state of the law.
Instead, craft your message as a business owner and focus on the economic impact this product has given you. Focus on the jobs you’ve created, the taxes you pay, the properties you rent and how you’ve assisted your community financially. Attend meetings and stay in tune with what is happening in your community. Visit the SFATA website to get more information about issues in your state. Rally your customers to attend meetings as well; have them share their stories. It’s important to engage with legislators and be part of the process as they are responsible for making decisions that affect your community and they need to hear from you.
Whatever the case is, consumer or business, advocating for an industry and the right to use new technology requires a lot of work. Consumer and businesses that engage and communicate with lawmakers have the ability to effectuate positive change. Legislators care about and listen to their constituents. Our website has tools to contact elected officials and information business owners can utilize for themselves and relay to their elected officials and communities in support of the industry.
The 499-page document places all vapor products under the jurisdiction of the Tobacco Control Act of 2007. Under the changes, vapor products including e-liquid containing no nicotine, will be held to the same requirements.
Numerous vaping advocacy groups have already denounced the regulations. The American VapingAssociation, in a statement, referred to the regulations as “downright prohibition.”
On Twitter this morning, AVA President Greg Conley noted that the regulations effectively freeze the market to new products 90 days after they are published. Any product moving forward that is not already on shelves, would have to go through theprocess immediately, as opposed to being allowed two years for compliance.
SFATA also weighed in on the discussion earlier this morning
“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,” according to SFATA President and Executive Director, Cynthia Cabrera. “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.”
The regulations include federally requiring age identification, banning of vending machines, free samples and a laundry list of other items. As we at VAPE Magazine are still investigating the documents, more will come in the near future.
Specific warning label instructions are included in the regulations as well, with active manufacturers having 24 months to come into compliance.
In addition, all products — hardware and e-liquid — will have to go through one of two processes to reach the public. The pre-market tobacco application would have to be completed; otherwise manufacturers will be required to show substantial equivalence to a product on the market prior to February 15, 2007.
SFATA is challenging this date with the idea that virtually no products were on the market at that time.
“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,” Cabrera said in a statement. “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.”
More information, reaction and specific requirements will be posted later today.
Corey Noles is the managing editor of VAPE Magazine. He has worked as a journalist for more than a decade and is the founder, owner of Inked Up E-Liquid Co.
Earlier this year the Child Nicotine Poisoning Prevention Act of 2015 was signed into law. Many members have asked what it means for them and how they can be sure they comply with the new law. SFATA members are invited to a member-only webinar on this topic on Wednesday, May 11, at 2 p.m. ET/11 a.m. PT.
The bill requires any nicotine provided in a liquid nicotine container sold, offered for sale, manufactured for sale, distributed in commerce, or imported into the United States to be packaged in accordance with the Consumer Product Safety Commission’s (CPSC’s) standards and testing procedures under the Poison Prevention Packaging Act of 1970. This webinar will review: the steps required to initiate testing, how the testing occurs, the testing process, and testing documentation.
SFATA is working with Lori Mitchell Dixon, Ph.D., from Great Lakes Marketing to bring this important information to SFATA members as implementation of the law approaches. Lori brings more than 30 years of packaging research and marketing consulting experience to your projects. She earned a doctorate in strategic marketing with minors in statistics and international business. Her academic training combined with front-line experience make her marketing insights and product innovation research invaluable.
Lori is an active member of several ASTM committees related to child-resistant packaging. She is also an active member of the Canadian Standards Association and the National Poison Prevention Week Council.
Great Lakes Media is an accredited lab and has been testing child resistant packaging since the enactment of the Poison Prevention Packaging Act in 1970. Located in Ohio, the company holds a GSA contract and has a staff of about 40 professionals.
Members have received a registration email. Email SFATA at Robert@SFATA.org if you have not.
The Food and Drug Administration’s announcement last week rocked the vaping industry. New rules stating e-cigarettes will now be subject to the same regulations of traditional tobacco products, a move which will change the face of the multibillion dollar industry, with experts expecting to see 99 percent of the American e-cigarette market cease to exist.
multiCIG, one of the UK’s leading independent e-cigarette brands, supplying vaping devices and UK-made award-winning e-liquids to both high-street and independent retailers across the country, as well as selling online through www.multicig.co.uk, shared this press release with Agent VAPE regarding its views on the regulation:
According to the FDA guidelines, the majority of brands will have to seek federal permission to continue marketing their products, as well as submitting a pre-market application which will evaluate their influence on public health. Companies will now have two years to submit the relevant data, as well as paying FDA user fees. The process is time consuming and expensive, and it is expected that many independent e-cigarette companies will not be able to meet the necessary demands to keep their products on the market place.
Christian Mulcahy, business development director of multiCIG, explains why he thinks the decision by the FDA will be detrimental to the independent e-cigarette market in the USA, and how this might foreshadow the fate of its British equivalent.
“As a result of e-cigarettes coming under federal jurisdiction in the States, all products introduced since 2007 will have to seek approval from the FDA. What this means for the marketplace is a consolidation of the sector, with smaller independents being unable to compete against the harsh time frames and expenses it will take to keep them in business. Not only will this result in less choice for the consumer but it jeopardizes free enterprise, creating an environment where the bigger brands have the monopoly and it is likely prices will go up. The European TPD has taken a much lighter touch in their regulations, so in the UK we will not see as much of a detrimental impact, but we will certainly be faced with some challenges nonetheless.”
This information comes just before the implementation of the European Tobacco Products Directive on May 20, which are not as severe as their U.S. counterparts but have likewise faced similar backlash from some health officials. Both reports from Public Health England and most recently The Royal College of Physicians have shown e-cigarettes to be significantly less harmful than traditional tobacco alternatives, and neither the FDA nor the TPD take into account the positive effects that e-cigarettes are having on the reduction of tobacco consumption which are also detailed in these findings.
There are currently around 2.6 million e-cigarette users in the UK, and studies by both ASH and the Smoking Study Toolkit had confirmed the vast majority are long-term ex-smokers. With e-cigarettes being the most popular method of tobacco cessation in the UK, a boundary on their accessibility could disrupt attempts to encourage more consumers to switch from traditional tobacco to less harmful electronic alternatives.
The Food and Drug Administration’s new commissioner did not waste any time: new vaping regulations will be in effect in 90 days: the agency announced Thursday.
In the regulations:
the sale of e-cigarettes of those 18 and under is prohibited
no more free samples of e-liquids
the FDA will govern everything in the industry: manufacturing, labelling, to distribution of products.“Manufacturers will now be required to report all ingredients and their facilities will be subject to health and safety standards. Vape shops will need to check photo ID and will no longer be able to let customers sample products before buying,” Motherboard.vice.com reports.
“This final rule is a foundational step that enables the FDA to regulate products young people were using at alarming rates, like e-cigarettes, cigars and hookah tobacco, that had gone largely unregulated,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, said in a press release. “The agency considered a number of factors in developing the rule and believes our approach is reasonable and balanced. Ultimately our job is to assess what’s happening at the population level before figuring out how to use all of the regulatory tools Congress gave the FDA.”
“The rules keep in place a grandfathering date for existing products that were on the market as of February 15, 2007. That means that any product that wasn’t on the market before that date now has two years to complete a lengthy, costly application process. In the new rules, the FDA estimates this process will take companies 1,500 hours to complete, for each individual product, plus an additional 200+ hours to do an environmental assessment—a time and cost constraint that the industry worries could choke out companies. Since the vaping industry really only started to emerge around 2006 and 2007, the vast majority of products currently on the market came out after that date, “Motherboard reports.
“The FDA now estimates that filing a PMTA will take over 1,700 hours per product, which brings the estimated cost for a single application up to over a million dollars [based on previous FDA cost estimations],” said Gregory Conley, the president of the American Vaping Association, a nonprofit advocacy group, told Motherboard. “This gigantic price tag is affordable to Big Tobacco companies, but small and medium-sized businesses will be crushed. This is not regulation, it is prohibition that will cost lives, kill jobs, and further entrench America’s largest cigarette companies.”