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FDA’s Regulation Proposal Ignites Controversy in the Ecig Community FDA’s Regulation Proposal Ignites Controversy in the Ecig Community

Just a few days ago, the FDA finally revealed their plans to regulate electronic cigarettes and published a 214-page proposal detailing their upcoming ecig rules. Since then, the vaping community has erupted in controversy with opinions ranging from wildly approving to completely outraged. Here is a closer look at what some of the ecig industry leaders are saying about the regulations.

Ecig Manufacturers Approve

Overall, the large ecig manufacturers are highly in favor of the FDA proposal, giving their full support to regulatory efforts. Lorillard believes proposed changes are “reasonable” and Chief Executive Murray Kessler said the FDA was using a “science-based” approach.

CEO Craig Weiss of NJOY also felt the regulations were a good move. “By resisting calls to regulate ahead of – and indeed in opposition to – the science and data, today the FDA has brought NJOY a giant step closer to achieving its corporate mission of obsoleting cigarettes… They are encouraging signs that 10 years from now, this date will be remembered as the beginning of the end of the tobacco epidemic.”

Miguel Martin, president of Logic E-Cigarettes also spoke in favor of the FDA’s proposal. “We support and have already implemented those steps to ensure that adult smokers are the audience and consumer base of our products… we work with the retailers to ensure the product is sold to adult consumers of legal smoking ago.”

Analysts Stay Cautiously Optimistic 

E-cig analysts had a mostly positive response to the regulation, however a few questions were raised and caution was advised. Morgan Stanley analyst David Adelman said the proposal was “very light, non-disruptive and unlikely to impact” the ecig industry in the long run. But he cautioned that further, more extreme action from the FDA in the future could be damaging. 

Analyst Bonnie Herzog from Wells Fargo also felt the regulatory proposal was favorable for the industry. She predicted that it would unite the 200+ ecig companies in one common mission. However, she warned that the regulations would be most beneficial to the big industry players rather than small businesses and start-ups. “It benefits the entrenched players,” she said.

Nik Modi, analyst from RBC Capital Markets, agreed that big companies would gain the most benefit from the regulatory changes. However, Modi questioned whether the regulations would cover all vaping devices or only basic ecigs. “We find it interesting this statement does not mention vapor products (open systems, e-liquids, tanks, mods). As we have pointed out… this is currently a fast-growing category within tobacco.”

Ecig Community Outraged

The ecig community as a whole did not take the regulatory announcement very well. Within just 24 hours, there was a major outcry from industry leaders and vaping activists. People expressed deep concern and some wrote angry responses on blog posts and forums. The Smoke Free Alternatives Trade Association was among the first to condemn the FDA’s proposal. “While there is a need for appropriate and proportionate regulation of vaporizers and e-cigarettes, these products represent a new and unique category… Trying to squeeze an innovative vapor product into a regulatory structure that was designed for traditional combustible and oral tobacco products is simply not appropriate,” said a SFATA representative. 

Dr. Michael Siegel has been an important voice of reason in the vaping community and many turned to him to get a balanced look at the regulatory proposal. However, Siegel was frustrated and outraged to see the FDA regulate ecigs under section 911, classifying them as “modified risk products”. He called the proposal a complete disaster, saying, “It is going to require manufacturers to implicitly lie about the intended purpose and relative safety of their products. Sadly, the agency concluded that it is not sure that e-cigarettes are any safer than tobacco cigarettes… (this) does not say a lot for the agency’s scientific standards. The provision is going to undermine the public’s appreciation of the health hazards of smoking and prevent companies from telling consumers the truth: that e-cigarettes are a lot safer than tobacco cigarettes.”

Ecig activists group CASAA also showed frustration with the FDA, claiming the regulations would close down many small ecig businesses. “The rules would eliminate the small businesses that provide the high-quality e-cigarette products that experienced vapers prefer. The filing requirements that would be imposed on manufacturers would put small-sized, and probably medium-sized, companies out of business. Only a half dozen large manufacturers (particularly including the major traditional tobacco companies and their suppliers) would be able to meet these requirements. Moreover, any smaller manufacturer that was able to complete the filings would face the prospect of being instantly put out of business by the FDA’s ruling as soon as the grace period (24 months) expires and the FDA gets through the backlog and rules on their applications. Thus, these regulations appear to eliminate the vast majority of e-cigarette manufacturers approximately two years after they take effect.”

Perhaps the strongest response came from an anonymous e-cig supporter that immediately started a petition for President Obama to veto the FDA regulation. Within less than 24 hours, the petition had well over 10,000 signatures. It must reach at least 100,000 signatures by May 24 in order to be considered by White House officials.

The petition states, “The FDA has classified e-cigarettes as tobacco products and will now severely restrict their use. These regulations are not like those of tobacco, but instead all manufacturers will be required to complete a lengthy and expensive application just for putting new products on the market. This includes mechanical mods, variable voltage, tanks, drippers, etc. Any new model after 2015 will be required to complete this application. The FDA has overstepped their boundaries. E-cigarettes CAN NOT be classified as a tobacco product as there is no tobacco in it. They fret about nicotine, but there is nicotine in many plants including tomatoes. They fret about the flavors, yet allow Smirnoff Vodka to advertise candy and fruit flavors. Do not allow the FDA to take control of a life saving product.”

What’s Your Opinion?

Who do you think has the right perspective on the FDA regulation? Did the ecig manufacturers get it right by lending their complete support? Should we be cautiously optimistic like the market analysts? Or does the proposal call for an outraged response like we have seen from other vaping activists? We want to hear from you! Leave a comment and weigh in with your thoughts on the FDA regulation of ecigs.

Dustin Erickson

Dustin Erickson - ECR.net Editor

Dustin can lay claim as one the first e-cigarette reviewers on the internet. Back in the summer of 2009 he set out on a mission to spread the word about e-cigs with this very site. Nearly 2.5 Million visitors, 1,700 Reviews collected and 5 years later, he’s still as passionate as ever and one of the leading Vaping advocates online.