When the FDA released its 241-page e-cigarette regulations proposal in April 2014, we were a little relieved. We’re already using a common sense approach, in the spirit of and in absence of regulation, with an emphasis on prohibiting the sale to minors and being transparent with our e-cigarette ingredients, as are many other e-cig companies. So what’s the FDA’s deal?
E-Cigs & the FDA: Frenemies?
While the proposed e-cig regulations weren’t quite as harsh as they could have been, they could still stall the e-cig industry and hand it over to the only groups that can afford costly regulations: Big Tobacco and Big Pharma. So how far should FDA e-cigarette regulations go?
FDA’s Premarket Approval for E-Cigs
While we have no issue with reasonable and evidence-based e-cigarette regulation, a few things in the FDA’s e-cigarette proposal concerned us. One is premarket approval.
Those familiar with tobacco regulations under the Tobacco Control Act know all about the premarket approval. Today’s tobacco regulations went into effect in 2009, with a grandfather date of February 2007. This means that any new tobacco products have to go through lengthy and expensive premarket approval from the FDA. However, most companies that have subsequently wanted to launch new products have chosen not to go through the premarket approval process, but instead go through the substantial equivalence (SE) process, which requires an existing approved product being on the market that is substantially equivalent.
If the FDA proposal goes into effect as it is written, e-cigarettes would have the same grandfather date as tobacco products – February 2007. There weren’t many e-cigarettes on the market in 2007, so this date would mean that most e-cigarettes on the market would not be able to use the SE process and could potentially face a long and costly application process.
Grandfathering E-Cigs: Turnabout is Fair Play
Recently, the e-cig industry gained a powerful ally: Congress. Yup. Congress. Members of Congress, led by political doghouse resident and House Majority Leader John Boehner, have come out in support of rational e-cigarette regulations. In a letter to the U.S. Health and Human Services (HHS) Secretary Sylvia Burwell, Boehner and his colleagues argued that existing e-cigarette products need to be grandfathered in as of the April 2014 date that the FDA e-cigarette regulation proposal was released.
Without this grandfathering, it would be next to impossible for smaller, less funded companies to get premarket approval for e-cigarettes, which is the FDA’s whole point. Vaping advocates estimate that 99% of the vapor industry will be wiped away without amending the grandfather date listed in the deeming rule. Basically, it appears that Boehner and Co. want to grant e-cig companies the same exemptions Big Tobacco got in their own industry. This would give a lifeline to smaller companies (like ours), providing adult consumers with the choices of products they want and, ironically, potentially keep Big Tobacco from dominating the e-cig industry that they only recently joined. Think the tobacco industry can recognize irony when they see it?
Common Sense E-Cigarette Regulations
We recently spoke up to challenge a lot of the e-cig safety concerns that is becoming ubiquitous in the media – and we will continue to do so. Rampant misinformation can lead to emotional, politicized and harsh e-cigarette regulations. The thing is, you’ll find that most e-cigarette companies are already taking measures to protect kids and to ensure that their e-cig products are manufactured to the highest standards, while focusing on an adult target audience.
People who truly care about public health should be embracing electronic cigarettes, as this Forbes.com opinion piece suggests. It’s just common sense, which is basically the message that some members of Congress are sending to the FDA. (We hope they are listening with open minds.)
What’s your view? What do you think about the FDA’s proposed regulations, and how far do you think they should go?