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Are FDA eCig Regulations Just Weeks Away?

By Tyler McCanus

Thursday May 14, 2015
electronic cigarette regulations are probebly going to be announced very soon

Electronic cigarette companies may need to gear up quickly, as word is spreading that FDA ecig regulations could be mere weeks away. Not that it’s the first time we have heard that new rules from the FDA are around the corner, but something about the recent batch of smoke signals makes us think this could be it.

Of course everyone is waiting on the actual details of FDA ecig regulations to come out, and with giants like RJ Reynolds, Lorillard, and Altria all lobbying to make sure the ruling fits their business models, there is certainly reason to worry. What is in store for the ecig industry as we move forward toward a more mainstream introduction to the market?

Perhaps mainstream isn’t the right word really, but when FDA ecig regulations are finally set in place we can assume that the detractors will have to tone down their rhetoric somewhat. They won’t be able to complain about a lack of control over the market, because it will then be really cemented as one that isn’t going anywhere and is under the jurisdiction of the FDA.

Unfortunately, we could also see electronic cigarette companies that aren’t from the Big Tobacco threesome of RJ Reynolds, Lorillard, and Altria be threatened in a major way. If those guys had it their way, our vaping options would be limited to say the least.

That’s why there is at least some level of concern when we hear that Susan Cameron from RJ Reynolds recently said at an annual shareholders meeting that FDA officials have indicated, “they hope to release that regulation in the next few weeks.” Perhaps that is premature, but when taken with several recent statements from industry insiders that FDA ecig regulations were indeed on the way, some even stating a target month of June, we’re starting to think that where there is smoke, there may be fire.

In fact, during a talk with congress on April 24th, U.S. Department of Health and Human Services secretary Sylvia Burwell, gave congressmen and women the impression that the FDA plans to finalize its recommendations by summer.

Maybe we should remain a little more optimistic, even in the face of all the lobbying from RJ Reynolds and the other tobacco giants. Mitch Zeller, the director of the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP), gave us some reason to think that way.

FDA eCig Regulations May Take Vaper’s Wishes Into Account

FDA ecig regulations may be impacted by public opinionIn an appearance at the Smoke-Free Alternatives Trade Association (SFATA) Conference that focused on the range of risk when it comes to nicotine products, Zeller surprised many.

In showing some understanding for the position of vapers in their approach toward nicotine, Zeller said that they were “preaching to the choir” in asking for a change in the language being used while debating ecigarettes.

Wells Fargo senior tobacco analyst Bonnie Herzog picked up on this right away.

Herzog noted “Encouragingly, Director Zeller underscored the importance of ‘opening up the dialogue’ across various stakeholders in the nicotine space, suggesting to us that he and the agency remain committed to using science and data to shape FDA ecig regulations while recognizing the nicotine continuum of risk, which is consistent with his previous comments.”

If that tells us anything about the upcoming release of the new rules to govern the ecig industry, at the very least we may be having our voices being heard. Whether or not the grandfather date for deeming FDA ecig regulations will change remains to be seen.  If the February 2007 date remains in tact, many ecig companies will experience huge challenges keeping their products in the market.

FDA Ecig Questions

Yet overall this could be a scary time for the industry. FDA ecig regulations loom large over electronic cigarette companies that aren’t backed by huge corporations like Lorillard or Altria. The final rules could make or break a lot of businesses. This is equally a nerve-wracking time for vapers who have grown accustomed to the availability of so many options.

While we look forward to having some basic standards set in place in the area of safety and marketing practices toward minors, the possible downsides are worrisome. If it really is true that an announcement is weeks or even months away, we’ll be waiting with bated breath on how this is all going to shake out. To be sure, we’ll be covering the news and providing analysis as soon as it hits. Stay tuned and cross your fingers for the best.

UPDATE:  The FDA has finalized regulations regarding electronic cigarettes and e-liquids. The grandfather date stands as of implementation on August 8, 2016. 99% of vapor products are subject to removal contingent on a very expensive FDA PMTA process. Vape shops are limited in what customer service they can offer. If you have any questions about FDA ecig regulations find out how to get them answered here.





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