How Vaping Can Survive FDA Rules

Association executive lays out legislative alternatives to restrictive ‘deeming’ regulations

WASHINGTON – As newly "deeming" federal regulations cast an ongoing pall over the entry of new tobacco products into the market, retailers are concerned over what the future holds for e-cigarettes and vaping as viable products in their stores.

To get a better idea of that future—especially in light of the recent bankruptcy of e-cigarette player NJOY, Scottsdale, Ariz., last month—the newly appointed executive director of the Washington, D.C.-based Smoke-Free Alternatives Trade Association, Pamela Gorman, sat with CSP for a robust question-and-answer session.

Q: What effect did the NJOY bankruptcy this past fall have on the industry as a whole?

A: We do not comment on individual companies. It is clear, however, that the U.S. Food and Drug Administration’s new deeming rule classifying vapor products as tobacco is having an adverse impact on our industry, which is primarily composed of small- and medium-sized businesses. Many such entrepreneurial businesses may not have the financial resources to comply with these draconian regulations, which essentially could eliminate nearly all vapor products on the market as a result of the ridiculous nature of the Feb. 15, 2007, predicate date in the Tobacco Act, combined with an impossible premarket tobacco approval (PMTA) requirement for anything that was not on the market at that time. Congress must act now to save our industry and keep vapor products on the market as alternatives to combustible tobacco.

Q: You mentioned legislative measures. Can you elaborate? What’s the status of these measures and what will they do?

A: Congress must change the Feb. 15, 2007, “predicate date” to Aug. 8, 2016, as there were no vapor products on the market on the original date, so it is really a ridiculous requirement for a new product category. There is legislation in the form of a bipartisan-sponsored amendment called the Cole-Bishop Amendment, which would modernize that predicate date for today’s modern product offerings. It passed the House Appropriations Committee and could be headed to a vote by the end of the year as part of an Omnibus bill, if our U.S. representatives and U.S. senators will impress upon their leadership the importance of this issue. Because of the time left in the legislative cycle, we feel this is our best chance to solve this through an act of Congress and we’ve encouraged every business owner and consumer of these products to reach out to their Congressmen to request they take this seriously and go to their party leadership quickly to be sure those people also understand this is important in their respective caucuses. Modernizing this predicate date is hugely important, because the current law will otherwise force every product off the market that wasn’t being sold in 2007.

The new FDA regulations recently imposed on vapor products inherited this date from the underlying tobacco law and didn’t update it for modern-day products. FDA claims it cannot change the date and so we turned to Congress to fix this problem in the 2009 law that created it. New products deserve a new date, since vapor products as we know them today weren’t sold commercially in the U.S. in 2007. Everything will technically become illegal if this isn’t changed. We at SFATA have been working aggressively with our own federal lobbyists and other industry groups to help ensure that the House Appropriations language (the Cole-Bishop Amendment) is included in the final spending bill. At the same time, SFATA is currently participating in the Right to Vape Tour, a cross-country mobile bus tour to spread advocacy about vapor products and meet with representatives in Congress so they recognize this unrealistic predicate date for our industry, and deliver us an 11th-hour “save” by making this simple, common-sense correction to the law. Updating this predicate date keeps our products legal, allows for the rest of the FDA regulations to continue to be applied, and gives us some time to pursue more appropriate regulations.

Q: Other thoughts?

A: People ask about who we are, so I tell them we were founded in 2012. And in that time, the Smoke-Free Alternatives Trade Association (SFATA) has become the largest trade group representing and protecting the interests of the vapor industry, with more than 1,400 members and 28 state chapters located across the country.

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