FDA Deeming Regs Discussed at NACS


Don Burke

Electronic nicotine delivery systems face hazy future because of stricter a regulatory policy.

By CSD Staff

Because of the deeming rule published by the U.S Food and Drug Admiration earlier this year, more tobacco products now fall under the same scrutiny as cigarettes. Today, cigars, pipe tobacco, other tobacco products including vape items and e-cigarettes face stricter regulations, however, the popular and fledging vapor industry faces a threat of being snuffed out.

That was one of the significant observations Don Burke, senior vice president with Management Science Associates Inc., a diversified information management company made by at NACS 2016 in Atlanta Oct. 20. In a session called “The Impact of FDA Deeming Regulations on the C-Store Tobacco and Vapor Business,” attendees learned the potential future for electronic nicotine delivery systems (ENDS), also called e-cigarettes, personal vaporizers and vape pens.

The FDA deeming rule that took effect Aug. 8, 2016 touts key provisions:

– bans sales of all deemed products that aren’t on the market on Aug. 8, 2016,

– bans manufacturers/retailers from making truthful health claims about deemed products,

– bans free sampling of all deemed products to adults,

– bans sales of deemed products to anyone under 18, and

– requires photo ID of consumers appearing under 27 who tries purchase products.

Burke explained that that while the primary onus of the regulatory policy remains on manufacturers, retailers must pay heed to the provision enacted in this past August

However, as most retailers have also learned, one key hallmark of the FDA regulations is that as of Aug. 8, 2016, no new vaping products are allowed on the market. Because the FDA considers virtually any change in a product to constitute a new product, this means that the deeming regulations will essentially freeze the vaping market. From that date forward, not only will companies not be able to introduce new products, but they will also be unable to make changes in their existing products.

Such changes would require a new product application, which is prohibitively expensive for most companies.

“It’s going to kill the vapor category,” Burke said.

Aside various manufacturers that have filed lawsuits deeming the new regulations harmful to their businesses, the National Association of Convenience Stores (NACS) is throwing its considerable weight into the fray, via a new education program designed for social media.

Lyle Beckwith, NACS’ senior vice president of government relations, explained that the initiative, Stop the Vape Ban, provides a platform for retailers and their consumers to speak directly about their thoughts on the ill-effects of the FDA policy.




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