Pep Rally or Pity Party?

Lou MaiellanoThe convenience store and tobacco industries need to respond to the FDA’s deeming regulations.

By Lou Maiellano

The U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) on April 25 released its deeming regulations, asserting regulatory authority over a variety of tobacco products. Of course, most of the attention in the press and throughout the industry focused on e-cigarettes.

This attention was an acknowledgment of the fact that CTP was asserting regulatory authority over one of the fastest growing product categories and certainly one of the most controversial.

Initially, the takeaways from the deeming regulations were split. Supporters of the products who feel they have the potential to significantly impact the traditional, combustible tobacco industry and make a positive contribution to public health were concerned that the FDA showed little flexibility in the regulations.

Those who see e-cigarettes as a diabolical innovation of the tobacco industry designed to normalize smoking and introduce youth to tobacco products-—as silly an assertion as has ever been made by otherwise serious individuals—saw the regulations as indecisive and incomplete, allowing flavored products and Internet sales to adults for now.

So there’s a lot that we don’t know now and, unfortunately, won’t know for some time.

Looking Forward
Regardless of the details of the regulations, we know that e-cigarettes will be regulated. Anybody who thought that this product category would escape regulation was wrong. As the result of the 2009 Family Smoking Prevention and Tobacco Control Act and the Sottera Ruling, CTP was designated to be the regulator of tobacco.

Now that the FDA has followed the directive of the Tobacco Act, here’s what we do know: regulation will come at real costs to the industry—costs that many in the industry have not had to budget for or incur to date. Among the rules, the CTP will demand that e-cigarette manufacturers certify to good management practices (GMP), that they responsibly label their products and they collect and submit critical data to support the quality and reliability of their products.

Without question, this will drive up the cost of manufacturing and affect the price of the products at every stage of the distribution chain.
In May, the Smoke-Free Alternatives Trade Association held its spring 2014 conference in Chicago. The mood at the conference ranged from a pep rally to a pity party. By the end of the day, attendees knew what they needed to do, which is what everyone who is invested in some segment of the e-cigarette industry needs to do immediately.

First, the FDA has established a 75-day period for comments and the first comment that stakeholders should make is going to the FDA Website to ask for an extension to the public comment period out to 180 days.

While no one is convinced that the FDA will grant a lengthy extension, there is no record of it not granting one. It’s only fair since the industry has waited three years for CTP to produce this 243-page document and then gives the public a mere 75 days to comment. It’s unreasonable and unrealistic.

Second, encourage your customers and people whose lives have been made better by their adoption of e-cigarettes to speak up. Let the FDA know that they would face significant hardship or health risks if these products are taken off the market or unreasonably regulated.
Finally, if you have solid, data- driven arguments as to why the proposed deeming regulations are inappropriate and ill-advised by all means post those comments.

That’s a great start and it’s very important information. The industry is facing a real challenge and you can make a difference.


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