Troutman Sanders tobacco practice partner Bryan Haynes was quoted in a February 27th Reason article titled “FDA Cigarette Regulations Protect Big Tobacco, Not Public Health.”
As we previously mentioned, last week the FDA ruled against four brands of bidis, labeling them as “Not Substantially Equivalent” and banning their sale in the United States. The FDA’s Center for Tobacco Products (“CTP”) touts the order as being “historic” and showcasing the “power of regulation.” However, what has not been mentioned was that those four brands had not been commercially marketed since 2010 when the flavored cigarette ban took effect. Indeed, the company’s regulatory filings apparently were so lacking they did not even include predicate product information – some of the most basic information asked for by the CTP. Their denial was low-hanging fruit for the FDA.
Since 2009, over 4,000 applications for new tobacco products have been received by the CTP. Although products proven to be in-market before March 2011 have provisional status and are able to be sold, some 500 applications languish. Nearly three years have passed, and the FDA has only granted or denied a handful of these applications. As Haynes states, most were relatively easy decisions.
The major takeaway from the lack of progress is this: What do the slow wheels of progress mean for the cigar and e-cigarette markets? Cigars, especially, would be greatly affected by the effort it currently takes to get a new product approved. In a market that is more comparable to wine than tobacco, where hundreds of small-batch runs and premium products dominate, the inability to innovate would be crippling. If the same logic and procedure that is currently being applied to cigarettes is applied to cigars, the market would grind to a halt. Director Zeller has stated that he “recognized that the cigar market is different” – but until the deeming regulations are made public, it is impossible to tell if his recognition will have a positive impact on the industry.
The burgeoning e-cigarette market is in equally dangerous waters. With a product so new to the market, the ability to be flexible and innovate is imperative. Moreover, as some types of liquid used in e-cigarettes are not even derived from tobacco and some even lack nicotine, can the CTP even regulate them as they would a tobacco product?
Many questions await the industry as they anticipate the next flexing of the CTP’s regulatory muscle.
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