Red-Tape Continues to Stall Growth, While New FDA Dept. Head Makes Promises

In June of 2009, President Obama signed into law the Family Smoking Prevention and Tobacco Control Act, giving the U.S. Food and Drug Administration (FDA) comprehensive authority to regulate the manufacturing, marketing, and sale of tobacco products. Outside the tobacco industry, this federal regulation is little known. Inside the industry it is very well known and continues to stymie the growth of an industry that otherwise, seems to be on the up-tick in many areas, most notable (and as it applied to this blog) in the pipe tobacco segment.

While the best known segments of this legislation cover issues like cigarette labeling, advertising restrictions, funding distribution, record keeping and distribution, it also has a stipulation that states the FDA must approve new products before they hit the marketplace adding yet another level of bureaucratic red-tape that must be satisfied (and funded), before the new products can be marketed.

If you take the time to read the entire 84 pages of the document, it will not take you long to realize that the stated cause for the legislation seems to be in the protection of children from the dangers of smoking. Regardless of your position on the left or right side of the isle, I think  as pipe smokers and enthusiasts we can all agree that this is not the job of the government, but the parents to make such directives in the lives of their children. While education is truly the answer to many of these questions regarding the choice of pipe smoking or not, we as smoking enthusiasts must also readily recognize that tobacco giants have crossed some lines in the past with regards to marketing campaigns, and the purposeful manipulation of health data, not to mention the contents of cigarettes adding non-indigenous chemicals to enhance the addictiveness of tobaccos used in cigarettes. So, while any regulation will cause some to decry “Nanny-State”, some regulation is clearly justified.

Acquiescing to some regulation is one thing, requiring a reviewed approval process for each and every new product does seem to go the extreme, especially when the process takes years. Since the signing of this legislation in 2009, a back-up of over 3,500 new product applications has been created, with no real end in site. This is the summit issue for tobacco industry officials who are looking to grow their businesses, and this issue seems to have been understood by Mitch Zeller, the incoming  Director of the FDA’s Center for Tobacco Products, the branch of the FDA that oversees these applications.

The agency’s first Center for Tobacco Products director, Dr. Lawrence Deyton, stepped down this year to take a position at George Washington University, creating the vacancy that Zeller now holds. Taking much criticism from the tobacco industry insiders as being one of the original tobacco control movements biggest supporters, skepticism, as you might imagine, ran rampant at the annual tobacco Merchants Association meeting this past Thursday in Williamsburg, VA.

Attended by over 200 of the Tobacco industries executives, Zeller’s speech produced some noteworthy quotes:

Zeller promised action on the back-log of new product applications stating, “You have my word that addressing the backlog … is a high priority and that we are working diligently…” with current Obama Administration scandals rocking Capital Hill, it would hardly be a surprise to find that this back-log was not by accident. While I must make it clear that I have no evidence that the current back-log was caused by wrong-doing, but with fraud and abuse now known to have been present within the IRS and that is was clearly agenda motivated (despite denials of the same), one must wonder with such an agenda motivated Administration where the truth really lies.

FDA head Zeller also made headlines by noting, “you all make a lawful product”. This self-evident statement is good to hear nonetheless. But we cannot be reluctant to remember that Zeller is guided  and bound by legislation that brands tobacco industry members as criminals. Paragraph 35 of the introduction to the legislation passed in 2009 that amends US Code 301 reads,

“(35) Tobacco products have been used to facilitate and finance criminal activities both domestically and internationally. Illicit trade of tobacco products has been linked to organized crime and terrorist groups”

It is interesting to note that the legislation show no accredited footnotes to document this statement.

We shall see where this goes from here. For me, I’m imagining  new blends from all my favorite blenders and tobacconists. This is what we the consumer truly wait for, and hope soon comes to fruition.



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