FDA Exercises Its Authority

In 2009, the Family Smoking Prevention and Tobacco Control Act was signed into law giving the Food and Drug Administration (FDA) “authority to regulate the manufacture, distribution, and marketing of tobacco products.”  One such authority involves “regulating new tobacco products to make sure they don’t cause additional or heightened public harm than existing products.”

Pall_MallOn Tuesday the FDA exercised that authority and R. J. Reynolds was hit with a ban on sales in the U.S. on four of its cigarette products: Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13.  The FDA found that these cigarettes “were not substantially equivalent to their respective ‘predicate’ products (i.e. products that were commercially marketed as of February 15, 2007) as identified by the manufacturer.”  Camel Crush was released in 2008 in the U.S. prior to the Act being signed, but after the 2007 date used by the FDA.  According to the FDA, the tobacco company “failed to demonstrate that these changes don’t make them more appealing, more addictive or more harmful.”  The products have been ordered off the U.S. market immediately.

What made Camel Crush cigarettes so interesting is each cigarette contained a bead or crushpowerball” of flavor that when bitten down on released a strong mint or menthol flavoring that infused the filter with flavor.  Putting the beads into the filter allowed the smoker to decide whether or not they wanted a menthol experience when they smoked. The beads allowed the company to essentially have several flavors of cigarettes, each with the capability of becoming a menthol cigarette as well.  According to Matt Meyers of Campaign For Tobacco-Free Kids, “the Camel Crush Bold style delivered menthol at higher levels than previous products, added sugars and other sweeteners, had new filters and tested differently for harmful and potential harmful constituents.”

One business analyst suggested that these are simply new versions of old products.  And while they didn’t change the tobacco, they did introduce higher levels of flavoring and additional sweeteners into the filter, making for a different experience for the smoker. With the additional sweeteners you are also making a product more appealing to youth. The cooling effect of the menthol reduces the harshness of the tobacco, making the smoking experience smoother smoke, and allowing the smoker to inhale the smoke deeper into the lungs making addiction easier.  The four brands mentioned above only make up less than 1% of RJ Reynolds’ sales volume so the effect on the bottom line won’t be dramatic. About 30% of smokers use menthol cigarettes, but about 57% of youth smoke menthols. If menthol was totally removed from the market, it could have a dramatic reduction in the number of youth who start smoking.

In 2013 the FDA ruled against Lorillard on four new products but allowed two others to go to market.  This new ruling removes highly flavored menthol products.  It will be interesting to see where the FDA stands in the future on menthol products.

Click HERE and HERE for more information on this subject.

 

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