Don’t Tell, Can’t Sell

On Friday, February 21, 2014, the FDA used its regulatory authority over tobacco products for the first time in its history when it halted the sale of a tobacco product.   One of the provisions of the FDA authority is the “prior FDA review and authorization before tobacco companies can market a new or changed product.”  The four products were all Sutra Bidis products: Red, Menthol, Red Cone and Menthol Cone.  According to the manufacturer, they haven’t sold these products in the U.S. in years.

bidis2Bidis (pronounced “bee-dees”) are “thin, hand-rolled cigarettes stuffed with tobacco, wrapped in leaves from a tendu tree and sometimes tired with a colorful string to hold them together.  They come flavored or unflavored.  A report from the Centers for Disease Control and Prevention (CDC) found 1.7% of middle school and 2.0% of high school students were current bidi smokers in 2011. According to the 2013 Florida Youth Tobacco Survey bidis have “a higher level of nicotine (3-5x the amount compared to a regular cigarette), carbon monoxide, and tar” than regular cigarettes.   Popular in India and Indonesia, youth in this country smoke them because of their novelty and higher nicotine levels.  They carry the same negative health effects you find with traditional cigarettes, such as cancers, heart disease and COPD.   Here in Florida in 2013, the numbers were higher than the national average with 2.5% of middle school and 5.9% of high school students reporting that they had tried smoking a bidi, kretek, or pipe tobacco at least once.

In the past, tobacco companies were the ones to decide which products were on or off the market.  In 2009 the Family Smoking Prevention and Tobacco Control Act gave the FDA authority over tobacco which “prohibits the introduction of a new or changed tobacco product unless the manufacturer provides evidence to the FDA that the product is either ‘appropriate for the protection of public health’ or at the very least that it is ‘substantially equivalent’ to a product already on the market and ‘does not pose different questions of public health.'” According to the FDA, the company “failed to give the agency adequate information to allow the products to remain on the market.”

This action by the FDA sends a powerful message to other tobacco companies that the FDA is serious about their “don’t tell, can’t sell” enforcement.

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