FDA bans US sale of 4 bidis...which weren't being sold for years, anyways

The first ban under 2009 Family Smoking Prevention and Tobacco Control Act has been issued - FDA has banned the sale and import of "bidi" products made by an Indian company because these products did not meet regulatory standards.

The Sutra line of tobacco products manufactured and imported by Jash International, based in Pune, have failed to meet the standard requirements of the Tobacco Control Act, and may no longer be legally imported and sold in the United States. Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone and Sutra Bidis Menthol Cone have already been ordered off the shelves, and any stocks that remain on the shelves after 30 days will be seized by the FDA.

"New tobacco products that FDA determines to be 'Not Substantially Equivalent' (NSE) to predicate products can no longer be legally imported, sold, or distributed in interstate commerce, and failure to comply may result in FDA initiating enforcement action-such as seizures or injunctions - without further notice," the FDA has said in a statement.

Bidis are thin, hand-rolled cigarettes made with leaves from the tendu tree, stuffed with tobacco, and tied with a colorful string. They are very popular in India but not in the US, although there is a small market for them, composed of adolescents who can appreciate their novelty.

Bidis pose a threat to the health of adolescents and the Centers for Disease Control and Prevention (CDC) has found that in 2011, about 1.7 percent of all middle school students and 2 percent of all high school students smoked bidis. The CDC has explained that smoke from a bidi, "contains three to five times the amount of nicotine as a regular cigarette and places users at risk for nicotine addiction."

Smoking these unusual cigarettes also increases the risk for oral, lung, stomach, and esophageal cancer. Risk for coronary heart disease and acute myocardial infarction are also three times more likely to occur in bidi smokers, while chronic bronchitis is four times more likely to occur. Emphysema is also closely related to bidi smoking.

The bidis were banned because their manufacturer has failed to provide information on the ingredients in the bidis, data which is necessary to determine any changes in their characteristics which may pose hazardous to public health. The FDA's drive is currently focusing on regulating precisely these undocumented ingredient changes. This particular ban came after the Surgeon General issued a report that cigarettes now are not the same as cigarettes before, and that cigarettes now are more likely to cause lung cancer compared with cigarettes formulated and manufactured decades ago.

"We don't want any tobacco products out there that we don't know what their ingredients are," said David B. Abrams, executive director of the Schroeder Institute for Tobacco Research and Policy Studies at Legacy, a nonprofit group in Washington. "But also because we don't want anything out there that's inexpensive, and therefore easier for kids to get a hold of."

Incidentally, the banned bidis have actually not been sold in the U.S. for the past couple of years. Nevertheless, this ban would ensure that the bidis shall no longer be legally sold even if people try to buy it.

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