US: FDA Nomination Provides Hope For Tobacco Farmers

Source from:  Forbes 04/11/2017

　　Last month, President Trump revealed his much anticipated pick to lead the Food and Drug Administration (FDA). His choice, Scott Gottlieb, was a deputy at the FDA during the George W. Bush administration. President Trump has tasked Gottlieb with speeding up the drug approval process as he highlighted during his joint address to Congress just a few years ago. But times have changed at the FDA since Gottlieb’s first term, with the scope of what the FDA now regulates being greatly expanded.

　　Thanks to the passage of the Tobacco Control Act in 2009, the FDA now has the authority to regulate all tobacco products. Since then, the FDA has wielded this authority with little regard to how their regulations would affect small businesses.

　　The latest issue to draw the ire of the FDA is a product known as "dark tobacco." This tobacco is used exclusively for products such as chewing tobacco and dip, as opposed to traditional cigarettes. Although these products represent a small part of the overall tobacco market, they have a large impact on our home states of Kentucky and Tennessee.

　　Dark tobacco is grown exclusively in southeastern Kentucky and northern Tennessee. There, some 1,200 farmers produce 66 million pounds of dark tobacco with a cash value of over $170 million a year according to industry data. But the production in the area doesn’t just stop with growing. The tobacco is also stored, cured and eventually processed all in the same area, bringing with it thousands of jobs and millions of dollars in economic activity.

　　The new rules by the FDA wouldn’t explicitly ban dark tobacco from being in products, but would do so for all practical purposes by creating regulatory standards that would be impossible to comply with. The rule would require all dark tobacco to have N-Nitrosonornicotine, or NNN, levels of 1 part per million or less.

　　One of the reasons that this standard is wildly unrealistic is that the level of NNN in dark tobacco is partially dependent on the weather, specifically the amount of moisture an area received while the crop was growing. So even if the industry did everything they could to meet this standard, which is impossible, a particularly moist season could leave a farmer with a crop that is totally worthless

　　To add insult to injury to this industry these destructive proposed rules came literally hours before the end of the Obama administration, presumably because the FDA knew this proposed rule wouldn’t have been allowed under a Trump administration. Although the Obama years were notorious for "midnight regulations," this one takes the cake. Enditem