LEXINGTON, Ky. — The attempts of the U.S. Food and Drug Administration (FDA) to limit N-nitrosonornicotine (NNN) in smokeless tobacco products is causing concern to the tobacco industry.

 

NNN, a class of carcinogens known as tobacco-specified nitrosamines, is labeled as a harmful or potentially harmful constituent in tobacco products by the FDA. Proposed guidelines would limit the levels of NNN to 1 microgram per gram, or one part per million (ppm) at any point through the product’s labeled expiration date.

This would be especially harmful to those growers who raise dark fire-cured tobacco, the primary type used for smokeless tobacco in the United States, as that crop tends to have more NNN by way of the crop itself and the way in which it is processed.

With most smokeless tobacco products containing NNN of between 1.5-5 ppm, and with the majority of products around 3 ppm or higher, the proposed limit of 1 ppm is concerning especially producers in Kentucky, where 90 percent of the tobacco grown is dark fire-cured. The state led the nation in production of dark fire-cured and dark air-cured tobacco in 2015, at 31.7 million and 13.75 million pounds, respectively.

According to the USDA, dark tobacco production in the U.S. totals approximately 24,000 acres, with a cash value of $173 million per year.

Originally, the FDA planned to accept public comments on the proposed standard until April 10; however, that was extended for an additional 90 days, to July 10, to allow more time to compile comments from the public.

“Hopefully this legislation doesn’t pass, because this will have an immediate effect on growers,” said University of Kentucky dark tobacco extension specialist Andy Bailey. “As it stands, it would have an enormous effect on dark-cured tobacco.” Changes in NNN can be caused by a number of different factors and they can vary significantly from year to year. Although tobacco plants produce a small amount of NNN, a wide variety of factors can affect the final levels of NNN found in finished tobacco products.

These factors, which can either increase or decrease NNN levels, include the tobacco type, growing conditions (e.g. geographic region, climate, rainfall), curing techniques (e.g. fire, flue, air, sun), production processes and storage conditions.

“We’re growing about 16,000 acres of dark cured tobacco and about 8,000 acres of air-cured,” said Bailey. “It’s about a $190 million crop. If this legislation went through, in the worst case, we wouldn’t have a market for 90 percent of our dark fire-cured tobacco.

“It would have a major, major impact. We have about 1,800 tobacco growers; probably 1,400 are growing dark-fire cured tobacco.”

The standard stems from the Swedish Snus, which is able to achieve the limit. The problem with that, Bailey explained, is that it is comparing apples to oranges.

“The Swedish Snus products don’t contain the same type of tobacco. Of the 15 or so products which the FDA reviewed, two were Swedish Snus and one was a loose-leaf tobacco product, which is different than the type used in most snuff in the U.S.

“Those three had less than 1 part per million,” he said. The FDA expects the rule to generate anywhere from $228.6 million-$2.46 billion in benefits by preventing an estimated 12,7000 new cases of oral cancer and approximately 2,2000 oral cancer deaths. It is also expected to cost the tobacco industry anywhere from $17.91 million-$42.72 million a year over the next 20 years to comply with the rule. 

“The whole idea with the FDA is they wanted the NNN levels to be 1 part per million in the finished product, and with the current technology and the current recipes with these moist smokeless products, there is no way to meet them,” said Joe Cain, director, Commodity Division, Kentucky Farm Bureau. “There is no way to meet those levels right now without changing the formulation.

“Right now, it’s about 70 percent fire cured and about 30 percent air-cured. You would have to reverse those formulations and most likely, it would be a product that people wouldn’t buy; it wouldn’t be a commercially accepted product.”

U.S. Rep. James Comer (R-Ky.), former agriculture commissioner of the Bluegrass State, urged the new presidential administration to withdraw the rule. “If finalized, (the rule) will have a devastating economic impact to the farmers and communities in my district,” he said in a letter to President Trump. “FDA’s proposed rule would require a standard … that is technically unachievable.

“Under the Family Smoking Prevention and Tobacco Control Act, any tobacco product standard established by the FDA must be technically achievable and consider the economic impact to domestic tobacco farmers and tobacco manufacturers.

Agronomic variability, including relative humidity during curing, is the largest contributor to tobacco-specific nitrosamines, including NNN, in tobacco on the farm.

“Because tobacco farmers cannot control changes in the weather, it is not achievable to meet the 1 ppm standard on an annual basis,” he added. “It would be almost impossible for them to continue that if this rule goes into effect,” noted Cain. “This is a really, really devastating standard they would have to meet. Producing tobacco more than just a recipe. This is a tradition that has been handed down for decades.