Ag Officials: “Unachievable” FDA Standard Would Devastate Ky Dark Fired Tobacco

Apr 13, 2017

Credit Matt Markgraf, WKMS

  A proposed Food and Drug Administration standard would have a “devastating economic impact” to Kentucky dark fire tobacco farmers according to state agriculture officials.

Kentucky Commissioner of Agriculture Ryan Quarles and 1st District Congressman James Comer have asked the Trump Administration to withdraw a tobacco product standard (21 CFR Part 1132) that would lower carcinogens in smokeless tobacco, specifically, N-Nitrosonornicotine (NNN). NNN is associated with mouth, throat and pancreatic cancers.

Opponents say the rule sets an impossible standard. The mandate would limit NNN to 1 part per million (ppm) and University of Kentucky Dark Tobacco Extension Specialist Andy Bailey said most smokeless tobacco products vary between 1.5 and 5 ppm, with the majority of products around 3 ppm or higher.

“But none of those [U.S. smokeless tobacco products] would be at the 1 ppm proposed NNN standard right now.” Bailey said.

A number of best management practices (BMP) have been researched by Bailey to limit NNN levels in tobacco production, and he says zero of the current known strategies are capable of producing a consistent crop that could meet the FDA standard. “We are just not there yet,” he said.  Seed varieties, growing conditions, curing techniques, weather variability, and other factors all contribute to concentrations of NNN throughout the production process. So, levels of NNN in tobacco plants “vary from year to year” said Bailey.

In addition, NNN is found in varying concentrations in smokeless tobacco products as well. The FDA study  utilized to create the standard, categorized the products into smokeless tobacco product subcategories (moist snuff, snus, dissolvable, dry snuff) and utilized literature reviews and data samples from brands both domestic and imported to determine the new standard.

“If you look at FDA proposed legislation on this, some of those [moist tobacco products] included some of the Swedish Snus products, which is a whole different product than what we have here in the U.S. with moist snuff.” Bailey said.

The Snus products are in a pouch and they don't contain any dark fire cured tobacco according to Bailey.  “But they compared U.S. moist snuff to Swedish Snus and they are two totally different smokeless tobacco products for different customer bases,” he said two totally different products should require two sets of standards.  

More than a fourth of U.S. dark fire tobacco is produced in western Kentucky, the Purchase District and some eastern parts of the state, a $173 million dollar economic impact for those areas. Bailey said it takes three years for dark fire tobacco to cure and any crops produced in 2016 would not be viable for market under the mandate.

Agriculture Commissioner Ryan Quarles said the proposal is upsetting for a number of reasons.

"The Obama FDA, literally the last day in office promulgated a rule that would have implemented a scientific standard that would be unachievable by tobacco farmers for NNN, “ said Quarles.

 

And the most disturbing part, he said,  is that “instead of proposing a rule and asking for comments from the public, which is the normal course of business, the Obama FDA issued the rule and asked for comments afterwards.” Quarles said it was a failure on the process.

"Last time I checked Tobacco is legal product in the United States,” said Quarles. If the proposal passes, he said the department of agriculture would fight to have it overturned.

The FDA has opened up public comment on the matter until July 10th. If enough concerns are recorded the FDA could reconsider its choice of action, said Quarles.

“At the Department of Agriculture I'm focused on advocating for all of our agricultural products, both new and old-- It’s important that we speak up because sometimes when we don't speak up, we get left out.” Quarles said.