Burning Questions in This New Era of Nicotine
Six topics discussed during CSP's 2017 Total Nicotine Conference
What Is NNN? Why Should You Care?
Definition: NNN stands for N-Nitrosonornicotine, a naturally occurring form of nicotine in the tobacco plant.
“It’s in every tobacco product ever made and is produced during the curing and processing of tobacco,” said Briant of NATO.
Why it matters now: On Jan. 23, 2017, the FDA issued a proposed rule to limit NNN in all smokeless products (moist smokeless tobacco, chewing tobacco, snus and dry snuff) to only 1 microgram per gram in a finished tobacco product.
“A quarter-teaspoon of sugar is 1 gram,” Briant said. “Take a millionth of that: That’s how much NNN nicotine they want in a finished smokeless tobacco product. It’s as close to absolute zero as the FDA can possibly get.” (When Congress gave the FDA authority to regulate tobacco products, it also wrote into law that the FDA cannot ban nicotine in its entirety from any tobacco product.)
If the rule is passed as written, manufacturers will be given three years to bring the NNN levels down to 1 microgram per gram.
Can it be done?: One major problem with the proposed rule is that it may not be possible for the majority of smokeless products to achieve this level of NNN. The main factor that affects NNN level, according to Briant, is the weather: the amount of sun or rain the tobacco plant receives, or how long it grows in the fields.
“NNN is naturally occurring, based on weather, curing and other factors,” he said, pointing out that the levels change all the time. “If you can’t control the weather, how can you control the 1-microgram-per-gram limit in a finished product?”
According to manufacturers, snus is the only product that can get there. For all other products, the lowest NNN level possible is closer to 4 micrograms per gram.
Meanwhile, the FDA indicated in the proposed rule that it may eventually drop the requirement even lower.
What this means for retailers: If manufacturers cannot meet the standard, the FDA would mandate that those products be removed from the shelves. That’s not just bad news for smokeless manufacturers—for retailers, it could potentially wipe out an entire tobacco segment.
“This is ‘prohibition by regulation,’ ” Briant said. “The FDA cannot outright ban any category of tobacco products, but this standard may be so difficult to reach that they effectively ban smokeless.”
Broader implications: While there has been a lot of discussion about the FDA’s July announcement to potentially lower the level of nicotine in cigarettes, Briant said the proposed NNN rule marked the agency’s first attempt to limit nicotine levels. It serves as a strong indication of the agency’s priorities moving forward.
“Mitch Zeller, director of the CTP, is very focused on nicotine levels because that’s the addictive property in tobacco,” said Briant. “He wants to really focus on lowering nicotine levels.”
Next steps: The FDA is reviewing more than 8,000 comments submitted on the proposed rule. The agency has three options: Adopt the rule, amend the rule or withdraw the proposed rule, Briant said. There is no timetable for when the FDA will make its decision.