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Vaping News: Clive Bates calls FDA proposed NNN rule ‘reckless and pointless’

Vaping advocate Clive Bates might be from the UK, but he had no trouble blasting the U.S. Food and Drug Administration (FDA) last week over the agency’s newly proposed NNN rule.  The new rule was initially proposed on January 23, 2017, and the FDA was accepting feedback and comments until July 10 from anyone who cared to submit them.  Mr. Bates was all too happy to comply.

The former Director General of Wales was joined by his friend and colleague David Sweanor in writing a ten-page report complete with footnotes and reference material explaining why the FDA NNN rule is both “reckless and pointless.”  The team of pro-vaping activists then submitted the letter through the Regulation.gov website before publishing a copy on CliveBates.com.

When all was said and done, there were 6,952 comments submitted to the FDA from people like Bates and Sweanor as well as world-class doctors, accomplished scientists, and multiple vaping advocacy groups like the Consumer Advocates for Smoke-Free Alternatives Association (CASAA).  The latter submitted a rather lengthy seven-page report of its own.  It is also a fair assumption that a substantial portion of those 6,952 comments were written by anti-tobacco and anti-vaping lobbyist.

What is NNN, and what is the FDA’s NNN rule?

Even the most experienced vaper may be wondering, “What the heck is NNN, and why should I care?”  NNN stands for N-Nitrosonornicotine, which is defined as a nitrosamine that is produced during the tobacco curing process.  What is a nitrosamine?  In layman’s terms, it is a chemical compound that is largely considered to be carcinogenic.  That’s allegedly why the FDA wants to regulate or limit its levels in smokeless tobacco. 


So, why does Clive Bates hate the proposed NNN rule so much?  According to his website, he’s all for setting standards, but only if the standards meet three specific criteria.

  1. They must serve a purpose to either mitigate risk, exploit an opportunity, or both.
  2. They must be achievable (and possible).
  3. Their perceived health benefits should far outweigh any potential health risks.

Bates and Sweanor suggest that the proposed FDA NNN rule fails on all three counts.

“First, the standard is set at the lower extremity of what is on the market in this sample.  This is a ridiculous thing for a regulator to do with an untried standard.  NNN is not a completely controllable component of tobacco – it can depend on weather and humidity, for example, and there is bound to be natural variability in any plant product.”

To put this another way, there are countless species and hybrids of tobacco plants, and they are always grown in varying environments, under inconsistent weather patterns, and with differing farming procedures.  Manipulating the amount of NNN that a tobacco plant produces on a predictable, consistent basis as defined by the NNN rule would be highly problematic, perhaps even impossible.

The co-authors also make several other observations.  They suggest that the proposed NNN standard overstates expected health benefits, underestimates future disruptions to the marketplace, and ignores projected consequences caused by these disruptions.  They also suggest that the rule fails to meet the public health test standards as set forth by the Tobacco Control Act of 2009.

What does this have to do with vaping?  Besides the above-mentioned problems with the FDA NNN rule, people like Bates and Sweanor simply believe that the FDA should be focusing on more important things, like “encouraging people to switch” (to vaping) or quit smoking altogether.  Micromanaging the NNN levels in tobacco is simply another example of excessive government overregulation gone amuck.




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