Problems Multiply for Proposed FDA Smokeless Tobacco Rule

The FDA on January 23 published a proposed smokeless tobacco (ST) regulation that would require a radical reduction in levels of N-nitrosonornicotine (NNN), a tobacco-specific nitrosamine.  I documented (here) that the rule is based on erroneous calculations of ST risks; others have since raised additional concerns.

Scott Ballin, Health Policy Advisor to the University of Virginia’s Morven Dialogues, observes that the FDA ignored its statutory requirement, when setting product standards, to “invite appropriate participation though joint conferences, workshops, or other means, by informed persons representative of scientific, professional, industry, agricultural or consumer organizations who in the Secretary's judgment can make a significant contribution.”

Brian Fojtik, Senior Fellow at the Reason Foundation, notes (here) that the FDA invited participation from selected stakeholders: “Within hours of publication in the [Federal] Register, a comment was filed by a coalition of interest groups collaboratively (American Academy of Pediatrics, Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco Free Kids and Truth Initiative) . . . a reasonable person is left wondering how six large organizations could possibly have each reviewed a highly technical, 50-page rule, reached conclusions on the rule’s specific merits and crafted a collaborative response that all agreed to sign within hours of the rule’s publication in the Register.  Even in the most forgiving of lights, the appearance is unseemly and should necessitate the withdrawal of the proposed rule.”

Another major error in the FDA’s proposed rule-making process was identified by Altria in a March 3 comment submission.  The agency filed a regulatory impact analysis (here) for the rule, estimating that 30% of moist snuff products currently meet the 1 ppm dry-weight limit (Table 3, panel A).  However, FDA miscalculated the wet-weight to dry-weight conversion, invalidating the estimate. 

Moist snuff is about 50% water; when it is dried, the level of any agent in the remaining tobacco will double.  The FDA did the reverse, calculating that a product with 2 ppm NNN wet-weight would have 1 ppm dry weight.  The correct conversion is 0.5 ppm wet-weight to 1.0 ppm dry weight.  Almost no moist snuff products on the U.S. market are at 0.5 ppm wet weight.

Altria urged the FDA to withdraw the proposed rule because it “would fail to provide a scientifically valid formula for manufacturers to measure and maintain records of NNN levels on a dry weight basis in order to demonstrate compliance with the product standard.”

Educating Air Force Generals About Tobacco Use & Risks

The Military Health System and the Defense Health Agency last November published a grossly misleading article on their website titled, “Quit the spit: Smokeless tobacco no better than lit” (archived article here).  After I educated Air Force officials, the article was removed.  Here is the story. 

The piece wrongly asserted that smokeless tobacco (ST) use is equally harmful as smoking:

“…putting in a dip or a chew can cause as much harm as lighting up cigarettes... ‘A lot of the effects smoking has on the body – causing blood vessels to narrow raising blood pressure and causing several cancers – are the same for smokeless tobacco,’ said Air Force Col. Thomas Moore, a preventive medicine doctor and in charge of health promotions for the Air Force Medical Support Agency... ‘You’re really not gaining anything by giving up cigarettes just to put in a load of chew,’ said Moore.” (emphasis added)

In a November 18 email I advised Colonel Moore of the article’s numerous errors:

“These passages send the clear, unmistakable and completely false message to military personnel that smokeless tobacco use is just as dangerous as smoking.  Numerous scientific studies published over the past twenty years provide indisputable evidence that smokeless tobacco use is vastly safer than smoking.  For example, a 2002 report by the British Royal College of Physicians (here), one of the world’s oldest and most prestigious medical societies, stated ‘As a way of using nicotine, the consumption of non-combustible [smokeless] tobacco is on the order of 10-1,000 times less hazardous than smoking, depending on the product.’

“Your just-as-dangerous message may be considered a breach of medical ethics.  A 2004 study (here) authored by a panel of international tobacco research and policy experts concluded: ‘…[smokeless] products pose a substantially lower risk to the user than do conventional cigarettes.  This finding raises ethical questions concerning whether it is inappropriate and misleading for government officials or public health experts to characterize smokeless tobacco products as comparably dangerous with cigarette smoking.’

“Members of our armed forces put their lives on the line every day.  The Military Health System and the Defense Health Agency should show them respect by giving them truthful information about tobacco use.  There is a lot at stake.  In another 2007 report (here) the Royal College concluded ‘...that smokers smoke predominantly for nicotine, that nicotine itself is not especially hazardous, and that if nicotine could be provided in a form that is acceptable and effective as a cigarette substitute, millions of lives could be saved.’

“I urge you to promptly retract the article or issue a substantial revision to reflect the indisputable evidence that smokeless tobacco use is vastly safer than smoking.  Please let me know if I can provide any additional information to facilitate this action.  I appreciate your prompt response to my request.”

In the absence of a response, I sent a similar email to U.S. Air Force Surgeon General Mark Ediger.  This generated a reply from Major General Roosevelt Allen, Jr., Director of Medical Operations & Research in the Office of the Surgeon General.  He wrote that I was “correct in stating that current scientific evidence clearly delineates different levels of health risk associated with the various forms of tobacco use,” and he promised “to see if it is possible to post a clarification of the article on the Health.mil site.”

At General Allen’s request, I supplied a portfolio of published medical articles on ST and tobacco harm reduction. 

Sometime in February, the offending article was removed from the military website.  It is evident that senior Air Force health officials recognized that the Defense Health Agency’s article was indefensible, given the vast difference in risks involved in smoking and ST use.  I am hopeful that this awareness will translate into a rational tobacco policy at the Department of Defense and beyond.

Department of Defense Anti-Smokeless Campaign Is “50” Shades Darker

February is a popular month for tobacco prohibitionists to attack smokeless tobacco (ST).  A year ago, this blog refuted seven false claims (here) from county health departments.  This year, the U.S. Department of Defense (DOD) escalated the attack.

Thanks to David Sweanor of the University of Ottawa Centre for Health Law, Policy & Ethics, we became aware of an outrageous DOD website called UCanQuit.  Sweanor, who has a long history of fighting cigarette company malfeasance, coauthored a commentary last month labeling an FDA ST misinformation campaign unethical (here). 

The DOD site prompts users to engage in chat sessions to obtain quitting advice.  The apparently scripted responses from human agents are filled with false information, such as these from Sweanor’s session:

“Chewers are 50 times more likely than nonusers to get cancer of the cheek, gums, and inner surface of the lips… long-term users have a 50% greater risk of developing oral cancers than non-users.”

A “50 times” risk is a boldface lie (here), as the proven risk is nearly nil (here).  While the American Cancer Society in 2010 told the Wall Street Journal that it would no longer use the 50 number (here), DOD perpetuates that falsehood, even as it makes a contradictory misstatement about a 50% increased risk.

DOD chats are numbingly focused on ST nicotine levels.  In Sweanor’s 12-minute session, the subject came up 16 times: “[ST users] are hooked on nicotine, a highly addictive drug… [ST] products deliver substantial doses of nicotine along with powerful cancer-causing chemicals… nicotine from [ST] is absorbed through the mouth… nicotine obtained from smokeless tobacco is comparable to that of cigarettes… One can of snuff gives you as much nicotine as 60 cigarettes. Nicotine gives you the ‘buzz’ but is highly addictive… [ST] contains MORE nicotine than cigarettes! Using snuff or chewing tobacco may give you three to four times as much nicotine as from smoking a cigarette. And the nicotine stays in the bloodstream longer. Use two cans a week and you'll get the same amount of nicotine as smoking a pack and a half a day…”

When Sweanor inquired, “any difference in relative risks? Is using snus safer than smoking cigarettes for someone addicted to nicotine?”, the response was only more of the same: “one can of snuff gives you as much nicotine as 60 cigarettes…Smokeless tobacco contains MORE nicotine than cigarettes! Using snuff or chewing tobacco may give you three to four times as much nicotine as from smoking a cigarette. And the nicotine stays in the bloodstream longer. Use two cans a week and you'll get the same amount of nicotine as smoking a pack and a half a day.”

Other experts subsequently visited the DOD site to engage in chats, with similar results.  My 12-minute session yielded 14 nicotine mentions, plus one particularly bizarre exchange.

This list appeared suddenly and without context: “1. Cadmium: used in car batteries 2. Formaldehyde: embalming fluid 3. Lead: a poison 4. Nicotine: an addictive drug 5. N-Nitrosamines: cancer-causing chemical 6. Polonium 210: nuclear waste 7. Acetaldehyde: irritant 8. Hydrazine: toxic chemical 9. Benzopyrene: cancer-causing chemical 10. Uranium 235: used in nuclear weapons 11. Sodium: salt, can cause high blood pressure 12. Sugar: can cause cavities 13. Fiberglass and Sand: abrasive”

The implication was that these are deadly constituents of ST.  I have previously noted that such lists are meaningless, as everything we consume contains trace amounts of contaminants (here).  Chew and dip are no exceptions, but the contaminants at trace levels pose zero risks (here).

Because tobacco prohibitionists often imply that such trace contaminants are added to ST, I asked my chat correspondent: “I don't understand the answer starting with cadmium. Do you mean that those things are added to dip and chew?”

Chat operator:  “Yes they are.”

I asked: “How do dip and chew makers get access to uranium?”
 Chat operator: “I have no idea.”

Finally, an honest answer.
  
DOD has gone to the dark side with their taxpayer-funded, unfactual, anti-smokeless website. It should be taken down.

E-Cigarette Toxic Chemical Exposure Is Same as for Nonsmokers

The new finding from British and U.S. e-cigarette researchers understated the good news for vapers.

“Long-term NRT-only and e-cigarette-only use…is associated with substantially reduced levels of measured carcinogens and toxins relative to smoking only combustible cigarettes,” reported scientists at the University College London; King's College, London; the Roswell Park Cancer Institute in Buffalo, New York; and the U.S. Centers for Disease Control and Prevention (CDC). Their work, with Lion Shahab as lead author, appeared in the Annals of Internal Medicine last month (abstract here). 

“The observed carcinogens and toxins” were a group of volatile organic compounds (VOCs), including acrolein, acrylamide, acrylonitrile, butadiene and a combination of ethylene oxide, acrylonitrile and vinyl chloride.  The researchers actually measured metabolites – products formed when the body breaks down the VOCs – in the urine.

The finding is good news for vapers, who avoid the thousands of toxins in smoke.  But the study and associated media coverage gave the impression that e-cigarette use also resulted in excess exposure to the VOCs.  That may not be true.

People are exposed every day to these VOCs, in the air and in our food and drinks.  Research published by K. Udeni Alwis et al. in 2012 (abstract here) showed that nonsmokers have measurable levels of these chemicals.    

Here are compared results from the Shahab and Alwis studies.  The former did not report absolute levels of the VOC metabolites; rather, it designated smokers as the referent group, and reported levels in vapers as a percentage of levels in smokers.  The Alwis study reported actual levels in smokers and nonsmokers, allowing me to calculate the percentages.       

Percentage Exposures to VOCs in Vapers (Shahab) and NonSmokers (Alwis), Compared to Smokers
VOC	Percentage in Vapers	Percentage in NonSmokers
Acrolein	33%	26%
Acrylamide	43%	42%
Acrylonitrile	2.9%	2.5%
Butadiene	11%	18%
Combination*	44%	35%

*ethylene oxide, acrylonitrile and vinyl chloride

The table shows that VOC exposures in vapers were similar to exposures in nonsmokers.  For example, in the Shahab study, vapers’ exposure to acrylamide was 43% of the exposure among smokers, whereas nonsmokers’ exposure was 42% of smokers in the Alwis study.

The authors of the Shahab report, particularly Dr. Alwis (who is at the CDC), should have made the connection between the results of the two studies.  The fact that vapers’ VOC exposures are similar to those of nonsmokers is headline-worthy.