Tuesday, November 24, 2015

Memo to the FDA: Please Correct Errors on Your Website

The FDA website includes several glaring errors on its Established List of Harmful and Potentially Harmful Constituents in Tobacco Products or Tobacco Smoke (here).  For example, the list wrongly identifies acrylamide as both a respiratory and a cardiovascular toxicant.  It is neither of these.  It is a probable human carcinogen, according to IARC, and it was correctly labeled in the list published in the federal register (here).  I recently collaborated with scientists from BAT to publish a comprehensive analysis of acrylamide in smokeless tobacco products from Sweden and the U.S. (here).  Our study showed that it is present in all products we tested, but “exposure… from consumption of smokeless tobacco products is small compared with exposure from food… or cigarette smoking.”

Other agents on the list are also incorrectly classified: acetone, acrolein, acrylonitrile and aflatoxin B1.  Another, acetamide, was omitted completely.

I described the problem to an FDA staffperson in late September, and she told me that a technical specialist would call back.  That did not happen, and the agency web page has not been corrected.

Government communications, including web resources, should contain accurate information.

Update, December 1, 2015: I am pleased to report that today the FDA corrected the webpage errors identified in this entry.  My compliments to agency officials.

Thursday, November 19, 2015

FDA and CDC Generate Smokeless Scaremongering

While the FDA and CDC refuse to acknowledge that smokeless tobacco causes almost no disease, agency staff have produced a fresh study (abstract here) showing that smokeless tobacco users have higher trace levels of nicotine and some contaminants than do smokers.  This meaningless finding (explained below) leads to grossly misleading headlines, such as “Smokeless Tobacco More Toxic Than Cigarettes, Study Says” from Time’s Alexandra Sifferlin. (Other recent tabloidish stories from this reporter include “Flavor Science Explains How You Can Hear the Way Your Food Tastes,” “I Tried It: A 6 am No-Booze Dance Party on a Boat,” and “Healthiest Halloween Candy”).   

The media was served up a juicy quote from the FDA’s Brian Rostron, the study’s first author, in a press release (here): “exposure to nicotine and the cancer-causing tobacco constituent NNK were higher among exclusive smokeless tobacco users than exclusive cigarette smokers. This continues to put smokeless tobacco users at risk for adverse health effects, including cancer.”

First, nicotine is not a toxin, and it doesn’t cause any “adverse health effects, including cancer.”  

Second, while the study found higher levels of NNK among smokeless users than smokers, that does not support the claim that “smokeless tobacco users [are] at risk for adverse health effects, including cancer.”  Decades of epidemiologic studies involving millions of Americans show that smokeless tobacco users’ risks are infinitesimal.  British researchers estimate that U.S. smokeless-related cancer deaths are zero.

Third, from 1999 to 2012, the period of the study, trace levels of NNK dropped by two-thirds in smokeless tobacco users.

And finally, the results show that smokeless tobacco users had lower levels of mercury (in their blood) and arsenic (in their urine) than nonusers of tobacco.  In fact, smokers also had lower levels of these metals.  The study authors did not discuss the health implications of these findings.       

Public health officials should focus on meaningful research and provide appropriate scientific context for their findings, rather than scaremonger via the media and deter smokers from transitioning to markedly less harmful smoke-free products.

Tuesday, November 10, 2015

FDA Authorizes Eight New Snus Products

The FDA today granted Swedish Match permission to market eight new snus products in the U.S.  This is the first time that new tobacco products have received a marketing order via the agency’s premarket tobacco product review process.  Swedish Match demonstrated (here) that the products are “beneficial to the population as a whole including users and non-users...[taking] into account the increased or decreased likelihood that existing tobacco users will stop using such products, and the increased or decreased likelihood that those who do not use tobacco products will start using them.”

The products (here) consist of loose or pouch (portion) variants of Swedish Match’s General Snus:

1.  Loose
2.  Dry Mint Portion Original Mini
3.  Portion Original Large
4.  Classic Blend Portion White Large
5.  Mint Portion White Large
6.  Nordic Mint Portion White Large
7.  Portion White Large
8.  Wintergreen Portion White Large

Swedish Match filed a modified risk application for the products in June 2014, asking the FDA to change mandated warning labels (discussed here and here).  No decision has been announced.   

Red Flag for Vapers: Avoid Some Flavoring Agents

As a health professional, I started telling smokers to switch to smokeless tobacco in 1994, based on decades of definitive epidemiologic evidence for the relative safety of smokeless tobacco.  But I was slow to endorse e-cigarettes as a reduced-risk option for smokers. 

There is no parallel body of evidence for e-cigarettes, but then, there is no scientific evidence that would link vapor inhalation to cancer, heart attacks or strokes.  That is significant, but as a pathologist, I must consider whether long-term vapor consumption can cause respiratory problems.  There is little human experience with intense, long-term inhalation of propylene glycol, vegetable glycerin and other agents, including flavorings. 

Konstantinos Farsalinos and colleagues in 2014 reported a laboratory analysis of 159 e-cigarette liquids from 36 manufacturers/retailers in six European countries and the U.S.  They found that almost 70% of the samples contained varying amounts of diacetyl (DA) and/or a similar flavor compound, acetyl propionyl (AP).  Although these substances naturally occur in fermented products like cheese and beer, they are also added to foods to provide a butter-like flavor.  They are generally recognized as safe by the FDA when added in small quantities to foods.

DA and AP are known, however, to cause bronchiolitis obliterans, a serious, sometimes fatal lung disease in exposed workers (here, here, here), most notably in plants producing buttered popcorn (here).

Farsalinos estimated the amount of DA and AP that vapers would inhale using the tested liquids.  He concluded, “The median daily exposure levels were slightly lower than the strict [National Institute on Occupational Safety and Hazards]-defined safety limits for occupational exposure and 100 and 10 times lower compared with smoking respectively; however, 47.3% of DA and 41.5% of AP-containing samples exposed consumers to levels higher than the safety limits.”

Farsalinos’ study should have prompted e-liquid suppliers to abandon those agents. They have not.

Raquel Rutledge, a reporter for the Milwaukee Journal Sentinel, recently worked with a Marquette University chemist to test liquids sold in local vape shops (here).  She “bought five e-liquids dubbed top-sellers by sales clerks… and had them tested for [DA and AP]… All five contained both chemicals.”  According to her story, some had high levels.

Staff at the vape shops selling the liquids were unaware of the presence of these toxins.

It is unacceptable for any vape shop to sell liquids with flavoring ingredients that are proven respiratory toxicants.  Vapers should only use liquids that are certified to be free of these agents.