Wednesday, September 22, 2010

FDA Can’t Handle the Truth

Recently the U.S. Food and Drug Administration (FDA) invited the public to submit suggestions to the Center for Tobacco Products for educational resources to be added to the training program for Tobacco Retailers.

I submitted the following suggestion on September 19, 2010.

Relative Risks

Provide printed information comparing risk of smoking-related diseases from cigarette smoke to reduced risk from switching to smokeless products.

After I submitted the suggestion, the following feedback was displayed: “Your suggestion is awaiting moderator approval.”

OK, it’s understandable that the FDA would want to make sure that off-topic or off-color suggestions are weeded out before displaying them to the rest of the word. Since my suggestion was submitted over the weekend, I waited until Monday to see my suggestion displayed so that others could vote upon it.

Returning to my specific suggestion at I saw that the “Awaiting moderator approval” message was still displayed.

I noticed the following message on the page.

PLEASE NOTE: To review our comment policy, visit We will only post on-topic comments on communication tool suggestions for retailers.

I clicked the link to determine whether the suggestion I submitted met the FDA guidelines, which read as follows:

FDA Center for Tobacco Product’s Tobacco Ideas Web site allows and encourages public comments and votes. We expect that participants will treat each other with respect and abide by the Terms of Service. All comments posted to the Web site will be reviewed and approved by the administrator before posting. We will not allow comments that contain vulgar or profane language; personal attacks of any kind; or offensive terms that target specific ethnic, religious or racial groups. We will not allow comments that are clearly off topic, spam, or that promote services or endorsement of any financial, commercial or non-governmental agency. The appearance of comments and external links on this site does not constitute official endorsement on behalf of the U.S. Food and Drug Administration.

Was my suggestion “off topic”? I found the following description of the program for which the FDA was seeking suggestions. ( )

Break the Chain is FDA's new campaign to educate retailers and raise awareness about tobacco product regulations designed to protect kids from the dangers of tobacco use and its negative health impacts.

Medical research shows that 98-99% of the negative health impacts of tobacco use are caused by inhaling tobacco smoke. Tobacco retailers probably don’t know this. Like the rest of the American public, they have been misled into believing that the health risks of smokeless tobacco products are equal to the health risks of smoking. One of the government-required warning messages on smokeless products, “This product is not a safe alternative to smoking,” is interpreted by 85% of the public as “This product is no safer than smoking.”

Allowing the public to believe “you might as well smoke” perpetuates the worst of the negative health impacts of tobacco use. What if, however, smokers were provided with truthful information about relative risks so that they could make informed decisions?

In Sweden, providing the public with truthful information about the reduced health risks of using low-nitrosamine “snus” (a type of moist snuff) has led to Sweden enjoying the lowest smoking rates of any country in Europe. One study surveyed 6752 adult Swedes on tobacco use. They found that those who used snus were significantly less likely to start smoking. Among male smokers who later began using snus, 88% ceased daily smoking completely. Women using snus were significantly more likely to be able to stop smoking than those using nicotine patches or gum. "The main lesson of this study is that significant sections of the public would select a less harmful high-nicotine smokeless product over cigarettes and use it long term in place of smoking."
Ramstrom (2006) Role of snus in initiation and cessation of tobacco smoking in Sweden. Tobacco Control 2006;15:210-214.

But what effect does switching to Swedish snus have on health? Researchers reviewed the literature to identify studies that provided quantitative risk estimates associated with Swedish snus and cigarette smoking in a single population.

“Seven studies were identified that addressed eight health outcomes. Although few in number, these seven studies do provide quantitative evidence that, for certain health outcomes, the health risks associated with snus are lower than those associated with smoking. Specifically, this is true for lung cancer (based on one study), for oral cancer (based on one study), for gastric cancer (based on one study), for cardiovascular disease (based on three of four studies), and for all-cause mortality (based on one study).”
Roth (2005) Health risks of smoking compared to Swedish snus. Inhalation Toxicology. 2005 Dec 1;17(13):741-8.

More recently, products have been bought to market that provide the look and feel of smoking without exposing the user or bystanders to the dangerous products of combustion. Instead of focusing on the huge potential of electronic cigarettes to reduce smoking-related disease, the FDA has chosen instead to exaggerate the importance of miniscule, harmless quantities of nitrosamines and utilize propaganda techniques to mislead the public into believing the products present "acute health risks."

So how could providing truthful information on relative risks of tobacco products to retailers protect kids from negative health impacts of tobacco use? Wouldn’t it lead to increased use of tobacco, resulting in increased negative health impacts?

If retailers were provided with documentation that switching to smokeless products reduces health risks, and if retailers informed smokers of the truth, odds are good that some smokers--perhaps many smokers--would make the switch, as happened in Sweden. There would be fewer adult smokers providing a role-model of smoking as a grown-up activity. If kids did learn this well-guarded secret, they would be less likely to start with or to progress to the much more harmful activity of smoking.

Two full business days have passed, and my suggestion still has not been published. On second thought, what did I expect?

Given the latest slogan coming out of the tobacco control community, “There is no safe form of tobacco,” it is doubtful that the FDA will ever agree to provide truthful information to the public. Admitting that some forms of tobacco are less harmful than others would expose the big, fat dirty lies for what they are.

Millions of smokers whose lives could have been saved by switching to safer alternatives have died over the past two decades as a result of the government-led disinformation campaign. Withholding the truth and engaging in misdirection are forms of lying, make no mistake. These lies kill people.


  1. Elaine, you couldn't be more on point if you used an arrow. Is there no means of contacting them and finding out why this has not been approved for publication?

    It's a travesty that the FDA is unwilling to inform the public about the truth on various tobacco products. Prohibition will never work, so they've used the method of prohibition of easily available information. Unless you're looking for the lie, you'll never realize it. After all, they've had decades to sell their propaganda.

  2. Where your suggestion missed the mark was its failure to address the request: "Help us identify or improve communication tools that educate retailers about FDA tobacco products regulations that protect America’s youth!"

    It could be argued that your omission of that portion of the FDA's online form from your story was a de facto lie.

    The essense of the request was clear, and had to do with the laws regarding the sale of tobacco products to minors. Were you seriously suggesting that retailers--confronted with a 12 year-old wearing a fake moustache, brandishing a fake ID and asking for a pack of Marlboro Red--should suggest he buy Swedish snus over the internet instead, due to their reduced risk factor?

    I use e-cigarettes myself, and will go to the wall in defense of my right to do so--but I'm well over 18. I have no problem, however, with restricting access of those or any other form of nicotine product to children--or assisting retailers in compliance thereof. THAT is the issue, of course. Answering a question that wasn't asked is a near-certain waste of energy, the worth of your answer notwithstanding.

  3. Ahhh - but we can't possibly tell people the truth...that leads to thinking for themselves and making informed decisions, instead of letting the public health advocates make all them hard decisions for us.

    Disinformation is running rampant, which is really a shame when it comes to an agency created and dedicated to protecting the public health.

  4. You made a good suggestion indeed! The FDA is foolish if they don't approve.

    Fewer adults smoking in front of children is what is really necessary to reduce youth smoking rates and NOT bans on flavors.

    Don't feel bad though. Joel L. Nitzkin, MD and chair of the American Association of Public Health Physicians Tobacco Control Task Force petitioned the FDA TWICE (with no response) to correct misleading statements about e cigs made during their infamous July 22 2009 announcement. Here is a URL to their second petition:

    As far as I know the FDA has yet to respond to them either.

    The AAPHP is also a supporter of smokeless tobacco products due to facts in the scientific research and success in Sweden.

  5. There isn't a state in the union that does not already have laws in place preventing sales of tobacco products to minors. In my state (which grows tobacco), retailers are provided with posters and table tents regarding checking IDs and other educational materials by the State. The FDA regulations regarding sales to minors bring nothing new to the party, so why waste Federal tax dollars producing unnecessary educational materials?

    The FDA is free to promulgate additional regulations with the goal of preventing kids from starting smoking and/or helping them to stop. The paragraph that starts "If retailers were provided..." explains how educating retailers, who in turn could educate adult smokers, could reduce the number of adult smokers, which in turn could reduce kids getting started with smoking.

    I did not address what a retailer should do with a teen-age smoker who is already heavily addicted to nicotine. Right now, all a retailer does is refuse to make the sale. Will that help the kid quit smoking? What would help youngsters quit? Do you have some suggestions?

  6. Thanks for this info. E-cigarette is indeed the best way to quit smoking or to smoke free without harm your health.