FDA Tobacco Regulation Begins with Deception

The FDA Center for Tobacco Products persists in misleading the public. Its website (here) misrepresents the facts with the statement “…tobacco use continues to be the leading cause of preventable death and disease in the United States.” 

CTP bureaucrats know that smoking, not tobacco, is a leading cause of death and disease.  But tobacco prohibitionists willfully obscure the scientific truth that smoke-free tobacco products are associated with minuscule health risks. When government employees use this tactic to influence public perception they defy the FDA mission and misuse taxpayer dollars.

An online search for the term “leading cause” in articles published in Nicotine and Tobacco Research over the past decade produces 456 articles.  Two hundred thirteen of those include a version of the FDA statement about leading cause of disease or death; some 40% misuse the terms “tobacco use” or “tobacco” for “smoking.” 

Health professionals do not tolerate such imprecision when writing or reporting on any other medical issue. 

The FDA claims that it will “use the full power of the law to protect consumers from the dangers of tobacco use.”  But if the agency purposefully conflates smoking and smoke-free tobacco use and continues to obscure and ignore the vast risk differences, who will protect consumers from the FDA?

Smokeless Tobacco Helps U.S. Air Force Achieve Low Smoking Rate

“According to the Centers for Disease Control and Prevention, smokeless tobacco is just as harmful as smoking…” 

This egregiously false claim appeared in a June 8 Air Force Times article by Phillip Swarts (here).

A mountain of scientific evidence amassed over two decades attests that smokeless tobacco use is at least 98% safer than smoking (here and here).  Further, while the CDC has been less than forthright in characterizing relative tobacco risks (here), the agency has never asserted that smokeless products are as dangerous as cigarettes.

I emailed Mr. Swarts, requesting a correction: “The CDC has never made such a claim in a public forum.  Please let me know if you have the CDC on record with such a claim.” 

The reporter’s response, void of fact checking, repeats a common misconception, to wit: “A quick Google search will turn up several such statements from the CDC, Mayo Clinic, American Cancer Society, and other health experts.” He is wrong, again.

Seven years ago, I wrote, “Our armed forces put their lives on the line every day; they use tobacco to help manage the resulting stress…It's time for DOD and other agencies to stop the misinformation campaign about tobacco. Show soldiers respect by giving them truthful information about smoking and smokeless tobacco use.” (here) 

Instead, military spokespeople continue to issue ill-informed and misleading pronouncements. Typical is Air Force Colonel John Oh’s 2015 remark (here): “If the Air Force was a state, we would have the second lowest smoking prevalence in the nation — that's the good news.  But we would also have the fourth highest smokeless tobacco use.”

Second lowest and fourth highest: Colonel Oh was complaining, but he should have been bragging.  His rankings are proof that, despite the government’s wrongheaded campaign against smokeless tobacco and the Air Force Times’ sloppy reporting, airmen and women are doing right by using far safer smoke-free products rather than smoking. 


         

Phantom Gateway: Kids Who Ever Try Stuff Are More Likely to Ever Try Other Stuff

Here we go again.  The journal Pediatrics just published a study claiming that e-cigarettes are a gateway to cigarettes.  In fact, the report simply demonstrates that kids who ever tried one tobacco product are more likely than never triers to ever try another tobacco product (abstract here).

The current study, by Jessica Barrington-Trimis, Ph.D., and co-workers, is a follow-up on research published in the same journal in 2015 (abstract here).  In that work, the authors surveyed 2,084 11^th and 12^th graders and found that 499 (about 24%) had ever tried an e-cigarette (even one puff), while 390 (19%) had ever tried a cigarette (table below).

Ever E-cigarette and Cigarette Use (Even One Puff) Among 11th and 12th Graders in Southern California, 2014
	E-Cigarettes
Cigarettes	Ever	Never	Total
Ever	286	104	390
Never	213	1,481	1,694
Total	499	1,585	2,084

Notice that 286 kids had ever used both cigarettes and e-cigarettes in 2014, which is the majority for both products.  In other words, ever trying both products was common. 

Now let’s turn to the current study.  Sixteen months after the original survey, Dr. Barrington-Trimis sent follow-up surveys to the 213 students who had ever used e-cigarettes and never smoked, and to a sample of the 1,481 students who had never used either product.  She found that ever e-cigarette users were more likely to have ever smoked a cigarette – an unsurprising finding, given that we already know that trying one of these products is highly correlated with trying another.

Indicating a research bias, the authors did not look at the other important group – the 104 students in 2014 who had ever used cigarettes and never used e-cigarettes.  Did these smokers try e-cigs in the subsequent 16 months, and was that correlation weaker or stronger than the one reported? 

Responsible research should entail examination of all correlations, and public health policy should only be based on uncompromised, comprehensive data.

FDA Deeming Rule Threatens Vapers’ Options and Health

Smokers and vapers, this post is for you.  The FDA’s proposed deeming rule could severely limit your e-cigarette choices in the next few years.

FDA tobacco center director Mitch Zeller and HHS Secretary Sylvia Burwell cast the FDA rule as necessary to protect children from products that lead to cigarette use.  That argument has no scientific basis.  Government surveys provide no evidence that e-cigarettes have slowed the steep decline in youth smoking; on the contrary, evidence suggests that e-cigarettes may have accelerated that decline (here).  E-cigarettes are actually a gateway to stop smoking for adults who cannot quit with FDA-approved medicines and other aids.  As for protecting children, nearly all states currently ban e-cigarette sales to minors.

The FDA is exercising its regulatory power over all tobacco manufacturers, encompassing not only giant cigarette companies but also the strip-mall vape shops that sell nicotine liquids (juice) and vaping hardware. The FDA’s authority over products containing nicotine derived from tobacco was granted in the 2009 Tobacco Control Act, discussed here and confirmed by the courts here.

With the FDA hell-bent on tobacco prohibition, Congress deaf to consumer demands for smokeless tobacco products and both institutions blind to scientific evidence of tobacco harm reduction’s public health validity, smokers and vapors are the worse off.

The only immediate hope for relief from the deeming rule is the Cole-Bishop amendment to the 2017 Agriculture appropriations bill (here).  It would affect the rule’s grandfather date, allowing most e-cigarette products to remain in the marketplace.  The FDA wants manufacturers whose e-cigarettes were not available prior to 2007 to seek FDA approval during the next two to three years, a daunting and expensive task that the FDA estimates will cost over $330,000 per product.  The Cole-Bishop amendment would change that date to August 8, 2016, assuring that all existing products would stay on the market.  Senator Ron Johnson (R-WI), chairman of the Senate Homeland Security and Governmental Affairs Committee, has addressed the potential “negative unintended health consequences” of the FDA’s grandfather date in a public letter (here).

Manufacturers are already challenging the FDA’s action in the courts (here).

If Congress and the courts fail to alter the FDA’s course, smaller independent vape shops and a host of e-cigarette products will disappear in that two- to three-year time frame.

If you are one of the six million vapers who also smoke or one of the two million vapers who no longer smoke (here), don’t become a casualty.  Monitor news on the deeming issue and tell elected officials to rein in runaway regulation.