Wednesday, March 13, 2019

FDA’s Campaign Against Tobacco Retailers Doesn’t Hold Up to Inspection


Today Dr. Scott Gottlieb announced a draft compliance policy predicting that ““some flavored e-cigarette products will no longer be sold at all…other flavored e-cigarette products that continue to be sold will be sold only in a manner that prevents youth access…” (here)

Gottlieb has blamed a so-called youth vaping “epidemic” on illegal retail sales and “kid-friendly marketing.” (here)  Last week he spotlighted Walgreens, saying that 22% of its stores had illegal sales of tobacco products to minors “since the inception of the FDA’s retailer compliance check inspection program in 2010.”  He also listed 14 other national retail chains that had violation rates of 15% to 44%. 

These shocking numbers are, in fact, inflated through the use of cumulative math covering a nine-year period. I reported on public FDA inspection data just after the program started (here) and again in 2016 (here).  In response to current FDA news, I have now analyzed the data from 2018 (available here), the year Dr. Gottlieb said youth vaping skyrocketed, based on still unpublished data from the National Youth Tobacco survey.  My findings on the 2018 FDA inspection data are illuminating.

FDA contractors conducted over 146,000 retailer inspections in 2018, resulting in a national average violation rate of 12%, just one percent higher than in 2015-16 (here).  The following table contrasts the cumulative violation rate (range) reported by Dr. Gottlieb with the actual rate in 2018.


National Retailers’ Tobacco Sales Violations: “Cumulative” Versus 2018 Rates
RetailerGottlieb “Cumulative” Rate (%)Actual 2018 Rate (%)



Walmart15-246
Walgreens15-249
Family Dollar15-2411
Circle K15-2412
Kroger15-2413



Casey’s General Stores25-3411
7-Eleven25-3414
Shell25-3419
Chevron25-3419



Marathon35-4426
Citgo35-4419
Exxon35-4420
Mobil35-4420
Sunoco35-4421
BP35-4424





Dr. Gottlieb did not need to use inflated cumulative numbers to demonstrate that national retail chains, especially those with gas stations, are still selling tobacco products to underage youth.  Additionally, his focus on Walgreens, with a 2018 violation rate of 9%, three points lower than the national average, seems inappropriate. 

Other key data points were omitted from Dr. Gottlieb’s remarks.  First, there is a large variation in state violation rates, from Georgia (2.2%), Montana (2.7%), Hawaii (3.0%) and California (4.2%) all the way to North Dakota and Michigan at 22.5%; Ohio and Nevada at 22.9%.  Retailers’ state rates were similarly diverse. For example, Walgreens and Walmarts in Georgia had much lower rates than those in Ohio.  This doesn’t absolve retailers of responsibility.  Rather, it indicates that state policies and attitudes may be contributing as significantly to underage sales as retailers.

While Dr. Gottlieb’s regulatory effort is aimed ostensibly at combatting youth access to e-cigarettes, only 19% of the cited 17,500 violations in 2018 involved those products.  Cigars were the most frequent culprit (44%), followed by cigarettes (33%), with smokeless tobacco at a mere 4%.

There is no excuse for a national tobacco sales violation rate of 12%; retailers everywhere must stop selling to underage youth.  Still, the federal government’s own survey data shows that more than 90% of teens who use tobacco products obtain them from social sources, such as friends or family.  Only 10% of current teen vapers buy their own e-cigs (here).  Given these facts, the FDA can’t hold retailers entirely responsible for teen e-cigarette use.

Thursday, March 7, 2019

Federally Funded Authors Promote Misperceptions of Smoke-Free Tobacco Products


In their recent journal article, “U.S. adult perceptions of the harmfulness of tobacco products” (abstract here), a group of researchers from the FDA, other federal agencies, Canadian and American universities suppress important information about safer tobacco products. 

G.T. Fong and 11 co-authors used federal funds to analyze the FDA Population Assessment of Tobacco and Health (PATH) Survey with respect to perceptions of eight non-cigarette tobacco products’ relative harms.  While their roughly 5,000-word treatise included three large tables, one figure, two supplemental tables, and 40 references, they included not a word about how these perceptions match up with reality.  The only time they used the word “misperception” was to suggest that Americans who view non-cigarette products as less harmful should be educated with “new information”.

The authors found that “40.7% of adults believed that electronic cigarettes were less harmful than cigarettes.” In their view, “These results point to the potential value of enhancing knowledge, within the U.S. population, of the harm of tobacco products to prevent tobacco use and to encourage tobacco users to quit, through providing new information about the harms that may not be widely known and/or through countering misperceptions that may exist.”

Readers of this blog know that numerous published studies document that smokeless tobacco use is vastly safer than smoking, and that the British Royal College of Physicians affirms that vaping is at least 95% less hazardous than smoking. 

It is appalling that 12 government-funded researchers have published a lengthy screed without acknowledging that smoke-free products are less harmful. 



Tuesday, February 26, 2019

The American Cancer Society: For and Against Tobacco 21


My op-ed about Virginia’s adoption of Tobacco 21 was published in the Richmond Times-Dispatch (available at Richmond.com here and below).  As I have documented before (here), the American Cancer Society is out of touch with American smokers and their need for reasonable and rational ways to quit.  Further evidence is seen in the Society’s U-turn from supporting to opposing Tobacco 21 in Virginia (below) and Utah (here).  The Society complained in both states that “the devil’s in the details,” but there are no details: states simply want to move the legal age for tobacco sales from 18 to 21.  The Society should advocate for the health, and respect the rights, of American teens and smokers.
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Virginia has raised the minimum age for buying all nicotine products, including e-cigarettes, from 18 to 21. The bill had widespread support from state medical societies and Gov. Ralph Northam, a pediatric neurologist; and it is part of a national trend in which states are responding to the growing number of adolescents choosing to vape. But some in the public health community tried to make the perfect the enemy of the good by standing in the way of a sensible regulation that has the potential to curtail teen nicotine use, without making it harder for adult smokers to access healthier alternatives.

It’s true there has been an increase in teen vaping — a problem exacerbated, in part, by older students legally buying tobacco products and selling them to their younger classmates. Raising the age from 18 to 21 will delegitimize tobacco sales to 18-year-olds and potentially disrupt high school “black markets.” Eighteen-year-olds make up 14 percent of all American high school students, but they account for one-quarter of high school smokers and smoker-vapers. Legal buyers — not manufacturers and retailers — are the primary source for tobacco products used by underage high schoolers. So Virginia’s Tobacco 21 law could make a big impact in limiting access to youth.

The problem comes from the growing contingent of “anti-tobacco” activists who won’t be happy until there is simply no tobacco — or nicotine — for sale at all. Specifically, the American Cancer Society needs to start acknowledging scientific facts and abandon its “tobacco-prohibition” stance. The society opposed the sensible Tobacco 21 bill in the Virginia legislature, despite the fact that the ACS’s lobbying arm, the Cancer Action Network (CAN), endorses Tobacco 21 at the national level. CAN spokesman Brian Donohue insists, “the devil is in the details.”


Similarly, the American Heart Association also supports Tobacco 21 in theory, but has been critical of the Virginia legislation. AHA spokesperson Ashley Bell said — somewhat incoherently — that youth access laws “may not be strong enough to support the current age … are not strong enough to support the enforcement of raising the age.” ACS-CAN’s Donohue added that Tobacco 21 “is a great goal, but it’s backwards.”


The only thing backwards is the public health community’s flip-flopping on support for Tobacco 21. ACS-CAN is critical of the bill’s focus on youth — rather than retailers — and is insisting additional changes ought to be made such as the elimination of fines for teen buyers (currently $100 for the first violation, $250 after that), and increased fines for retailers (currently set at $500 for the first violation and up to $2,500 subsequently). But the reality is, they don’t intend to settle halfway because they want the complete elimination of nicotine and tobacco products.


Efforts to stem the use of tobacco and vaping products through Tobacco 21 laws — like the one signed into law in Virginia — are growing. Hawaii, California, New Jersey, Oregon, Maine, and Massachusetts have already raised the purchase age to 21, and Alabama, Alaska, and Utah bumped it to 19. The leadership at organizations like ACS-CAN and the AHA know that the FDA punishes retailers who sell tobacco to anyone under 18. E-cigarette companies have implemented stringent age verification systems online to support these measures.


No tobacco product is perfectly safe, but vaping is considered 95 percent safer than smoking. E-cigarettes not only provide a safer alternative for adult smokers; but, as the New England Journal of Medicine just confirmed, they are used more often by smokers, and they are more effective than medicinal nicotine in helping smokers quit.


Each year more than 16 million Americans live with, and almost half a million die from, smoking-attributable illnesses; the total economic cost is more than $300 billion. We can’t afford to let politics interfere with sensible policies.


Kudos to Governor Northam for ignoring tobacco policy u-turners in order to remove legal tobacco consumers from Virginia high schools.