Wednesday, March 27, 2019

Tobacco Sales to Kids Is a Problem For States, Not Retailers

FDA Commissioner Scott Gottlieb recently threatened 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)

Dr. Gottlieb blames the so-called youth vaping “epidemic” on illegal retail sales and “kid-friendly marketing.” (here)  Focusing so heavily on retailers, he ignores the fact that underage sales rates are extremely low in many states – Georgia (2.2%), Montana (2.7%), Hawaii (3.0%) and California (4.2%) for example, according to 2018 FDA inspection data – while violation rates in others is extremely high -- North Dakota, Michigan, Ohio and Nevada are close to 23% (here).

In order to explore the connection between retailers’ violations and state enforcement efforts, I downloaded FDA information on 26,000 inspections conducted in 2018 at national retail chain stores – Walgreens, Walmart, Rite Aid, Shell, Family Dollar, Dollar General, Circle K and 7-Eleven.  I calculated the rate of violations for these chains stores in each state (excluding Nevada and North Dakota, with very low numbers of inspections).   

The chart shows the combined results for these retailers.  Note that the x axis is the state rate, based on 146,000 inspections, and the y axis is the retailers’ rate, based on 26,000 inspections.  There is a strong correlation between violations in these chain stores and the state in which they were located (correlation coefficient, CC = +0.77).  The correlation is also seen with individual companies.  For example, Walgreens’ violation rate was 2.2% in Georgia (based on 46 inspections) and 17% in Ohio (with 229 inspections). 

Note that nearly all of the retailers’ rates are below the green diagonal line, showing that they were lower than the state rates in all jurisdictions except DC, Connecticut, Oregon, Minnesota, Alaska and Hawaii.

The FDA blames retailers for selling tobacco products to children, but it ignores the significant differences in violation rates among states.  Youths in Georgia, Montana, Hawaii and California can seldom buy tobacco products, suggesting that those states’ enforcement efforts are far more effective than the other 46 states. The simplest route to obtaining age restriction compliance seems to be FDA pressure for stronger state enforcement, rather than agency action against retailers or product categories.

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 (%)

Family Dollar15-2411
Circle K15-2412

Casey’s General Stores25-3411


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.