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 Gottlieb said youth vaping skyrocketed, based on still unpublished data from the National Youth Tobacco survey.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
Retailer	Gottlieb “Cumulative” Rate (%)	Actual 2018 Rate (%)
Walmart	15-24	6
Walgreens	15-24	9
Family Dollar	15-24	11
Circle K	15-24	12
Kroger	15-24	13
Casey’s General Stores	25-34	11
7-Eleven	25-34	14
Shell	25-34	19
Chevron	25-34	19
Marathon	35-44	26
Citgo	35-44	19
Exxon	35-44	20
Mobil	35-44	20
Sunoco	35-44	21
BP	35-44	24

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.

FDA Is Targeting E-Cigarette Retailers, But They’re Not Teens’ Primary E-Cigarette Source

FDA Commissioner Scott Gottlieb reportedly testified at a House Appropriations subcommittee April 17 about “excessive use of e-cigarettes among youths…Gottlieb said the FDA will crack down on youths' use of e-cigarettes in the coming weeks.  ‘We are going to take some vigorous enforcement steps to try to perceive what we see is inappropriate use by youth,’ Gottlieb said, refusing to elaborate on when the action will happen.  The agency has several avenues for targeting retailers that are selling to minors.  Those include a warning letter, massive fines, or banning the retailer from selling any tobacco or e-cigarettes.”

A common theme among e-cigarette prohibitionists is that the protection of children justifies all forms of regulation.  Beyond that, the commissioner’s remarks are undercut by the fact that only a small percentage of children have tried e-cigarettes, and only a tiny fraction of those youths bought c-cigarettes from retailers.  Support for this is seen in the FDA’s Population Assessment of Tobacco and Health (PATH) survey.  The PATH youth survey collected detailed information about tobacco use from 13,628 participants age 12-17 years in 2013-2014.  Based on the survey’s sophisticated weighting formula, the figures below are estimates for 25 million teens across the U.S.

The data reveal that about 2.6 million teens had ever used an e-cigarette in 2013-14.  Of these, about 771,000 had used e-cigarettes in the past 30 days – the widely accepted definition of “current” use among youth and consistent with another federal survey of teen tobacco use (discussed here).  This means that there were far fewer current e-cig users in PATH than currently used alcohol (1.83 million) or marijuana (1.24 million), which is also consistent with other federal surveys (discussed here).

Current e-cig users were asked: “In the past 30 days, how did you usually get your own e-cigarettes/cartridges and e-liquid?”  Here are the results:

PATH Survey: How Did You Get Your E-Cigarettes?
How	Number of teens	Percentage
Someone offered me one	353,700	46%
Gave someone else money to buy them	126,500	16%
Bought them myself	75,700	9.9%
Asked someone to give me one	73,700	9.7%
Got them some other way	52,500	6.9%
Took them from a store or another person	31,600	4.1%
Bought them from another person	24,700	3.2%
Don’t know, refused to answer	32,400	4.2%
All	770,800	100%

The table shows that only 10% of current teen users, about 76,000, bought e-cigarettes for themselves.  In other words, while the FDA and other government agencies pursue vaping manufacturers and retailers, the vast majority of teens get e-cigarettes from unregulated sources.  Of course, even more teens use alcohol, which is only sold to adults age 21+ years, and marijuana, the sale of which is legal to adults only in limited states.

Tobacco Retailer Compliance High, Says FDA Data

The Food and Drug Administration issued a press release on November 10 (here), titled “FDA acts to protect children from illegal tobacco sales.” It advises that “most retail establishments inspected by the FDA have been found to be in compliance with the law” restricting sales of tobacco to minors. The release focused on warning letters sent “to more than 1,200 retailers, the majority of which respond to violations relating to selling tobacco to minors, as part of its ongoing effort to reduce tobacco use among children.”

FDA Commissioner Margaret A. Hamburg is quoted: “It should worry every parent that 20 percent of U.S. high school students smoke cigarettes…Retailers are vital partners in the FDA’s efforts to prevent tobacco use among kids.”

What the FDA didn’t report is that in most states, retailer compliance is outstanding. I downloaded the raw data from the agency’s website and noted compliance statistics for the available states:

FDA Tobacco Retail Compliance Inspections in 16 States
State	Number of Inspections	Compliance Rate (%)
Alabama	2,122	99
Arkansas	680	96
Arizona	818	94
Colorado	1,682	92
Idaho	323	99+
Illinois	950	93
Kansas	2,016	99+
Massachusetts	2,813	96
Maryland	1,477	99
Maine	3,137	99+
Missouri	1,033	88
Mississippi	3,419	94
New Jersey	1	--
Pennsylvania	1,813	94
Tennessee	829	96
Washington	1,305	93
All	24,418	96

Retailers in all states combined showed a 96% compliance rate, with every state except Missouri above 90%. Retailers in Alabama, Idaho, Kansas, Maryland and Maine demonstrated compliance rates of at least 99%.

As I noted in an earlier post (here), the principal suppliers of tobacco to underage users are adult friends or relatives, according to a 2004 study (abstract here).

The FDA should continue to monitor retailers, but when it comes to children’s access to tobacco, retailers are clearly not the major problem.