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 Gottlieb said youth vaping skyrocketed, based on still unpublished data from the National Youth Tobacco survey.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.

Teen Smoking-to-Vaping Is More Frequent Than Vaping-to-Smoking, Says Data in New Study

FDA Commissioner Gottlieb on February 10 tweeted, “Now, a new study, published in the Journal of the American Medical Association (JAMA), further demonstrates what we’ve seen from other data: Teens who vape are more likely to start smoking cigarettes.” (Tweet here)  The study (here), by Kaitlyn Berry at Boston University and colleagues there and at the Universities of Louisville and Southern California, appeared in JAMA Network Open.

Berry et al. examined the FDA Population Assessment of Tobacco and Health (PATH) survey involving youth, which started in 2013-14 and had two follow-ups, one and two years later.  The researchers identified 6,123 youths age 12-15 years who had not used a tobacco product at enrollment.  Some of the participants first tried a tobacco product over the next two years.  Berry et al. assessed whether first use of a particular product resulted in youth ever or current (past 30 days) cigarette smoking.  They concluded that “e-cigarette use is associated with increased risk for cigarette initiation and use.”

Taking a closer look at the study, New York University professors David Abrams and Ray Niaura and I produced a comment, which has been published in the journal, making the following important observations.

While Berry et al., and Commissioner Gottlieb, emphasized the 4.0% probability of current smoking among e-cigarette first users, we found a reverse result buried in a supplemental table: The probability of current e-cigarette use at follow up among cigarette first users was 8.3%.  This means that twice as many first-smoking teens currently used e-cigarettes at follow-up than first-vaping teens who currently used cigarettes. 

We also noted that 527 teens first used e-cigarettes during follow-up, 202 used cigarettes first, and 306 used other products.  The table shows that out of 130 current smokers at follow-up, the relative impact is 25% for first e-cigarette use and 75% for all others.

First Use of Tobacco Products By Teens in the PATH Survey and Current Smoking at Follow-up
First Product Used (n)	Percentage Currently Smoking at Follow-up (n)
E-cigarette (527)	5.9% (31)
Other Tobacco (306)	8.2% (25)
Cigarette* (202)
None* (5,088)	1.4% (74)
All (6,123)	2.1% (130)

*First cigarette users were combined with nonusers by Berry et al.

This is entirely relevant to the FDA public health standard.  The absolute population impact (API) can be calculated using the full denominator of 6,123 teens. This reveals that e-cigarette first use resulted in 31/6,123 or about 0.5% API, contrasted with 25+74 = 99 /6123 or 1.6 % for teens without any first e-cigarette use.  In short, the API for teens without e-cigarette first use was triple that for teens with first e-cigarette use.

Drs. Abrams, Niaura and I concluded:

“Even with this small impact [0.5% API], e-cigarette first use cannot be causally linked to current smoking two years later, because plausible shared liability factors have not been ruled out. As a result of the issues we raise, scientists, journalists, regulators, policymakers and the public may be misled into thinking that e-cigarette first use is a unidirectional gateway into smoking. When information about API and the opposite gateway to smoking cessation are included, a much more complete picture emerges.”

We look forward to a response from Ms. Berry and her colleagues.

Vapers: Tell the FDA You’re Not Merely An Anecdote!

A year and a half ago, I blogged about government agencies ignoring federal survey data showing that 2.5 million former smokers were current vapers (here).  When FDA tobacco center director Mitch Zeller dismissed this evidence as mere “anecdotal reports,”  I argued that such data constitutes legitimate population-level evidence.

Aiming to build a fresh dataset on smokers’ success in using vapor as a quitting aid, the Vapor Technology Association (VTA) and Consumer Advocates for Smoke-Free Alternatives (CASAA) just launched a national campaign called “I Am Not An Anecdote” (here).

The groups are asking vapers to submit to the FDA detailed, sworn statements to “encourage Congress and federal regulators to reject any proposal that would ban OR limit flavored e-liquid products.” The groups note that “FDA Commissioner Scott Gottlieb has said that your ‘personal stories are important to me.’  But, he also refers to your stories of quitting cigarettes with vapor products as ‘anecdotes.’”

While individual cases are, in scientific terminology, anecdotal, their cumulative value is considerable.  Vapor is replacing combustion at dramatic rates worldwide.  My research team used 2013 FDA-funded survey data to produce a peer-reviewed report on U.S. e-cigarette use (here and here).  Our analysis showed that e-cigarettes are the most popular quit-smoking aid among American smokers and that they are the only aid more likely to make them former smokers (i.e., successful quitters) than are cold-turkey attempts (here).

FDA should give weight to published studies, even when they do not conform to visions of a tobacco-free society.  The agency should also recognize the scientific value of mass declarations of smoking cessation accomplished through vaping substitution.