FDA Blocks Consumer Access to New Smokeless Products

When Congress gave the FDA regulatory authority over tobacco in 2009, it specified that manufacturers wanting to sell a new product must get a “substantial equivalence” (SE) order demonstrating to the FDA that the product has the “same characteristics as a predicate tobacco product [i.e. on the market before February 15, 2007]; or has different characteristics than the predicate tobacco product but…does not raise different questions of public health.” (here)

Copenhagen brand moist snuff has been available in the U.S. since 1822.  The U.S. Tobacco Company (UST) had 17 different styles of the brand, including 5 pouches and 4 with wintergreen flavoring on the market in 2007.

It's worth examining UST's SE application submitted on November 13, 2015 for a variant to be called Copenhagen Bold Wintergreen Pouches.  According to the Troutman Sanders law firm blog (here):

“The Copenhagen Bold [WG Pouches] SE submission compared the new product, a portioned smokeless tobacco in pouches with a grandfathered product in the same format (pouched smokeless tobacco) but containing different tobacco.  UST had considered using a different grandfathered product – a loose tobacco product with the exact same blend and formula as Copenhagen Bold – but the FDA discouraged UST from doing so because the grandfathered product was in a different format.  At the FDA’s suggestion, UST designated the grandfathered loose tobacco product with the exact same tobacco blend and formula as Copenhagen Bold as a ‘surrogate’ product.”

Despite the company’s acquiescence in using its loose wintergreen snuff as the predicate product, the FDA denied the SE on July 13, 2017.  UST’s appeal of that decision was denied by the agency on January 2, 2018. The company sued the FDA on February 2, seeking to overturn the agency’s action. The filing is available here.

This lengthy, so far futile attempt to gain marketing approval for a simple variation of a moist snuff product that is associated with nearly zero health risks underscores the broken state of the FDA review process.

To be clear, my criticism of FDA is not intended to further the interests of any company, but rather to advance the health interests of American smokers who should be encouraged to switch to safer smoke-free cigarette substitutes. Limiting the market entry of potentially attractive cigarette alternatives reduces the chance that smokers will give up their dangerous habit.

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.

Another UC San Francisco E-Cigarette Gateway Claim, Based on Tiny Numbers

Last week I called for retraction of a flawed study by University of California San Francisco’s Benjamin W. Chaffee, Shannon Lea Watkins and Stanton A. Glantz that appeared in the journal Pediatrics (here and here).  

Once again using the FDA Population Assessment of Tobacco and Health (PATH) survey, the same authors exaggerated the gateway effect of e-cigarettes, hookah and smokeless tobacco in a January JAMA Pediatrics article (here).  I criticized at that time the omission of information that would have provided context for their findings (here).  The exaggerations were amplified in the media.

In an interview with National Public Radio (here), Dr. Watkins failed to note the minuscule numbers used in her study to support the gateway claim.  I have inserted those numbers in bold in her quote, here:

“We found that kids who tried e-cigarettes [n=11] or hookah [n=8] or smokeless tobacco [n=3] or cigars [n=7] – any noncigarette tobacco product – were all twice as likely to try cigarettes a year later compared to kids who hadn’t used any of those other tobacco products [n=175].  Kids who were using two or more noncigarette products [n=15] were four times as likely to report using cigarettes a year later.” (I have confirmed these numbers in the FDA data; they are in the table below)

Dr. Watkins added the extraordinary claim that trying one tobacco product changes one’s perception of cigarettes: “Using these products might change a kid’s perception of the harm of cigarettes, and so they are perceived as less dangerous and they get used to using tobacco and so using conventional cigarettes is not so scary or ‘bad’.”

In her view, trying a tobacco product causes one to change friends: “It will expose them to different kinds of kids, maybe kids that are already using conventional cigarettes, and then they might go on to try them.”

Instead of sharing her conjecture on how e-cigarettes led 11 children to begin smoking, Dr. Watkins should have focused on the fact that 80% of the 219 new smokers [n=175] in her study had not previously used any tobacco product.

Odds Ratios And Numbers of Teens Smoking Cigarettes After One Year, According to Ever Tobacco Status at Baseline
Ever Tobacco Status- Baseline (n)	Odds Ratio	Number Smoking At One Year (%)
Never tobacco use (9,058)	Referent	175 (79.9)
E-cigarettes (255)	2.12	11 (5.0)
Hookah (189)	2.15	8 (3.7)
Other combustible (114)	3.08	7 (3.2)
Smokeless tobacco (93)	1.53	3 (1.4)
Two or more products (200)	3.81	15 (6.8)
All (9,909)		219 (100)