August 27, 2019

Acting Commissioner Ned Sharpless
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002

On behalf of millions of taxpayers and consumers across the United States, the Taxpayers Protection Alliance (TPA) and undersigned groups urge the Food and Drug Administration (FDA) to abandon proposed “graphic warning labels” for cigarettes. Across the world, these warning labels have been proven ineffective in smoking cessation, and in some cases, graphics warning labels have led to increased cigarette use. Instead of doubling-down on failed policies that may increase cigarette consumption, the FDA should protect First Amendment rights, act in accordance with the overwhelming scientific evidence, and promote reduced-risk products such as vapes and heat-not-burn products that provide an effective exit-ramp away from deadly combustible cigarettes.

Recently, the Ninth Circuit Court of Appeals unanimously ordered an injunction to block a similar warning label proposal earlier this year. The Court found that such labels would chill protected commercial speech. Without a fair playing ground to compete, the market would be hindered from creating innovative reduced-risk products that respond to consumer demands for safety.

Undeterred, the FDA recently proposed 13 new warning labels designed to scare smokers away from combustible products by advertising links between smoking and a host of medical problems including: bladder cancer, amputation, macular degeneration, and stunted fetal growth. When Congress passed the 2009 Tobacco Control Act mandating graphic health warning labels, lawmakers believed that alarming illustrations are a sure-fire way to curb smoking, but the evidence indicates otherwise.

The FDA has previously admitted that graphic warning labels will have no statistical impact on smoking rates whatsoever, which is consistent with evidence from other countries. In the United Kingdom, the effects of the introduction of graphic health warnings were analyzed by the University of Stirling’s National Centre for Social Research and the Institute for Social Marketing. The researchers determined that there was no impact whatsoever on cigarette consumption, smoking prevalence, or any aspect of smoking behavior.

In fact, the relationship between smoking rates and warning labels may be the exact opposite to that postulated by FDA leadership. In Canada, a long-term analysis of smoking rates prior to and after the introduction of graphic health warnings demonstrated a complete failure to reduce smoking prevalence. Perhaps even more disturbingly, a ten-year anthropological study concluded by Professor Simone Dennis from the Australian National University in 2016 found that pregnant teenagers were using warning label information to smoke in the hopes that their newborns would have a low birthweight. These shocking findings, along with decades of research finding little benefit from warning labels, should convince the FDA to nix its proposed policy.

Instead of doubling-down on warning labels and fearmongering, the agency must do everything in its power to promote safe, reduced-risk alternatives to cigarettes. Public Health England found in 2015 that e-cigarettes are 95 percent safer than ordinary cigarettes, a finding echoed by dozens of governments and health organizations around the world. A 2019New England Journal of Medicine study found that vaping is nearly doubly as effective for smoking cessation as traditional nicotine replacement therapy (i.e. patches, gum). Recently- approved heat-not-burn devices promise similar public health benefits. This is why leading public health bodies and governments across the world are urging smokers to make the switch.

The FDA continues to insist on subjecting reduced-risk products to the costly, time- consuming process of premarket approval, and will take scores of life-saving products off the shelves unless companies submit lengthy applications to the agency within ten months. Health information contained in these applications would merely duplicate the wealth of information already at the agency’s disposal, at a significant cost to producers and consumers.

The FDA’s proposed warnings not only violate the First Amendment by replacing the producer’s speech with the government’s voice, but also fail to reduce smoking rates. The FDA should embrace proven harm-reduction products that are helping millions of adult smokers quit their dangerous habits every day and have the potential to save millions of lives. Thank you for your consideration of this pressing matter.