NTU Comments to FDA on Nicotine Levels

Division of Dockets Management

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, Maryland 20852

 

Re:      Docket No. FDA-2017-N-6189 (83 Fed. Reg. 11,818, March 16, 2018), Advance Notice of Proposed Rulemaking on Tobacco Product Standard for Nicotine Level of Combusted Cigarettes

 

To whom it may concern,

 

National Taxpayers Union (NTU) appreciates the opportunity to comment on the Food and Drug Administration’s (FDA) advanced notice of proposed rulemaking (ANPRM) “to obtain information for consideration in developing a tobacco product standard to set the maximum nicotine level for cigarettes.” This comment letter responds to the FDA’s request for information on the potential repercussions that reduced nicotine levels will have on smoking rates, economic impacts, and other unintended effects.

 

The FDA serves an important purpose to safeguard and promote public health through appropriate regulation and oversight of food safety, prescription medication, and other goods. With the enactment of the Tobacco Control Act of 2009, the FDA was granted the authority to regulate the manufacture, distribution and marketing of tobacco products, which includes electronic cigarettes and vapor products. We strongly believe that the FDA can use its rule-making and regulatory power to simultaneously foster a thriving market and prioritize public safety. However, it is our strong belief that this ANPRM will not achieve its stated purpose and the costs will far outweigh any potential benefit.

 

We agree with FDA’s assertion that individuals use tobacco in order consume nicotine. While smokers are drawn to cigarettes for the nicotine, it is the toxins and harmful chemicals within cigarettes that results in harmful effects, not the nicotine. Lowering the addictive compounds of cigarettes could actually result in an increase in cigarette smoking, as individuals would need to consume more cigarettes to reach their desired level of nicotine. The potential risk of severe unintended consequences is quite high, and to the administration's credit, has been recognized by regulators within FDA. We hope you will consider the following points as you weigh the prospect of regulation:

 

 

FDA’s stated goal from the proposed rule is to reduce the incidence of smoking deaths among American adults. The notice specifically claims that a reduction in nicotine will give smokers the “ability to quit more easily, and it could help to prevent experimenters (mainly youth) from initiating regular use and becoming regular smokers.” We respect the FDA’s goal to achieve better health outcomes for all Americans. However, the FDA is attempting to tackle a problem that is already being solved through changes in consumer behavior. Government data show fewer adults and young adults are smoking cigarettes. While millions of people continue to smoke, the smoking population has decreased from 20.9 percent to 15.5 percent since 2005, according to data from the National Health Interview Survey. In fact, the number of adults who smoke is at its lowest since cigarette smoking was first recorded by the U.S. Centers for Disease Control and Prevention (CDC) in 1965. Further, only 5.4 percent of teenagers reported smoking a cigarette, down from 5.9 percent in 2016. The CDC’s own data shows cigarette smoking among U.S. high school students stands at an all-time low.

 

 

Black markets form around goods and services that are prohibited by government law. These markets commonly occur due to substantial demand of buyers who wish to evade restrictive government price controls, avoid paying hefty taxes on goods, or wish to purchase goods outlawed by government policies. While the proposed FDA rule does not ban cigarettes or tobacco products, it would constitute a de facto prohibition of conventional cigarettes by placing a ceiling of nicotine levels 98 percent lower than current levels. It is reasonable to expect that cigarette users will attempt to find a way to get cigarettes with a higher level of nicotine, which would likely be found on a shadow market.

 

Conventional cigarettes would still be readily available on the worldwide market, making it easy to smuggle them into the United States.This would create a huge untaxed, unregulated market and undermining the purpose of the FDA’s proposed regulations. Looking to history as a guide, the illicit market would likely be a boon to organized crime, spread law enforcement’s scarce resources thinner, and lead to other undesirable outcomes. These problems would all have large taxpayer implications as they would require federal, state, and local jurisdictions to allocate more funds to combat these underground networks. As we have seen from state cigarette taxes artificially raising the cost of cigarettes, many law enforcement agencies struggle with combating criminals who acquire cheaper packs from low-tax states to peddle in high-tax jurisdictions.

 

 

Rather than use heavy-handed government policy to direct consumer behavior, FDA should embark on regulatory reforms to empower consumers to choose non-combustible, lower-risk nicotine alternatives. As it stands, regulatory burdens and roadblocks put up by the FDA are preventing innovative new products  from reaching millions of consumers. FDA should reduce costs and unnecessary paperwork burdens of new product applications, clarify and simplify requirements for pre-market approval of new products, and pursue other effective regulatory reductions.

 

Research indicates electronic cigarettes and heat-not-burn products are significantly less likely to cause the harmful impacts associated with conventional tobacco products. Heat-not-burn products use a normal tobacco lead but are heated, rather than burned, to produce an inhalable vapor. This gives users a taste and experience closer to smoking than other products currently on the market and is a safer alternative. Heat-not-burn products, namely the IQOS product, are unfortunately unavailable for sale in the United States, but that could change should the FDA approve a premarket tobacco application for IQOS.

 

 

If enacted, this rule will have significant negative impacts on taxpayers, farmers, retailers, consumers, manufacturers, state and local governments, and supply chains across the country. This action would cause harm to tobacco farmers, their families, and their communities,all of whom rely on the cultivation of tobacco plants to sustain their livelihood. While no in depth findings or economic analysis is readily available detailing the full extent of economic loss, we hope you leave this comment period open to allow stakeholders to submit further information as it becomes available.

 

We once again appreciate the opportunity to offer our views on this proposed rule. We are eager to work with you to represent the nation’s taxpayers as the FDA evaluates its path forward. Thank you for your consideration of these views.

 

Sincerely,

 

Thomas Aiello, Policy and Government Affairs Associate

National Taxpayers Union