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Truth Initiative supports tobacco harm minimization effort

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POSITION IN SUPPORT OF THE PUBLIC HEALTH STRATEGY OF TOBACCO HARM MINIMIZATION

Tobacco is the leading cause of preventable death in the U.S. 540,000 Americans die prematurely from tobacco use each and every year. Millions more suffer from tobacco-related diseases. Truth Initiative strives to build a generation of Americans for whom tobacco use is a thing of the past. Furthermore, because the vast majority of tobacco users begin as teens or young adults, our mission is to achieve a culture where all youth and young adults reject tobacco.

As we actively pursue our vision, we recognize two important additional factors. First, as established by the 2014 Surgeon General’s Report, The Health Consequences of Smoking – 50 Years of Progress, combustible tobacco products – cigarettes, cigars, little cigars, cigarillos, hookah and roll your own tobacco – are responsible for the overwhelming majority of the toll of death and disease caused by tobacco. Second, some tobacco users may be unable or unwilling to quit using combustible products. Therefore, as we continue to work toward our ultimate goal, we endorse the important public health strategy of harm minimization. This strategy holds that the best way to eliminate tobacco-based harms is to eliminate tobacco use entirely and as early in life as possible. However, for those who have tried other methods and still are not able to quit, the death and disease that flow from tobacco use can be significantly reduced if those users switch to the exclusive use of regulated, least harmful, non-combustible nicotine delivery products. Given their particular vulnerability, there is no appropriate use of tobacco or nicotine-containing products by youth. 

PREVENTION AND EARLY CESSATION ARE THE MOST EFFECTIVE HARM MINIMIZATION STRATEGIES.

  • Prevention is the right policy for youth. The best way to avoid tobacco-related death and disease is to not use tobacco products in the first place. There is no appropriate role for youth tobacco or nicotine use, regardless of the product – except in the limited circumstance where established youth smokers are using low-risk products as a strategy to end all tobacco use. 

  • Cessation is the best course for tobacco users. The most effective way for a current tobacco user to minimize tobacco-related harms is to stop all tobacco use and to do so as soon as possible. It is certainly difficult for many people to quit tobacco use – and simply not achievable for some – but for most people it is not impossible. Many smokers have been able to quit, either on their own or with the aid of evidence-based therapies approved by the United States Public Health Service (USPHS) Clinical Practice Guidelines. Any harm minimization strategy – and certainly any tobacco control policy – should include universal access to effective cessation interventions.

FOR THOSE UNABLE OR UNWILLING TO QUIT, HARM WILL BE MINIMIZED MOST EFFECTIVELY BY ELIMINATING USE OF COMBUSTIBLE TOBACCO IN FAVOR OF THE EXCLUSIVE USE OF THE LEAST HARMFUL NONCOMBUSTIBLE PRODUCTS.

  • While combustible products are by far the most dangerous tobacco products, there is also a continuum of risk among non-combustible tobacco and nicotine-containing products.
    • Current evidence demonstrates that the least harmful of these products are FDA-approved Nicotine Replacement Therapies (NRTs), which are regulated as drugs. Long-term use of nicotine in medicinal form has been found to be sufficiently safe and non-addictive to be available over the counter without prescription for all but high-risk individuals. These include pregnant women and those with health conditions for which nicotine is contra-indicated.
    • Among tobacco products, Swedish-style, low-nitrosamine snus are low on the risk continuum. In fact, the FDA concluded, based on a properly submitted new product application, that evidence shows that snus can benefit public health. As a result, FDA has allowed these products on the market.
    • Available evidence also indicates that properly regulated electronic nicotine delivery systems (ENDS) would be notably lower in risk than combustible tobacco, especially when used to facilitate cessation or a complete switch from combustible tobacco. We strongly encourage e-cigarette manufacturers to follow the precedent set by Swedish snus and submit new product applications for FDA review.
    • While less harmful than combustible tobacco, traditional chew tobacco still exposes users to higher levels of nitrosamines than some other currently available non-combustible products and thus presents the greatest risk within this class.
  • Concurrent use, also called dual or poly use, of non-combustible and combustible tobacco can minimize harms only if such use is of limited duration and not on a long-term basis, leading to the timely cessation of all combustible product use. Current combustible tobacco users who switch as soon as possible to the exclusive use of a noncombustible product on the low end of the risk continuum will greatly reduce their exposure to tobacco-related harms. 

FDA REGULATION OF ALL TOBACCO PRODUCTS IS ESSENTIAL FOR THE EFFECTIVE IMPLEMENTATION OF A HARM MINIMIZATION STRATEGY.

Truth Initiative strongly supports the federal regulation of all tobacco and nicotine-containing products because all such products, even those relatively low on the harm continuum, present demonstrable health and safety risks to consumers. This is particularly so for youth. Proper regulation would lower risk by, among other important and common-sense public health goals, establishing a national minimum age for the sale of tobacco products; barring youth targeted tobacco advertising; ensuring that consumers have accurate and verifiable information about the ingredients in the products they are using; and providing manufacturing standards for the quality and basic safety of any mechanical devices including requiring child-resistant packaging for all tobacco products.

Regulation would enable the FDA to issue product standards to: 1) reduce toxicity levels (as in the recently proposed rule reducing NNN levels in smokeless tobacco); 2) decrease the appeal of tobacco products, for example, by eliminating flavors which are so attractive to youth; and 3) minimize the addictiveness of these products. Of significant importance, regulation would protect consumers against unverified claims of reduced harm. In the absence of regulation, manufacturers can (and some have) made unsubstantiated claims of reduced harms, putting consumers at substantial risk by making it virtually impossible for them to know which products are safer and which will help them quit tobacco. Meaningful regulation would establish a pathway for manufacturers of harm-minimized products to make verified reduced harm claims. 

In May 2016, FDA issued its "deeming regulation," which takes important steps toward achieving the regulatory steps listed above by bringing all tobacco products under its jurisdiction. Truth Initiative strongly supports this regulation. We note with great concern that FDA has delayed the implementation dates of certain key provisions and the regulation itself is under attack in both the courts and Congress. For more specifics on the deeming regulation please see our resources here and here.  

Despite its important role, the FDA is not the only agency with the ability to contribute to an effective harm minimization strategy. Examples of additional policies that will advance a harm minimization strategy include:

  • Tax policies should be designed to encourage adult consumers to use lower risk products by taxing more harmful products at a significantly higher rate than less dangerous products. However, because all tobacco products present risks, all tobacco products should be taxed.

  • Clean air regulations should be expanded to cover the use of all tobacco products that produce smoke or vapor. While there is not a definitive answer yet as to the extent of the harm caused by e-cigarette vapor, evidence supports that this vapor contains at least some nicotine and other chemicals and may be harmful. Non-users should not be exposed to these risks.

This statement is based on our best current understanding of the state of the science and the products on the market. Both the science and range of consumer products are rapidly evolving. There is also the possibility for regulatory changes at the state and local level. We will update this statement on a continuing basis to take into account relevant developments.

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