New regulation plan for preventing tobacco and nicotine related adverse effects by FDA

Jul 31 2017

A novel comprehensive plan for the regulation of tobacco and nicotine was announced by the Food and Drug Administration (FDA), USA, on 28^th July 2017. This plan is expected to serve as a roadmap that can be implemented through multiple years in improving the protection of kids as well as reducing the diseases and deaths related to tobacco.

In this approach, nicotine and the problem of addiction are placed at the center of the tobacco regulation efforts by the agency.  It aims at ensuring that the FDA has a scientific, as well as regulatory, foundation for the effective and proficient implementation of the Family Smoking Prevention and Tobacco Control Act.

The FDA must maintain a suitable balance between regulating and motivating the development of less dangerous innovative tobacco products when compared with cigarettes. In order to do this, they are providing targeted alleviations on a few timelines that were described in the May 2016 final rule, which gave authority to the FDA on additional tobacco products.

A timeline extension is being given for review submission of the newly regulated tobacco products that were on the market from 8th August 2016. This will give the agency enough time to search for meaningful as well as clear steps to make the tobacco products less toxic, addictive and appealing.

Inputs on serious public health issues, for example, flavors, such as menthol, role in tobacco products; as well as e-cigarette flavors that appeal to children, will also be sought by the agency.

In the U.S., the major cause of preventable deaths as well as diseases is tobacco. It causes over 480,000 deaths per year. Tobacco also affects the society with a huge financial cost, via direct health care and lost productivity, which together cost the U.S. a sum of approximately $300 billion per year.

Demonstrating a better awareness that nicotine, which is highly addictive, embodies a range of risks when delivered through products is a key piece of the approach by the FDA. And that when it is supplied through smoke particles in combustible cigarettes, the nicotine is even more harmful.

Scott Gottlieb, M.D, the FDA Commissioner said: “The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes – the only legal consumer product that, when used as intended, will kill half of all long-term users.”  Currently, 5.6 million young people who use tobacco will die prematurely later on in life as a result of their habit. The FDA commissioner, envisions a world where cigarettes no longer create or sustain addiction, and that less harmful alternative sources are used to appease nicotine addiction. He emphasizes that his must be the focus of the FDA’s efforts and pursuit for common ground.

The FDA plans to start a public dialogue on decreasing the levels of nicotine to a non-addictive level in combustible cigarettes by attainable product standards. An Advance Notice of Proposed Rulemaking (ANPRM) is indented to be issued by the agency, through which seeking input on possible benefits on public health as well as any probable negative effects of decreasing the nicotine in cigarettes can be done.

Lowering levels of nicotine can possibly decline the future generations' chance of addiction to cigarettes and let more smokers who are presently addicted to quit, as nearly 90% of the adult smokers began smoking prior to 18 years of age and in the U.S., each day, approximately 2,500 young people smoke their first cigarette.

According to Commissioner Gottlieb, the approach to nicotine must be accompanied by a strict base of rules and standards for newly-regulated products which should be done in concert and not in isolation, if it is to be successful.

The FDA plans to issue guidance that describes a new enforcement policy in the near future. For newly-regulated combustible products, like cigars, hookah tobacco, and pipe tobacco, under expected revised timelines, the applications to be submitted by 8th August 2021; and for non-combustible products like electronic nicotine delivery systems (ENDS) and e-cigarettes, the applications should be submitted by 8th August 2022. The manufacturers are expected to continue marketing the products while the reviewing of the application is done by the FDA.

The current requirements for smokeless tobacco and cigarettes will not be affected by the probable enforcement of the policy. This also exempts provisions of the final rule like compulsory age and photo-ID checks for preventing illegal sales to minors, of which compliance deadlines are already over. Future deadlines for other provisions of the rule, which includes needed cautioning statements, the listing of ingredients, required warning statements etc. will also not be affected.   

Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products said: “This comprehensive plan and sweeping approach to tobacco and nicotine allows the FDA to apply the powerful tools given by Congress to achieve the most significant public health impact.”

The FDA also plans to investigate on actions to improve access to and use of medical nicotine products that are approved by the agency and work along with sponsors for finding steps under the safety and efficacy standard for products aimed to help smokers quit.

As a complementary step - to make the process of product reviewing more predictable, efficient and transparent for the manufacturers while maintaining its public health mission - the FDA has plans to provide foundational rules.  

In addition, regulations that outline the details on the information the agency expects to be included in the Modified Risk Tobacco Product (MRTP), Premarket Tobacco Applications (PMTAs), and reports to demonstrate Substantial Equivalence (SE) are intended to be released by the agency. Efforts to assist the industry in complying with federal tobacco regulations through online information, webinars, meetings and guidance documents will be continued.