July 28, 2017
2 min read
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FDA pursuing lower levels of nicotine in cigarettes

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The FDA announced a multiyear plan today that could limit the amount of nicotine in cigarettes.

The plan will better protect kids and substantially lower the number of illnesses and death attributed to tobacco, agency officials said.

“Tobacco ... is the only legal consumer product that, when used as intended, will kill half of all long-term users,” FDA Commissioner Scott Gottlieb, MD, said in a press release. “Unless we change course, 5.6 million young people alive today will die prematurely later in life from tobacco use. Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts — and we believe it’s vital that we pursue this common ground.”

According to the release, the agency wants to have an adequate regulatory and scientific base to productively carry out the Family Smoking Prevention and Tobacco Control Act, the 2009 law that gave the FDA the power to govern the distribution, marketing and manufacturing of such products.

A critical component of the strategy, according to the FDA, is showing more awareness that nicotine reaches consumers through items that categorize a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes.

Among the items on the FDA’s to-do list:

•request public comment on the role that flavors, including menthol, in tobacco products play in drawing in youth and may play in helping some smokers switch to potentially less harmful forms of nicotine delivery;

•seek additional comments and scientific data related to the patterns of use and resulting public health impacts from premium cigars that were part of the FDA’s 2016 rule;

•enhance use and availability of FDA-approved medicinal nicotine products;

•work with stakeholders to come up with a strategy that’s within the efficacy and safety standards but can also assist smokers who want to quit; and

•establish rules that make the product review process more efficient, predictable and transparent for manufacturers, but still remain true to FDA’s mission.

“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,” Mitch Zeller, JD, director of the FDA’s Center for Tobacco Products, said in the release. “Public input on these complex issues will help ensure the agency has the proper science-based policies in place to meaningfully reduce the harms caused by tobacco use.”

According to the FDA, tobacco is leading cause of preventable disease and death in the United States, causing nearly a half million deaths and costing almost $300 billion a year in lost productivity and direct health care costs.

Reference:

Tobacco Control Act. Available at: www.fda.gov/tobaccoproducts/guidancecomplianceregulatoryinformation/ucm246129.htm. Accessed on July 28, 2017.

Disclosure: Gottlieb and Zeller are employed by the FDA.