The first authorized modified-risk tobacco product (MRTP) was General Snus by Swedish Match, which was authorized in October of 2019. In July 2020, the Food and Drug Administration (FDA) authorized the marketing of the IQOS tobacco heating system by Philip Morris with reduced exposure claims, but as of late, due to patent litigation, it is no longer available on the U.S. market.
In late December, the FDA authorized a modified-risk marketing order for 22nd Century Group’s VLN King and VLN Menthol King, which contain 95% less nicotine than traditional cigarette formulations. This is the first, and likely only, modified-risk authorization for a combustible tobacco cigarette product.
To date U.S. Smokeless Tobacco Company is in substantive review of its Copenhagen Fine Cut product, as is R.J. Reynolds Tobacco Co. with its Camel Snus product. In addition, Philip Morris has also submitted its IQOS 3 System to the FDA as a modified-risk product, and it is also currently in substantive review.
What is an MRTP?
In order to reach a decision to authorize marketing of a proposed MRTP, FDA must consider under section 911 of the Federal Food, Drug, and Cosmetic (FD&C) Act:
- the relative health risks to individuals of the tobacco product that is the subject of the application;
- the increased or decreased likelihood that existing users of tobacco products who would otherwise stop using such products will switch to the tobacco product that is the subject of the application;
- the increased or decreased likelihood that persons who do not use tobacco products will start using the tobacco product that is the subject of the application;
- the risks and benefits to persons from the use of the tobacco product that is the subject of the application as compared to the use of products for smoking cessation approved as medical products to treat nicotine dependence; and
- comments, data and information submitted by interested persons.
In March of 2019, the acting FDA Director of the Center for Tobacco Products Mitch Zeller hosted a Ted Talk titled “The Past, Present, and Future of Nicotine Addiction.” Zeller started the presentation with how, “the work that we are doing is to create the cigarette of the future, one that is no longer capable of creating or sustaining addiction.”
With 22nd Century Group’s landmark modified-risk tobacco product authorization, tobacco companies like 22nd Century Group understand the FDA’s direction and how they plan to reduce the harm caused by smoking.
“FDA has it within its regulatory reach to use the tools of product regulation to render cigarettes as we know them minimally or non-addictive,” Zeller said. “We’re working on this. The generational impact of this nicotine-reduction policy is profound.”
It appears the FDA’s intentions are clear when you combine the Ted Talk in 2019 and the landmark decision for 22nd Century Group’s VLN products, which include the following four authorized claims:
- Helps you Smoke Less
- Greatly Reduces your Nicotine Consumption
- Helps reduce your Nicotine Consumption
- 95% Less Nicotine.