Less Risky Business?

Since 2019, the FDA has authorized 15 tobacco products to be marketed as modified risk

By Renée M. Covino

WHEN DID the tobacco industry get into risk management?

It began with product names bearing adjectives like “light” and “mild.” But legislators thought these terms might give consumers the false impression that the products posed less of a health risk than other tobacco products. Hence, the term “Modified Risk Tobacco Products” (MRTP) was born, and the Family Smoking Prevention and Tobacco Control Act of 2009 made it illegal for tobacco products to be marketed as such unless the Food and Drug Administration (FDA) specifically authorized it.

Fast forward more than a decade to 2022. Thus far, the FDA has authorized only 15 products to be marketed as MRTPs — and the first weren’t granted until 2019, an indication of the lengthy process and rigorous scientific analysis that each product seeking MRTP status must go through. To obtain the designation, a manufacturer must demonstrate to the FDA that the product “will, or is expected to, benefit the health of the U.S. population as a whole.”

If the application is authorized, the manufacturer is then directed to conduct certain studies to determine how the modified risk authorization order impacts consumer perception, behavior and health, giving the FDA the ability to review whether the basis for its granting of the MRTP application was indeed correct. granted for fixed time periods (no more than five years). To continue marketing the product as an MRTP beyond that time, the manufacturer must submit a new application that shows it still satisfies the requirements of MRTP authorization.

The good news is that after a period of nearly 18 months with no new MRTP authorizations, the FDA has granted three since December.

“Helps You Smoke Less”

In December 2021, the FDA granted 22nd Century Group Inc., an agricultural biotechnology company focused on tobacco harm reduction, the first MRTP designation for combustible cigarettes for its VLN King and VLN Menthol King products, both of which have significantly reduced nicotine content.

The company maintains that in contrast to costly extraction and “de-nicotinization” technologies that strip out not just nicotine, but also flavor and aroma compounds, 22nd Century’s reduced nicotine tobacco “naturally grows with very low levels of nicotine resulting in products that smoke, taste and smell like conventional cigarettes, but contain 95 percent less nicotine than conventional, highly addictive cigarettes.”

The FDA authorized the marketing of VLN with the following MRTP claims: • “Helps you smoke less.” • “95% less nicotine.” • “Helps reduce your nicotine consumption.” • “Greatly reduces your nicotine consumption.”

claim that James A. Mish, CEO of 22nd Century Group, refers to as “the shot heard around the tobacco world.”

This “means that every time an adult smoker goes to the store to get a pack of cigarettes, sitting on the shelf right next to the other premium cigarette brands will be a pack of our VLN staring them in the face with the statement ‘helps you smoke less’ printed boldly right on the front of the package,” Mish said, speaking during the company’s March 1, 2022 earnings call. “We took a collaborative, patient and thoughtful approach to our interactions with the FDA and cannot have asked for a better result.”

VLN is also the first and only combustible cigarette to come to market that complies with the FDA’s proposed nicotine cap for conventional cigarettes, laid out in the agency’s Comprehensive Plan for Tobacco and Nicotine Regulation.

“Our mission is to find ways to stop tobacco-related disease and death. We know that three out of four adult smokers want to quit and the data on these products show they can help addicted adult smokers transition away from highly addictive combusted cigarettes," Mitch Zeller, director of the FDA's Center for Tobacco Products, said at the time of VLN authorization. “…If adult smokers were less addicted to combusted cigarettes, they would likely smoke less and may be exposed to fewer harmful chemicals that cause tobacco-related disease and death."

VLN cigarettes are now available exclusively at more than 150 Circle K convenience stores across Chicagoland. Participating pilot launch stores are located in Chicago, suburban Cook County, and the collar counties.

The three- to six-month pilot will be the first U.S. sales of VLN King and VLN Menthol King cigarettes. From there, the company expects to roll out VLN to more than 7,000 Circle K stores nationwide, as well as other regional and national trade partners.

A pack of VLN cigarettes will be similarly priced to full nicotine premium brands, approximately $9 to $12 depending on tax, according to the manufacturer. Illinois is the second most expensive cigarette retail market in the United States.

The New Generation of IQOS

On March 11 of this year, the FDA issued its latest modified risk authorizations for two next-generation versions of products already granted the status. Philip Morris Products S.A. can now market its IQOS 3 system holder and charger with the following

The MRTP 15

In October 2019, the Food and Drug Administration authorized the first products permitted to use the modified risk tobacco products (MRTP) designation. As of March 11, 2022, 15 products from three companies have been granted MRTP status. They are:

PRODUCT NAME MANUFACTURER DATE APPROVED

IQOS 3 System Holder & Charger Philip Morris 3/11/2022 VLN King 22nd Century Group 12/23/2021 VLN Menthol King 22nd Century Group 12/23/2021 IQOS System Holder & Charger Philip Morris 07/07/2020 Marlboro HeatSticks Philip Morris 07/07/2020 Marlboro Smooth Menthol HeatSticks Philip Morris 07/07/2020 Marlboro Fresh Menthol HeatSticks Philip Morris 07/07/2020 General Loose Swedish Match 10/22/2019 General Dry Mint Portion Original Mini Swedish Match 10/22/2019 General Portion Original Large Swedish Match 10/22/2019 General Classic Blend Portion White Large 12ct Swedish Match 10/22/2019 General Mint Portion White Large Swedish Match 10/22/2019 General Nordic Mint Portion White Large 12ct Swedish Match 10/22/2019 General Portion White Large Swedish Match 10/22/2019 General Wintergreen Portion White Large Swedish Match 10/22/2019

MRTP claims:

• “The IQOS system heats tobacco but does not burn it.” • “This significantly reduces the production of harmful and potentially harmful chemicals.” • “Scientific studies have shown that switching completely from conventional cigarettes to the

IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.”

This reduced exposure information is the same as the information previously authorized by the FDA in July 2020 for an earlier version of the device.

The IQOS 3 device is similar in design to the previous version with mainly aesthetic changes. It uses the same tobacco source, and the company requested to use the same exposure reduction claims as authorized for the previous version of the device. Given these similarities, the FDA said it largely relied on past evaluations in determining that the IQOS 3 met the criteria to be marketed as an MRTP.

Since November 2021, IQOS and Marlboro HeatSticks, which were also granted MRTP status in July 2020, have been banned for sale and import in the United States by the U.S. International Trade Commission. The ruling followed a finding that IQOS infringes on two patents by British America Tobacco Group, the London-based parent company of Reynolds American Inc.

The recent MRTP authorization does not override that ruling. Rather, it allows Philip Morris to consider the approved reduced exposure claims in the future marketing of IQOS 3. The authorization is effective through July 7, 2024, barring any finding that the order is no longer expected to benefit the health of the population.

“At the present time, we do not expect to have access to IQOS devices or Marlboro HeatSticks in 2022,” Altria Group CEO Billy Gifford said during the company's recent fourth-quarter and full-year 2021 earnings call. (Altria is responsible for IQOS manufacturing). “However, we remain focused on returning IQOS to the market as soon as possible. Our teams are actively working on re-entry plans and we expect to be ready to bring IQOS back to U.S. consumers when available.”

Altria has long maintained that heated tobacco products will play an important role in U.S. harm reduction efforts. “We have gained significant knowledge from our IQOS commercialization efforts, which we expect to use going forward,” Gifford said during the January call. “Our teams learned how to educate U.S. smokers on a brand-new tobacco category and how to effectively support their transition journey to smoke-free alternatives. We demonstrated improved performance in each successive market and gained valuable knowledge on leveraging MRTP claims to transition smokers.”

Select Circle K stores are piloting VLN cigarettes, which contain 95 percent less nicotine than conventional combustible cigarettes.

The Evolving Backbar

Convenience store retailers need to start thinking about how their backbar will evolve and incorporate modified risk tobacco products, if they haven’t already, according to Don Stuart, managing partner at Wilton, Conn.-based Cadent Consulting Group.

He predicts that well over half the backbar space will be devoted to “non-combustible, tobacco-like products,” potentially with a modified risk classification.

C-stores need to continually aim to differentiate their backbars through new and emerging categories and forms of tobacco that qualify as reduced risk, agrees Matt Domingo, senior director of external relations at Reynolds Marketing Services Co.

C-stores that take chances in the category “are typically the ones who end up capturing the bigger slices of the volume that becomes available from market to market,” he said. CSN