FDA’s unorthodox tactic to lower smoking rates: Permits cigarette to be marketed as MRTP

2021 was a very interesting year at the FDA Center for Tobacco Products as several never-tried-before tactics to battle smoking rates were implemented. Besides from the “Modified Risk” grant of General Snus, a smokeless tobacco from Swedish Match USA Inc. that was authorized back in 2019, very few alternatives have previously been referred to as lower risk options for smokers. The fall of 2021 could prove to be a game-changer. 

During studies, the FDA has found that “three out of four adult smokers want to quit” but find it hard to do so without alternatives to help reduce nicotine intake. Over the years, campaigns to help adults kick their smoking habits involved cold-turkey methods of quitting, with very few alternatives endorsed as modified risk tobacco products (MRTP),all in fear of attracting non-smokers and youths. 

With this in mind, the FDA informed in a press announcement on December 23, 2021 that the marketing of 22nd Century Group Inc.’s two types of low-nicotine cigarettes; “VLN King” and “VLN Menthol King” as modified risk products will be permitted. This decision was made as a way forward to “stop tobacco-related disease and death… and the data on these products show they can help addicted adult smokers transition away from the highly addictive combusted cigarettes,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. 

For the authorization to be maintained, 22nd Century Group Inc. will need to adhere to a set of very strict marketing restrictions including recommended labels like: “Nicotine is addictive. Less nicotine does NOT mean safer. All cigarettes can cause disease and death” and with very clear adult-targeted advertising. The following claims are permitted for the marketing of “VLN King” and “VLN Menthol King”:

“…Greatly reduces your nicotine consumption.”“Contains 95% less nicotine.”“Helps reduce your nicotine consumption.”

Claims that, when looking at product data and previous research are“..unlikely to lead to addiction and initiation among non-users, including youth.” The fact is, if any of the assessed modified risk tobacco products overtime prove to entice new or young users the permissions will be withdrawn. 

Which are the other Modified Risk Tobacco Products?

The specific grant of VLN was surprising, being a cigarette, but it was among one of three other equally unprecedented authorizations, only last year:

Vuse E-Cigarettes October 13thVerve Oral Tobacco Discs October 19thVLN Cigarettes December 23rd

Given the different natures of these alternatives, including the already-authorized General Snus by Swedish Match USA Inc., it’s not unlikely that we will see authorizations within other product types too such as nicotine pouches that are already being reviewed by the FDA. 

However, these recent strategies to aid adult smokers is not only met with positive attitude; the FDA is also being heavily criticized for their “bold moves” and are accused of “ignores[ing] its own data” by medical associations who point out the large number of youths that are already using some of these authorized products, such as Vuse. 

That said, the FDA clarifies that “authorized for marketing” does not mean FDA approved, endorsement or imply safety but is hoped to guide smokers toward less nicotine consumption and is therefore considered “appropriate for the protection of the public health”.

What the long-term consequences of these permissions are has yet to be revealed. 

Although smoking a cigarette never rose to the concern of becoming a legal problem that could make anyone end up as an inmate in prison, the rising numbers related to tobacco consumption did raise health concerns that caught the attention of different departments in the US.