TOBACCO
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.”
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.”
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.
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.”
What’s more, MRTP designations are only
It is the “helps you smoke less” authorized marketing
52 Convenience Store News C S N E W S . c o m
