FDA Authorizes Reduced Risk Claims for Cigarettes with Very Low Nicotine

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On December 23, the Food and Drug Administration (FDA) authorized two combustible cigarettes with low nicotine levels to be marketed as “modified risk tobacco products” (MRTPs).

The designation allows 22nd Century Group, which describes itself as “a leading agricultural biotechnology company focused on tobacco reduction,” to advertise its VLN King and VLN Menthol cigarettes under reduced exposure claims.

The company can state each of these products has “95 percent less nicotine,” “helps reduce your nicotine consumption” and “greatly reduces your nicotine.”

To a layman, the MRTP process is almost indistinguishable from the premarket tobacco product application (PMTA) process that e-cigarette manufacturers have had to go through over the past year. The latter has dominated the news—since late summer, the FDA has denied the PMTAs for many small- to medium-size vape producers, some of which have sued the agency to put their submissions back under review.

Read full article here.

Alex Norcia – Filter – 2021-12-30.

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