February 7, 2020
Lauren Lempert and I just sent this letter to Mitch Zeller at FDA urging them to withdraw the PMTA awarded to 22nd Century very low nicotine cigarettes. This letter raises issues beyond the issues with the MRTP public comments we recently submitted.
February 7, 2020
Mr. Mitchell Zeller
Director, Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
VIA EMAIL
Dear Mr. Zeller,
FDA issued marketing orders for 22nd Century’s Moonlight and Moonlight Menthol reduced nicotine cigarettes on December 17, 2019 based on premarket tobacco product applications (PMTAs) that used the names “VLN King and VLN Menthol King.” On October 2, 2019, 22nd Century submitted an amendment to its PMTAs changing the names of the subject cigarettes from “VLN” to “Moonlight” after FDA had already conducted its scientific review using the “VLN” names. Therefore, none of the evidence before FDA when it considered the PMTAs used the Moonlight names that 22nd Century is now authorized to use when it brings these products to market.
February 7, 2020
Today we submitted this public comment to FDA and its Tobacco Products Scientific Advisory Committee. The regulations.gov tracking number is 1k4-9evp-yi5f. A PDF is available here.
22nd Century’s VLN cigarettes marketing with modified exposure claims has not been tested and will likely be appealing to youth and young adults
Lucy Popova, PhD*; Bonnie Halpern-Felsher, PhD; Benjamin Chaffee, DDS, MPH, PhD; Lauren K. Lempert, JD, MPH; Stanton A. Glantz, PhD
February 6, 2020
Today we submitted this public comment to the FDA explaining why they should not approve modified risk or exposure claims for very low nicotine cigarettes. It also points out that FDA erred in approving this product for sale because the company changed the name for the cigarette from VLN to Moonlight after FDA finished assessing the PMTA application. This means that the assessment was not based on the actual name of the product, which is important for marketing and the public health effect. The regulations.gov tracking number is 1k4-9eva-3mp5. A PDF of the comment is here. We also submitted a similar comment to the FDA Tobacco Product Scientific Advisory Committee, which will be considering this application soon.
22nd Century’s MRTP application for its VLN cigarettes should be denied because it does not adequately address how its product would be actually used and because the modified exposure claim misleads consumers to believe this product is less harmful than conventional cigarettes
