February 7, 2020

Stanton A. Glantz, PhD

FDA should withdraw its approval for 22nd Century to sell VLN low nicotine cigarettes

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.

As we describe in detail in the attached comment that we submitted to both TPSAC and the docket for 22nd Century’s MRTP applications, FDA erred in authorizing the marketing of Moonlight and Moonlight Menthol cigarettes because these product names were not considered by FDA in its scientific review.

The product name is critical to a determination as to whether a product is “appropriate for the protection of the public health” under Tobacco Control Act section 910(c)(4) because the name may well influence whether it is more likely than not that nonusers of tobacco products will initiate with the product, and/or whether it is more likely than not that current users of tobacco products will quit. This is particularly true for the product name “Moonlight” that includes the explicitly prohibited descriptor “light.” 

After 22nd Century amended its PMTAs to change the product name to “Moonlight,” FDA should have immediately suspended its review of the product until 22nd Century provided a complete application that fully addresses the public health implications of the new name.  More important, FDA should withdraw the marketing order for Moonlight and Moonlight Menthol cigarettes under Tobacco Control Act section 910(d)(1)(A) because the continued marketing of this product using a name that was not studied is no longer appropriate for the protection of the public health.

The name change from “VLN” to “Moonlight” is especially relevant to the MRTP applications. To demonstrate that a product should be awarded a reduced exposure MRTP order, Tobacco Control Act section 911(g) requires that the applicant demonstrate consumer understanding of the product’s harmfulness or exposure based on the label, labeling, and advertising. Because the MRTP applications were based on studies using a different name (“VLN” instead of “Moonlight,” which is what the actual labeling and advertising would use if the MRTP order were granted), the applications should be rejected outright and FDA must not issue a MRTP order.

The name “Moonlight” is especially troublesome since its contains the descriptor “light” which is explicitly prohibited in the law’s MRTP provisions, Tobacco Control Act section 911(b)(2)(A)(ii).  Indeed, in explaining the intent of the MRTP provisions in the Findings section of the Tobacco Control Act, Congress referred to the federal court decision in the RICO case (USA v. Philip Morris) and declared that the term “light” was inherently deceptive and misled consumers to believe that products labeled “light” were less harmful than other products. The law is clear and unambiguous: FDA must not authorize a company to sell any product with the term “light” in its name and labeling, and must not authorize a company to sell such a product with modified risk or exposure claims.

For these reasons, FDA should withdraw its marketing order for Moonlight and Moonlight Menthol cigarettes and should reject 22nd Century’s MRTP application to sell these cigarettes with reduced exposure claims.

Best wishes,

Stanton A. Glantz, PhD

Professor of Medicine

Truth Initiative Distinguished Professor of Tobacco Control

Director, Center for Tobacco Control Research and Education

 

Lauren K. Lempert, JD, MPH

Law and Policy Specialist

Center for Tobacco Control Research and Education

 

cc:          Dr. Matthew R. Holman, Director, Office of Science

Members of the Tobacco Products Scientific Advisory Committee, c/o Serina Hunter-Thomas

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