Saturday, August 22, 2020 11:40:13 AM
Mike22 hours ago
Overall the VLNTM King and VLNTM King Menthol cigarettes meet the following criteria specified in section 910(c)(2) of the FD&C Act:
1. The methods used in, and the facilities or controls used for, the manufacture, processing, and packing of these products do not fail to conform to the requirements in section 906(e)3 of the FD&C Act.
2. Based on a fair evaluation of all material facts, the labeling is not false or misleading in any particular.
3. The products do not fail to conform to a tobacco product standard in effect under section 907 of the FD&C Act.
4. Permitting the marketing of the products is at this time appropriate for the protection of the public health, as described in section 910(c)(4) of the FD&C Act.
I recommend that FDA grant marketing authorization for the proposed products that are the subject of PM0000491 and PM0000492 for the reasons described above.
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