Date of Substantial Equivalence submissions to FDA

To Whom It May Concern:

This is a request under the Freedom of Information Act. I hereby request the following records:

Please provide the dates that Tabacalera Del Este, SA submitted Substantial Equivalence reports for each of its products by brand and subbrand.

Palermo

Red King Box
Red 100 Box
Red Non-Filter Soft
Blue King Box
Blue 100 Box
Green King Box
Green 100 Box
Silver 100 Box
Silver Green 100 Box

The requested documents will be made available to the general public, and this request is not being made for commercial purposes.

In the event that fees cannot be waived, I would be grateful if you would inform me of the total charges in advance of fulfilling my request. I would prefer the request filled electronically, by e-mail attachment if available or CD-ROM if not.

Thank you in advance for your anticipated cooperation in this matter. I look forward to receiving your response to this request within 20 business days, as the statute requires.

Sincerely,

Ben Zeidler