WARNING LETTER

Florida Import Export Services MARCS-CMS 587055 — September 24, 2019

Delivery Method:: Certified Mail and Electronic Mail
Product:: Tobacco

Recipient:: Recipient Name

Lazara Ors; Florida Import Export Services; 425 NE 22nd Street, Suite 2006
Miami, FL 33137
United States

Issuing Office:: Center for Tobacco Products; 10903 New Hampshire Avenue
Silver Spring, MD 20993
United States

SEP 24, 2019

WARNING LETTER

Dear Ms. Ors:

The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) has reviewed our records and determined that Florida Import Export Services is a domestic importer of cigar tobacco products for the purposes of section 919 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. § 387s) and subject to user fees in accordance with that provision. Section 919(b)(6) of the FD&C Act (21 U.S.C. § 387s(b)(6)) requires that each domestic importer of certain tobacco products, including cigars, remit payment of its user fee assessment by the last day of the applicable quarter.

Failure to Pay Assessed User Fees

FDA has determined that all regulated tobacco products imported by Florida Import Export Services are adulterated under section 902(4) of the FD&C Act (21 U.S.C. § 387b(4)) because you have failed to pay user fees assessed to you as required by section 919 of the FD&C Act (21 U.S.C. § 387s). Specifically, based on our records, you import tobacco products into the United States, you import products subject to section 919 user fees, and you were assessed user fees by FDA’s Office of Financial Management (OFM) on the dates indicated below. To date, FDA has not received payment from you for the assessment invoices enumerated in the table below.

Fiscal Quarter/Year of Assessment	Assessment Invoice Date	Assessment Due Date
2^nd Quarter 2018	3/1/2018	3/31/2018
3^rd Quarter 2018	6/1/2018	7/1/2018
4^th Quarter 2018	9/1/2018	10/1/2018
1^st Quarter 2019	12/1/2018	12/31/2018
2^nd Quarter 2019	3/1/2019	3/31/2019
3^rd Quarter 2019	6/1/2019	7/1/2019

Section 919(b)(6) of the FD&C Act (21 U.S.C. § 387s(b)(6)) requires that payments of all assessments must be made by the last day of the applicable quarter. Because you have failed to pay user fees assessed pursuant to section 919 of the FD&C Act by the last day of the applicable quarter, or by the 30^th day after final agency action on a resolution of any dispute as to the amount of fees assessed, regulated tobacco products imported by Florida Import Export Services are adulterated under section 902(4) of the FD&C Act (21 U.S.C. § 387b(4)).

Conclusion and Requested Actions

Under section 301(a) of the FD&C Act (21 U.S.C. § 331(a)), the introduction or delivery for introduction into interstate commerce of any tobacco product that is adulterated is a prohibited act.

In addition, compliance with the requirements of the FD&C Act under section 910(a)(2)(A)(i) of the FD&C Act (21 U.S.C. § 387j(a)(2)(A)(i)) includes payment of assessed user fees as set forth in section 919 of the FD&C Act. Accordingly, FDA is unable to issue an order finding a new tobacco product described in a pending or future substantial equivalence (SE) Report -- other than for products marketed between February 15, 2007 and March 22, 2011, and for which an SE report was submitted by March 22, 2011— to be substantially equivalent to the predicate tobacco product until a firm has paid its assessed fees in their entirety.

Please note that entering a repayment plan for assessed user fees does not render a product compliant with the requirements of the FD&C Act. A firm in arrears, even if on a repayment plan, “fails to pay a user fee assessed to such manufacturer or importer pursuant to section 919 by the date specified in section 919 or by the 30th day after final agency action on a resolution of any dispute as to the amount of such fee,” (section 902(4) of the FD&C Act) and thus its products are adulterated.

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that all of your tobacco products comply with the applicable provisions of the FD&C Act and implementing regulations. Failure to ensure full compliance with the FD&C Act and regulations may result in FDA initiating further action without notice, including, but not limited to, civil money penalties, criminal prosecution, seizure, and/or injunction.

You should immediately correct the violations stated above and take all necessary actions to bring your tobacco products into compliance with the FD&C Act. Please submit a written response within 15 working days from the date of receipt of this letter describing your corrective actions and your plan for maintaining compliance with the FD&C Act. Your response should include:

Documentation showing that you have paid or have contacted OFM at userfees@fda.gov for information on how to pay your assessed user fees and set up a plan to pay those fees.
Documentation to show the steps you have taken to prevent similar violations from occurring again in the future.
If your firm’s planned corrections will occur over time, please include a timetable for implementation of those activities.

Please note your reference number, ER1900026, in your response and direct your response to the following address:

DEM-WL Response, Office of Compliance and Enforcement

FDA Center for Tobacco Products

c/o Document Control Center

Building 71, Room G335

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

ctpcompliance@fda.hhs.gov

If you have any questions about the content of this letter, please contact Kristina Peters, Office of Compliance and Enforcement, CTP, at (301) 796-4083 or kristina.peters@fda.hhs.gov.

Sincerely,
/S/

Ann Simoneau, J.D.

Director

Office of Compliance and Enforcement

Center for Tobacco Products

cc:

Florida Import Export Services

Attn: Michael Garcia

340 West Flagler Street, Suite 3302

Miami, Florida 33130