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WARNING LETTER

Transphere, Inc. MARCS-CMS 629645 —


Delivery Method:
VIA UPS and Electronic Mail
Product:
Tobacco

Recipient:
Recipient Name
Eugene Potemkin
Recipient Title
Chief Executive Officer
Transphere, Inc.

261 Robbyn Lane
Oceanside, NY 11572
United States

transpherenyc@gmail.com
Issuing Office:
Center for Tobacco Products

United States


WARNING LETTER

March 28, 2022

Dear Mr. Potemkin,

The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) has reviewed our records and determined that Transphere, Inc. is a domestic importer of cigarettes, cigars, and roll-your-own tobacco 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 cigarettes, cigars, and roll-your-own tobacco, remit payment of its user fee assessment by the last day of the applicable quarter.

Please be aware that, effective August 8, 2016, FDA deemed additional products meeting the definition of a tobacco product, except accessories to these newly deemed products, to be subject to regulation under the FD&C Act. These products include, but are not limited to, cigars and pipe tobacco. See Final Rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 81 Fed. Reg. 28,974 (May 10, 2016), available at https://federalregister.gov/a/2016-10685.

Failure to Pay Assessed User Fees

FDA has determined that all regulated tobacco products imported by Transphere, Inc. 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 user fees under section 919 of the FD&C Act, 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 invoices enumerated in the table below.

Fiscal Quarter/Year of Assessment Assessment Invoice Date Assessment Due Date
2nd Quarter 2019 3/1/2019 3/31/2019
3rd Quarter 2019 6/1/2019 7/1/2019
4th Quarter 2019 8/31/2019 9/30/2019
1st Quarter 2020 12/1/2019 12/31/2019
1st Quarter 2020 12/1/2019 12/31/2019
1st Quarter 2020 12/1/2019 12/31/2019
2nd Quarter 2020 3/1/2020 3/31/2020
3rd Quarter 2020 5/31/2020 6/30/2020
4th Quarter 2020 8/31/2020 9/30/2020
1st Quarter 2021 12/1/2020 12/31/2020
3rd Quarter 2021 5/31/2021 6/30/2021
3rd Quarter 2021 5/31/2021 6/30/2021
4th Quarter 2021 8/31/2021 9/30/2021
1st Quarter 2022 12/1/2021 12/31/2021


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 30th day after final agency action on a resolution of any dispute as to the amount of fees assessed, regulated tobacco products imported by Transphere, Inc. 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.

It is your responsibility to ensure that all of your tobacco products comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to address any violations of the FD&C Act, 21 U.S.C. § 301 et seq., Chapter IX, relating to tobacco products including the tobacco regulations in 21 C.F.R. Parts 1140, 1141, and 1143, may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction. However, this Warning Letter does not constitute “written notice” for purposes of section 303(f)(9)(B)(i)(II) of the FD&C Act. Please note that tobacco products offered for import into the United States that appear to be adulterated and/or misbranded may be detained or refused admission.

The violations discussed in this letter do not necessarily constitute an exhaustive list. You should take prompt action to address any violations that are referenced above, as well as violations that are the same as or similar to the ones stated above, and take any necessary actions to bring your tobacco products into compliance with the FD&C Act.

Please submit a written response to this letter within 15 working days from the date of receipt describing your actions to address any violations and bring your products into compliance and your plan for maintaining compliance with the FD&C Act. Your response should include:

1. 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.

2. Documentation to show the steps you have taken to prevent similar violations from occurring again in the future.

3. If your firm’s planned corrections will occur over time, please include a timetable for implementation of those activities.

If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. This letter notifies you of our findings and provides you with an opportunity to address them. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.

Please note your reference number, ER2200484, 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

or

ctpcompliance@fda.hhs.gov

If you have any questions about the content of this letter, please contact Office of Compliance and Enforcement, CTP, at ctpcompliance@fda.hhs.gov.

Sincerely,
/S/

Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products

 
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