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  1. Warning Letters

WARNING LETTER

Heritage Tobacco, LLC MARCS-CMS 609065 —

Delivery Method:
VIA UPS and Electronic Mail
Product:
Tobacco
Recipient:
Recipient Name
Jose Espinosa
Recipient Title
President
Heritage Tobacco, LLC

8455 Northwest 74th Street
Miami, FL 33166
United States

Laz@HeritageTOB.com
Issuing Office:
Center for Tobacco Products

United States

WARNING LETTER

AUG 6, 2020

Dear Mr. Espinosa:

The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) has reviewed your submissions to the FDA and our inspection records, and determined that Heritage Tobacco, LLC manufactures, distributes, and/or imports cigars, pipe tobacco, and cigarettes for commercial distribution in the United States, and that the cigars, pipe tobacco, and cigarettes are manufactured for sale or distribution to customers in the United States.

Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 321(rr)), these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including cigars, pipe tobacco, and cigarettes, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)) and 21 C.F.R. § 1100.1.

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 Act. These products include, but are not limited to, electronic nicotine delivery systems (including ecigarettes), e-liquids, 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.

New Tobacco Products Without Required Marketing Authorization Are Adulterated and/or Misbranded

The FD&C Act generally requires “new tobacco products” to have premarket authorization. A “new tobacco product” is any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modified tobacco product that was commercially marketed after February 15, 2007 (section 910(a) of the FD&C Act; 21 U.S.C. § 387j(a)). Generally, a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)) is required for a new tobacco product unless (1) the manufacturer of the product submitted a report under section 905(j) of the FD&C Act (21 U.S.C. § 387e(j)) and FDA issues an order finding the product substantially equivalent to a predicate tobacco product (section 910(a)(2)(A) of the FD&C Act) or (2) the manufacturer submitted a report under section 905(j)(1)(A)(ii) of the FD&C Act (21 U.S.C. § 387e(j)(1)(A)(ii)) and all modifications are covered by exemptions from the requirements of substantial equivalence granted by FDA under section 905(j)(3) of the FD&C Act (21 U.S.C. § 387e(j)(3)).

During FDA’s January 14-16, 2020 inspection of your manufacturing establishment, FDA determined that you manufacture, sell, and/or distribute to customers in the United States the following new tobacco products after receiving Not Substantially Equivalent (NSE) orders: HOBBY Full Flavor King Box 84mm, HOBBY Gold King Box 84mm, and HOBBY Menthol King Box 84mm.1

The tobacco products listed above are new tobacco products because they were not commercially marketed in the United States as of February 15, 2007. These products do not have FDA marketing authorization orders in effect under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt from the marketing authorization requirement. Therefore, these products are adulterated under section 902(6)(A) of the FD&C Act and/or misbranded under section 903(a)(6) of the FD&C Act because a notice or other information respecting these products was not provided as required by section 905(j) of the FD&C Act. The doing of any act with respect to a tobacco product while such article is held for sale after shipment in interstate commerce which results in such product being adulterated or misbranded is a prohibited act under section 301(k) of the FD&C Act (21 U.S.C. § 331(k)). Additionally, to the extent that a report was required under section 905(j) of the FD&C Act, the failure to provide such report is a prohibited act under section 301(p) of the FD&C Act (21 U.S.C. § 331(p)).

Tobacco Products Manufactured in an Unregistered Establishment Are Misbranded

During FDA’s January 14-16, 2020 inspection, FDA observed that you did not register your manufacturing establishment, located at 8455 Northwest 74th Street, Miami, FL 33166, as required by section 905(c) of the FD&C Act (21 U.S.C. § 387e(c)). Section 905(c) states that “[e]very person upon first engaging in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products in any establishment owned or operated in any State by that person shall immediately register with the Secretary that person's name, place of business, and such establishment.” While you submitted initial registration and listing information to FDA in December 2016, FDA informed you by letter on August 6, 2018 that your registration and listing submission could not be processed due to several deficiencies, which you failed to correct.

Because your establishment was not registered in violation of section 905(c) of the FD&C Act, your tobacco products that were manufactured, prepared, propagated, compounded, or processed at that establishment are misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)). The introduction into interstate commerce of any tobacco product that is misbranded is a prohibited act under section 301(a) of the FD&C Act (21 U.S.C. § 331(a)). In addition, the failure to register your establishment in accordance with section 905 is a prohibited act under section 301(p) of the FD&C Act (21 U.S.C. § 331(p)).

Tobacco Products Not Listed with FDA Are Misbranded

FDA has determined that no tobacco products manufactured by Heritage Tobacco, LLC are included in a list required by section 905(i) of the FD&C Act (21 U.S.C. § 387e(i)). Section 905(i)(3)(A) of the FD&C Act (21 U.S.C. § 387e(i)(3)(A)) requires that each person who registers with FDA under section 905 biannually report to FDA a list of each tobacco product introduced by the registrant for commercial distribution which has not been included in any list previously filed by that person with the FDA under section 905(i).

Because no tobacco products manufactured by Heritage Tobacco, LLC are included in a product listing in violation of 905(i) of the FD&C Act (21 U.S.C. § 387e(i)), these products are misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)). The introduction into interstate commerce of any tobacco product that is misbranded is a prohibited act under section 301(a) of the FD&C Act (21 U.S.C. § 331(a)). Additionally, the failure to provide any information required by section 905(i) of the FD&C Act is a prohibited act under section 301(p) of the FD&C Act (21 U.S.C. § 331(p)).

Failure to Pay Assessed User Fees

Heritage Tobacco, LLC is a domestic manufacturer and/or importer of cigars, pipe tobacco, and cigarettes for the purposes of section 919 of 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 manufacturer and importer of certain tobacco products, including cigars, pipe tobacco, and cigarettes remit payment of its user fee assessment by the last day of the applicable quarter.

FDA has determined that all regulated tobacco products manufactured and/or imported by Heritage Tobacco, LLC 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 manufacture and/or import tobacco products in the United States, you manufacture 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 the required payment from you for the assessment invoices enumerated in the table below.

  Fiscal Quarter/Year of Assessment      Assessment Invoice Date      Assessment Due Date   
1st Quarter 2017 12/1/2016 12/31/2016
2nd Quarter 2017 3/1/2017 3/31/2017
3rd Quarter 2017 6/1/2017 7/1/2017
4th Quarter 2017 9/1/2017 10/1/2017
1st Quarter 2018 12/1/2017 12/31/2017
2nd Quarter 2018 3/1/2018 3/31/2018
3rd Quarter 2018 6/1/2018 7/1/2018
4th Quarter 2018 9/1/2018 10/1/2018
1st Quarter 2019 12/1/2018 12/31/2018
2nd Quarter 2019 3/1/2019 3/31/2019
3rd Quarter 2019 6/1/2019 7/1/2019
4th Quarter 2019 9/1/2019 9/30/2019
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

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 manufactured and/or imported by Heritage Tobacco, LLC are adulterated under section 902(4) of the FD&C Act (21 U.S.C. § 387b(4)).

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 but 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,” (§902(4) of the FD&C Act) and thus its products are adulterated.

Conclusion and Requested Actions

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.

It is your responsibility to ensure that 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 type described above may result in FDA’s taking regulatory action. These actions may include, but are 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 any adulterated and/or misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission.

Please submit a written response to this letter within 15 working days from the date of receipt describing your corrective actions, including the dates on which you discontinued the violative sale, and/or distribution of these tobacco products, documentation that you have paid or have contacted OFM at userfees@fda.gov for information on how to pay your assessed user fees and how to set up a plan to pay those fees, and your plan for maintaining compliance with the FD&C Act. If you do not believe that your products are in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.

Please note your reference number, ER2000060, 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

If you have any questions about the content of this letter, please contact Lillian Ortega at (240) 402-9041 or Lillian.Ortega@fda.hhs.gov.

Sincerely,
/S/

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

_________________________

1 FDA issued NSE orders to Heritage Tobacco, LLC for these three cigarettes under the Union brand name. However, Heritage Tobacco, LLC markets these NSE products under the HOBBY brand name.

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