Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kretek-international-inc-525410-07112017
Timestamp: 2019-06-26 11:51:13
Document Index: 580922588

Matched Legal Cases: ['§ 321', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§331', '§331', '§387', '§387', '§387', '§387', '§331', '§331']

Kretek International, Inc. - 525410 - 07/11/2017 | FDA
Kretek International, Inc. - 525410 - 07/11/2017
Kretek International, Inc. MARCS-CMS 525410 — 11/07/2017
VIA UPS, Electronic Mail, and Facsimile
Attn: Mark Cassar, CEO
5449 Endeavour Ct.
markcassar@kretek.com
Fax: (805) 531-8999
Dear Mr. Cassar:
The Center for Tobacco Products (CTP) of the U.S. Food and Drug Administration (FDA) has reviewed your submissions to the FDA and our inspection records and determined that Kretek International Inc. imports and distributes smokeless tobacco products for commercial distribution 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)), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), these smokeless tobacco products are tobacco products because they are made or derived from tobacco and intended for human consumption. Smokeless tobacco products are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).
Adulterated and Misbranded Tobacco Product(s) Without a Marketing Authorization Order
FDA has determined that you import, sell, and/or distribute to customers in the United States the following smokeless tobacco products without a marketing authorization order: Dry Snuff Silver Dollar Scotch, Snus Thunder Pouch Wintergreen Extra Strong, Snus Thunder Pouch Frosted Extra Strong, and Snus Thunder Pouch Original Extra Strong.
The FD&C Act requires premarket review for any “new tobacco product,” which means any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modification of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007 (21 U.S.C. § 387j(a)(2)(A)). 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 unless (1) 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) FDA issues an order finding the product to be exempt from the requirements of substantial equivalence and you make the required submission under section 905(j)(1)(A)(ii) of the FD&C Act.
Because these products require premarket review and do not have FDA marketing authorization orders in effect under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)), they are adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)). In addition, because a notice or other information respecting these products was not provided as required by section 905(j) of the FD&C Act (21 U.S.C. § 387e(j)), 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 adulterated or misbranded is a prohibited act under section 301(a) of the FD&C Act (21 U.S.C. §331(a)). The receipt in interstate commerce of any tobacco product that is adulterated or misbranded and the delivery or proffered delivery thereof for pay or otherwise is a prohibited act under section 301(c) of the FD&C Act (21 U.S.C. §331(c)).
FDA has determined that the Dry Snuff Silver Dollar Cherry, Dry Snuff Silver Dollar Spearmint, Dry Snuff Silver Dollar Apricot, Dry Snuff Silver Dollar Original, Dry Snuff Silver Dollar Blueberry, Dry Snuff Silver Dollar Raspberry, Dry Snuff Silver Dollar Natural, Dry Snuff Silver Dollar Vanilla, and Dry Snuff Silver Dollar Scotch tobacco products imported by Kretek International Inc. are misbranded under section 903(a)(2)(D) of the FD&C Act (21 U.S.C. §387c(a)(2)(D)) because the product labels do not contain a statement required under section 920(a) of the FD&C Act (21 U.S.C. §387t(a)). Section 920(a) requires that the label, packaging, and shipping containers of tobacco products other than cigarettes for introduction into interstate commerce in the United States bear the statement, “Sale only allowed in the United States.” Failure to comply with section 920(a) of the FD&C Act (21 U.S.C. §387(a) renders a product misbranded under section 903(a)(2)(D) of the FD&C Act (21 U.S.C. §387c(a)(2)(D)). 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)). The receipt in interstate commerce of any tobacco product that is misbranded and the delivery or proffered delivery thereof for pay or otherwise is a prohibited act under section 301(c) of the FD&C Act (21 U.S.C. §331(c)).
The violations discussed in this letter do not necessarily constitute an exhaustive list, and 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 implementing regulations may result in FDA initiating further action without notice, including but not limited to, seizure or injunction.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction. Please note your reference number, ER1700002, in your response and direct your response to the following address:
If you have any questions about the content of this letter, please contact David Keith at (301) 796-2722 or David.Keith@fda.hhs.gov.