Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm427151.htm
Timestamp: 2019-04-26 11:41:20+00:00

Document:
Midwest Service & Supply, Inc.
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your eBay Store, Midwest Service Closeouts, and determined that the smokeless tobacco products listed there are offered for sale 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)), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including smokeless tobacco, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).
FDA has determined that certain of your smokeless tobacco products are adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)) and misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) because the products are new tobacco products that are required to have premarket review and do not have a marketing authorization order in effect under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)) and for which a notice or other information respecting the products has not been provided as required by section 905(j) of the FD&C Act (21 U.S.C. § 387e(j)). You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
Section 910(a)(2) of the FD&C Act (21 U.S.C. § 387j(a)(2)) requires premarket review of new tobacco products, subject to certain exceptions. Under section 910(a)(1) of the FD&C Act (21 U.S.C. § 387j(a)(1)), a “new tobacco product” includes “any tobacco product . . . that was not commercially marketed in the United States as of February 15, 2007.” The FD&C Act permits a tobacco product first introduced or delivered for introduction into interstate commerce for commercial distribution in the United States after February 15, 2007, and prior to March 22, 2011, and for which a substantial equivalence (SE) report was submitted by March 22, 2011, to remain on the market pending FDA’s review of the report (“provisional” tobacco products). In the event that FDA finds under section 910(a)(3) of the FD&C Act (21 U.S.C. § 387j(a)(3)) that the provisional tobacco product is not substantially equivalent to a predicate tobacco product commercially marketed in the United States as of February 15, 2007, and issues an order that the product is not substantially equivalent (NSE), the provisional tobacco product will be subject to premarket review under section 910(a)(2)(A) of the FD&C Act (21 U.S.C. § 387j(a)(2)(A)). A product that is required by section 910(a) of the FD&C Act (21 U.S.C. § 387j(a)) to have premarket review and does not have an order in effect under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)) is adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(a)). A product is misbranded under section 903(a)(6) (21 U.S.C. § 387c(a)(6)) if a notice or other information respecting it is not provided as required by section 905(j) of the FD&C Act (21 U.S.C. § 387e(j)).
Our review of your eBay Store, Midwest Service Closeouts, revealed that you sell or distribute to customers in the United States the following smokeless tobacco products for which FDA issued NSE orders on August 28, 2014: Ariva Cinnamon, Ariva Citrus, Ariva Mint, and Ariva Wintergreen. Because these products are required to have 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 (subsequent to the NSE orders) 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)).
FDA posts a list of tobacco products that are adulterated and misbranded due to an NSE order. This list can be found by visiting FDA’s website at http://www.fda.gov/tobacco and searching for “Misbranded and Adulterated NSE Tobacco Products” using the search box.
It is your responsibility to ensure that your tobacco products and all related promotional materials on this website, on any other websites (including e-commerce, social networking, or search engine websites), and in any other media in which you advertise, comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to ensure full compliance with the FD&C Act may result in FDA initiating further action without notice, including, but not limited to, civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Please note that adulterated and misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission.

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