Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/smokin-java-inc-01212016
Timestamp: 2019-06-16 03:00:41
Document Index: 382147450

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

Smokin Java Inc. - 01/21/2016 | FDA
Smokin Java Inc. - 01/21/2016
Smokin Java Inc. 21/01/2016
Smokin Java Inc.
d/b/a S.J. Cigar Co.
Attn: David Leavy
Bala Cynwyd, Pennsylvania 19004-2814
Dear Mr. Leavy:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.sjcigars.com and determined that the cigarette tobacco and/or roll-your-own tobacco products listed there are offered for sale or distributed 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 cigarette tobacco and roll-your-own 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 the website http://www.sjcigars.com offers for sale or distributes cigarette tobacco and/or roll-your-own tobacco products. Section 900(4) of the FD&C Act (21 U.S.C. § 387(4)) defines “cigarette tobacco” as “any product that consists of loose tobacco that is intended for use by consumers in a cigarette.” Section 900(15) of the FD&C Act (21 U.S.C. § 387(15)) defines “roll-your-own tobacco” as “any tobacco product which, because of its appearance, type, packaging, or labeling, is suitable for use and likely to be offered to, or purchased by, consumers as tobacco for making cigarettes.”
We note that on the website you present loose tobacco products containing the package description “pipe tobacco” that are offered for sale or distributed as cigarette tobacco and/or roll-your-own tobacco, including, for example, OHM Pipe Tobacco and Captain Black Pipe Tobacco. The overall presentation of these products on the website strongly suggests that they are intended for use in a cigarette, likely to be offered to consumers for making cigarettes, and/or likely to be purchased by consumers for making cigarettes. Specifically, the website has a category of products under the header “RYO,” which includes “Filters and Tubes,” “Rolling Machines and Injectors,” “Rolling Paper,” “Smoking Accessories,” and several brands of loose tobacco products, including OHM Tobacco, Captain Black Pipe Tobacco, Bugler, Samson Rolling Tobacco, and Peter Stokkebye Tobacco. Additionally, the website states under the “RYO” header: “Rolling your own cigarettes just got easier thanks to our line of roll your own cigarette tobacco and accessories.” Therefore, the products meet the definition of “cigarette tobacco” and/or “roll-your-own tobacco” in the FD&C Act.
FDA has determined that several cigarette tobacco and/or roll-your-own tobacco products are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)) or misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because they purport to contain a natural or artificial characterizing flavor.
Our review of the website http://www.sjcigars.com revealed that you offer for sale or distribute the following cigarette tobacco and/or roll-your-own tobacco products: OHM Mint, Captain Black Regular Pipe Tobacco (vanilla), and Captain Black Royal Pipe Tobacco (vanilla).
Cigarette tobacco and/or roll-your-own tobacco that is distributed or offered for sale in the United States in violation of this provision are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)). Thus, your flavored cigarette tobacco and/or roll-your-own tobacco products areadulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)).
If, however, these cigarette tobacco and/or roll-your-own tobacco products do not contain a characterizing flavor, they are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) as theirlabeling or advertising is false or misleading because it makes the representation that the products contain, for example, mint or vanilla as a characterizing flavor of the tobacco products.
Please note your reference number, RW1500441, in your response and direct your response to the following address:
pq5ur5489z4@networksolutionsprivateregistration.com
abuse@abuse.hostasaurus.com
hostmaster@81.180.199.in-addr.arpa