Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/el-fumador-cigars-pipes-tobacco-inc-08312015
Timestamp: 2020-01-24 23:49:00
Document Index: 384642042

Matched Legal Cases: ['§ 321', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 4402', '§ 387', '§ 387']

El Fumador Cigars Pipes Tobacco, Inc. - 08/31/2015 | FDA
El Fumador Cigars Pipes Tobacco, Inc. - 08/31/2015
El Fumador Cigars Pipes Tobacco, Inc. August 31, 2015
El Fumador Cigars Pipes Tobacco, Inc.
d/b/a El Fumador
Attn: Ed Moidel
info@elfumador.com
Dear Mr. Moidel:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.elfumador.com and determined that the smokeless tobacco products listed there are offered 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)), 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 McChrystals Supermint smokeless tobacco is adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because it is a modified risk tobacco product sold or distributed without an FDA order in effect that permits such sale or distribution. Additionally, FDA has determined that several smokeless tobacco products are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) and/or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because your webpages regarding smokeless tobacco products fail to include any health warning label statements.
Our review of the website, http://www.elfumador.com, revealed that you sell or distribute the following smokeless tobacco product, which is listed or described as being “mild” or using similar descriptors: McChrystals Supermint (“mild nasal snuff”).
The above listed product is a modified risk tobacco product because the website uses the descriptor “mild” or similar descriptors to describe this product. Because this product is sold or distributed to customers in the United States without an appropriate FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)), this product is adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).
Additionally, our review of the website, http://www.elfumador.com, revealed that the following smokeless tobacco products that you offer for sale or distribute in the United States do not include any health warning statements: McChrystals Supermint, Lotzbeck Mild Menthol, and Lotzbeck Vanilla. Section 3(b) of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (Smokeless Tobacco Act) (15 U.S.C. § 4402), as amended by section 204 of the Tobacco Control Act (P.L. 111-31, 123 Stat. 1846), requires that advertisements for smokeless tobacco products bear one of the following health warning label statements:
Because your webpages regarding smokeless tobacco products donot include any health warnings, your smokeless tobacco products aremisbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) and/or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)).
It is your responsibility to ensure that your tobacco products and all related labeling and/or advertising on this website, on any other websites (including e-commerce, social networking, or search engine websites), any other media in which you advertise, and in any retail establishments 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.
Please note your reference number, RW1500376, in your response and direct your response to the following address:
el.fumador@verizon.net
bobby@fujipub.com
hostmaster@fujipub.com
abuse@verio.net
El Fumador Cigars Pipes Tobacco, Inc. - Close Out Letter 12/30/15