Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2019/ucm631886.htm
Timestamp: 2019-03-18 18:21:03
Document Index: 702920571

Matched Legal Cases: ['§ 321', '§ 387', '§ 387', '§ 387', '§ 387', '§ 1143']

The Sabagh Group LLC d/b/a LighterUSA.com 3/4/19
Robert Sabagh
The Sabagh Group LLC d/b/a Lighterusa.com
43422 West Oaks Dr. Unit #155
email@lighterusa.com
Dear Robert Sabagh:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website, http://www.lighterusa.com, and determined that the e-liquid products listed there are advertised and 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, these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including e-liquid products, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).
FDA has determined that several e-liquid products advertised and offered for sale or distribution on your website are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) and 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 website regarding e-liquid products fails to include the required nicotine warning statement for these e-liquid products.
Our review of the website, http://www.lighterusa.com, revealed that the labeling and/or advertising for several e-liquid products that you advertise and offer for sale or distribution in the United States does not include the required nicotine warning statement, for example: Eon Pods Cool Mint, Loon Pods Mr. Grapefruit ICE, Loon Pods Blueberry Bliss, Loon Pods Lemon Lightning ICE, Loon Pods Mo Mango, Loon Pods Pineapple Express ICE, NicPuff Flavor Pod Mango, NicPuff Flavor Pod Honeydew Carmel, NicPuff Flavor Pod Menthol Tobacco, Njoy Daily eCig Blue and Blackberry, Njoy Daily eCig Cool Menthol, Njoy Prefilled Tank Apple Melon, Njoy Daily eCig Tropical Twist, Njoy Daily eCig Watermelon, Phix by MLV Ice Tobacco, Phix by MLV Mixed, Phix by MLV Spearmint, Phix by MLV Hard Strawberry, Zoor Vapor - Zoor Pods Apple, and Zoor Vapor - Zoor Pods Mint. Under 21 C.F.R. § 1143.3, labeling and advertising for cigarette tobacco, roll-your-own tobacco, and covered tobacco products (other than cigars), such as e-liquid products, must bear the following warning statement:
Please note your reference number, RW1901029, in your response and direct your response to the following address:
1mntd593au1m@contactprivacy.email
Farmington Hills, MI 48335-1611