FDA WARNING_LETTER - Tripl3 eCigs and eGos
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The FDA Center for Tobacco Products issued a Warning Letter to the operator of http://www.triple-eciq.com after determining that e-liquid products, specifically Tripl3 Bubble Gum e-liquid, were offered for sale or distribution to U.S. customers. These products are classified as tobacco products under the FD&C Act.
The primary violation identified was the sale of Tripl3 Bubble Gum e-liquid to a person younger than 18 years of age, which constitutes misbranding under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). This violates 21 C.F.R. § 1140.14(b), which prohibits retailers from selling covered tobacco products, including e-liquids, to minors. The product is deemed a "covered tobacco product" under 21 C.F.R. § 1100.2.
The letter requires immediate correction of this violation and similar issues, ensuring all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. The company must submit a written response within 15 working days detailing corrective actions, including discontinuation dates for violative sales/distribution
- Company
- Tripl3 eCigs and eGos
- Product Type
- Tobacco
ID · 25c7e45a-a315-4d57-9cb9-0c26afd41ee8
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