FDA WARNING_LETTER - The Sub Ohm Syndicate
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The FDA's Center for Tobacco Products issued a Warning Letter to Kassim Al-Derzi regarding the website http://www.thesubohmsyndicate.com, which sells e-liquid products in the U.S. The FDA determined that "T-Sauce Eclipse with Nicotine Booster" e-liquid products are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because they were sold to a person younger than 18 years of age.
This sale to a minor violates 21 C.F.R. § 1140.14(b), which prohibits retailers from selling covered tobacco products, including e-liquids, to individuals under 18. The FDA's investigation confirmed a minor purchased the specified e-liquid products from the website. Covered tobacco products are defined under 21 C.F.R. § 1140.3 and include e-liquids.
The letter requires immediate correction of this violation and similar issues to ensure compliance with the FD&C Act and FDA's implementing regulations across all advertising and sales platforms. Failure to comply may result in further FDA actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions, including discontinuation
- Company
- The Sub Ohm Syndicate
- Product Type
- Tobacco
ID · f2f6b568-f765-4046-8433-229dca677999
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