# FDA WARNING_LETTER - Puckerfish, LLC - September 29, 2020

Source: https://www.keypedia.com/records/warning_letter/puckerfish-llc/08f611ab-0ee5-4088-b2ed-de5292332f94

> FDA WARNING_LETTER for Puckerfish, LLC on September 29, 2020. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Puckerfish, LLC
- Inspection Date: 2020-09-29
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: On September 11, 2020, the FDA issued a Warning Letter to Matt Dawson regarding e-liquid products sold on http://www.puckerfishvape.com. The FDA determined these e-liquid products are tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is that several e-liquid products, including Puckerfish Coffee, Puckerfish Choco, and Puckerfish Flewps, are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). This is because their website advertising fails to include the required nicotine warning statement, violating 21 CFR 1143.3(b). This regulation mandates that advertising for covered tobacco products, such as e-liquids, must bear the warning: "WARNING: This product contains nicotine. Nicotine is an addictive chemical."

The letter emphasizes the company's responsibility to ensure all tobacco products, labeling, and advertising across all platforms comply with the FD&C Act and FDA regulations. Failure to correct these violations may lead to regulatory action, including detention and refusal of admission for imported products. The company is required to submit a written response within 15 working days detailing corrective actions, including dates of discontinuation of violative advertising/sales, and a plan for maintaining

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Company: https://www.keypedia.com/companies/puckerfish-llc/88ce85aa-6361-4ee5-ad5f-5caf5d53a47b

Office: https://www.keypedia.com/offices/center-for-tobacco-products/65f73cae-ef6f-4e9f-a311-a111daa67374