FDA WARNING_LETTER - Finest Ounce Vape Store d/b/a Finest Ounce Vape Malaysia - August 23, 2023

On August 23, 2023, the FDA's Center for Tobacco Products issued a Warning Letter to Finestounce.com after reviewing their website and determining they offer Electronic Nicotine Delivery System (ENDS) products for sale or distribution in the United States. These products are classified as tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, to include nicotine from any source.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. Specifically, the products Gamepuff 10K Puff Disposable Pod – Watermelon, Gazzbar 11K Puff Disposable Pod – Classic Cola, and Elf Bar 9K Puff Disposable Pod – ElfDream (Pineapple) were found to be new tobacco products not commercially marketed before February 15, 2007, and lacking FDA marketing authorization. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA expressed additional concern that the labeling and advertising for Gamepuff and Gazzbar products imitate children's video gaming devices and soda bottles, potentially promoting youth use and concealing the products' nature as tobacco products.

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