Smokers Unit – FDA Warning Letter, Sep 8, 2020

The FDA issued a Warning Letter to Smoker's Unit on July 17, 2020, after reviewing their website, https://smokersunit.com, and determining that they offer cigarettes and waterpipe tobacco products for sale or distribution in the United States.

The FDA identified several violations:

1. **Flavored Cigarette Violations:** Smoker's Unit offers flavored cigarette products (e.g., Bentoel Biru, Djarum Black, Sampoerna Avolution) that purport to contain characterizing flavors like clove or cappuccino. These products are adulterated under section 902(5) of the FD&C Act because cigarettes are prohibited from containing artificial or natural flavors (other than tobacco or menthol) as characterizing flavors. If these products do not contain characterizing flavors, their labeling/advertising is considered false or misleading, making them misbranded under section 903(a)(1) or 903(a)(7)(A).

2. **Modified Risk Tobacco Product Violations:** Several cigarette products (e.g., Bentoel Biru, Djarum Black, Gudang Garam Neslite Black Edition) are sold with explicit or implicit representations of reduced risk, such as "less harmful," "low tar," "mild, light, and with less nicotine," or "lighter and mild on the throat." These products are considered modified risk tobacco products and are adulterated under section