FDA WARNING_LETTER - Royal Smoke LLC

The FDA's Center for Tobacco Products issued a Warning Letter to Mohammad Tahir Javed after reviewing the website http://www.royalsmoke.com, which offers Electronic Nicotine Delivery Systems (ENDS) for sale in the U.S. The FDA determined that Royal Smoke Cotton Candy E-Hookah and Royal Smoke Egyptian Gold E-Hookah ENDS products are tobacco products under section 201(rr) of the FD&C Act. The primary violation identified was the sale of these ENDS products to persons younger than 18 years of age, which was confirmed through an investigation. This action renders the products misbranded under section 903(a)(7)(B) of the FD&C Act, as it violates 21 C.F.R. § 1140.14(b), which prohibits retailers from selling covered tobacco products to minors. The letter requires immediate correction of these and similar violations, ensuring all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations across all platforms. A written response detailing corrective actions, including dates of discontinuance for violative sales and a compliance plan, is required within 15 working days. Failure to comply could lead to severe consequences, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and refusal of admission for imported products.