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FDA Warns Shopcalismokes.com Over Unauthorized Zyn Nicotine Pouches

The FDA Center for Tobacco Products issued a warning letter to shopcalismokes.com (Farmington Hills, MI) for offering for sale or distribution two new tobacco products—Zyn Pouches Slim Cool Skittle 15mg and Zyn Pouches Slim Fizzy Cola 15mg—without the required marketing authorization order under Section 910 of the Federal Food, Drug, and Cosmetic Act. FDA determined the products are adulterated under Section 902(6)(A) and misbranded under Section 903(a)(6) of the FD&C Act. The letter requests a written response within 15 working days describing corrective actions.