shopcalismokes.com — FDA Warning Letter, April 10, 2026: Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

FDA Warning Letter — Violations FDA cited at shopcalismokes.com

WARNING LETTER shopcalismokes.com MARCS-CMS 727256 — April 10, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UPS and Electronic Mail Reference #: RW2602402 Product: Tobacco Recipient: shopcalismokes.com 29598 Orchard Lake Road Farmington Hills , MI 48334 United States calismokes19@gmail.com Issuing Office: Center for Tobacco Products United States April 10, 2026 WARNING LETTER To Whom It May Concern: The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://shopcalismokes.com and determined that nicotine pouch products listed there are offered for sale or distribution to customers in the United States. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 321(rr)), these products are tobacco products because they are made or derived from tobacco or contain nicotine from any source and intended for human consumption. Certain tobacco products, including nicotine pouch products, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)) and 21 C.F.R. § 1100.1 and are required to be in compliance with the requirements in the FD&C Act. Generally, to be legally marketed in the United States, the FD&C Act requires “new tobacco products” to have a premarket authorization order in effect. A “new tobacco product” is any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modified tobacco product that was commercially marketed after February 15, 2007 (section 910(a) of the FD&C Act; 21 U.S.C. § 387j(a)). Generally, a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)) is required for a new tobacco product unless (1) the manufacturer of the product submitted a report under section 905(j) of the FD&C Act (21 U.S.C. § 387e(j)) and FDA issues an order finding the product substantially equivalent to a predicate tobacco product (section 910(a)(2)(A) of the FD&C Act) or (2) the manufacturer submitted a report under section 905(j)(1)(A)(ii) of the FD&C Act (21 U.S.C. § 387e(j)(1)(A)(ii)) and all modifications are covered by exemptions from the requirements of substantial equivalence granted by FDA under section 905(j)(3) of the FD&C Act (21 U.S.C. § 387e(j)(3)). New Tobacco Products Without Required Marketing Authorization Are Adulterated and Misbranded FDA has determined that you offer for sale or distribution to customers in the United States nicotine pouch products that lack a marketing authorization order: Zyn Pouches Slim – Cool Skittle 15mg and Zyn Pouches Slim – Fizzy Cola 15mg. The tobacco products listed above are new tobacco products because they were not commercially marketed in the United States as of February 15, 2007. These products do not have FDA marketing authorization orders in effect under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt from the marketing authorization requirement. Therefore, these products are adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)). In addition, they are misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) because a notice or other information respecting these products was not provided as required by section 905(j) of the FD&C Act (21 U.S.C. § 387e(j)). Conclusion and Requested Actions FDA has determined that your firm markets new tobacco products in the United States that lack premarket authorization. All new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and are subject to enforcement action at FDA’s discretion. For a list of all products that have been authorized by the FDA and certain others that may be legally marketed, please visit the Searchable Tobacco Products Database: https://www.fda.gov/searchtobacco. It is your responsibility to ensure that all tobacco products you sell