Sunflora, Inc./The CBD Store, LLC Dba your CBD Store MARCS-CMS 585390 - November 22, 2026 This letter is to advise you that the U.S. The claims on your websites and social media website establish that your "Sunmed Tincture," "Sunmed Water Soluble," "Sunflora CBD Daytime Ageless Moisturizer," "Sunflora CBD Nighttime Ageless Serum," and "Sunmed Topical Relief Cream" products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, these products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). FDA has also determined that your "SunMed Bacon Dog Treats," "SunMed Pet Bark Bits Beef," "SunMed Dog Lamb Bits," and "SunMed Pet Tincture," products, which you promote as products containing CBD, are unapproved new animal drugs that are unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5). FDA has also determined that your "SunMed Peach Rings," "SunMed Sour Bears," "SunMed Sour Worms," and "SunMed Watermelon Rings" products are adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i), because they bear or contain an unsafe food additive. Furthermore, it is a prohibited act to introduce your "SunMed Peach Rings," "SunMed Sour Bears," "SunMed Sour Worms," and "SunMed Watermelon Rings" products into interstate commerce under section 301(ll) of the FD&C Act, 21 U.S.C. As explained further below, introducing or delivering these products for introduction into interstate commerce violates the FD&C Act. However, your products cannot be dietary supplements because they do not meet the definition of dietary supplement under section 201(ff) of the FD&C Act, 21 U.S.C. 321(ff).