1965599 ONTARIO LTD. · 99-39 · CANADA (1-6360 Hawthorne Dr , Windsor, Ontario CANADA)

Product code, Product and FDA notes

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 09/20/2022 Desc: DEBLOATING - DIGESTION Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(e)(1) in that it fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. Section 403(i)(2) in that the product label fails to declare the ingredient list immediately below the nutrition label in accordance with 21 CFR 101.4(g). Section 403(q)(1)(A) because the serving size declared on the label is incorrect. Section 403(q)(1)(B) because the label fails to list the servings per container under the serving size on the left-hand side of the nutrition label or fails to include this information as part of the net quantity of contents declaration in accordance with 21 CFR 101.36(b)(1)(ii). Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.36. Section 403(s)(2)(C) because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).