# WILLIAM XYLITOL · 99-39 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For WILLIAM XYLITOL · 99-39 · KOREA (THE REPUBLIC OF), import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is KOREA (THE REPUBLIC OF); product is XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors) | XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors) | XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors) | XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors) | XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors) | XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors) | XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors) | XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors) | XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors) | XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors) | XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors); product code is 28 C - - 36 Peppermint, Natural Extract or Flavor (Spice) | 33 C - - 06 Flavored Candy, Hard (Live Savers, Etc.), with Fruit (without Chocolate) | 33 C - - 11 Mint Candy, Hard, with Fruit (without Chocolate) | 33 E - - 06 Flavored Candy, Hard (Live Savers, Etc.), without Nuts and Fruit (without Chocolate) | 33 E - - 11 Mint Candy, Hard, without Nuts and Fruit (without Chocolate) | 33 E - - 13 Rock Candy, Hard, without Nuts and Fruit (without Chocolate) | 33 E - - 99 Hard Candy without Nuts and Fruit, N.E.C. (without Chocolate) | 33 S - - 99 Candy Specialties, N.E.C. (without Chocolate) | 33 Y - - 99 Candy Without Chocolate N.E.C. | 54 B - - 99 Mineral N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 09/20/2023; address is 8 Geoma-Ro 77beon-Gil , Ulsan, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** WILLIAM XYLITOL _(verified: appears in the quote below)_
- **Import alert:** 99-39
- **Import alert name:** Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
- **Country:** KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Address:** 8 Geoma-Ro 77beon-Gil , Ulsan, KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 09/20/2023 _(verified: appears in the quote below)_
- **Product code:** 28 C - - 36 Peppermint, Natural Extract or Flavor (Spice) | 33 C - - 06 Flavored Candy, Hard (Live Savers, Etc.), with Fruit (without Chocolate) | 33 C - - 11 Mint Candy, Hard, with Fruit (without Chocolate) | 33 E - - 06 Flavored Candy, Hard (Live Savers, Etc.), without Nuts and Fruit (without Chocolate) | 33 E - - 11 Mint Candy, Hard, without Nuts and Fruit (without Chocolate) | 33 E - - 13 Rock Candy, Hard, without Nuts and Fruit (without Chocolate) | 33 E - - 99 Hard Candy without Nuts and Fruit, N.E.C. (without Chocolate) | 33 S - - 99 Candy Specialties, N.E.C. (without Chocolate) | 33 Y - - 99 Candy Without Chocolate N.E.C. | 54 B - - 99 Mineral N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. _(verified: each item appears in the quote below)_
- **Product:** XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors) | XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors) | XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors) | XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors) | XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors) | XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors) | XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors) | XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors) | XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors) | XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors) | XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors) _(verified: each item appears in the quote below)_
- **FDA notes:** The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)). | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)). | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)). | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)). | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)). | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)). | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)). | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)). | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)). | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)). | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)). _(verified: each item appears in the quote below)_

## What the source says

> WILLIAM XYLITOL Date Published : 09/20/2023 8 Geoma-Ro 77beon-Gil , Ulsan, KOREA (THE REPUBLIC OF) 28 C - - 36 Peppermint, Natural Extract or Flavor (Spice) Date Published: 09/20/2023 Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)). 33 C - - 06 Flavored Candy, Hard (Live Savers, Etc.), with Fruit (without Chocolate) Date Published: 09/20/2023 Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)). 33 C - - 11 Mint Candy, Hard, with Fruit (without Chocolate) Date Published: 09/20/2023 Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)). 33 E - - 06 Flavored Candy, Hard (Live Savers, Etc.), without Nuts and Fruit (without Chocolate) Date Published: 09/20/2023 Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)). 33 E - - 11 Mint Candy, Hard, without Nuts and Fruit (without Chocolate) Date Published: 09/20/2023 Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)). 33 E - - 13 Rock Candy, Hard, without Nuts and Fruit (without Chocolate) Date Published: 09/20/2023 Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)). 33 E - - 99 Hard Candy without Nuts and Fruit, N.E.C. (without Chocolate) Date Published: 09/20/2023 Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)). 33 S - - 99 Candy Specialties, N.E.C. (without Chocolate) Date Published: 09/20/2023 Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)). 33 Y - - 99 Candy Without Chocolate N.E.C. Date Published: 09/20/2023 Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)). 54 B - - 99 Mineral N.E.C. Date Published: 09/20/2023 Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)). 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 09/20/2023 Desc: XYLITOL STONE CANDY (Green Grape; Strawberry; Peppermint Booster; Lemon; and Coke flavors) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(r)(1)(A). Labeling for the products bear a nutrient content claims that is not authorized by regulation. Claims that characterize the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim for sugar in 21 CFR 101.60(c). Product labeling on the firm’s Amazon.com website store bear claims that implies that the products meet the definition for healthy (e.g., “healthy candies”, “healthy indulgence”, “in your healthy living journey”, “Savour the balance of taste and health with Xylitol Stone”, etc…; however, these products do not meet the requirements for the implied nutrient content claim “healthy” as defined in 21 CFR 101.65(d)(2). Section 403(q). Products do not present nutrition information on the labeling (21 CFR 101.9). Section 403(i)(2). Each ingredient is not declared by its common or usual name (21 CFR 101.4). Several different flavoring ingredients are not declared appropriately in accordance with 21 CFR 101.4(b)(1) and 21 CFR 101.22(h)(1). If artificial flavors are being used, the products’ labels must declare as such. Also, if these ingredients contain sub-ingredients, those sub-ingredients should be declared appropriately. Section 403(i)(1). Labels fail to bear the common or usual name of the food (21 CFR 101.3(b)). Section 403(e)(2). Products outer container is not labeled in accordance with 21 CFR 101.7(a) in that the declaration of the net quantity of contents does not appear on the principal display panel of the outside container. Individual unit containers which can be sold separately fail to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)).

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_1144.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).