Homart Pharmaceuticals Pty. Ltd. · 99-39 · AUSTRALIA
For Homart Pharmaceuticals Pty. Ltd. · 99-39 · AUSTRALIA, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is AUSTRALIA; product is Aussie Kids Gummy Lutein (Berry Shaped NO Added Sugar) | Kids Genius Fish Oil | Propolis Liquid (alcohol free) 40% | SpringLeaf brand Inner Beauty Collagen 6 In 1 | Aussie Kids Gummy Lutein (NO Added Sugar); product code is 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C; date published is 07/31/2024; address is 59 Kirby St , Rydalmere, New South Wales AUSTRALIA, verified against its source on 2026-09-16.
- Firm
- Homart Pharmaceuticals Pty. Ltd. verified
- Import alert
- 99-39
- Import alert name
- Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
- Country
- AUSTRALIA verified
- Address
- 59 Kirby St , Rydalmere, New South Wales AUSTRALIA verified
- Date published
- 07/31/2024 verified
- Product code
- 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. each item verified
- Product
- Aussie Kids Gummy Lutein (Berry Shaped NO Added Sugar) | Kids Genius Fish Oil | Propolis Liquid (alcohol free) 40% | SpringLeaf brand Inner Beauty Collagen 6 In 1 | Aussie Kids Gummy Lutein (NO Added Sugar) each item verified
- 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(s)(2)(B) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a), (b), and (g)]. Section 403(q) of the Act. presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. The Aussie Kids Gummy Lutein (Berry Shaped, NO Added Sugar) dietary supplement products incorrectly display nutrition labeling under the heading of “Nutrition Information” for a serving of a dietary supplement product. The nutrition information should be presented using the formatting of a Supplement Facts label and include the Daily Values for (b)(2)-dietary ingredients if present in amounts greater than amounts that can be declared as 0, in according with 21 CFR 101.36(b). Section 403(i)(2) of the Act. The label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(y) of the Act. The labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. 379aa-1], may receive a report of a serious adverse event with such dietary supplements. | 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(s)(2)(B) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a), (b), and (g)]. Section 403(q) of the Act. presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. The Kids Genius Fish Oil dietary supplement products incorrectly display nutrition labeling under the heading of “Nutrition Information” for a serving of a dietary supplement product. The nutrition information should be presented using the formatting of a Supplement Facts label and include the Daily Values for (b)(2)-dietary ingredients if present in amounts greater than amounts that can be declared as 0, in according with 21 CFR 101.36(b). Section 403(i)(2) of the Act. The label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(y) of the Act. The labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. 379aa-1], may receive a report of a serious adverse event with such dietary supplements. | 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(s)(2)(b) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a), (b), and (g)]. Section 403(q) of the Act. presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. The Propolis Liquid (alcohol free) 40% (outer and inner container labels) dietary supplement products incorrectly display nutrition labeling under the heading of “Nutrition Information” for a serving of a dietary supplement product. The nutrition information should be presented using the formatting of a Supplement Facts label and include the Daily Values for (b)(2)-dietary ingredients if present in amounts greater than amounts that can be declared as 0, in according with 21 CFR 101.36(b). Section 403(i)(2) of the Act. The label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(y) of the Act. The labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. 379aa-1], may receive a report of a serious adverse event with such dietary supplements. | 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(s)(2)(B) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a), (b), and (g)]. Section 403(q) of the Act. presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. The Inner Beauty Collagen 6 in 1 dietary supplement products incorrectly display nutrition labeling under the heading of “Nutrition Information” for a serving of a dietary supplement product. The nutrition information should be presented using the formatting of a Supplement Facts label and include the Daily Values for (b)(2)-dietary ingredients if present in amounts greater than amounts that can be declared as 0, in according with 21 CFR 101.36(b). Section 403(i)(2) of the Act. The label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(y) of the Act. The labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. 379aa-1], may receive a report of a serious adverse event with such dietary supplements. | 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(s)(2)(B) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a), (b), and (g)]. Section 403(q) of the Act. presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. The Aussie Kids Gummy Lutein (NO Added Sugar) dietary supplement products incorrectly display nutrition labeling under the heading of “Nutrition Information” for a serving of a dietary supplement product. The nutrition information should be presented using the formatting of a Supplement Facts label and include the Daily Values for (b)(2)-dietary ingredients if present in amounts greater than amounts that can be declared as 0, in according with 21 CFR 101.36(b). Section 403(i)(2) of the Act. The label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(y) of the Act. The labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. 379aa-1], may receive a report of a serious adverse event with such dietary supplements. each item verified
What the source says
Homart Pharmaceuticals Pty. Ltd. Date Published : 07/31/2024 59 Kirby St , Rydalmere, New South Wales AUSTRALIA 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 07/31/2024 Desc: Aussie Kids Gummy Lutein (Berry Shaped NO Added Sugar) 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(s)(2)(B) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a), (b), and (g)]. Section 403(q) of the Act. presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. The Aussie Kids Gummy Lutein (Berry Shaped, NO Added Sugar) dietary supplement products incorrectly display nutrition labeling under the heading of “Nutrition Information” for a serving of a dietary supplement product. The nutrition information should be presented using the formatting of a Supplement Facts label and include the Daily Values for (b)(2)-dietary ingredients if present in amounts greater than amounts that can be declared as 0, in according with 21 CFR 101.36(b). Section 403(i)(2) of the Act. The label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(y) of the Act. The labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. 379aa-1], may receive a report of a serious adverse event with such dietary supplements. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 07/31/2024 Desc: Kids Genius Fish Oil 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(s)(2)(B) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a), (b), and (g)]. Section 403(q) of the Act. presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. The Kids Genius Fish Oil dietary supplement products incorrectly display nutrition labeling under the heading of “Nutrition Information” for a serving of a dietary supplement product. The nutrition information should be presented using the formatting of a Supplement Facts label and include the Daily Values for (b)(2)-dietary ingredients if present in amounts greater than amounts that can be declared as 0, in according with 21 CFR 101.36(b). Section 403(i)(2) of the Act. The label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(y) of the Act. The labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. 379aa-1], may receive a report of a serious adverse event with such dietary supplements. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 07/31/2024 Desc: Propolis Liquid (alcohol free) 40% 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(s)(2)(b) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a), (b), and (g)]. Section 403(q) of the Act. presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. The Propolis Liquid (alcohol free) 40% (outer and inner container labels) dietary supplement products incorrectly display nutrition labeling under the heading of “Nutrition Information” for a serving of a dietary supplement product. The nutrition information should be presented using the formatting of a Supplement Facts label and include the Daily Values for (b)(2)-dietary ingredients if present in amounts greater than amounts that can be declared as 0, in according with 21 CFR 101.36(b). Section 403(i)(2) of the Act. The label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(y) of the Act. The labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. 379aa-1], may receive a report of a serious adverse event with such dietary supplements. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 07/31/2024 Desc: SpringLeaf brand Inner Beauty Collagen 6 In 1 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(s)(2)(B) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a), (b), and (g)]. Section 403(q) of the Act. presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. The Inner Beauty Collagen 6 in 1 dietary supplement products incorrectly display nutrition labeling under the heading of “Nutrition Information” for a serving of a dietary supplement product. The nutrition information should be presented using the formatting of a Supplement Facts label and include the Daily Values for (b)(2)-dietary ingredients if present in amounts greater than amounts that can be declared as 0, in according with 21 CFR 101.36(b). Section 403(i)(2) of the Act. The label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(y) of the Act. The labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. 379aa-1], may receive a report of a serious adverse event with such dietary supplements. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 07/31/2024 Desc: Aussie Kids Gummy Lutein (NO Added Sugar) 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(s)(2)(B) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a), (b), and (g)]. Section 403(q) of the Act. presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. The Aussie Kids Gummy Lutein (NO Added Sugar) dietary supplement products incorrectly display nutrition labeling under the heading of “Nutrition Information” for a serving of a dietary supplement product. The nutrition information should be presented using the formatting of a Supplement Facts label and include the Daily Values for (b)(2)-dietary ingredients if present in amounts greater than amounts that can be declared as 0, in according with 21 CFR 101.36(b). Section 403(i)(2) of the Act. The label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(y) of the Act. The labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. 379aa-1], may receive a report of a serious adverse event with such dietary supplements.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1144.html
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