Jamieson Laboratories · 99-39 · CANADA
For Jamieson Laboratories · 99-39 · CANADA, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is CANADA; product is Jamieson Calcium Magnesium Caplets; product code is 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 03/27/2015; address is 2 St Clair Ave W 16 Th Floor , Toronto, Ontario CANADA, verified against its source on 2026-09-16.
- Firm
- Jamieson Laboratories verified
- Import alert
- 99-39
- Import alert name
- Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
- Country
- CANADA verified
- Address
- 2 St Clair Ave W 16 Th Floor , Toronto, Ontario CANADA verified
- Date published
- 03/27/2015 verified
- Product code
- 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
- Product
- Jamieson Calcium Magnesium Caplets verified
- FDA notes
- Jamieson Calcium Magnesium Caplets NOTE: The article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(s)(2) (B)of the Act [21 U.S.C. 343 §(s)(2)(B)]in that the label of the dietary supplement fails to identify the product by using the term "dietary supplement." 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 921 CFR 101.3 (g)). The article appears to be misbranded within the meaning of 403(y) of the Act [21 U.S.C. § 343 (y)] because the label does not bear an accurate domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. The article appears to be misbranded within the meaning of section 403(e)(1) [21 U.S.C. § 343(e)(1)] in that the package does not contain the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5;Jamieson Calcium Magnesium Caplets;The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(a)(1)(B) because the labeling bears an unauthorized health claim. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)(5) (F) .The article appears to be misbranded within the meaning of section 403(i) (2) of the Act [21 U.S.C.§ 343(i)(2)] because it is fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4. Published on 03/31/2015 | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(s)(2) (B)of the Act [21 U.S.C. 343 ?(s)(2)(B)]in that the label of the dietary supplement fails to identify the product by using the term ?dietary supplement.? 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 921 CFR 101.3 (g)). The article appears to be misbranded within the meaning of 403(y) of the Act [21 U.S.C. ? 343 (y)]because the label does not bear an accurate domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. The article appears to be misbranded within the meaning of section 403(e)(1) [21 U.S.C. ? 343(e)(1)] in that the package does not contain the name and place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5;The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(a)(1) (B) because the labeling bears an unauthorized health claim. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)(5) (F) in that the nutrition labeling The article appears to be misbranded within the meaning of section 403(i) (2) of the Act [21 U.S.C.§ 343(i)(2)] because it is fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4. Published on 03/31/2015 each item verified
What the source says
Jamieson Laboratories Date Published : 03/27/2015 2 St Clair Ave W 16 Th Floor , Toronto, Ontario CANADA 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 03/27/2015 Notes: Jamieson Calcium Magnesium Caplets NOTE: The article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(s)(2) (B)of the Act [21 U.S.C. 343 §(s)(2)(B)]in that the label of the dietary supplement fails to identify the product by using the term "dietary supplement." 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 921 CFR 101.3 (g)). The article appears to be misbranded within the meaning of 403(y) of the Act [21 U.S.C. § 343 (y)] because the label does not bear an accurate domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. The article appears to be misbranded within the meaning of section 403(e)(1) [21 U.S.C. § 343(e)(1)] in that the package does not contain the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5;Jamieson Calcium Magnesium Caplets;The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(a)(1)(B) because the labeling bears an unauthorized health claim. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)(5) (F) .The article appears to be misbranded within the meaning of section 403(i) (2) of the Act [21 U.S.C.§ 343(i)(2)] because it is fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4. Published on 03/31/2015 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 03/27/2015 Desc: Jamieson Calcium Magnesium Caplets Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(s)(2) (B)of the Act [21 U.S.C. 343 ?(s)(2)(B)]in that the label of the dietary supplement fails to identify the product by using the term ?dietary supplement.? 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 921 CFR 101.3 (g)). The article appears to be misbranded within the meaning of 403(y) of the Act [21 U.S.C. ? 343 (y)]because the label does not bear an accurate domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. The article appears to be misbranded within the meaning of section 403(e)(1) [21 U.S.C. ? 343(e)(1)] in that the package does not contain the name and place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5;The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(a)(1) (B) because the labeling bears an unauthorized health claim. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q)(5) (F) in that the nutrition labeling The article appears to be misbranded within the meaning of section 403(i) (2) of the Act [21 U.S.C.§ 343(i)(2)] because it is fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4. Published on 03/31/2015
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1144.html
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