Reference Source

Medicap Laboratories · 99-39 · CANADA

For Medicap 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 Edica EZestro Supplement | Edica EZestro Supplement | Edica EZestro Supplement; product code is 54 E - - 99 Herbals & Botanical Teas, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C; date published is 06/25/2024; address is 3190 Devon Dr , Windsor, Ontario CANADA, verified against its source on 2026-09-16.

Firm
Medicap 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
3190 Devon Dr , Windsor, Ontario CANADA verified
Date published
06/25/2024 verified
Product code
54 E - - 99 Herbals & Botanical Teas, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. each item verified
Product
Edica EZestro Supplement | Edica EZestro Supplement | Edica EZestro Supplement 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(q)(5)(F) of the Act. Nutritional information does not comply with 21 CFR Part 101.36. Label fails to declare: Quantitative amount by weight specified for the proprietary blend (EstroG-100) shall be the total weight of all other dietary ingredients contained in the proprietary blend and shall be placed on the same line to the right of the term “Proprietary Blend” or other appropriately descriptive term or fanciful name underneath the column of amounts described in paragraph (b)(2)(ii) of this section (21 CFR 101.36(c)(3)). The other dietary ingredients in descending order of predominance by weight, in a column or linear fashion, and indented under the term “Proprietary Blend” or other appropriately descriptive term or fanciful name (21 CFR 101.36 (c)(2)). The other ingredients list fails to be placed immediately below the Supplement Facts label (21 CFR 101.4(g)). Section 403(y) of the Act. Label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such a dietary supplement. | 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(q)(5)(F) of the Act. Nutritional information does not comply with 21 CFR Part 101.36. Label fails to declare: Quantitative amount by weight specified for the proprietary blend (EstroG-100) shall be the total weight of all other dietary ingredients contained in the proprietary blend and shall be placed on the same line to the right of the term “Proprietary Blend” or other appropriately descriptive term or fanciful name underneath the column of amounts described in paragraph (b)(2)(ii) of this section (21 CFR 101.36(c)(3)). The other dietary ingredients in descending order of predominance by weight, in a column or linear fashion, and indented under the term “Proprietary Blend” or other appropriately descriptive term or fanciful name (21 CFR 101.36 (c)(2)). The other ingredients list fails to be placed immediately below the Supplement Facts label (21 CFR 101.4(g)). Section 403(y) of the Act. Label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such a dietary supplement. | 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(q)(5)(F) of the Act. Nutritional information does not comply with 21 CFR Part 101.36. Label fails to declare: Quantitative amount by weight specified for the proprietary blend (EstroG-100) shall be the total weight of all other dietary ingredients contained in the proprietary blend and shall be placed on the same line to the right of the term “Proprietary Blend” or other appropriately descriptive term or fanciful name underneath the column of amounts described in paragraph (b)(2)(ii) of this section (21 CFR 101.36(c)(3)). The other dietary ingredients in descending order of predominance by weight, in a column or linear fashion, and indented under the term “Proprietary Blend” or other appropriately descriptive term or fanciful name (21 CFR 101.36 (c)(2)). The other ingredients list fails to be placed immediately below the Supplement Facts label (21 CFR 101.4(g)). Section 403(y) of the Act. Label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such a dietary supplement. each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Medicap Laboratories Date Published : 06/25/2024 3190 Devon Dr , Windsor, Ontario CANADA 54 E - - 99 Herbals & Botanical Teas, N.E.C. Date Published: 06/25/2024 Desc: Edica EZestro Supplement 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(q)(5)(F) of the Act. Nutritional information does not comply with 21 CFR Part 101.36. Label fails to declare: Quantitative amount by weight specified for the proprietary blend (EstroG-100) shall be the total weight of all other dietary ingredients contained in the proprietary blend and shall be placed on the same line to the right of the term “Proprietary Blend” or other appropriately descriptive term or fanciful name underneath the column of amounts described in paragraph (b)(2)(ii) of this section (21 CFR 101.36(c)(3)). The other dietary ingredients in descending order of predominance by weight, in a column or linear fashion, and indented under the term “Proprietary Blend” or other appropriately descriptive term or fanciful name (21 CFR 101.36 (c)(2)). The other ingredients list fails to be placed immediately below the Supplement Facts label (21 CFR 101.4(g)). Section 403(y) of the Act. Label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such a dietary supplement. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 06/25/2024 Desc: Edica EZestro Supplement 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(q)(5)(F) of the Act. Nutritional information does not comply with 21 CFR Part 101.36. Label fails to declare: Quantitative amount by weight specified for the proprietary blend (EstroG-100) shall be the total weight of all other dietary ingredients contained in the proprietary blend and shall be placed on the same line to the right of the term “Proprietary Blend” or other appropriately descriptive term or fanciful name underneath the column of amounts described in paragraph (b)(2)(ii) of this section (21 CFR 101.36(c)(3)). The other dietary ingredients in descending order of predominance by weight, in a column or linear fashion, and indented under the term “Proprietary Blend” or other appropriately descriptive term or fanciful name (21 CFR 101.36 (c)(2)). The other ingredients list fails to be placed immediately below the Supplement Facts label (21 CFR 101.4(g)). Section 403(y) of the Act. Label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such a dietary supplement. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 06/25/2024 Desc: Edica EZestro Supplement 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(q)(5)(F) of the Act. Nutritional information does not comply with 21 CFR Part 101.36. Label fails to declare: Quantitative amount by weight specified for the proprietary blend (EstroG-100) shall be the total weight of all other dietary ingredients contained in the proprietary blend and shall be placed on the same line to the right of the term “Proprietary Blend” or other appropriately descriptive term or fanciful name underneath the column of amounts described in paragraph (b)(2)(ii) of this section (21 CFR 101.36(c)(3)). The other dietary ingredients in descending order of predominance by weight, in a column or linear fashion, and indented under the term “Proprietary Blend” or other appropriately descriptive term or fanciful name (21 CFR 101.36 (c)(2)). The other ingredients list fails to be placed immediately below the Supplement Facts label (21 CFR 101.4(g)). Section 403(y) of the Act. Label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such a dietary supplement.

accessdata.fda.gov, retrieved 2026-09-15

Source

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