# Omega Alpha Pharmaceuticals · 99-39 · CANADA — FDA import alert red lists: firms subject to detention without physical examination

For Omega Alpha Pharmaceuticals · 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 Maculex | Aeolus Lung Cleanse | Maculex | Maculex | Maculex | Maculex; product code is 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not 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. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 07/06/2020; address is 795 Pharmacy Ave , Scarborough, Ontario CANADA, verified against its source on 2026-09-16.

- **Firm:** Omega Alpha Pharmaceuticals _(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:** CANADA _(verified: appears in the quote below)_
- **Address:** 795 Pharmacy Ave , Scarborough, Ontario CANADA _(verified: appears in the quote below)_
- **Date published:** 07/06/2020 _(verified: appears in the quote below)_
- **Product code:** 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not 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. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. _(verified: each item appears in the quote below)_
- **Product:** Maculex | Aeolus Lung Cleanse | Maculex | Maculex | Maculex | Maculex _(verified: each item appears in the quote below)_
- **FDA notes:** The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the FD&C Act [21 U.S.C. § 343(s)(2)(B)], in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(s)(2)(C) of the FD&C Act [21 U.S.C. § 343(s)(2)(C)], in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived. Section 403(q) of the FD&C Act [21 U.S.C. § 343(q)(1)(A)], in that the label or labeling fails to bear the required nutrition information. Section 403(f) of the FD&C Act [21 U.S.C. §343(f)] in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use. | The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the FD&C Act [21 U.S.C. § 343(s)(2)(B)], in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(s)(2)(C) of the FD&C Act [21 U.S.C. § 343(s)(2)(C)], in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived. Section 403(q) of the FD&C Act [21 U.S.C. § 343(q)(1)(A)], in that the label or labeling fails to bear the required nutrition information. Section 403(f) of the FD&C Act [21 U.S.C. §343(f)] in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use. | The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the FD&C Act [21 U.S.C. § 343(s)(2)(B)], in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(s)(2)(C) of the FD&C Act [21 U.S.C. § 343(s)(2)(C)], in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived. Section 403(q) of the FD&C Act [21 U.S.C. § 343(q)(1)(A)], in that the label or labeling fails to bear the required nutrition information. Section 403(f) of the FD&C Act [21 U.S.C. §343(f)] in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use. | The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the FD&C Act [21 U.S.C. § 343(s)(2)(B)], in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(s)(2)(C) of the FD&C Act [21 U.S.C. § 343(s)(2)(C)], in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived. Section 403(q) of the FD&C Act [21 U.S.C. § 343(q)(1)(A)], in that the label or labeling fails to bear the required nutrition information. Section 403(f) of the FD&C Act [21 U.S.C. §343(f)] in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use. | The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the FD&C Act [21 U.S.C. § 343(s)(2)(B)], in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(s)(2)(C) of the FD&C Act [21 U.S.C. § 343(s)(2)(C)], in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived. Section 403(q) of the FD&C Act [21 U.S.C. § 343(q)(1)(A)], in that the label or labeling fails to bear the required nutrition information. Section 403(f) of the FD&C Act [21 U.S.C. §343(f)] in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use. | The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the FD&C Act [21 U.S.C. § 343(s)(2)(B)], in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(s)(2)(C) of the FD&C Act [21 U.S.C. § 343(s)(2)(C)], in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived. Section 403(q) of the FD&C Act [21 U.S.C. § 343(q)(1)(A)], in that the label or labeling fails to bear the required nutrition information. Section 403(f) of the FD&C Act [21 U.S.C. §343(f)] in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use. _(verified: each item appears in the quote below)_

## What the source says

> Omega Alpha Pharmaceuticals Date Published : 07/06/2020 795 Pharmacy Ave , Scarborough, Ontario CANADA 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 07/06/2020 Desc: Maculex Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the FD&C Act [21 U.S.C. § 343(s)(2)(B)], in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(s)(2)(C) of the FD&C Act [21 U.S.C. § 343(s)(2)(C)], in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived. Section 403(q) of the FD&C Act [21 U.S.C. § 343(q)(1)(A)], in that the label or labeling fails to bear the required nutrition information. Section 403(f) of the FD&C Act [21 U.S.C. §343(f)] in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 07/06/2020 Desc: Aeolus Lung Cleanse Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the FD&C Act [21 U.S.C. § 343(s)(2)(B)], in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(s)(2)(C) of the FD&C Act [21 U.S.C. § 343(s)(2)(C)], in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived. Section 403(q) of the FD&C Act [21 U.S.C. § 343(q)(1)(A)], in that the label or labeling fails to bear the required nutrition information. Section 403(f) of the FD&C Act [21 U.S.C. §343(f)] in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 07/06/2020 Desc: Maculex Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the FD&C Act [21 U.S.C. § 343(s)(2)(B)], in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(s)(2)(C) of the FD&C Act [21 U.S.C. § 343(s)(2)(C)], in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived. Section 403(q) of the FD&C Act [21 U.S.C. § 343(q)(1)(A)], in that the label or labeling fails to bear the required nutrition information. Section 403(f) of the FD&C Act [21 U.S.C. §343(f)] in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 07/06/2020 Desc: Maculex Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the FD&C Act [21 U.S.C. § 343(s)(2)(B)], in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(s)(2)(C) of the FD&C Act [21 U.S.C. § 343(s)(2)(C)], in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived. Section 403(q) of the FD&C Act [21 U.S.C. § 343(q)(1)(A)], in that the label or labeling fails to bear the required nutrition information. Section 403(f) of the FD&C Act [21 U.S.C. §343(f)] in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 07/06/2020 Desc: Maculex Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the FD&C Act [21 U.S.C. § 343(s)(2)(B)], in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(s)(2)(C) of the FD&C Act [21 U.S.C. § 343(s)(2)(C)], in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived. Section 403(q) of the FD&C Act [21 U.S.C. § 343(q)(1)(A)], in that the label or labeling fails to bear the required nutrition information. Section 403(f) of the FD&C Act [21 U.S.C. §343(f)] in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 07/06/2020 Desc: Maculex Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the FD&C Act [21 U.S.C. § 343(s)(2)(B)], in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(s)(2)(C) of the FD&C Act [21 U.S.C. § 343(s)(2)(C)], in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived. Section 403(q) of the FD&C Act [21 U.S.C. § 343(q)(1)(A)], in that the label or labeling fails to bear the required nutrition information. Section 403(f) of the FD&C Act [21 U.S.C. §343(f)] in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use.

## 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/).