# 1965599 ONTARIO LTD. · 66-41 · CANADA — FDA import alert red lists: firms subject to detention without physical examination

For 1965599 ONTARIO LTD. · 66-41 · CANADA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is CANADA; product is Alpha Max Test Funk Supplements | Alpha Max Test Funk Supplements | CLEARB5 Acne Control Vitamin Powder- Strawberry Lemonade | CLEARB5 Acne Control Vitamin Powder- Strawberry Lemonade; product code is 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. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 01/17/2025; address is 1-6360 Hawthorne Dr , Windsor, Ontario CANADA, verified against its source on 2026-09-16.

- **Firm:** 1965599 ONTARIO LTD. _(verified: appears in the quote below)_
- **Import alert:** 66-41
- **Import alert name:** Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- **Country:** CANADA _(verified: appears in the quote below)_
- **Address:** 1-6360 Hawthorne Dr , Windsor, Ontario CANADA _(verified: appears in the quote below)_
- **Date published:** 01/17/2025 _(verified: appears in the quote below)_
- **Product code:** 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. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. _(verified: each item appears in the quote below)_
- **Product:** Alpha Max Test Funk Supplements | Alpha Max Test Funk Supplements | CLEARB5 Acne Control Vitamin Powder- Strawberry Lemonade | CLEARB5 Acne Control Vitamin Powder- Strawberry Lemonade _(verified: each item appears in the quote below)_
- **FDA notes:** This product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): "...enhanced blood flow lowering blood pressure....and preventing cataracts...", "...Treat Erectile Dysfunction...is a treatment for erectile dysfunction...", "...Lower Bad Cholesterol...". These claims are disease claims under section 201(g)(1)(B) of the Act and cause the product above to be in violation of an unapproved new drug under section 505(a) of the Act. | This product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): "...enhanced blood flow lowering blood pressure....and preventing cataracts...", "...Treat Erectile Dysfunction...is a treatment for erectile dysfunction...", "...Lower Bad Cholesterol...". These claims are disease claims under section 201(g)(1)(B) of the Act and cause the product above to be in violation of an unapproved new drug under section 505(a) of the Act. | This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product’s labeling and website includes statements such as (not an all-inclusive list): "..."Formulated for acne control", “To help control acne”...", "Science-backed ingredients designed to target acne at its roots..", "Groundbreaking clinical trial participants with mild to moderate acne saw visibly clearer skin in just 12 weeks…" | This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product’s labeling and website includes statements such as (not an all-inclusive list): "..."Formulated for acne control", “To help control acne”...", "Science-backed ingredients designed to target acne at its roots..", "Groundbreaking clinical trial participants with mild to moderate acne saw visibly clearer skin in just 12 weeks…" _(verified: each item appears in the quote below)_

## What the source says

> 1965599 ONTARIO LTD. Date Published : 01/17/2025 1-6360 Hawthorne Dr , Windsor, Ontario CANADA 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 01/17/2025 Desc: Alpha Max Test Funk Supplements Notes: This product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): "...enhanced blood flow lowering blood pressure....and preventing cataracts...", "...Treat Erectile Dysfunction...is a treatment for erectile dysfunction...", "...Lower Bad Cholesterol...". These claims are disease claims under section 201(g)(1)(B) of the Act and cause the product above to be in violation of an unapproved new drug under section 505(a) of the Act. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 01/17/2025 Desc: Alpha Max Test Funk Supplements Notes: This product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): "...enhanced blood flow lowering blood pressure....and preventing cataracts...", "...Treat Erectile Dysfunction...is a treatment for erectile dysfunction...", "...Lower Bad Cholesterol...". These claims are disease claims under section 201(g)(1)(B) of the Act and cause the product above to be in violation of an unapproved new drug under section 505(a) of the Act. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 04/28/2025 Desc: CLEARB5 Acne Control Vitamin Powder- Strawberry Lemonade Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product’s labeling and website includes statements such as (not an all-inclusive list): "..."Formulated for acne control", “To help control acne”...", "Science-backed ingredients designed to target acne at its roots..", "Groundbreaking clinical trial participants with mild to moderate acne saw visibly clearer skin in just 12 weeks…" 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 04/28/2025 Desc: CLEARB5 Acne Control Vitamin Powder- Strawberry Lemonade Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product’s labeling and website includes statements such as (not an all-inclusive list): "..."Formulated for acne control", “To help control acne”...", "Science-backed ingredients designed to target acne at its roots..", "Groundbreaking clinical trial participants with mild to moderate acne saw visibly clearer skin in just 12 weeks…"

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_190.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/).