Reference Source

1965599 ONTARIO LTD · 66-41 · CANADA

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 | CLEARB5 Acne Control Vitamin Powder- Strawberry Lemonade | Alpha Max Test Funk Supplements | 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 2795 Kew Dr , Windsor, Ontario CANADA, verified against its source on 2026-09-16.

Firm
1965599 ONTARIO LTD verified
Import alert
66-41
Import alert name
Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
Country
CANADA verified
Address
2795 Kew Dr , Windsor, Ontario CANADA verified
Date published
01/17/2025 verified
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. each item verified
Product
Alpha Max Test Funk Supplements | CLEARB5 Acne Control Vitamin Powder- Strawberry Lemonade | Alpha Max Test Funk Supplements | CLEARB5 Acne Control Vitamin Powder- Strawberry Lemonade each item verified
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 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 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…" 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

1965599 ONTARIO LTD Date Published : 01/17/2025 2795 Kew 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: 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…" 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. 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…"

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

Source

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