# English Bay Blending · 66-41 · CANADA — FDA import alert red lists: firms subject to detention without physical examination

For English Bay Blending · 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 GEM Calm Essentials; Banana Cinnamon Bites | GEM Calm Essentials; Banana Cinnamon Bites | GEM Calm Essentials; Banana Cinnamon Bites | GEM Calm Essentials; Banana Cinnamon Bites | GEM Calm Essentials; Banana Cinnamon Bites; product code is 34 G - - 01 Chocolate Candy Bar, with Nuts and Fruit | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 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; date published is 02/29/2024; address is 1066 Cliveden Ave , Delta, British Columbia CANADA, verified against its source on 2026-09-16.

- **Firm:** English Bay Blending _(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:** 1066 Cliveden Ave , Delta, British Columbia CANADA _(verified: appears in the quote below)_
- **Date published:** 02/29/2024 _(verified: appears in the quote below)_
- **Product code:** 34 G - - 01 Chocolate Candy Bar, with Nuts and Fruit | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 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. _(verified: each item appears in the quote below)_
- **Product:** GEM Calm Essentials; Banana Cinnamon Bites | GEM Calm Essentials; Banana Cinnamon Bites | GEM Calm Essentials; Banana Cinnamon Bites | GEM Calm Essentials; Banana Cinnamon Bites | GEM Calm Essentials; Banana Cinnamon Bites _(verified: each item appears in the quote below)_
- **FDA notes:** The product appears to be a new drug within the meaning of section 201 (p) of the FD&C Act, without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. Labeling on manufacturer’s website, for the products sold under this brand, makes claims for ingredients used in the product, but are not limited to the following: “Coconut”: “May help people struggling with obesity lose body fat”, “Linked to numerous health benefits, including…lower blood sugar levels” and “Lower levels of low-density lipoprotein (LDL) "bad" cholesterol in the body, which can lower the overall risk of heart disease… Higher levels of HDL cholesterol correlate to a lower risk of heart disease because HDL cholesterol is responsible for removing extra LDL cholesterol from the blood and plaque buildup from the blood vessels… Lower total cholesterol levels and reduced plaque buildup lower the overall risk of heart disease, heart attack, and stroke”. “Dates”: “Helps prevent constipation”, “Helps control blood sugar levels…and preventing a spike in blood sugar levels” and “Help reduce inflammation… Phenolic acid, which acts as an anti-inflammatory and may reduce the risk of cancer and heart disease”. The product appears to be a new drug within the meaning of by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for the intended uses. | The product appears to be a new drug within the meaning of section 201 (p) of the FD&C Act, without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. Labeling on manufacturer’s website, for the products sold under this brand, makes claims for ingredients used in the product, but are not limited to the following: “Coconut”: “May help people struggling with obesity lose body fat”, “Linked to numerous health benefits, including…lower blood sugar levels” and “Lower levels of low-density lipoprotein (LDL) "bad" cholesterol in the body, which can lower the overall risk of heart disease… Higher levels of HDL cholesterol correlate to a lower risk of heart disease because HDL cholesterol is responsible for removing extra LDL cholesterol from the blood and plaque buildup from the blood vessels… Lower total cholesterol levels and reduced plaque buildup lower the overall risk of heart disease, heart attack, and stroke”. “Dates”: “Helps prevent constipation”, “Helps control blood sugar levels…and preventing a spike in blood sugar levels” and “Help reduce inflammation… Phenolic acid, which acts as an anti-inflammatory and may reduce the risk of cancer and heart disease”. The product appears to be a new drug within the meaning of by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for the intended uses. | The product appears to be a new drug within the meaning of section 201 (p) of the FD&C Act, without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. Labeling on manufacturer’s website, for the products sold under this brand, makes claims for ingredients used in the product, but are not limited to the following: “Coconut”: “May help people struggling with obesity lose body fat”, “Linked to numerous health benefits, including…lower blood sugar levels” and “Lower levels of low-density lipoprotein (LDL) "bad" cholesterol in the body, which can lower the overall risk of heart disease… Higher levels of HDL cholesterol correlate to a lower risk of heart disease because HDL cholesterol is responsible for removing extra LDL cholesterol from the blood and plaque buildup from the blood vessels… Lower total cholesterol levels and reduced plaque buildup lower the overall risk of heart disease, heart attack, and stroke”. “Dates”: “Helps prevent constipation”, “Helps control blood sugar levels…and preventing a spike in blood sugar levels” and “Help reduce inflammation… Phenolic acid, which acts as an anti-inflammatory and may reduce the risk of cancer and heart disease”. The product appears to be a new drug within the meaning of by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for the intended uses. | The product appears to be a new drug within the meaning of section 201 (p) of the FD&C Act, without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. Labeling on manufacturer’s website, for the products sold under this brand, makes claims for ingredients used in the product, but are not limited to the following: “Coconut”: “May help people struggling with obesity lose body fat”, “Linked to numerous health benefits, including…lower blood sugar levels” and “Lower levels of low-density lipoprotein (LDL) "bad" cholesterol in the body, which can lower the overall risk of heart disease… Higher levels of HDL cholesterol correlate to a lower risk of heart disease because HDL cholesterol is responsible for removing extra LDL cholesterol from the blood and plaque buildup from the blood vessels… Lower total cholesterol levels and reduced plaque buildup lower the overall risk of heart disease, heart attack, and stroke”. “Dates”: “Helps prevent constipation”, “Helps control blood sugar levels…and preventing a spike in blood sugar levels” and “Help reduce inflammation… Phenolic acid, which acts as an anti-inflammatory and may reduce the risk of cancer and heart disease”. The product appears to be a new drug within the meaning of by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for the intended uses. | The product appears to be a new drug within the meaning of section 201 (p) of the FD&C Act, without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. Labeling on manufacturer’s website, for the products sold under this brand, makes claims for ingredients used in the product, but are not limited to the following: “Coconut”: “May help people struggling with obesity lose body fat”, “Linked to numerous health benefits, including…lower blood sugar levels” and “Lower levels of low-density lipoprotein (LDL) "bad" cholesterol in the body, which can lower the overall risk of heart disease… Higher levels of HDL cholesterol correlate to a lower risk of heart disease because HDL cholesterol is responsible for removing extra LDL cholesterol from the blood and plaque buildup from the blood vessels… Lower total cholesterol levels and reduced plaque buildup lower the overall risk of heart disease, heart attack, and stroke”. “Dates”: “Helps prevent constipation”, “Helps control blood sugar levels…and preventing a spike in blood sugar levels” and “Help reduce inflammation… Phenolic acid, which acts as an anti-inflammatory and may reduce the risk of cancer and heart disease”. The product appears to be a new drug within the meaning of by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for the intended uses. _(verified: each item appears in the quote below)_

## What the source says

> English Bay Blending Date Published : 02/29/2024 1066 Cliveden Ave , Delta, British Columbia CANADA 34 G - - 01 Chocolate Candy Bar, with Nuts and Fruit Date Published: 02/29/2024 Desc: GEM Calm Essentials; Banana Cinnamon Bites Notes: The product appears to be a new drug within the meaning of section 201 (p) of the FD&C Act, without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. Labeling on manufacturer’s website, for the products sold under this brand, makes claims for ingredients used in the product, but are not limited to the following: “Coconut”: “May help people struggling with obesity lose body fat”, “Linked to numerous health benefits, including…lower blood sugar levels” and “Lower levels of low-density lipoprotein (LDL) "bad" cholesterol in the body, which can lower the overall risk of heart disease… Higher levels of HDL cholesterol correlate to a lower risk of heart disease because HDL cholesterol is responsible for removing extra LDL cholesterol from the blood and plaque buildup from the blood vessels… Lower total cholesterol levels and reduced plaque buildup lower the overall risk of heart disease, heart attack, and stroke”. “Dates”: “Helps prevent constipation”, “Helps control blood sugar levels…and preventing a spike in blood sugar levels” and “Help reduce inflammation… Phenolic acid, which acts as an anti-inflammatory and may reduce the risk of cancer and heart disease”. The product appears to be a new drug within the meaning of by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for the intended uses. 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 02/29/2024 Desc: GEM Calm Essentials; Banana Cinnamon Bites Notes: The product appears to be a new drug within the meaning of section 201 (p) of the FD&C Act, without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. Labeling on manufacturer’s website, for the products sold under this brand, makes claims for ingredients used in the product, but are not limited to the following: “Coconut”: “May help people struggling with obesity lose body fat”, “Linked to numerous health benefits, including…lower blood sugar levels” and “Lower levels of low-density lipoprotein (LDL) "bad" cholesterol in the body, which can lower the overall risk of heart disease… Higher levels of HDL cholesterol correlate to a lower risk of heart disease because HDL cholesterol is responsible for removing extra LDL cholesterol from the blood and plaque buildup from the blood vessels… Lower total cholesterol levels and reduced plaque buildup lower the overall risk of heart disease, heart attack, and stroke”. “Dates”: “Helps prevent constipation”, “Helps control blood sugar levels…and preventing a spike in blood sugar levels” and “Help reduce inflammation… Phenolic acid, which acts as an anti-inflammatory and may reduce the risk of cancer and heart disease”. The product appears to be a new drug within the meaning of by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for the intended uses. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 02/29/2024 Desc: GEM Calm Essentials; Banana Cinnamon Bites Notes: The product appears to be a new drug within the meaning of section 201 (p) of the FD&C Act, without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. Labeling on manufacturer’s website, for the products sold under this brand, makes claims for ingredients used in the product, but are not limited to the following: “Coconut”: “May help people struggling with obesity lose body fat”, “Linked to numerous health benefits, including…lower blood sugar levels” and “Lower levels of low-density lipoprotein (LDL) "bad" cholesterol in the body, which can lower the overall risk of heart disease… Higher levels of HDL cholesterol correlate to a lower risk of heart disease because HDL cholesterol is responsible for removing extra LDL cholesterol from the blood and plaque buildup from the blood vessels… Lower total cholesterol levels and reduced plaque buildup lower the overall risk of heart disease, heart attack, and stroke”. “Dates”: “Helps prevent constipation”, “Helps control blood sugar levels…and preventing a spike in blood sugar levels” and “Help reduce inflammation… Phenolic acid, which acts as an anti-inflammatory and may reduce the risk of cancer and heart disease”. The product appears to be a new drug within the meaning of by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for the intended uses. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 02/29/2024 Desc: GEM Calm Essentials; Banana Cinnamon Bites Notes: The product appears to be a new drug within the meaning of section 201 (p) of the FD&C Act, without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. Labeling on manufacturer’s website, for the products sold under this brand, makes claims for ingredients used in the product, but are not limited to the following: “Coconut”: “May help people struggling with obesity lose body fat”, “Linked to numerous health benefits, including…lower blood sugar levels” and “Lower levels of low-density lipoprotein (LDL) "bad" cholesterol in the body, which can lower the overall risk of heart disease… Higher levels of HDL cholesterol correlate to a lower risk of heart disease because HDL cholesterol is responsible for removing extra LDL cholesterol from the blood and plaque buildup from the blood vessels… Lower total cholesterol levels and reduced plaque buildup lower the overall risk of heart disease, heart attack, and stroke”. “Dates”: “Helps prevent constipation”, “Helps control blood sugar levels…and preventing a spike in blood sugar levels” and “Help reduce inflammation… Phenolic acid, which acts as an anti-inflammatory and may reduce the risk of cancer and heart disease”. The product appears to be a new drug within the meaning of by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for the intended uses. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 02/29/2024 Desc: GEM Calm Essentials; Banana Cinnamon Bites Notes: The product appears to be a new drug within the meaning of section 201 (p) of the FD&C Act, without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. Labeling on manufacturer’s website, for the products sold under this brand, makes claims for ingredients used in the product, but are not limited to the following: “Coconut”: “May help people struggling with obesity lose body fat”, “Linked to numerous health benefits, including…lower blood sugar levels” and “Lower levels of low-density lipoprotein (LDL) "bad" cholesterol in the body, which can lower the overall risk of heart disease… Higher levels of HDL cholesterol correlate to a lower risk of heart disease because HDL cholesterol is responsible for removing extra LDL cholesterol from the blood and plaque buildup from the blood vessels… Lower total cholesterol levels and reduced plaque buildup lower the overall risk of heart disease, heart attack, and stroke”. “Dates”: “Helps prevent constipation”, “Helps control blood sugar levels…and preventing a spike in blood sugar levels” and “Help reduce inflammation… Phenolic acid, which acts as an anti-inflammatory and may reduce the risk of cancer and heart disease”. The product appears to be a new drug within the meaning of by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for the intended uses.

## 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/).