# 8 Knot Co Ltd · 66-41 · JAPAN — FDA import alert red lists: firms subject to detention without physical examination

For 8 Knot Co Ltd · 66-41 · JAPAN, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is JAPAN; product code is 29 W - - 01 Bottled Water | 29 W - - 02 Bottled Spring or Mineral Water | 29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 09/30/2009; address is 3 Chome 7-21 , Fuku-Machi; Nishiyodogawa , Osaka, Osaka JAPAN, verified against its source on 2026-09-16.

- **Firm:** 8 Knot Co 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:** JAPAN _(verified: appears in the quote below)_
- **Address:** 3 Chome 7-21 , Fuku-Machi; Nishiyodogawa , Osaka, Osaka JAPAN _(verified: appears in the quote below)_
- **Date published:** 09/30/2009 _(verified: appears in the quote below)_
- **Product code:** 29 W - - 01 Bottled Water | 29 W - - 02 Bottled Spring or Mineral Water | 29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. _(verified: each item appears in the quote below)_
- **FDA notes:** 7/25/08. Tokpela's Mist Bottled Water. A pamphlet accompanying this product claims: "Tokpela's Mist eliminates ROS (Reactive Oxygen Species). It is believed to cause conditions including cancer, high blood pressure, diabetes and kidney disease" Also, "Tokpela's Mist makes stressed erythrocytes- Red Blood Cells - more flexible. RBCs can then effortlessly pass smoothly through our capillaries. RBC's accordingly can quickly carry oxygen to our extremities." Although the water appears to be sold as a food, in that its label bears a Nutrition Facts panel, the above claims cause the product to be a new drug. | 7/25/08. Tokpela's Mist Bottled Water. A pamphlet accompanying this product claims7/25/08. Tokpela's Mist Bottled Water. A pamphlet accompanying this product claims: "Tokpela's Mist eliminates ROS (Reactive Oxygen Species). It is believed to cause conditions including cancer, high blood pressure, diabetes and kidney disease" Also, "Tokpela's Mist makes stressed erythrocytes- Red Blood Cells - more flexible. RBCs can then effortlessly pass smoothly through our capillaries. RBC's accordingly can quickly carry oxygen to our extremities." Although the water appears to be sold as a food, in that its label bears a Nutrition Facts panel, the above claims cause the product to be a new drug. | 7/25/08. Tokpela's Mist Bottled Water. A pamphlet accompanying this product claims: "Tokpela's Mist eliminates ROS (Reactive Oxygen Species). It is believed to cause conditions including cancer, high blood pressure, diabetes and kidney disease" Also, "Tokpela's Mist makes stressed erythrocytes- Red Blood Cells - more flexible. RBCs can then effortlessly pass smoothly through our capillaries. RBC's accordingly can quickly carry oxygen to our extremities." Although the water appears to be sold as a food, in that its label bears a Nutrition Facts panel, the above claims cause the product to be a new drug. | 7/25/08. Tokpela's Mist Bottled Water. A pamphlet accompanying this product claims: "Tokpela's Mist eliminates ROS (Reactive Oxygen Species). It is believed to cause conditions including cancer, high blood pressure, diabetes and kidney disease" Also, "Tokpela's Mist makes stressed erythrocytes- Red Blood Cells - more flexible. RBCs can then effortlessly pass smoothly through our capillaries. RBC's accordingly can quickly carry oxygen to our extremities." Although the water appears to be sold as a food, in that its label bears a Nutrition Facts panel, the above claims cause the product to be a new drug. _(verified: each item appears in the quote below)_

## What the source says

> 8 Knot Co Ltd Date Published : 09/30/2009 3 Chome 7-21 , Fuku-Machi; Nishiyodogawa , Osaka, Osaka JAPAN 29 W - - 01 Bottled Water Date Published: 09/30/2009 Notes: 7/25/08. Tokpela's Mist Bottled Water. A pamphlet accompanying this product claims: "Tokpela's Mist eliminates ROS (Reactive Oxygen Species). It is believed to cause conditions including cancer, high blood pressure, diabetes and kidney disease" Also, "Tokpela's Mist makes stressed erythrocytes- Red Blood Cells - more flexible. RBCs can then effortlessly pass smoothly through our capillaries. RBC's accordingly can quickly carry oxygen to our extremities." Although the water appears to be sold as a food, in that its label bears a Nutrition Facts panel, the above claims cause the product to be a new drug. 29 W - - 02 Bottled Spring or Mineral Water Date Published: 09/30/2009 Notes: 7/25/08. Tokpela's Mist Bottled Water. A pamphlet accompanying this product claims7/25/08. Tokpela's Mist Bottled Water. A pamphlet accompanying this product claims: "Tokpela's Mist eliminates ROS (Reactive Oxygen Species). It is believed to cause conditions including cancer, high blood pressure, diabetes and kidney disease" Also, "Tokpela's Mist makes stressed erythrocytes- Red Blood Cells - more flexible. RBCs can then effortlessly pass smoothly through our capillaries. RBC's accordingly can quickly carry oxygen to our extremities." Although the water appears to be sold as a food, in that its label bears a Nutrition Facts panel, the above claims cause the product to be a new drug. 29 Y - - 99 Soft Drinks and Waters Not Mentioned Elsewhere, N.E.C. Date Published: 09/30/2009 Notes: 7/25/08. Tokpela's Mist Bottled Water. A pamphlet accompanying this product claims: "Tokpela's Mist eliminates ROS (Reactive Oxygen Species). It is believed to cause conditions including cancer, high blood pressure, diabetes and kidney disease" Also, "Tokpela's Mist makes stressed erythrocytes- Red Blood Cells - more flexible. RBCs can then effortlessly pass smoothly through our capillaries. RBC's accordingly can quickly carry oxygen to our extremities." Although the water appears to be sold as a food, in that its label bears a Nutrition Facts panel, the above claims cause the product to be a new drug. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 09/30/2009 Notes: 7/25/08. Tokpela's Mist Bottled Water. A pamphlet accompanying this product claims: "Tokpela's Mist eliminates ROS (Reactive Oxygen Species). It is believed to cause conditions including cancer, high blood pressure, diabetes and kidney disease" Also, "Tokpela's Mist makes stressed erythrocytes- Red Blood Cells - more flexible. RBCs can then effortlessly pass smoothly through our capillaries. RBC's accordingly can quickly carry oxygen to our extremities." Although the water appears to be sold as a food, in that its label bears a Nutrition Facts panel, the above claims cause the product to be a new drug.

## 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/).