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

For 8 Knot · 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 09/13/2019; address is 1339-1 , Shin'Asahichoshinjo , Takashima, Shiga JAPAN, verified against its source on 2026-09-16.

- **Firm:** 8 Knot _(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:** 1339-1 , Shin'Asahichoshinjo , Takashima, Shiga JAPAN _(verified: appears in the quote below)_
- **Date published:** 09/13/2019 _(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:** Tokpela's Mist eliminates ROS* (Reactive Oxygen Species) is believed to cause conditions including cancer, high blood pressure, diabetes, kidney disease. Tokpela's Mist makes stressed erythrocytes "Red Blood Cells" (RBC's) more flexible. RBC's ... can then effortlessly pass smoothly through our capillaries . RBC's accordingly can quickly carry oxygen to our extremities. Although "Tokpela's Mist (Miracle 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. | Tokpela's Mist eliminates ROS* (Reactive Oxygen Species) is believed to cause conditions including cancer, high blood pressure, diabetes, kidney disease. Tokpela's Mist makes stressed erythrocytes "Red Blood Cells" (RBC's) more flexible. RBC's ... can then effortlessly pass smoothly through our capillaries . RBC's accordingly can quickly carry oxygen to our extremities. Although "Tokpela's Mist (Miracle 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. | Tokpela's Mist eliminates ROS* (Reactive Oxygen Species) is believed to cause conditions including cancer, high blood pressure, diabetes, kidney disease. Tokpela's Mist makes stressed erythrocytes "Red Blood Cells" (RBC's) more flexible. RBC's ... can then effortlessly pass smoothly through our capillaries . RBC's accordingly can quickly carry oxygen to our extremities. Although "Tokpela's Mist (Miracle 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. | Tokpela's Mist eliminates ROS* (Reactive Oxygen Species) is believed to cause conditions including cancer, high blood pressure, diabetes, kidney disease. Tokpela's Mist makes stressed erythrocytes "Red Blood Cells" (RBC's) more flexible. RBC's ... can then effortlessly pass smoothly through our capillaries . RBC's accordingly can quickly carry oxygen to our extremities. Although "Tokpela's Mist (Miracle 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 Date Published : 09/13/2019 1339-1 , Shin'Asahichoshinjo , Takashima, Shiga JAPAN 29 W - - 01 Bottled Water Date Published: 09/13/2019 Notes: Tokpela's Mist eliminates ROS* (Reactive Oxygen Species) is believed to cause conditions including cancer, high blood pressure, diabetes, kidney disease. Tokpela's Mist makes stressed erythrocytes "Red Blood Cells" (RBC's) more flexible. RBC's ... can then effortlessly pass smoothly through our capillaries . RBC's accordingly can quickly carry oxygen to our extremities. Although "Tokpela's Mist (Miracle 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: 09/13/2019 Notes: Tokpela's Mist eliminates ROS* (Reactive Oxygen Species) is believed to cause conditions including cancer, high blood pressure, diabetes, kidney disease. Tokpela's Mist makes stressed erythrocytes "Red Blood Cells" (RBC's) more flexible. RBC's ... can then effortlessly pass smoothly through our capillaries . RBC's accordingly can quickly carry oxygen to our extremities. Although "Tokpela's Mist (Miracle 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: 09/13/2019 Notes: Tokpela's Mist eliminates ROS* (Reactive Oxygen Species) is believed to cause conditions including cancer, high blood pressure, diabetes, kidney disease. Tokpela's Mist makes stressed erythrocytes "Red Blood Cells" (RBC's) more flexible. RBC's ... can then effortlessly pass smoothly through our capillaries . RBC's accordingly can quickly carry oxygen to our extremities. Although "Tokpela's Mist (Miracle 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: 09/13/2019 Notes: Tokpela's Mist eliminates ROS* (Reactive Oxygen Species) is believed to cause conditions including cancer, high blood pressure, diabetes, kidney disease. Tokpela's Mist makes stressed erythrocytes "Red Blood Cells" (RBC's) more flexible. RBC's ... can then effortlessly pass smoothly through our capillaries . RBC's accordingly can quickly carry oxygen to our extremities. Although "Tokpela's Mist (Miracle 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/).