Reference Source

8 Knot Co Ltd · 66-41 · JAPAN

For 8 Knot Co Ltd, import alert is 66-41; country is JAPAN; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; 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 2026-10-01.

Firm
8 Knot Co Ltd verified
Import alert
66-41
Import alert name
Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
Country
JAPAN verified
Address
3 Chome 7-21 , Fuku-Machi; Nishiyodogawa , Osaka, Osaka JAPAN verified
Date published
09/30/2009 verified
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. each item verified
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. 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

8 Knot Co Ltd Date Published : 09/30/2009 3 Chome 7-21 , Fuku-Machi; Nishiyodogawa , Osaka, Osaka JAPAN

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

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

Product code and FDA notes

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.

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

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