# Capsule Factory Nutraceuticals Ltd. · 66-41 · CANADA — FDA import alert red lists: firms subject to detention without physical examination

For Capsule Factory Nutraceuticals 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 TUDCA LIVER PROTECTANT | TUDCA LIVER PROTECTANT; product code is 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 09/30/2021; address is 969 Juliana Dr , Woodstock, Ontario CANADA, verified against its source on 2026-09-16.

- **Firm:** Capsule Factory Nutraceuticals 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:** CANADA _(verified: appears in the quote below)_
- **Address:** 969 Juliana Dr , Woodstock, Ontario CANADA _(verified: appears in the quote below)_
- **Date published:** 09/30/2021 _(verified: appears in the quote below)_
- **Product code:** 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:** TUDCA LIVER PROTECTANT | TUDCA LIVER PROTECTANT _(verified: each item appears in the quote below)_
- **FDA notes:** The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): ‘It shows great potency in treating bile acid backup in the liver…’; ‘TUDCA can also protect and help rehabilitate the liver, and in general protects cells from free radical damage…’; ‘Research has validated TUDCA as a potent and effective treatment for repairing and supporting the liver from alcohol-induced damage, as well as from damage as a result of compounds that must do a double pass through the liver…’. | The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): ‘It shows great potency in treating bile acid backup in the liver…’; ‘TUDCA can also protect and help rehabilitate the liver, and in general protects cells from free radical damage…’; ‘Research has validated TUDCA as a potent and effective treatment for repairing and supporting the liver from alcohol-induced damage, as well as from damage as a result of compounds that must do a double pass through the liver…’. _(verified: each item appears in the quote below)_

## What the source says

> Capsule Factory Nutraceuticals Ltd. Date Published : 09/30/2021 969 Juliana Dr , Woodstock, Ontario CANADA 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 09/30/2021 Desc: TUDCA LIVER PROTECTANT Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): ‘It shows great potency in treating bile acid backup in the liver…’; ‘TUDCA can also protect and help rehabilitate the liver, and in general protects cells from free radical damage…’; ‘Research has validated TUDCA as a potent and effective treatment for repairing and supporting the liver from alcohol-induced damage, as well as from damage as a result of compounds that must do a double pass through the liver…’. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 09/30/2021 Desc: TUDCA LIVER PROTECTANT Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): ‘It shows great potency in treating bile acid backup in the liver…’; ‘TUDCA can also protect and help rehabilitate the liver, and in general protects cells from free radical damage…’; ‘Research has validated TUDCA as a potent and effective treatment for repairing and supporting the liver from alcohol-induced damage, as well as from damage as a result of compounds that must do a double pass through the liver…’.

## 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/).