# Jyothy Lab · 66-41 · INDIA — FDA import alert red lists: firms subject to detention without physical examination

For Jyothy Lab · 66-41 · INDIA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is INDIA; product is Neem Active Toothpaste | Neem Active Toothpaste | Neem Active Toothpaste; product code is 53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products) | 53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 06/09/2025; address is Ujala House , Ram Krishna Mandir Road , Mumbai, Maharashtra INDIA, verified against its source on 2026-09-16.

- **Firm:** Jyothy Lab _(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:** INDIA _(verified: appears in the quote below)_
- **Address:** Ujala House , Ram Krishna Mandir Road , Mumbai, Maharashtra INDIA _(verified: appears in the quote below)_
- **Date published:** 06/09/2025 _(verified: appears in the quote below)_
- **Product code:** 53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products) | 53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. _(verified: each item appears in the quote below)_
- **Product:** Neem Active Toothpaste | Neem Active Toothpaste | Neem Active Toothpaste _(verified: each item appears in the quote below)_
- **FDA notes:** This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Natural Antibacterial Protection for strong teeth and healthy gums”, “…Not only does Neem Toothpaste help fight bacteria, but it also promotes healthy gums. Its gentle yet effective formula helps reduce inflammation... , “…Reduce the deposition of plaque”. | This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Natural Antibacterial Protection for strong teeth and healthy gums”, “…Not only does Neem Toothpaste help fight bacteria, but it also promotes healthy gums. Its gentle yet effective formula helps reduce inflammation... , “…Reduce the deposition of plaque”. | This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Natural Antibacterial Protection for strong teeth and healthy gums”, “…Not only does Neem Toothpaste help fight bacteria, but it also promotes healthy gums. Its gentle yet effective formula helps reduce inflammation... , “…Reduce the deposition of plaque”. _(verified: each item appears in the quote below)_

## What the source says

> Jyothy Lab Date Published : 06/09/2025 Ujala House , Ram Krishna Mandir Road , Mumbai, Maharashtra INDIA 53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products) Date Published: 06/09/2025 Desc: Neem Active Toothpaste Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Natural Antibacterial Protection for strong teeth and healthy gums”, “…Not only does Neem Toothpaste help fight bacteria, but it also promotes healthy gums. Its gentle yet effective formula helps reduce inflammation... , “…Reduce the deposition of plaque”. 53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C. Date Published: 06/09/2025 Desc: Neem Active Toothpaste Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Natural Antibacterial Protection for strong teeth and healthy gums”, “…Not only does Neem Toothpaste help fight bacteria, but it also promotes healthy gums. Its gentle yet effective formula helps reduce inflammation... , “…Reduce the deposition of plaque”. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 06/09/2025 Desc: Neem Active Toothpaste Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Natural Antibacterial Protection for strong teeth and healthy gums”, “…Not only does Neem Toothpaste help fight bacteria, but it also promotes healthy gums. Its gentle yet effective formula helps reduce inflammation... , “…Reduce the deposition of plaque”.

## 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/).