Reference Source

Jyothy Lab · 66-41 · INDIA

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
Import alert
66-41
Import alert name
Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
Country
INDIA verified
Address
Ujala House , Ram Krishna Mandir Road , Mumbai, Maharashtra INDIA verified
Date published
06/09/2025 verified
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. each item verified
Product
Neem Active Toothpaste | Neem Active Toothpaste | Neem Active Toothpaste each item verified
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”. 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

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”.

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

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.