# Zermat Internacional Sa De Cv · 66-41 · MEXICO — FDA import alert red lists: firms subject to detention without physical examination

For Zermat Internacional Sa De Cv · 66-41 · MEXICO, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is MEXICO; product is Intimate Shampoo / Shampoo de Higiene Intima | Intimate Shampoo / Shampoo de Higiene Intima | Intimate Shampoo / Shampoo de Higiene Intima | Intimate Shampoo / Shampoo de Higiene Intima; product code is 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) | 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. | 53 U - - 10 Personal Cleanliness, Cosmetic products containing animal by-products (other animal by-products) | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C; date published is 11/08/2018; address is Torre 3 , Calzada Melchor Ocampo 193; Colonia Veronica Anzures , Miguel Hidalgo, Ciudad de Mexico MEXICO, verified against its source on 2026-09-16.

- **Firm:** Zermat Internacional Sa De Cv _(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:** MEXICO _(verified: appears in the quote below)_
- **Address:** Torre 3 , Calzada Melchor Ocampo 193; Colonia Veronica Anzures , Miguel Hidalgo, Ciudad de Mexico MEXICO _(verified: appears in the quote below)_
- **Date published:** 11/08/2018 _(verified: appears in the quote below)_
- **Product code:** 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) | 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. | 53 U - - 10 Personal Cleanliness, Cosmetic products containing animal by-products (other animal by-products) | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. _(verified: each item appears in the quote below)_
- **Product:** Intimate Shampoo / Shampoo de Higiene Intima | Intimate Shampoo / Shampoo de Higiene Intima | Intimate Shampoo / Shampoo de Higiene Intima | Intimate Shampoo / Shampoo de Higiene Intima _(verified: each item appears in the quote below)_
- **FDA notes:** Website claims include, "[A]nti-inflammatory, and anti-bacterial properties of aloe extracts and chamomile..." The product is not generally recognized as safe and effective for the referenced uses and therefore, the product is a "new drug" under Section 201(p) of the FD&C Act. The article is subject to refusal of admission in that it appears to be a new drug without an effective new drug application (NDA). | Website claims include, "[A]nti-inflammatory, and anti-bacterial properties of aloe extracts and chamomile..." The product is not generally recognized as safe and effective for the referenced uses and therefore, the product is a "new drug" under Section 201(p) of the FD&C Act. The article is subject to refusal of admission in that it appears to be a new drug without an effective new drug application (NDA). | Website claims include, "[A]nti-inflammatory, and anti-bacterial properties of aloe extracts and chamomile..." The product is not generally recognized as safe and effective for the referenced uses and therefore, the product is a "new drug" under Section 201(p) of the FD&C Act. The article is subject to refusal of admission in that it appears to be a new drug without an effective new drug application (NDA). | Website claims include, "[A]nti-inflammatory, and anti-bacterial properties of aloe extracts and chamomile..." The product is not generally recognized as safe and effective for the referenced uses and therefore, the product is a "new drug" under Section 201(p) of the FD&C Act. The article is subject to refusal of admission in that it appears to be a new drug without an effective new drug application (NDA). _(verified: each item appears in the quote below)_

## What the source says

> Zermat Internacional Sa De Cv Date Published : 11/08/2018 Torre 3 , Calzada Melchor Ocampo 193; Colonia Veronica Anzures , Miguel Hidalgo, Ciudad de Mexico MEXICO 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) Date Published: 11/08/2018 Desc: Intimate Shampoo / Shampoo de Higiene Intima Notes: Website claims include, "[A]nti-inflammatory, and anti-bacterial properties of aloe extracts and chamomile..." The product is not generally recognized as safe and effective for the referenced uses and therefore, the product is a "new drug" under Section 201(p) of the FD&C Act. The article is subject to refusal of admission in that it appears to be a new drug without an effective new drug application (NDA). 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. Date Published: 11/08/2018 Desc: Intimate Shampoo / Shampoo de Higiene Intima Notes: Website claims include, "[A]nti-inflammatory, and anti-bacterial properties of aloe extracts and chamomile..." The product is not generally recognized as safe and effective for the referenced uses and therefore, the product is a "new drug" under Section 201(p) of the FD&C Act. The article is subject to refusal of admission in that it appears to be a new drug without an effective new drug application (NDA). 53 U - - 10 Personal Cleanliness, Cosmetic products containing animal by-products (other animal by-products) Date Published: 11/08/2018 Desc: Intimate Shampoo / Shampoo de Higiene Intima Notes: Website claims include, "[A]nti-inflammatory, and anti-bacterial properties of aloe extracts and chamomile..." The product is not generally recognized as safe and effective for the referenced uses and therefore, the product is a "new drug" under Section 201(p) of the FD&C Act. The article is subject to refusal of admission in that it appears to be a new drug without an effective new drug application (NDA). 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 11/08/2018 Desc: Intimate Shampoo / Shampoo de Higiene Intima Notes: Website claims include, "[A]nti-inflammatory, and anti-bacterial properties of aloe extracts and chamomile..." The product is not generally recognized as safe and effective for the referenced uses and therefore, the product is a "new drug" under Section 201(p) of the FD&C Act. The article is subject to refusal of admission in that it appears to be a new drug without an effective new drug application (NDA).

## 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/).