# 2187954 ALBERTA INC · 66-41 · CANADA — FDA import alert red lists: firms subject to detention without physical examination

For 2187954 ALBERTA INC · 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 Smelling Salts | Smelling Salts | Smelling Salts; product code is 53 D - - 02 Perfumes (Fragrance Preparations) | 60 B - - 01 Ammonium Chloride (Acidifier) | 66 B - - 30 Ammonia Spirit, Arommatic (Stimulant); date published is 11/08/2023; address is 1135 Pacific Ave , Kelowna, British Columbia CANADA, verified against its source on 2026-09-16.

- **Firm:** 2187954 ALBERTA INC _(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:** 1135 Pacific Ave , Kelowna, British Columbia CANADA _(verified: appears in the quote below)_
- **Date published:** 11/08/2023 _(verified: appears in the quote below)_
- **Product code:** 53 D - - 02 Perfumes (Fragrance Preparations) | 60 B - - 01 Ammonium Chloride (Acidifier) | 66 B - - 30 Ammonia Spirit, Arommatic (Stimulant) _(verified: each item appears in the quote below)_
- **Product:** Smelling Salts | Smelling Salts | Smelling Salts _(verified: each item appears in the quote below)_
- **FDA notes:** Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. | Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. | Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. _(verified: each item appears in the quote below)_

## What the source says

> 2187954 ALBERTA INC Date Published : 11/08/2023 1135 Pacific Ave , Kelowna, British Columbia CANADA 53 D - - 02 Perfumes (Fragrance Preparations) Date Published: 11/08/2023 Desc: Smelling Salts Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. 60 B - - 01 Ammonium Chloride (Acidifier) Date Published: 11/08/2023 Desc: Smelling Salts Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. 66 B - - 30 Ammonia Spirit, Arommatic (Stimulant) Date Published: 11/08/2023 Desc: Smelling Salts Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

## The same source also states

> 2187954 ALBERTA INC Date Published : 11/08/2023 1606 Findlay Rd , Kelowna, British Columbia CANADA 53 D - - 02 Perfumes (Fragrance Preparations) Date Published: 11/08/2023 Desc: Smelling Salts Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. 60 B - - 01 Ammonium Chloride (Acidifier) Date Published: 11/08/2023 Desc: Smelling Salts Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. 66 B - - 30 Ammonia Spirit, Arommatic (Stimulant) Date Published: 11/08/2023 Desc: Smelling Salts Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

Source: https://www.accessdata.fda.gov/cms_ia/importalert_190.html

## 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/).