2187954 ALBERTA INC · 66-41 · CANADA
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
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- CANADA verified
- Address
- 1135 Pacific Ave , Kelowna, British Columbia CANADA verified
- Date published
- 11/08/2023 verified
- Product code
- 53 D - - 02 Perfumes (Fragrance Preparations) | 60 B - - 01 Ammonium Chloride (Acidifier) | 66 B - - 30 Ammonia Spirit, Arommatic (Stimulant) each item verified
- Product
- Smelling Salts | Smelling Salts | Smelling Salts each item verified
- 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. each item verified
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.
— accessdata.fda.gov, retrieved 2026-09-15
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.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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