2187954 ALBERTA INC · 66-41 · CANADA (1135 Pacific Ave , Kelowna, British Columbia CANADA)
For 2187954 ALBERTA INC (1135 Pacific Ave , Kelowna, British Columbia CANADA), import alert is 66-41; country is CANADA; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; 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 listed twice: 1135 Pacific Ave , Kelowna, British Columbia CANADA and 1606 Findlay Rd , Kelowna, British Columbia CANADA, verified against its source on 2026-10-01.
- 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
- 1606 Findlay Rd , Kelowna, British Columbia CANADA also listed
- 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
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
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.
— all from 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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