2187954 ALBERTA INC. · 66-41 · CANADA (12a St N Suite 162-210a , Lethbridge, Alberta CANADA)
For 2187954 ALBERTA INC. (12a St N Suite 162-210a , Lethbridge, Alberta 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 12a St N Suite 162-210a , Lethbridge, Alberta 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
- 12a St N Suite 162-210a , Lethbridge, Alberta 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 12a St N Suite 162-210a , Lethbridge, Alberta 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
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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.