Nicotine in Nicotine malate

References:
ECHA


Chemical Substance - Nicotine

NHPID name:
Nicotine

Reference:
MIO

Proper name(s):
3-[(2S)-1-Methyl-2-pyrrolidinyl]pyridine

Common name(s):
Nicotine

Category:
Approved Chemical Name
Structure:
Image of molecular structure representing Nicotine


Schedule 1:
Isolate

CAS registry number:
54-11-5


Source ingredients:


Additional details:

Detail:
The presence of this ingredient as prohibited on the List of Prohibited and Restricted Cosmetic Ingredients (the Cosmetic Ingredient Hotlist) indicates that there are potential safety issues. This ingredient cannot be used in natural health products without the submission of additional evidence for safety.


Roles

Medicinal

Rationale:

Classified as an NHP under Schedule 1, item 2 (an isolate) of the Natural Health Products Regulations when the following conditions are met: a. in natural substances; b. in the form of a chewing gum containing 4 milligrams or less of nicotine per dosage unit; c. in the form of a transdermal patch with a delivery rate of 22 milligrams or less of nicotine per day; d. in the form of a spray or inhaler (namely, non-active devices operating on energy generated by the human body or gravity) that delivers 4 milligrams or less of nicotine per dosage unit into the oral cavity for buccal absorption; e. in the form of a lozenge containing 4 milligrams or less of nicotine per dosage unit; f. in the form of a buccal pouch containing 4 milligrams or less of nicotine per dosage unit; or g. in the form of an orally disintegrating or sublingual tablet containing 4 milligrams or less of nicotine per dosage unit for buccal absorption.

Reference:  NNHPD

Non-NHP

Rationale:

Other than the exceptions listed above, it is classified a non-NHP because it is on the Prescription Drug List as follows: Nicotine or its salts, for human use.

Reference:  NNHPD
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