Chemical Substance - Nicotine

NHPID name:

Nicotine

Reference:

USP_31

Proper name(s):

Common name(s):

Nicotine

Category:

Approved Chemical Name

Structure:

Schedule 1:

Isolate

CAS registry number:

54-11-5

Source ingredients:

Additional details

Detail:

The presence of this ingredient without conditions on the List of Prohibited and Restricted Cosmetic Ingredients (the Cosmetic Ingredient Hotlist) indicates that there are potentially significant safety issues. This ingredient cannot be used in topical natural health products without the submission of additional evidence for safety. Reference: http://www.hc-sc.gc.ca/cps-spc/person/cosmet/info-ind-prof/_hot-list-critique/prohibited-eng.php

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 a form to be administered into the oral cavity by means of a non-active device (one that operates on energy generated by the human body or by gravity) that delivers 4 milligrams or less of nicotine per dose for buccal absorption; or (e) in the form of a lozenge containing 4 milligrams or less of nicotine per dosage unit.

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