Repeal - Schedule F of the Food and Drug Act

[JayTheVapingGuy]

OK...


Many of you know that Canadians Advocating Vapers Rights (CAVR) is currently writing a letter to CCS and in it we quote Schedule F of the Food and Drug Act... Just before we send out our letter, Matt asked if we could double check the Schedule to ensure that everything was in order... So... background information First... What is or was Schedule F? Essentially, its a listing of drugs that are controlled by the Food and Drug Act (and thereby Health Canada) and what limitations on those restriction there are. Under Schedule F, the following information regarding nicotine is stated:


http://laws-lois.justice.gc.ca/eng/r.../FullText.html

Nicotine and its salts, for human use, except


(a) in natural substances;


(b) in the form of a chewing gum containing 4 mg or less of nicotine per dosage unit;


(c) in the form of a transdermal patch with a delivery rate of 22 mg or less of nicotine per day;


(d) in a form to be administered orally by means of an inhalation device delivering 4 mg or less of nicotine per dosage unit; or


(e) in the form of a lozenge containing 4 mg or less of nicotine per dosage unit

What this means is that Nicotine falls under the regulations of the Food and Drug Act unless it was in the forms listed above... and as per subpara (d) ecigs are good to go because there isn't a vendor in canada that sells nicotine fluid for direct consumption that comes anywhere near 4mg.


This is what we have always been lead to believe and was the foundation of our argument that vaping nicotine fluid is perfectly legal in Canada... But as i was researching, to ensure that there were no questions or loopholes that they could jump through and use against us, specifically trying to find out exactly how Schedule F was dealt with in the Food and Drug Act, i Ctrl-F searched for "Schedule F" in the Full Text Version of the Food and Drug Act and at the very bottom of the page... i found this which threw me into a panic for a brief moment:


Food and Drug Regulations

— SOR/2013-122, s. 18


18. Schedule F to the Regulations is repealed.

...??? when did this happen... so we all start to panic and as the CAVR BoD start to panic to find out what is going on we discover that


A) this is really happening:


ARCHIVED — Canada Gazette – Regulations Amending Certain Regulations Concerning Prescription Drugs (Repeal of Schedule F to the Food and Drug Regulations)


which states:

Schedule F to the Food and Drug Regulations lists medicinal ingredients that are required to be sold pursuant to a prescription when sold as a drug in Canada. Currently, adding or removing medicinal ingredients to Schedule F requires approval from the Governor in Council following a well-established scientific review process.


Amendments to the Food and Drug Regulations are required to bring into force recent updates to the Food and Drugs Act that were introduced as part of Bill C-38 (Jobs, Growth and Long-term Prosperity Act) that received Royal Assent on June 29, 2012. More specifically, the Jobs, Growth and Long-term Prosperity Act gives the Minister of Health the power to establish a list that sets out prescription drugs or classes of prescription drugs and to provide that the list may be incorporated by reference. This process would continue to respect the scientific review process, but eliminate the need for the approval of the Governor in Council to amend the list of prescription drugs.

and

The proposed Regulations would repeal Schedule F and incorporate the Prescription Drug List (PDL) that is to be established by the Minister in accordance with the enabling amendments to the Food and Drugs Act.

now... currently the 'idea' is to replace the items listed in Schedule F on a one for one basis... which means that what we currently see in Schedule F is what will be in the new Prescription Drug List...


and to that end the current DRAFT Prescription Drug List shows that fact:


Draft Prescription List - 2012 Health Canada Consultation Document

Nicotine or its salts
for human use, except: (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 orally by means of an inhalation device delivering 4 milligrams or less of nicotine per dosage unit; (e) in the form of a lozenge containing 4 milligrams or less of nicotine per dosage unit

B) this IS the Law


as passed by Parliament, but has not been enacted as of yet... at least everything we can see and find talks about "proposed" as nothing gives an effective date of change. Even the first line above of "18. Schedule F to the Regulations is repealed" is currently sitting in the "AMENDMENTS NOT IN FORCE" section of the Food and Drug Act.


so right now, no change, but it will be changing....


C)HOW DOES THIS AFFECT YOU!??


Basically, once this listing becomes official and the Food and Drug Act is amended to remove Schedule F, it will be easier for the Minister of Health to make changes without having to gain approval from the Governor in Council following a well-established scientific review process.


currently it suggests that it is ONLY removing the Governor in Council from the process:


ARCHIVED — Canada Gazette – Regulations Amending Certain Regulations Concerning Prescription Drugs (Repeal of Schedule F to the Food and Drug Regulations)

The objective of the amendments is to bring greater efficiency to the process of adding or removing drugs from a schedule maintained in regulations without compromising the well-established scientific review and consultation process.

The proposal to condense the existing Schedule F criteria under three overarching scientific criteria was generally well supported with the understanding that adding or removing the prescription status of a drug will continue to be done on the existing scientific basis.

Wait... Understanding? isn't it clearly written in??? nope... it does not create a legal requirement for following the "well-established scientific review and consultation process"


so basically, the Government has given the Minister of Health a way to backdoor a change to the Prescription Drug List, without having to be overseen by the Governor In Council...


WHAT CAN YOU DO??


Well... there is one thing that we can do... be vigilant...under the new change new provisions would be introduced to Part C, Division 1, of the Food and Drug Regulations that says the Minister of Health must:


ARCHIVED — Canada Gazette – Regulations Amending Certain Regulations Concerning Prescription Drugs (Repeal of Schedule F to the Food and Drug Regulations)

Allow for public consultation. The Minister would be required to consult the public on any proposal to remove a drug from the PDL for a period of time sufficient to allow comments from external stakeholders that would also meet international obligations under the World Trade Organization’s Agreement on Technical Barriers to Trade (TBT).

so we will need to keep our eyes open and if/when the Minister attempts to change Schedule F on us... we can take our cause public and decry the change and hopefully protect our rights as Vapers...




so right now, we're still good... in the immediate future, we're still good... but give it time... and we could find ourselves fighting to keep the laws the same.


Cheers Guys,






Jason H. Hubbard (aka JayTheVapingGuy)
Deputy Director - Canadians Advocating Vapers Rights - https://www.facebook.com/groups/canadiansadvocatingvapersrights/
Co-Presenter - VapeCan 2013 Vapecan 2013 - Home
Youtube Channel: Jay the Vaping Guy Reviews - YouTube
Email: Jason@Vapecan.ca hubbard_jason@hotmail.com

 

[DitShick]

Interesting. Thanks for the post.