Email from Health Canada on E-Cigs

Discussion in 'eCig Industry News & Reports' started by MasterVapes, Nov 8, 2012.

  1. MasterVapes

    MasterVapes Sysop Admin

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    Someone I know emailed Health Canada about e-cig rules in Canada asking why these products cannot be sold, advertised or imported. The resulting email is lengthy but it illustrates what Health Canada expects a vendor to do in order to receive approval for sales in Canada.

    ---snip

    Good morning,
    This email is in response to your inquiry regarding electronic smoking products. On March 27, 2009, Health Canada posted a Public Advisory and a Notice to Stakeholders about electronic smoking products which are available at the following URL addresses:
    Public Advisory: http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_53-eng.php
    Notice to Stakeholders: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/pol/notice_avis_e-cig-eng.php

    As per this advisory/notice, electronic cigarettes fall within the scope of the Food and Drugs Act and Regulations. As such, market authorization must be granted by Health Canada prior the importation and sale of these products in Canada. Currently, no electronic smoking products have been granted market authorization in Canada.
    The Therapeutic Products Directorate (TPD) of Health Canada is the Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use. Prior to being given market authorization, a manufacturer must submit substantive scientific evidence of a product’s safety, efficacy and quality as required by the Food and Drugs Act and Regulations. This is done through the filing of a drug submission to the TPD.

    Here are additional information to clarify the sale and the importation of electronic cigarettes:
    a non-refillable disposable electronic smoking product (e.g., e-cigarette) prefilled with nicotine (or any other drug or Natural Health Product [NHP]) is considered to be a drug (or NHP)/medical device combination product and requires a DIN (or NPN). In this case, its drug delivery system is to be reviewed for safety and efficacy but a medical device license is not required;

    a refillable electronic smoking product (e.g., e-cigarette) with nicotine or intended to be used with nicotine (or any other drug or NHP) is considered to be a drug (or NHP) delivery system and, therefore, a Class II medical device, and its nicotine (or drug or NHP) component requires a DIN (or NPN). (Please note that no medical device licence is to be issued until the associated drug component has received a DIN [or NPN].);

    an electronic smoking product (e.g., e-cigarette) associated with a health claim but not associated with nor intended to be used with nicotine (nor any other drug nor NHP) is considered to be a Class I medical device; and
    an electronic smoking product (e.g., e-cigarette) not associated with any health claim and not associated with nor intended to be used with nicotine (nor any other drug nor NHP) is not regulated under the Food and Drugs Act.

    General information
    For information on drug submission filing in Canada, please see the links below:

    Drugs and Health Products: Drug Products website
    http://www.hc-sc.gc.ca/dhp-mps/prodpharma/index-eng.php

    Regulatory Process in Canada
    http://www.hc-sc.gc.ca/ahc-asc/pubs/hpfb-dgpsa/access-therapeutic_acces-therapeutique-eng.php

    Drug Identification Number (DIN)
    http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/fs-fi/dinfs_fd-eng.php

    For applicants
    Health Canada classifies the nicotine component of an electronic cigarette product as a “New Drug” under the Food and Drug Regulations and its delivery system component as a “Medical Device” under the Medical Devices Regulations.

    Please see the following document called Listing of Drugs currently Regulated as New Drugs http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/newdrug-drognouv/ndrugs_ndrogue-eng.php

    New Drugs are regulated under Part C, Division 8 of the Food and Drug Regulations and require the filing of a New Drug Submission (NDS). Information on this process and requirements are provided via the links below. New Drug Submissions must be supported by data obtained from non-clinical and clinical trials, conducted in accordance with international standards, or scientific rationales, to support the quality, safety, and efficacy of the New Drug.

    Please see the URL to the Food and Drugs Act and Regulations
    http://laws.justice.gc.ca/eng/regulations/C.R.C.,_c._870/ - then choose PART C: DRUGS

    The data requirement may vary according to the inhaled product and associated health claims (e.g. smoking cessation, temporary abstinence). Pharmacokinetic data, addictive properties, long-term safety (local and systemic), bystander exposure and the possibility of overdosage are examples of important issues/ information that would need to be addressed in the NDS. The fact that non-smoker could use this product and develop addiction is another issue that would need to be addressed in the submission.

    As well, the nicotine delivery system component of the electronic smoking product is considered to be a Class II medical device. In order to sell this device in Canada, the manufacturer must first obtain an ISO 13485:2003 CMDCAS certificate from one of Health Canada’s recognized registrars. Once this certification has been obtained, the manufacturer must submit a Class II medical device licence application to the Medical Devices Bureau.

    Guidance Documents and Application Forms
    Drug Submission/ Application Fee Form
    http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/form/feef_fraisf-eng.php

    Health Canada 3011: Drug Submission Application for: Human, Veterinary, or Disinfectant Drugs and Clinical Trial Applications/Attestation
    http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/form/hc3011_sc3011-eng.php

    Clinical Trials
    http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/clini/index-eng.php

    Drug Submission
    Guidance for Industry: Management of Drug Submissions
    http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/mgmt-gest/mands_gespd-eng.php

    Submission Evaluation Fees Guide
    http://www.hc-sc.gc.ca/dhp-mps/prodpharma/fees-frais/fee_frais_guide-eng.php

    Draft Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)
    http://www.hc-sc.gc.ca/dhp-mps/prod...ide-ld/ctd/qual_ndsands_pdnpadn_07-01-eng.php

    Preparation of New Drug Submissions in the CTD Format
    http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ctd/ctdnds_ctdpdn-eng.php

    Guidance for Industry: Product Monograph
    http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/monograph/pm_mp-eng.php

    Establishment Licences and the Good Manufacturing Practices guideline (GMP) can be accessed on the Health Products and Food Branch Inspectorate website
    http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/index-eng.php
    http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/index-eng.php

    Medical Devices
    Cost Recovery for Medical Devices: Establishment Licence and Licence Fee
    http://www.hc-sc.gc.ca/dhp-mps/md-im/fees-frais/index-eng.php

    Class II licence application form
    http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/licapp_demhom_cla2-eng.php

    Contacts
    If you have any complaint related to electronic cigarettes or with regards to the importation of these products, please contact the Health Products and Food Branch Inspectorate (HPFB-I) Operational Centre in your region by calling 1-800-267-9675 or by the following website:http://www.hc-sc.gc.ca/home-accueil/contact/hpfb-dgpsa/hpfb-dgpsa-eng.php

    If you have any questions with regards to the regulatory requirements in filing, please contact the Bureau of Cardiology, Allergy and Neurological Sciences (BCANS):
    E-mail: bcans_enquiries@hc-sc.gc.ca

    Telephone: (613) 941-1499
    Fax: (613) 941-1668
    If you need additional assistance in filing a new drug submission, please contact: SIPDMAIL@hc-sc.gc.ca.
    For further information on medical devices licensing, please contact the Medical Devices Bureau by telephone at 613-957-7285 or by email at mdb_enquiries@hc-sc.gc.ca.

    With regards,
    Submission and Information Policy Division/ Division des politiques sur les présentations et renseignements
    Therapeutic Products Directorate/Direction des produits thérapeutiques
    Health Products and Food Branch/ Direction générale des produits de santé et des aliments
     
    Last edited: Jul 6, 2015
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  2. ChrisUp2Late

    ChrisUp2Late New Member Member

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    Here's the key line: "an electronic smoking product (e.g., e-cigarette) not associated with any health claim and not associated with nor intended to be used with nicotine (nor any other drug nor NHP) is not regulated under the Food and Drugs Act". Vague but useful...
     
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  3. Derrick.S

    Derrick.S New Member Member

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    It is difficult for me to believe that 'studies' haven't been done on nicotine and it's effects in all the years that cigarettes have been around. So is the "new drug" classification serving some other purpose do you think?
     
  4. Rare Air eCigs

    Rare Air eCigs Vendor Vendor

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    I agree with your sentiment, Derrick.. But it's not that studies haven't been done on the subject. They have. What's missing is studies on the "long term" effects of ingesting nicotine in this manner. And of course, the only way to look at something long terms.. is to look at at long term. That takes more than just a few years.
     
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    marian ne96 New Member Member

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    rick_greenlight New Member Member

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