Notice: Implications of the Tobacco and Vaping Products Act for Health Products Regulated Under the Food and Drugs Act
Introduction of the Tobacco and Vaping Products Act
On May 23, 2018, Bill S-5 (An Act to amend the Tobacco Act and the Non-Smokers’ Health Act and to make consequential amendments to other Act) received Royal Assent. As a result, the Tobacco Act has been replaced with the Tobacco and Vaping Products Act (TVPA), which is intended to support the Government of Canada’s tobacco control objectives and prevent the use of vaping products from leading to tobacco product use by young persons and non-users of tobacco. The TVPA creates a legal framework to regulate vaping products by prohibiting their sale to persons under 18 years of age, restricting how they are advertised and limiting what ingredients they can include.
Application of the TVPA to Health Products
The TVPA defines a “vaping product” as any device, substance or mixture of substances that “produces emissions in the form of an aerosol that is intended to be brought to the mouth for inhalation” (regardless of whether or not it contains nicotine). This definition is deliberately broad so as to capture a range of vaping product designs and technologies that exist today, or that could exist in the future. Some of the products captured by this definition are health products authorized under Food and Drugs Act (FDA) and do not cause any of the tobacco or vaping-related harms targeted by the TVPA. These products, such as asthma inhalers, aromatherapy products and nebulizers (i.e. devices used to deliver a drug to the lungs in the form of a mist), are used by Canadians to treat a variety of health conditions and their symptoms.
To ensure that Canadians maintain their current access to these authorized health products, Health Canada published new regulations under the TVPA in the Canada Gazette, Part II on July 11, 2018. These regulations exclude certain categories of health products authorized under the FDA from the application of the TVPA in cases where they do not cause tobacco or vaping-related harms and/or already have sufficient oversight under the provisions and regulations of the FDA. Under these new regulations, the following three categories of health products are fully excluded from the application of the TVPA, provided they have been authorized under the FDA:
- Prescription Drugs
The regulations exclude human prescription drugs authorized for sale under the Food and Drug Regulations (FDR) from the application of the TVPA in full.
- Certain Natural Health Products (NHP) and Non-Prescription Drugs
The regulations exclude the following products from the application of the TVPA in full:
- a non-prescription drug authorized under the FDR, or an NHP authorized under the Natural Health Product Regulations (NHPR), that does not contain nicotine and is authorized to be sold for the treatment of a respiratory illness or its symptoms (e.g., liquids for nebulizers) and
- a non-prescription drug authorized under the FDR, or an NHP authorized under the NHPR, that does not contain nicotine and is administered by a facial steamer or mask (e.g., aromatherapy)
- Certain Medical Devices
The regulations exclude all vaping products that are licensed medical devices from the application of the TVPA in full, except in the following cases:
- When the medical device is licenced to be used with a drug or NHP that has been authorized under the FDR or NHPR, respectively, the device would be subject to the TVPA in the same way as the drug or NHP it is licensed to deliver (e.g., a Class II vaporizer that is refillable and delivers a licensed NHP)
- When the medical device has an appearance, packaging or labelling for which there are reasonable grounds to believe that they are appealing to a young person
The regulations also partially exclude the following additional natural health products and non-prescription drugs from the application of the TVPA:
- a non-prescription drug authorized under the FDR or an NHP authorized under the NHPR that meets the following criteria:
- is not delivered by an active device (section 1 of the Medical Device Regulations (MDR))
- does not depend on a source of energy (other than energy generated by the human body or gravity) for its administration into the body and
- does not have an appearance, packaging or labelling that is appealing to a young person
Products in the above category would still be subject to prohibitions relating to cross-branding practices that involve the use of tobacco product-related brand elements on vaping products, their packaging, or in their promotion. The effect of this is that tobacco companies would not be allowed to promote their brand through marketing of an FDA-authorized product.
Any remaining vaping health products with health claims that do not fall within one of the excluded categories above remain subject to the TVPA, but are exempted from a few of its provisions so that their sponsors may:
- Distribute product samples to licensed health practitioners as per existing FDA rules
- Manufacture and sell vaping products using ingredients that are otherwise prohibited under Schedule 2 of the TVPA (subject to authorization by Health Canada prior to being commercially imported, advertised or sold) and
- Use their corporate name in sponsorship activities, provided they do not sell or advertise any other vaping products that are not associated with an FDA-authorized health claim
More information on these regulations, including their full text, is available in the July 11, 2018 Canada Gazette, Part II.
Application of the Food and Drugs Act to Vaping Products
The FDA and its regulations continue to apply to any vaping product that makes a health claim, including those that contain nicotine or any other drugs as defined by the FDA. These products must receive an authorization from Health Canada before they can be commercially imported, advertised or sold in Canada. Before Health Canada issues a market authorization, it conducts a careful review of evidence provided by the product sponsor to confirm that the product meets the requirements for safety, efficacy and quality established by the FDA and its regulations. In addition, product sponsors must obtain a valid establishment or site license from Health Canada before commercially importing, manufacturing, packaging or labelling a vaping health product in Canada.
Vaping products that do not make health claims are not subject to the FDA and do not require a market authorization from Health Canada. However, these products cannot contain any drugs other than nicotine and must be sold in accordance with the provisions and regulations of the TVPA and the Canada Consumer Product Safety Act (CCPSA).
For information about the TVPA, consult www.canada.ca/vaping or contact Health Canada’s Tobacco Control Directorate at email@example.com
For more information regarding the review process and regulation of prescription health products under the Food and Drug Regulations, contact the Therapeutic Products Directorate at firstname.lastname@example.org
For more information regarding the authorization non-prescription drugs as per the FDR as well as product and site licences for natural health products as per the Natural Health Product Regulations, contact the Natural and Non-Prescription Health Products Directorate at email@example.com
You can report a vaping product that you believe is unsafe or not in compliance with the provisions and regulations of the TVPA, CCPSA or the FDA through the Cosmetic or Consumer Product Incident Report - Form for Consumer
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