Regulations Amending the Food and Drug Regulations and the Natural Health Products Regulations (Vaping Products): SOR/2018-132
Canada Gazette, Part II, Volume 152, Number 14
June 22, 2018
FOOD AND DRUGS ACT
P.C. 2018-848 June 21, 2018
Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 30footnote a of the Food and Drugs Actfootnote b, makes the annexed Regulations Amending the Food and Drug Regulations and the Natural Health Products Regulations (Vaping Products).
Regulations Amending the Food and Drug Regulations and the Natural Health Products Regulations (Vaping Products)
Food and Drug Regulations
1 (1) Subsection C.01.029(1) of the Food and Drug Regulationsfootnote 1 is amended by striking out “or” at the end of paragraph (a) and by adding the following after that paragraph:
- (a.1) that contains nicotine or any of its salts and is a vaping product as defined in section 2 of the Tobacco and Vaping Products Act but that is not referred to in paragraph 2(b) or (c) or section 3 of the Regulations Excluding Certain Vaping Products Regulated Under the Food and Drugs Act from the Application of the Tobacco and Vaping Products Act, or
(2) The portion of subsection C.01.029(2) of the Regulations before paragraph (a) is replaced by the following:
(2) Subject to subsections C.01.031.2(1) and (2), the inner label and outer label of a drug that is in a package shall carry a cautionary statement, to the effect that there is enough drug in the package to seriously harm a child, if the package contains
(3) Subsection C.01.029(2) of the Regulations is amended by striking out “or” at the end of paragraph (d), by adding “or” at the end of paragraph (e) and by adding the following after paragraph (e):
- (f) in the case where the drug is a vaping product as defined in section 2 of the Tobacco and Vaping Products Act but is not referred to in paragraph 2(b) or (c) or section 3 of the Regulations Excluding Certain Vaping Products Regulated Under the Food and Drugs Act from the Application of the Tobacco and Vaping Products Act, 0.1 mg/ml or more of nicotine or the equivalent quantity of any of its salts.
(4) The portion of subsection C.01.029(2) of the English version of the Regulations after paragraph (f) is repealed.
2 (1) Paragraph C.01.031(1)(a) of the Regulations is amended by striking out “or” at the end of subparagraph (i) and by replacing subparagraph (ii) with the following:
- (ii) where the drug is not recommended solely for children, other than a drug referred to in subparagraph (iii), at least one of the sizes of packages available for sale is packaged in a child resistant package, and
- (iii) where the drug is a vaping product referred to in paragraph C.01.029(1)(a.1), it is packaged in a child resistant package; and
(2) Section C.01.031 of the Regulations is amended by adding the following after subsection (1):
(2) Subsection C.01.031.2(2) and paragraph C.01.031.2(3)(a) do not apply to a drug referred to in paragraph C.01.029(1)(a.1).
Natural Health Products Regulations
3 Item 3 of Schedule 2 to the Natural Health Products Regulationsfootnote 2 is repealed.
Coming into Force
4 (1) These Regulations, except sections 1 and 2, come into force on the day on which the Regulations Excluding Certain Vaping Products Regulated Under the Food and Drugs Act from the Application of the Tobacco and Vaping Products Act come into force.
(2) Sections 1 and 2 come into force on the day that, in the sixth month after the month in which section 3 comes into force, has the same calendar number as the day on which section 3 comes into force or, if that sixth month has no day with that number, the last day of that sixth month.
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the regulations.)
Bill S-5, An Act to amend the Tobacco Act and the Non-smokers Health Act and to make consequential amendments to other Acts, received royal assent on May 23, 2018, bringing parts of the Tobacco and Vaping Products Act (TVPA) into force. The purpose of the TVPA in respect of vaping products is to support the legislation’s overall tobacco control objectives and to prevent the use of vaping products from leading to tobacco product use by young persons and non-users of tobacco. In particular, the TVPA seeks to protect young persons and non-users of tobacco products from inducements to use vaping products; to limit exposure to and dependence on nicotine as a result of their use; to restrict access to them by young persons; to prevent the public from being deceived or misled with respect to the health hazards of using vaping products; and to enhance public awareness of those hazards.
The definition of “vaping product” in the TVPA establishes which products are subject to that Act. The definition is intended to capture a range of devices, as well as substances, regardless of their form (e.g. liquid, powder, gel).
As a result of this definition, there are over 450 individual health products currently authorized under the Food and Drugs Act (FDA) that are subject to the TVPA. These products are not considered by Health Canada (the Department) to be associated with any of the harms intended to be addressed by the TVPA and should therefore be excluded from the application of the TVPA. These health products would otherwise be prohibited from being furnished to youth (with the exception of prescription drugs and certain controlled substances), and subject to additional restrictions on promotion. These added restrictions could lead to barriers to access and disincentives for manufacturers to bring health products to the market.
The Bill makes consequential amendments to the Canada Consumer Product Safety Act (CCPSA) which extend the scope of the Act to include vaping products that contain nicotine and are marketed without health claims authorized under the FDA. The CCPSA and its regulations set out child-resistant packaging and associated labelling requirements for all containers of vaping substances with nicotine, except for vaping products that are subject to the FDA. The same safeguards, therefore, are not in place for vaping health products with nicotine regulated under both the FDA and the TVPA.
Application of the Tobacco and Vaping Products Act to products regulated under the Food and Drugs Act
The TVPA regulates vaping products (with and without nicotine) as a separate set of products from tobacco products.
Under the TVPA, a “vaping product” is defined as
- (a) a device that produces emissions in the form of an aerosol and is intended to be brought to the mouth for inhalation of the aerosol;
- (b) a device that is designated to be a vaping product by the regulations;
- (c) a part that may be used with those devices; and
- (d) a substance or mixture of substances, whether or not it contains nicotine, that is intended for use with those devices to produce emissions.
The TVPA restricts youth access by prohibiting the furnishing of vaping products to persons under the age of 18. It also prohibits the manufacture, promotion and sale of vaping products containing ingredients set out in Schedule 2 of the Act, such as those that may give the impression that they have positive health effects or are associated with a health benefit (e.g. vitamins) or energy (e.g. caffeine). This would limit their potential to make them attractive to youth and adult non-users of tobacco. Under the TVPA, prescription vaping products are exempt from these prohibitions.
The TVPA also restricts the promotion of vaping products to protect young persons and non-users of tobacco products from inducements to vaping product use. These include, but are not limited to, the following: advertising appealing to young persons, lifestyle advertising and sponsorship promotion.
Health products currently authorized for sale under the FDA and its regulations that meet the TVPA definition of a vaping product include the following: prescription drugs indicated for asthma and other respiratory disorders, natural health products (NHPs) for aromatherapy, respiratory therapy and smoking cessation, and medical devices such as nebulizers (i.e. a device used to deliver a drug in the form of a mist to the lungs). These products are subject to the FDA and the TVPA and their regulations (the FDA aims to ensure the safety, efficacy, and quality of all health products in Canada; the TVPA aims to address the public health problems associated with tobacco use and to protect Canadians from health hazards associated with smoking and/or vaping). Vaping products authorized for veterinary use do not contribute to the public health concerns intended to be addressed by the TVPA and are therefore not included in the scope of its application.
To ensure harmony between these two regimes, as well as to ensure that the TVPA is applied to products that are associated with harms consistent with its objectives, the TVPA allows for regulations to exclude FDA-regulated products from the application of any or all of its provisions.
Child resistant packaging for vaping products containing nicotine
Vaping products that do not make health claims authorized under the FDA are subject to the CCPSA and its applicable regulations, including the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001). The CCCR, 2001 impose safety requirements for consumer chemicals, including certain vaping products, to help prevent exposure to hazardous household chemicals, including child-resistant containers (CRC) and toxicity labelling requirements for toxic chemicals. Immediately upon royal assent of the TVPA, stand-alone containersfootnote 3 of vaping substances with nicotine that are not subject to the FDA will be subject to all applicable requirements under the CCPSA and the CCCR, 2001, including CRC and toxicity labelling provisions. The same safeguards are not in place for vaping health products with nicotine regulated under both the FDA and the TVPA.
The CCCR, 2001 set out a classification-based approach to establishing rules for consumer chemicals, including a prohibition against the sale of very toxic substances and requirements for labelling and child-resistant containers for toxic substances. Stand-alone containers of vaping liquids that contain nicotine at concentrations between 10 mg/mL and 66 mg/mL must adhere to all requirements of the CCCR, 2001 for “toxic” products, including the requirement for a child-resistant container. Vaping liquids containing nicotine at concentrations equal to or more than 66 mg/mL meet the classification of “very toxic” under the CCCR, 2001 and are prohibited from being manufactured, imported, advertised, or sold as consumer products.
Under the Food and Drug Regulations (FDR), child-resistant packaging is only required for specific substances. These substances are limited to the following: specified concentrations of salicylic acid, acetylsalicylic acid, acetaminophen, elemental iron, and fluoride ion.
The objective of the Regulations Excluding Certain Vaping Products Regulated Under the Food and Drugs Act from the Application of the Tobacco and Vaping Products Act (the Regulations) is to ensure that the application of the TVPA and the FDA and their regulations on vaping products regulated under the FDA is representative of their associated harms while achieving the purposes of the TVPA.
The Regulations exclude human prescription drugs authorized for sale under the FDR from the application of the TVPA in full.
Natural health products and non-prescription drugs
The Regulations exclude the following categories of vaping products from the full application of the TVPA:
(1) 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
(2) 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).
With the exception of section 30.71 of the TVPA, the Regulations also exclude the following third category of vaping products from the application of the TVPA:
(3) 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 this category would still be subject to section 30.71 of the TVPA to continue to prohibit 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.
All other NHPs and non-prescription drugs
A vaping product that is a non-prescription drug or an NHP that does not fall within the three categories noted above is still subject to the application of the TVPA, with the exception of the following TVPA provisions:
- Sections 7.21, 7.22, and 30.47: prohibitions on the manufacture and sale of vaping products containing ingredients listed in Schedule 2 of the TVPA (e.g. vitamins, mineral nutrients, amino acids and caffeine) and promotion related to those ingredients; and
- Paragraph 30.5(a): restrictions on manufacturers regarding the giving or offering of vaping products.
An NHP or non-prescription drug that is a vaping product that does not fall within the three categories is still subject to the TVPA restrictions on sponsorship promotion and on the naming of certain facilities (sections 30.3 and 30.4). Promotion that associates a vaping product brand element or the name or a vaping product manufacturer with an event, activity, or facility is prohibited under the TVPA.
However, the Regulations include a partial exclusion from these provisions to allow a manufacturer of an FDA authorized health product to continue to use their corporate name in these sponsorship activities, so long as they do not sell or advertise any other vaping product that is not associated with an FDA-authorized health claim.
The Regulations exclude all vaping products that are licensed medical devices from the application of the TVPA, except in the following cases:
- When the medical device is licensed to be used with a drug or an 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 it is appealing to a young person.
Other authorized drugs, NHPs and medical devices
The Regulations also exclude all vaping products that are drugs, NHPs, or medical devices from the full application of the TVPA whose sale has been authorized in the following circumstances:
- A drug, an NHP or a medical device authorized for clinical testing in humans;
- A drug authorized for clinical testing in animals;
- A drug that is the subject of a letter of authorization issued under subsection C.08.010(1) of the FDR (Special Access Program);
- A drug authorized for sale under Division 7 (General Council Decisions) or Division 10 (Urgent Public Health Need) of the FDR; and
- Cannabis and marihuana that are exempt from the application of the FDR by way of the Cannabis Exemption (Food and Drugs Act) Regulations.
Consequential amendments to the Natural Health Products Regulations
The Regulations make consequential amendments to Schedule 2 of the NHPR. The Regulations repeal the following text: “a substance regulated under the Tobacco and Vaping Products Act.” Bill S-5 amended the FDA to exclude tobacco products from its application, therefore a listing in Schedule 2 to exclude such products from the NHPR is not required. The repeal also maintains a path to market vaping products as NHPs, including currently licensed and future nicotine replacement therapies.
Child-resistant packaging for vaping products containing nicotine
The Regulations extend existing requirements for child-resistant packaging under the FDR to any drug or NHP that contains nicotine and to which the TVPA applies. The Regulations also require warning statements on the labels that the drug should be kept out of the reach of children and that there is enough nicotine in the package to seriously harm a child. These requirements do not extend to prescription drugs, NHPs or non-prescription drugs, or medical devices that are excluded from the TVPA under the Regulations.
Coming into force
The Regulations come into force upon registration, with the exception of the new child-resistant packaging and labelling requirements for nicotine-containing vaping products. Those requirements will come into force six months after registration.
The “One-for-One” Rule does not apply to this proposal, as there is no change in administrative costs to business.
Small business lens
The small business lens does not apply to this proposal as there are no costs to small business.
A public consultation was held between August and October 2017 on the Health Canada website (https://www.canada.ca/en/health-canada/programs/consultation-regulation-vaping-products/proposals-regulate-vaping-products.html). The consultation solicited comments from consumers, health care professionals, public health organizations and the vaping industry on regulatory proposals for packaging and labelling, reporting, relative risk statements and advertising restrictions that would apply to vaping products, including those authorized under the FDA.
Representatives from the consumer health product industry provided comments during the consultation period. In general, industry supported the application of the TVPA and its regulations for vaping products without health claims authorized under the FDA. There was strong support among industry representatives for excluding FDA-authorized health products from the TVPA on the grounds that an appropriate level of oversight was already provided under the FDA and its regulations for these products.
Specific concerns were also reported respecting the new TVPA prohibitions on advertising and promotion. Representatives from the consumer health product industry were concerned that restricting advertising with respect to the availability of authorized treatment options for smoking cessation would not support the Government’s mandate to improve the health of Canadians. The position of industry was that vaping products regulated by the FDA should be subject to the same level of regulatory oversight as other products regulated by the FDA.
Prescription drugs authorized under the FDA are excluded from the application of the TVPA. The TVPA is intended to protect young persons and non-users of tobacco products from nicotine exposure and addiction, as well as from inducements to vaping product use. Furthermore, since the FDR requires a prescription by a practitioner before a prescription drug can be dispensed, any risks associated with prescription vaping products are managed through the oversight from a practitioner. The FDA and FDR include measures in respect of safety, effectiveness, quality, post-market surveillance, advertising and promotion, to manage the risks associated with prescription vaping products.
Natural health products and non-prescription drugs
The following two categories of vaping products are excluded from the full application of the TVPA:
1. A non-prescription drug or an NHP that does not contain nicotine and is authorized to be sold for the treatment of a respiratory illness or its symptoms
This category captures all drugs indicated for the treatment of a respiratory condition or respiratory symptoms. Drugs such as liquids for nebulizers for individuals with respiratory problems (i.e. lung disease) would fall within this category. These drugs fall outside of the scope of the purposes of the TVPA as they do not contain nicotine and are not associated with a risk of inducement to vaping or tobacco product use. Imposing the TVPA restrictions on youth access to these products would be inappropriate and could be detrimental to the health of young Canadians who need these medicines.
2. A non-prescription drug or an NHP that does not contain nicotine and is administered through facial steamers or masks
Certain products, such as aromatherapy products, are licensed as NHPs or non-prescription drugs and are administered through a facial steamer or mask. Facial steamers and masks are very different from vaping devices on the market today as they are brought to the face, as opposed to being brought to the mouth. Their use does not resemble the act of smoking or vaping. These products therefore fall outside of the scope of the purposes of the TVPA, as they do not contain nicotine and are not associated with the risk of inducement to vaping or tobacco product use.
With the exception of section 30.71 of the TVPA, the Regulations also exclude the following third category of NHPs and non-prescription drugs from the application of the TVPA:
3. A non-prescription drug or an NHP that is administered by a medical device that is not an active device, does not depend on a source of energy (other than energy generated by the human body or gravity) and does not have an appearance, packaging or labelling that is appealing to a young person (i.e. nicotine inhaler)
Even though nicotine is listed on the Prescription Drug List (PDL), qualifiers for its listing make exceptions for products that contain lower doses of nicotine. Specifically, products that deliver 4 mg of nicotine or less per dosage unit, and are administered orally by means of an inhalation device, do not require a prescription before they can be sold. There are two nicotine inhalers currently on the market that fall within this exception and are licenced as NHPs, available without a prescription.
Although products in this category may contain nicotine, they would not consist of an active device or rely on external energy sources to administer the drugs, like heat or pressure, and would therefore only rely on the user’s suction or inhalation to deliver a drug. As a result, these devices are considered lower risk because the absence of external energy sources like heat or pressure in their administration disassociates these products from vaping products on the market today. The risk profiles of these passive or inactive inhalers are similar to those of other non-prescription nicotine replacement therapies (NRTs). Like other non-prescription NRTs, products in this category are not associated with an increased risk of nicotine addiction because unlike vaping products, these products do not use energy sources like heat or pressure to facilitate the substance to be inhaled directly into the lungs, thus contributing to its addiction potential.
Non-prescription drugs or NHPs that meet the exclusion criteria of this category, however, are still prohibited from being furnished if tobacco product-related brand elements, like brand names or logos are used in their promotion material or on their packaging (section 30.71 of the TVPA). Maintaining the prohibition of cross-branding between tobacco products and vaping products maintains the integrity of the TVPA and protects young persons and non-users of tobacco products from inducements to use vaping or tobacco products.
All other NHPs and non-prescription drugs
NHPs and non-prescription drugs that meet the TVPA definition of a vaping product and fall outside the three categories listed above are subject to the full application of the TVPA (including restrictions on furnishing to a young person, as well as promotion restrictions) with the exception of the following:
- Prohibited ingredients: Sections 7.21 and 7.22 of the TVPA prohibit the manufacture and sale of a vaping product if it contains an ingredient listed in Schedule 2 of the TVPA (e.g. vitamins, minerals, and caffeine). Further, section 30.47 of the TVPA prohibits promoting a vaping product, including through packaging or using indications or illustrations that suggest that the product contains any of these ingredients, or selling a product that has such promotion. By not applying these prohibitions to health products, an NHP or non-prescription drug manufacturer can continue to use the existing regulatory pathway to submit evidence under the FDA in support of a health claim for a vaping product with these ingredients.
- Promotion: A partial exclusion to sections 30.3 and 30.4 of the TVPA (sponsorship promotion, use of promotional material and name of facility restrictions) ensures that a manufacturer of an FDA authorized NHP or non-prescription drug will be able to continue engaging in sponsorship activities not related to vaping (for example, by advertising their corporate name in sponsorship promotion). Manufacturers of health products, including those manufacturing prescription drugs, non-prescription drugs and NHPs, are currently able to carry out such sponsorship promotion. A partial exclusion ensures that FDA-regulated vaping products are on a level playing field with other FDA-approved products when it comes to this form of promotion.
- Sampling/Giving: Paragraph 30.5(a) of the TVPA prohibits manufacturers and retailers from giving or offering to give a vaping product (e.g. free gifts and samples). The FDA allows for limited distribution of samples of authorized health products to health care practitioners. Not applying this paragraph to health products maintains the existing sampling abilities under the FDA, should a vaping product be authorized in the future under the FDA as an effective therapeutic option for indications such as to quit smoking.
The three non-application categories are intended to capture non-prescription drugs and NHPs that are not associated with the types of harms intended to be addressed by the TVPA, particularly with respect to vaping product use leading to tobacco product use. Health products that meet the definition of a vaping product and fall outside these categories should remain subject to the full application of the TVPA to ensure the health of Canadians is protected. From a public health perspective, the TVPA offers an added level of protection in the form of restrictions on promotion, advertising and youth access that is not already provided for under the FDA.
Medical devices that are currently licensed under the FDA and MDR are not associated with any of the harms intended to be addressed by the TVPA. At present, most licensed medical devices that would meet the definition of “vaping product” under the TVPA include nebulizers, medical mask vaporizers and inhalers intended to be used with other respiratory drugs. These products fall outside of the scope of the purposes of the TVPA as they do not contain nicotine and are not associated with the risk of inducements to vaping product use. They do not resemble vaping products that are meant to be addressed by the TVPA and are licensed to be used in respiratory therapy.
To ensure that the TVPA applies to any medical device licensed in the future where there are associated concerns related to the objectives of the TVPA, the Regulations exclude medical devices from the full application of the TVPA, with the exception of the following:
- When the vaping device is licenced to be used with a non-prescription drug or an 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 non-prescription drug or NHP it is licensed to deliver
This ensures that TVPA oversight is consistently applied between devices and the drugs they are delivering. In addition, when a device and a drug are integrated into a singular product, Health Canada considers these to be combination products. Combination products are authorized as either a drug or medical device, depending on which component is the principle mechanism of action. With a combination vaping product, the primary mechanism of action is always the drug since the device component is simply the means to deliver the drug which is associated with the therapeutic effect, therefore, combination products would be subject to the TVPA to the same extent as the drug or NHP being delivered.
- When any vaping device has an appearance, packaging or labelling for which there are reasonable grounds to believe that they could make the device appealing to a young person
One of the objectives of the TVPA is to protect the health of young persons and non-users of tobacco products from inducements to use vaping products. These licensed medical devices would be used with non-prescription drugs and NHPs and would not include devices to be used with prescription drugs since those are already exempted from the TVPA. In the absence of evidence to support the need for packaging, labelling and appearances that appeal to youth in non-prescription products, and to support the objectives of the TVPA, these characteristics would continue to be prohibited for medical devices.
Other authorized drugs, NHPs and medical devices
There are a number of other circumstances by which the FDA regulates the sale, distribution or importation of drugs, NHPs and medical devices that do not fall into the categories noted above and for which the TVPA would apply, if they are not excluded. These circumstances include distributing drugs, NHPs and medical devices for clinical or investigational testing; authorizations for drugs to be sold through Health Canada’s Special Access Program; for humanitarian purposes under Division 7 of the FDR; and authorizations for the import and distribution of drugs to address an urgent public health need (Division 10 of the FDR). Under these circumstances, the harms that are intended to be captured by the TVPA have not been identified or are mitigated through the oversight of a health care practitioner, or in the case of a drug authorized for an urgent public health need, a public health official. In addition, the pathway intended for these products is meant to be accelerated, so as to ensure that they can be available to Canadians who need them under extenuating circumstances. Additional burden to access such products could have a detrimental effect on the health of Canadians. Application of the TVPA is therefore not necessary or appropriate.
Consequential amendments to the Natural Health Products Regulations
Schedule 2 of the NHPR is a list of substances that cannot be found in NHPs. The Schedule includes “a substance regulated under the Tobacco and Vaping Product Act” with the objective of excluding tobacco products from NHPs. With the passing of Bill S-5, the FDA was amended to specify that it does not apply to a tobacco product. Given this amendment, reference to the TVPA in Schedule 2 of the NHPR is no longer required. The repeal also maintains a regulatory pathway to market vaping products as NHPs while not disrupting the status of currently licenced and future nicotine replacement therapies.
Child-resistant packaging for products containing nicotine
For vaping products subject to the FDA that are not excluded from the TVPA through these Regulations and contain nicotine, new requirements for cautionary statements and child-resistant packaging would apply. Although no such products have been authorized under the FDA to date, these products are likely to consist of nicotine in liquid form, which has a greater risk of exposure than other dosage forms. These requirements are consistent with requirements under the CCPSA and its regulations for stand-alone containers of vaping liquids containing nicotine. This action will provide the same oversight for all vaping liquids subject to the TVPA by putting in place the necessary safety measures to protect children against accidental exposure to nicotine.
Studies have demonstrated that as little as one tablespoon of “commercially available liquid nicotine is capable of killing four small children” (Frey and Tilburg, 2016). Even lower levels of exposure to liquid nicotine, whether ingested or absorbed through the skin, can lead to nausea, vomiting, cardiac arrest, seizures, or coma (Frey and Tilburg, 2016). Between 2010 and 2014, the reported number of human exposures in the United States involving liquid nicotine increased more than tenfold (from 271 to 3 783). Nearly half of these reported exposures occurred among children younger than 6 years (Frey and Tilburg, 2016; Kamboj et al., 2016).
Benefits and costs
All health products that are regulated under the FDA currently on the market are excluded from the application of the TVPA through these regulations, which capture over 450 authorized health products, the majority of which are non-prescription drugs, NHPs and medical devices. The regulatory amendments exclude these products from the prohibition on sales to youth and from certain promotion restrictions (e.g. nebulizers and their solutions, nicotine-replacement therapies). As a result, the health product and prescription drug industry will avoid the burden associated with additional restrictions on promotion required by the TVPA for vaping products that would disproportionately affect it, as compared to other health products and prescription drugs.
Canadians will also benefit from safer nicotine-containing vaping products with the application of child-resistant packaging requirements. Nicotine is a highly toxic substance that can cause serious harms or even death if a child consumes or comes into contact with it.
There are no costs associated with the Regulations that exclude products from the application of the TVPA, since any burden associated with the TVPA’s prohibitions is being removed for authorized health products. There are, however, potentially modest costs associated with extending child-resistant packaging requirements to vaping products that contain nicotine that are not subject to the CCPSA.
While these requirements do not apply to any currently authorized drug or NHP, any future FDR-authorized vaping product that is not excluded from the TVPA through these Regulations will be subject to the FDR requirements for child-resistant packaging before the product can be sold. Health Canada has not yet authorized such a vaping product to date, therefore the available data on compliance cost estimates is limited. Data obtained from the vaping product market suggests that the requirement for child-resistant packaging on a vaping liquid container could result in an additional cost to industry of approximately $0.08 per packaged unit.
Implementation, enforcement and service standards
Health products currently authorized for sale under the FDA that meet the TVPA definition of a vaping product and that are not excluded from the application of the TVPA by these regulatory amendments are subject to compliance and enforcement requirements under the provisions of the FDA and its regulations, as well as those pursuant to the TVPA and any associated regulations.
Compliance and enforcement strategies will be consistent with the current overall approach to other prohibitions set out in the FDA or the TVPA and their associated regulations. Compliance and enforcement with these requirements is overseen by the Regulatory Operations and Regions Branch (RORB) at Health Canada (HC). If either the legislation or the regulations have been contravened, HC inspectors have the authority to, among other things, seize products or refer cases for prosecution.
Policy, Planning and International Affairs Directorate
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