Recent events highlight contrasting regulatory approaches for market access: US FDA vs. Canada

This week, the Canadian subsidiary of Philip Morris International (Rothmans, Benson and Hedges) announced the launch of their new vaping product, VEEV. 

On the same day, the U.S. Food and Drug Administration granted permission to Reynolds American (a subsidiary of British American Tobacco) to sell a version of its VUSE e-cigarette in that market.

This post looks at the different regulatory pathways that led to these decisions.

No permission is needed in Canada to launch new e-cigarette designs in Canada.

In Canada, there is no process for tobacco or vaping products to be reviewed by public health officials efore they can be marketed. As long as they meet the requirements set out in the Tobacco and Vaping Products Act and the Canada Consumer Product Safety Act (eg. maximum nicotine concentration and labelling) the company is free to market them.

Canada's open door policy for new tobacco and vaping products is in contrast to that in the United States, where pre-market authorization is now required.

The FDA now controls market access for e-cigarette manufacturers in the USA

When the U.S. federal government adopted the Family Smoking Prevention and Tobacco Control Act in 2009, it included provisions measures to prohibit the sale of any new types of tobacco products which had not been authroized by the Food and Drug Administration (Section 910 of the Federal Food, Drug and Cosmetic Act). The law directs the FDA to authorize these products only if it is determined that doing so is "appropriate for the protection of public health." It also directs the organization to consider whether allowing this product on the market will result in fewer people quitting or more people starting to use tobacco when it makes that decision.

Until this week, the FDA had issued 15 premarket authorizations based on such applications. These were to allow the sale of the IQOS brand of heated tobacco, of a brand of denicotinized cigarettes and some snus brands. (A separate FDA regulatory review is involved if these products are to be marketed as being less harmful - "modified risk" - as has been done for 8 snus products.)

It was only in 2016 that this requirement was extended to manufacturers of e-cigarettes (now considered to be tobacco products under U.S. law). E-cigarettes were already on the market when this happened, and the FDA did not require them to be immediately withdrawn even though no review had been conducted to determine whether their sale was appropriate for the protection of public health.

Instead, despite a series of changing deadlines, it established a market authorization process that culminated last month with millions of products being ordered off the market while others are allowed to remain on sale until the application review process is completed. This week it announced the results of its first completed review.

The first authorization - a tobacco-flavoured Cigalike

FDA's first authorization for e-cigarettes was issued for the VUSE SOLO cigalike and its replacement cartridges. This is a 'cigalike' design that was introduced to the U.S. market by BAT's subsidiary around 2013.

A similar designed product, the VYPE/VUSE e-STICK, was introduced by the Canadian BAT branch in 2018, but which was subsequently withdrawn (presumably because of low sales). It is different than the VUSE ePOD which is the only VUSE product now marketed north of the border.

The FDA explained it decided to permit the sale of this e-cigarette design because it had "determined that the potential benefit to smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth."

At this point, only the tobacco-flavoured version is authorized for sale. The FDA turned down the compay's request to sell 20 other flavours and ordered any that were on the market to be withdrawn. The decision on menthol flavourings is pending, and by inference the company can continue to sell that flavour until that happens.

Also pending are the FDA's decisions on JUUL, VUSE ALTO and other e-cigarette products that are closer to those that are currently for sale in Canada. Philip Morris has not yet publicized any agreement with its U.S. partner, ALTRA, for VEEV to be submitted to the FDA for review.

The FDA requires manufacturers to submit massive amounts of information before and after products are marketed

Last week the FDA released requirements for future submissions from manufacturers, including those wanting to introduce a new design (through the Premarket Tobacco Product Application, PMTA process) and those wishing to market a new version of existing design (through the Substantial Equivalent, SE process). Both sets of requirements come into effect next month.

(These rules were originally planned for release in January, but were suspended as a result of the transfer from the Trump to the Biden administrations. This delay resulted in the seemingly odd sequence whereby the FDA announced its new application process AFTER it dispensed with millions of applications and directed manufacturers to remove millions of products from the market.)

The final rules published this week give more indication of the issues that the FDA will consider when assessing whether approving new tobacco products is appropriate for the protection of public health. The list of items that companies are required to submit covers almost 20 pages of small print. Documents that must be submitted for review include:

• detailed descriptions of the design, manufacture and ingredients
• details on their marketing plans (and how young people will be protected from them)
• an environmental impact assessment
• an assessment of the health risks to users and non-users
• an assessment of the perception of the product and impact of "human factors" on usage
• an analysis of the population effect
• the impact the product will have on other tobacco use.
• comprehensive results from any studies

Once the U.S. FDA has authorized the sale of a new tobacco product by issuing a "marketing order", it maintains the right to withdraw that order at any time. Manufacturers are obliged to keep records and to file reports with the FDA that will be used to assess their marketing privileges.

The obligations on Philip Morris to continue marketing IQOS, and those for VUSE SOLO, show that these reports cover a wide range of concerns, including:

• any changes made to the product or manufacturing process and the rationale for each change
• reports on health impact or related scientific investigations
• data on sales and distribution
• demographic characteristics of purchasers
• information on age verification procedures and their effectiveness
• summaries of findings from consumer research
• details on marketing activities, including copies of all advertisements, PR and consumer engagement activities and marketing reach.

Other U.S. government agencies impose reporting requirements on tobacco manufacturers. The U.S. Federal Trade Commission requires reports on commercial activities and earlier this year released a report on cigarette and smokeless tobacco sales and expenditures. It recently ordered 5 e-cigarette manufacturers to also provide such information.

The European Union requires pre-market and post-market information from e-cigarette manufacturers

The European Union Directive on tobacco (Directive 2014/40/EU) requires EU countries to permit the sale of e-cigarettes, and to pass laws which impose certain requirements on manufacturers or products. These include an obligation on manufacturers to give provide post-market information on "sales volumes, preference of various consumer groups and mode of sales" and also on toxicological data. The directive requires that "this information is made available to the general public, taking the need to protect trade secrets duly into account."

In a study to support the European Commission's review of the first 5 years of this process, researchers found that the notification and reporting requirements were costly to enforce.

Many EU countries collaborate in managing these obligations through the EU Joint Action on Tobacco Control (JATC), and the European Union manages a Common entry gate (EU-CEG) for some reporting.

Information provided during pre- and post-market reporting is on (seemingly rare) occasion made public as a result of government agency reports. In France, for example, ANSES (agence nationale de securite sanitaire) allows the public to download data files with the ingredients and other design elements of tobacco products and some information on vaping products. It has published its own analysis of that data in separate reports on tobacco and vaping products. (It also reported significant non-compliance with these reporting obligations).

Canada currently has few pre- or post-market reporting obligations for e-cigarette manufacturers, although post-market reports on tobacco products must be submitted.

E-cigarette manufacturers need only get authorization from the Canadian federal government if they intend to sell vaping products as a cessation aid or other therapeutic product. In such cases, the process is set under the Food and Drugs Act.

Although provincial governments have the constitutional right to control market access for these products, few have chosen to do so. Those which require reporting include British Columbia, [which has required pre-market notification of vaping products for over a year] (https://www2.gov.bc.ca/gov/content/health/keeping-bc-healthy-safe/tobacco-vapour/notice-of-intent-vapour-products) and Nova Scotia, where it is a component of their vaping tax law.

Health Canada has imposed extensive reporting requirements for manufacturers of cigarettes, with somewhat lesser requirements for other tobacco products. The federal Tobacco and Vaping Products Act also gives Health Canada the authority to request similar information from vaping product manufacturers and for the past 4 years the department has indicated that such regulations are in development. Under the Canadian Consumer Product Safety Act, manufacturers are currently required to inform the department of any adverse incidents.
Considerations for Canadian public health

By scrutinizing the marketing plans and designs for e-cigarettes and novel tobacco products before allowing their sale, the United States is pioneering approaches to tobacco regulation that have not yet been tried in Canada. The U.S. experience may provide examples for future approaches in Canada, as may the regulatory requirements in Europe.

Implications for new Canadian regulations:

• Requiring that new tobacco products be authorized by government health authorities before they can be marketed.
• Requiring a separate regulatory review for each product before government views on reduced harm can be claimed.
• Putting the burden of proof on manufacturers to show that their new tobacco products are appropriate for the protection of public health, instead of putting the burden on regulators to say they are not.
• Requiring extensive reporting by manufacturers both before and after products are marketed.
• Establishing a common portal for receipt of data by different jurisdictions, and collaboration in the use of the data.

Documents and resources referenced in this post:

1. British Columbia. E-substances Regulation. 2020.
2. Canada. Tobacco Reporting Regulations (SOR/2000-273), 2000.
3. European Commission. Tobacco Products Directive 2014/40/EU b
4. European Commission. Report on the application of Directive 2014/40/EU concerning the manufacture, presentation and sale of tobacco and related products.
5. European Commission: Final report: Support Study to the report on the application of Directive 2014/40/EU.
6. European Union. Joint Action for Tobacco Control
7. France. Agence national de securité sanitaire. Déclaration des produits du tabac et produits connexes en France. Produits du tabac - Bilan 2016-2020
8. France. Agence national de securité sanitaire Déclaration des produits du tabac et produits connexes en France. Produits du vapotage - Bilan 2016-2020
9. United Kingdom: The Tobacco and Related Products Regulations 2016
10. US FDA: Premarket Tobacco Product Applications and Recordkeeping Requirements. Final Rule. 2021
11. US FDA: Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports. Final Rules. 2021
12. US FTC. Order to File Special Section 6(b) Report on E-Cigarette Products in Calendar Year 2021
13. USA. Federal Food, Drug and Cosmetic Act, s. 910 Application for Review of Certain Tobacco Products.