Regulation and Control
Countries Where HNB Products are Sold
- No Fire, No Smoke: The Global State of Tobacco Harm Reduction
Heat not burn (HNB) products are available in more than 37 countries, including Japan, Korea, New Zealand, Italy, Portugal, Switzerland, Spain, Ukraine, Russia, the United Kingdom, Guatemala, Colombia, and South Africa. Many of these countries, and others, regulate these products differently than cigarettes and other combustible tobacco products.
In the EU, these products are regulated as novel smokeless tobacco products under Article 19 of the European Union TPD.38 Article 19 establishes a separate regulatory category for novel tobacco products that do not fall within the tobacco product categories as defined in Article 2. Novel tobacco products can either be products for smoking or smokeless; the key differentiator being the presence or absence of combustion. However, the electronic part of an HNB device is not subject to regulation under the TPD.
In addition to receiving a separate regulatory category under the TPD, HNB products are also regulated differently than combustible tobacco products. For example, health warnings for these products are different from those required for cigarettes, both in terms of size and content. Other elements in the TPD also treat these products differently, such as the use of additives and ingredients necessary to produce products that operate differently from combustible cigarettes.
Under the TPD, Member States must establish a system of notification or authorisation, with which manufacturers must comply before placing a product on the market, consisting of available scientific studies on a number of topics and other available and relevant information, such as risk/benefit analysis of the product.
See also p. 90 of the report: No Fire, No Smoke: The Global State of Tobacco Harm Reduction 2018 — Global State of Tobacco Harm Reduction (gsthr.org)
Center for Tobacco Products (CTP) Map
- No Fire, No Smoke: The Global State of Tobacco Harm Reduction
The FDA in the USA has long held the authority to regulate nicotine replacement therapies such as gum, patch, and lozenges through the Center for Drug Evaluation and Research (CDER). In 2009, with the passage of the Family Prevention Smoking and Tobacco Control Act, the FDA gained the authority to regulate tobacco products and marketing for cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. On May 10, 2016, the FDA published a final ‘deeming rule’ allowing the agency to begin regulating all tobacco products, including cigars, pipe tobacco, waterpipes (or hookahs), dissolvable products, e-cigarettes, and other electronic nicotine delivery systems.
The deeming rule requires that any new product (any tobacco product not commercially marketed in the US as of February 15, 2007) must go through a Pre-Market Tobacco Application (PMTA) process to stay on the market (the deadline to submit a PMTA was August 8, 2022 for non-combustible products and August 8, 2021 for combustible products), and a Modified Risk Tobacco Product Application (MRTPA) in order to make any health claims about relative risk compared to continuing to smoke cigarettes. Products that have been subjected to small changes from the original “grandfathered product” (products on the market before February 15, 2007) must submit a Substantial Equivalence Report (SE) or an Abbreviated SE report so the product can stay on the market without a PMTA. This infographic maps the pathways a nicotine containing product can take to get to market). The PMTA pathway requires that the applicant proves that the product would be appropriate for the protection of the public health. The statute does not define that standard further. The FDA has released draft guidance documents, however, at the time of writing, none of them have been finalised meaning that they are not enforceable and the agency can change them at any time. To date, only eight PMTA orders have been granted for Swedish Match’s General Snus products.
See also p. 93 of the report: No Fire, No Smoke: The Global State of Tobacco Harm Reduction 2018 — Global State of Tobacco Harm Reduction (gsthr.org)
The European Union (EU) Tobacco Products Directive (TPD) 2016 Changes to the EU TPD
- No Fire, No Smoke: The Global State of Tobacco Harm Reduction
The TPD is a Directive of the EU which means that all EU countries must ‘transpose’ or incorporate the TPD requirements into their national laws. The only flexibility permitted is the ability to enact additional regulations. The current Directive entered into force on 19th May 2014 and became applicable in the EU Member States on 20th May 2016.
In 2014 a revised Tobacco Products Directive known as TPD 2 was issued by the EU to update the 2001 Tobacco Products Directive. TPD2 regulates all tobacco products in the European Union and its scope is wide. It covers product regulation in terms of reporting obligations of ingredients and emissions for all tobacco products. It includes product packaging and labelling including the size and appearance of products, traceability features to be fixed onto packaging as well as health warnings. It covers cross-border advertising of tobacco products; it reinforces the ban on oral tobacco products (snus), but importantly it provides for the placing on the market of e-cigarettes and refill containers, as well as making provision for notification of novel tobacco products. It also provides for herbal cigarettes.
See also p. 96 of the report: No Fire, No Smoke: The Global State of Tobacco Harm Reduction 2018 — Global State of Tobacco Harm Reduction (gsthr.org)
Philanthrocapitalism: Direction of the Global Funding Streams
- Burning Issues: The Global State of Tobacco Harm Reduction 2020
The second and more significant financial input into both US and global campaigning against THR has come from Bloomberg Philanthropies (BP), with some assistance from the Bill and Melinda Gates Foundation (BMGF).
This is a ‘simplified’ picture of the direction of the global funding streams, much of which appears devoted to action against tobacco harm reduction. There will be many in-country local grantees and other organisations who also campaign against THR and who cite CFTK, Bloomberg and Gates as ‘partners’, without any clarity as to what this means.
Foundation funding is differentiated from other forms of charitable financing as there are no public donations, government or other charitable third-party funding. Money derives from the profits of the founder’s business and investment interests. Foundations are nothing new; the Rockefeller Foundation was established in 1913; the Ford Foundation in 1936. A new ethos driving modern day philanthropy applies management methods and metrics to the running of philanthropic projects on the basis that doing good is good for business.
See also p.100 of the report: Burning Issues: The Global State of Tobacco Harm Reduction 2020