People who use white snus instead of smoking cigarettes are at a lower risk of developing oral cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.
This is the view of the US Food and Drug Administration (FDA), which has now granted Swedish Match permission to use the message in its marketing of its ZYN nicotine pouches.
Amid the regulatory chaos currently prevailing in the US nicotine market, the US Food and Drug Administration (FDA) has granted Swedish Match, which is owned by Philip Morris, authorisation to market its ZYN nicotine pouches as a less harmful alternative to cigarettes.
– Today’s decision means that these products may be marketed with a reduced-risk claim, informing adult smokers that the products are associated with lower health risks, says Bret Koplow, acting director of the FDA’s Centre for Tobacco Products, in a press release.
Comprehensive scientific review
In the US, companies must obtain special approval from the FDA in order to market a tobacco or nicotine product with claims of reduced risk compared with cigarettes. To obtain such authorisation, comprehensive scientific documentation is required to demonstrate that the claim is accurate and that the marketing is deemed likely to benefit public health as a whole.
However, approval does not mean that the FDA considers the product to be safe or risk-free. Instead, the agency permits a specific risk claim based on the scientific evidence.
“The FDA’s review of products with reduced-risk claims aims to ensure that adult users receive clear and scientifically sound information about the relative health risks of different tobacco products, so that they can make informed decisions,” says Bret Koplow.
Millions of Americans use smoke-free nicotine products
The background to the decision is that both e-cigarettes and nicotine pouches are used by millions of American adults. At the same time, the latest national surveys show that the use of e-cigarettes among young people has fallen from previous peak levels.
E-cigarettes are currently the most common smoke-free nicotine product in the US. Around 18 million American adults – equivalent to just over seven per cent of the adult population – use e-cigarettes regularly. Among young people, it is estimated that around 1.4 million secondary school pupils, or 5.2 per cent, use e-cigarettes.
At the same time, nicotine pouches are the fastest-growing category in the US nicotine market. Around 10.5 million adults currently use nicotine pouches, and the proportion who have used the products in the last month has risen to 4.2 per cent. Among young people, it is estimated that around 470,000 secondary school pupils, equivalent to 1.7 per cent, use nicotine pouches.
Only a handful of products have been authorised
This is an unusual situation. Previously, only two other nicotine products have received similar approval from the FDA: IQOS, which uses heated tobacco, and the Swedish snus brand General. All are produced by Philip Morris or its subsidiary, Swedish Match.
A controversial system
At the same time, the FDA’s system for approving marketing claims relating to reduced risk has been the subject of criticism for many years.
Although several products – such as modern e-cigarettes – would likely meet the scientific criteria for such a warning, the FDA also takes into account the risk that young people who do not currently use nicotine might start using these products. The agency therefore assesses how the marketing affects public health as a whole, not just how the product affects the individual user.
At the same time, the cost of applying for such a licence is estimated at between 10 and 100 million dollars per product. The largest part of this consists of the extensive research and documentation required by the FDA.
In practice, this means that only the largest tobacco companies have the financial resources to pursue legal action, whilst small and medium-sized enterprises – which have, to a large extent, built up the modern vejp market – find it considerably more difficult to navigate the system.
Fact: What does the FDA’s decision mean?
The FDA’s approved messaging for ZYN
Under the terms of the licence, Swedish Match is permitted to inform adult smokers of the following:
”People who use ZYN instead of smoking cigarettes are at a lower risk of developing oral cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.”
What does ”modified risk” mean?
- The FDA must approve all claims regarding a reduced risk associated with tobacco and nicotine products.
- The company must demonstrate that the claim is supported by extensive scientific evidence.
- The FDA also assesses whether the marketing is likely to benefit public health as a whole.
- Approval means not that the product is considered to be completely safe or risk-free – without the authority deeming that the specific risk claim may be used in marketing.
The authorisation covers 26 variants (containing 3 mg and 6 mg respectively) in various flavours: ZYN Chill, Cinnamon, Citrus, Coffee, Cool Mint, Wintergreen, Menthol, Peppermint, Smooth and Spearmint
