Snus - The Regulatory Anomaly
The derogation has now been in place for more than 15 years and continues to be a regulatory anomaly. One of the founding principles of the EU is free and unrestricted trade between member states. Any derogation from this principle is viewed as creating a compartmentalization of the EU internal market so they are typically avoided or limited to a few years when a new member state enters the union. But Sweden’s derogation is permanent which remains a constant source of concern for the EU tobacco regulators in Brussels.
How much snus are European consumers allowed to buy on the internet and import for personal use? Are internet sales outside of Sweden legal in the first place? Tax-free sales of snus on the ferries between Sweden, Finland, and the Baltic states are an important source of revenue for many shipping lines, but is it allowed on Finnish-registered cruise ships? Is it allowed outside of Swedish territorial waters?
Nobody really knows the answer to all these questions, and the regulatory ambiguities continue to hurt snus users all over Europe as well as the Nordic shipping lines. The ban has been challenged in the EU Supreme Court, but the ruling said in essence that the ban is a political issue. Therefore it cannot be revoked on strictly legal grounds. The Court did not comment on the awkward situation in the EU where cigarettes can be traded freely and unrestricted across all borders, whereas manufacturers are prohibited from exporting snus from Sweden to any other member state.
Pending revision of European TPD
DG SANCO is charged with regularly updating the European regulatory framework for tobacco (Tobacco Products Directive, TPD). In practice, this happens every 10 to 15 years. Each member state has agreed to align its national legislation and regulations with this directive. It comprises requirements for reporting of ingredients and constituents, marketing restrictions, age limits, labeling, warning texts, etc.
Since many years it appears to be the ambition of DG SANCO to align the TPD with the recommendations in the WHO Framework Convention for Tobacco Control (FCTC), a set of recommended tobacco control measures intended to be copy-pasted into national legislation world-wide. Consequently, the FCTC may be seen as a blueprint for what EU tobacco regulation will look like in the future. However, DG SANCO is also specifically charged with considering tobacco products that may pose reduced health risks than products currently on the EU market although, in contrast to the U.S., current EU legislation does not include a special regulatory route for such products.
The current EU TPD dates back to 2001. It is now under revision since about two years. On the surface, the process follows strict routines and is supposed to be transparent with formal impact assessments of proposed new elements in the regulation, and stake-holder consultations that are open to the public. In reality, some analysts consider the TPD revision to be a highly politicized process driven by hidden agendas.
An example is perhaps DG SANCO’s original position that the EU snus ban should not be included in the revision in which case it would remain in place by default. Possibly because of widespread criticism they now seem to have abandoned that position and smokeless tobacco including the snus ban is now part of the the stake-holder consultations (which in December 2010 had generated the record number of 85,000 submissions to the EU Commission).
DG SANCO is responsible for developing the EU Commission’s proposal for the new directive, but is required to consult with the other EU Directorate-Generals in so-called inter-service consultations which are currently ongoing (behind closed doors). The final proposal is not due until the end of this year, so the details remain largely unknown. But analysts expect it to be like a tsunami for the cigarette industry including things like plain packaging, total exposure bans, graphic health warnings covering most of the cigarette packs, etc., etc.
Part of this increased regulatory stringency is likely to also concern smokeless products including snus. But what will happen with the snus ban and the Swedish derogation is at this point in time uncertain. The pharma industry appears to view snus as a potentially dangerous competitor to their pharmaceutical nicotine products, so they are lobbying intensely in Brussels to keep snus from the European market.
Others, including the Swedish government, have stated that the ban should be uplifted because it is inconsistent with the EU principle of free trade. They have so far not used arguments based on consideration of relative health effects of different tobacco products, probably because that is viewed as a politically sensitive issue. If the EU snus ban is revoked in the new TPD, it will be the first time in tobacco regulatory history that a once outlawed product has “come in from the cold”. The fact that many anti-tobacco activists view that scenario with considerable dismay comes as no surprise.
US Tobacco Control Act
In June 2009 President Obama signed the “Family Smoking Prevention and Tobacco Control Act” giving regulatory authority over the U.S. tobacco market to the FDA. The Act is intended to provide a basis for regulations that are grounded in science, and with protection of public health as the most important aim.
Much of the Act has to do with issues that from an industry perspective can be described as “regulatory compliance”. This include things like the ban on characterizing flavors in cigarettes (except menthol), new and larger warning texts on all tobacco products, mandatory reporting of ingredients and constituents, registration of production facilities, etc, etc. However, from a public health point of view the perhaps most interesting part of the Act is its Section 911 which has to do with special regulatory routes for Modified Risk Tobacco Products.
Modified Risk Tobacco Products
According to the Act, a modified risk tobacco product is required to not only pose less health risks to the individual user than other commonly used tobacco products on the market, but also to “benefit the population as a whole taking into account both current users and non-users of tobacco”. To have a product approved by the FDA according to this definition has sometimes been described as the Holy Grail for the tobacco industry.
The crux of the matter is that the Act is not very informative as to what type of evidence is required to satisfy the criteria for “modified risk”. Therefore, the FDA has signed a contract with the Institute of Medicine (IOM) which is part of the most prestigious scientific authority in the U.S: the National Academies of Science. The IOM is charged with issuing a report that deals with the scientific requirements for “modified risk”.
The IOM has recently appointed a committee that will issue a report by November 2011. It is believed that the final guidance from FDA (due in April 2012) on these matters will largely be based on the IOM conclusions. It is noteworthy that it was the IOM that published the ground-breaking “Clearing the Smoke” report back in 2001, which in many areas served as a blueprint for the current Tobacco Control Act.
Up to now the Center for Tobacco Products at the FDA has struggled to meet all the statutory requirements and dead-lines. It probably has had little time to consider issues related to “modified risk”. But this will change once the IOM report is on the table.
The whole question of “modified risk” is directly related to current discussions in the tobacco regulatory community about the concept of tobacco harm reduction which remains a highly controversial subject. Some researchers say that tobacco harm reduction is simply a red herring in tobacco control, whereas others believe it represents a worthwhile addition to societal efforts to reduce smoking-related disease. These differing views are likely to be reflected in the scientific debate that will undoubtedly emerge once the IOM report is made public.
Some are likely to say that the proposed scientific requirements are unreasonably stringent; others will claim that they are too lax. It will be a daunting task for the FDA to strike a balance between these two camps in their final guidance document. When that is published in April, 2012, they have indicated that it might take them up to 12 months to process an application, so FDA approval of a Modified Risk Tobacco Product will probably not happen until 2013 at the earliest.
Modified Risk Tobacco Products: US vs Europe
Having been involved in both the European TPD process, and the U.S. process for implementing the new Tobacco Control Act, I have noted both similarities and differences. On both sides of the Atlantic the work by the regulatory authorities is done against a backdrop of a highly polarized and at times acrimonious debate within the scientific community about the merits of tobacco harm reduction as an integral part of tobacco control, as well as intense lobbying from Big Tobacco, Big Pharma, and a multitude of non-governmental organizations with varying vested interests.
In the U.S. the processes are in general much more transparent and evenhanded, and there is an explicit aim to produce regulations that are driven by science. In Europe, Mr. Barroso, the head of the EU Commission, has for a long time talked about “better” and “more efficient” regulations. The most recent buzz word in Brussels is “smart” regulations. But there is unfortunately no explicit mention of making them science-driven which leaves considerable room for ideological and political considerations.
In summary, 2013 will an interesting year; the FDA is likely to rule on the first application for “modified risk” status, and there should be a clear picture as to how the EU envisages the future of tobacco control in Europe including what will happen with the ban on snus. Let’s hope that President Obama’s words in his inaugural presidential speech about the need to “put science back in its rightful place” will prevail on both continents when it comes to tobacco control.
/L. E. Rutqvist
Lars Erik Rutqvist; MD, PhD
Writing for SnusCENTRAL.org