Regulatory Responses to Tobacco and Legal Challenges

Chapter 5
Regulatory Responses to Tobacco and Legal Challenges

A Regulation Rather Than Litigation?

Attempts to counter tobacco through product liability litigation may provide compensation to a few, generate work (and possibly lots of) money for lawyers, reveal information on industry misconduct, ensure tobacco control has high visibility, punish rogue manufacturers and be an irritant to the tobacco industry generally. But under existing laws it will not provide a killer blow to eradicate tobacco use. This is most obviously the case in Europe, but fundamentally the same conclusion can be reached for the US. ‘Clean’ tobacco properly sold without any misrepresentations as to safety is unlikely to be considered a defective or unsatisfactory/unmerchantable product. Any case brought on the basis of conduct, be it fraud, deception or negligence, will only have transitory effects on those participants found liable for misconduct. Thus attention should focus on how tobacco can be regulated to reduce the number of smokers and improve the health of those who continue to smoke. Europe started on this route, but the US is also increasingly regulating tobacco as instanced by many of the terms of the MSA and the new powers granted the FDA under the FSPTCA 2009. Indeed tobacco regulation has even been considered a ‘human right’¹ and a matter of special concern for the protection of female human rights.²

B Regulating a Product You Would Rather Ban

Given that tobacco is such a dangerous product ‘a man from mars’ might be forgiven for wondering why it is not banned. Governments are after all generally eager to ban the commercialisation of unsafe and dangerous products. Indeed in Europe some oral tobacco products have been banned.3 This section considers on what basis product bans can be justified; the difficulty of applying a ban to tobacco and the resulting tensions generated for its regulation?

Sometimes bans are introduced out of a concern to protect the seller. This may also be intertwined with moral values. This might explain bans on the sale of human body parts or the provision of sexual services. Such concerns are not relevant to tobacco. Nobody is suggesting that the tobacco companies are being harmed by supplying the product. The concern is with the health of the buyer. It is true though that businesses may risk damaging their reputation if they become connected with a tobacco industry that has become increasing unpopular as it is associated with malpractices and a product favoured by people on the margins of good society.⁴ But that is a matter for their commercial judgment.

There have at times been less than laudable motivations for bans on the sale of products based on one group seeking to impose their moral standards. Occasionally these have focused on concern for the morality of the seller, prostitution being a classic example. More usually they have focused on the moral harm to the consumer. Alcohol prohibition was the cause célèbre, when puritan virtue mixed and overwhelmed arguments based on the prevention of harm. Indeed it has been suggested that the reason that 13 states banned the sale of cigarettes before the First World War was because like alcohol they were treated as a ‘mark of deviancy’.⁵ In fact alcohol prohibition in the US may have promoted smoking as it took on the social and leisure role previously occupied by drinking.⁶ The spectre of prohibition has often been invoked by the tobacco companies to suggest proposed regulations were the thin end of the wedge leading to prohibition. More recently the same debate has been had regarding drugs. Some people also suggest prohibitions on recreational drugs are about enforcing moral codes. Indeed the flamboyant French lawyer, Francis Cabellero, has combined a campaign against tobacco with support for the legalisation of cannabis. Presumably he believes it is tobacco which is the more dangerous product. Such overt or disguised attempts to impose moral values through restrictions on the commercialisation of commodities should usually be rejected. There might in many instances be valid moral reasons going beyond puritanical gesturing for imposing bans. Prostitution and drugs may be good examples where sound arguments for bans can be advanced. However, equally both are topics on which society should at least have a debate about the desirability of their being the object of legal commerce. Nowadays, it is unlikely that a ban on tobacco could be supported on the ground of moral harm even if in earlier times a moral case was put forward for its prohibition.7 That was, however, before the evidence of the harm tobacco caused became clear.

More commonly, products are banned because they are deemed too dangerous. These regulatory debates are usually carried out using risk assessment analysis often through the medium of licensing and standardisation bodies which allow the input of a wide spectrum of interested parties so that the eventual decision is often widely supported. Normally the debated issues do not centre on whether the product should be allowed to be commercialised at all, but rather focus on the margins as to just how safe a product should be. Of course there are important debates to be had about how much freedom individuals should have to risk harming themselves and deciding for themselves the trade-off between safety and other aspects of the product including its utility and price. The decision to ban consumer products, outside the pharmaceutical field, is only taken in such rare circumstances that only the most extreme risk taker would object. Bans on safety grounds are extreme policy choices only adopted where the evidence is overwhelming. The risks of smoking might of course justify such a ban if tobacco was first proposed to be commercialised today.

An additional dimension is added when it is proposed to ban products that consumers enjoy, but society feels they would be better off not having access to. So called recreational drugs, such as cannabis, are examples of such products. There are debates about whether some of these products should be legalised; either because it is alleged the prohibition arises from moral outrage or prurience rather than a real assessment of the risks or due to the difficulty of preventing black markets arising and the increased problems of addressing the ill effects when the product is forced underground. Nevertheless, for the most part society accepts that it is better off without them.

However, drugs, like cannabis, were banned before a legitimate market had been established for them. It is far more difficult to remove a product when it has woven itself into the societal fabric. This has been labelled as the ‘battleground of desire’.⁸ The infamous attempt to prohibit alcohol in the US failed. The analogy between alcohol prohibition and tobacco control, is not in all respects apt. Alcohol is not inherently dangerous to the drinker. Rather the prohibition movement used the ills caused by abuse of alcohol to impose a puritan moral order. Tobacco control is motivated by real concern for the smoker and others who breathe polluted air. It is of course sometimes suggested that this represents the nanny-state interfering in freedoms,⁹ but most would accept that the motives are health and environmental concerns rather than any revulsion at the practice of smoking per se. Moreover, policy-makers to-date have not promoted an outright prohibition on tobacco.10 That much has been learned from the experience of alcohol prohibition. However, it should not be overlooked that one product oral snuff has in fact been banned in Europe.¹¹ Moreover high tar products are now illegal in Europe. So some inroads have been made into the availability of tobacco products.

Tobacco remains unique in being a legally marketed product, whose potential dangers so outweigh its possible benefits that if the product were introduced today it would certainly be banned. As Chapman observes, ‘The paradox with tobacco is that it is so dangerous, that no routine regulatory approach can make sense of it’.¹² Indeed one of the arguments of the US Supreme Court against allowing the US Food and Drug Administration jurisdiction over tobacco was that if granted jurisdiction it would have to ban it and that was not socially acceptable.¹³ It is widely agreed that it would be impracticable to prevent people having the choice to smoke tobacco as it has been for generations a common feature of everyday life.¹⁴ Nevertheless, tobacco is a product that would for public health reasons undoubtedly be better removed from the market place. Governments globally acknowledge the dangers of smoking and attempt to reduce its consumption as reflected in the title of the World Health Organisation’s Tobacco Free Initiative seeking a Un Monde Sans Tabac. The World Bank has also produced a report favouring tobacco controls.¹⁵

Herein lies the paradox. Most consumer products involve some risks and regulation and standardisation procedures evaluate the risks and costs of ameliorating them and seek to produce a consensus standard for the product that the industry and public can live with.¹⁶ The objective of many promoting tobacco regulation on the other hand is not to make the product acceptable, but just the opposite to make it less acceptable so that sales are reduced – ideally to zero. Those favouring strong regulation may concede that members of the public should have the freedom to smoke if they want to, but they would rather they did not and seek do everything to make it hard for them to do so – they warn them of the consequences, often control the content of the product, penalise them through the pricing mechanism with judicious use of taxes and make it more difficult to smoke due to ETS controls. The controls this study is particularly concerned with are those related on the product and its marketing. Warnings of risks and bans or restrictions on advertising and promotion all seek to make the product less appealing by ‘de-normalising’ its use.

Like in no other sector, a deep seated mistrust exists between the tobacco industry on one hand and its regulators and public health groups. This is regrettable, but not surprising. Why should the industry be other than suspicious and uncooperative with its regulator? There is little in regulation for the tobacco companies. In other sectors products benefit for the imprimatur of safety associated with strong regulatory standards, but tobacco regulators have been reluctant to endorse any tobacco products as safe, or even as safer than other tobacco products.17 These regulators are not seeking to provide an environment in which the industry can flourish, even if some of the EU directives have used the justification of promoting the internal market as a legal base. Their policies are aimed at removing the product from the market. It is true that regulation has been long recognised as being part of the landscape in Europe and even in the US Phillip Morris has become a convert to regulation, but the suspicion with which many in the public health community view that conversion is a testament to the gulf between the parties.¹⁸

It is sad to reflect that even when the regulatory climate was more open to debate about the risks of smoking or even sympathetic to tobacco, the industry was at times less than candid with regulators.¹⁹ Probably this was because it either knew there were dangers with tobacco or feared inspection might discover some unwelcome hazards. The position in the UK is often compared favourably to the US as industry seemed to be more open to engagement and research into the risks of smoking.²⁰ However, given the knowledge there now is about the close working relationships between tobacco companies internationally,²¹ it may be questioned how far this open approach would have been allowed to go if the results were seriously unfavourable to the interests of the tobacco industry.

Viscusi notes that in the US government has in the past positively discouraged technological advances that reduce risk.22 There have been times when producing a safer product was a genuine aspiration of regulators and even some in the industry.²³ Even today one regulatory strategy is to control design of the product in the hope of reducing the harm caused, by setting limits on tar, nicotine and carbon monoxide. Moreover there is renewed interest both by industry and the anti-tobacco movement in the development of less harmful tobacco products and nicotine alternatives (PREPs).²⁴ This strategy took a knock from the ‘light’ cigarette scenario when the anti-tobacco movement thought the industry misled smokers about their health benefits. Public health advocates also feared additional overall negative impact on public health if PREPs encourage some people to start smoking who otherwise might have been risk adverse to doing so or provide an alternative to quitting for existing smokers.

The development of PREPs might be welcomed as providing safer alternatives for those that will not or cannot stop smoking. However, a central issue is how the industry can market them. Aggressive marketing of their benefits might encourage some to believe smoking poses a tolerable risk and result in the same problems as arose in relation to ‘light’ cigarettes, but if the companies cannot market their benefits they have little incentive to develop them. Some in the anti-tobacco movement might appreciate the need to find safer alternatives for those who cannot or will not quit, but there is another strand of the movement that promotes the stance that there is no such thing as a safe tobacco product and therefore regulation should be aimed at strangling the industry.²⁵ This is the source of inherent tension between the tobacco industry, its regulators and the anti-tobacco lobby. Naturally regulators tend to be more in tune with the anti-tobacco groups as they realise there is no prospect of their producing regulations that make the product safe. Therefore the inevitable tendency is to adopt strategies that may make the product marginally safer, but underpinning most public health approaches is the larger public health agenda that requires a policy of deterrence that is premised on the ‘de-normalisation’ of smoking.

In contemporary debates this plays out both in relation to attitudes towards PREPs and also the disclosure of tar and nicotine content. Many in the public health lobby not only oppose any promotion of PREPs but in the US especially some would oppose disclosures of tar and nicotine content to prevent consumers making wrong assessments that lower tar products are safer. Although well intentioned such approaches risk alienating smokers who might react against regulation which does not trust them with information to make an informed choice. If PREPs really could be less dangerous surely those that continue to smoke should be informed of that and be allowed make an informed choice. Trusting consumers with information seems the only rational policy if government will not ban products. Whilst there may be uncertainty about whether alternatives can be made that are much safer, surely this possibility should be explored. The reluctance of the industry to engage in such work in the past may now be matched by a lack of enthusiasm in the public health community, but for the sake of the vast numbers that still smoke such options should be explored. Ironically those most fervent about the risks of smoking are often those least interested in reducing those risks apart from through cessation.

Admittedly, sometimes one may wonder how serious some governments are about their anti-smoking objectives. In Europe, Germany stands out as a country reluctant to deal with the problem seriously.26 In many developing countries the controls on tobacco are rudimentary or at least not fully enforced. States also have a ‘Janus’ faced attitude to tobacco. Not only do some, including the EU, subsidise tobacco growing, but if the anti-tobacco policy was truly successful, they would face at least in the short term a financial crisis due to loss of tax revenue and potentially in the longer term even more serious social problems resulting from an increasing ageing population as smoking stopped culling large numbers every year. Not that increased life expectancy should be seen as a bad outcome from successful tobacco controls.

All these factors make for an interesting regulatory context. Tobacco is accepted as a legitimate product, but many governments and anti-tobacco activists want to reduce its use and hopefully one day remove it entirely from the market. Industry knows it is in a corner. For a long time it claimed that its product was not dangerous or at least not too dangerous. Now it has little option, but to accept it is peddling a dangerous product. Some controls such as warnings have been accepted for many years by the tobacco companies and there seems to be an increased acceptance that the future will bring more regulation of the product and its promotion, but the industry clearly has an incentive to reduce the impact of these laws.²⁷ After all it may know its product kills, but its only rational action is to seek to sell more – even if that means inevitably killing more of its users. There may be a debate about whether the industry actively targets youth smokers, but it is an undoubted fact that new generations of smokers are needed if the industry is to replace those that are dying off. There is no equivalent of the set aside subsidies offered to farmers, under which governments would reward tobacco firms with falling sales figures. Perhaps there should be! Indeed, David Kessler, the former FDA Commissioner has argued that the state should take over tobacco companies with the objective of running down sales.28 However, such intervention seems impractically expensive assuming compensation would have to be paid and no doubt would have many believing the state was wanting to appropriate property and establish a profitable monopoly. Indeed an irony of the US litigation is that not only does it force the tobacco companies to maintain profits to meet legal and liability costs, but also ties the states into the economic wellbeing of the companies as they are relying on future payments from the MSA.

Another far reaching solution proposed has been to develop a regulated market controlled by a state Tobacco Products Agency that would be the only buyer from manufacturers and importers (like the alcohol monopolies in Nordic states) so it could incentivise the production of safer products and would be able to control the marketing, even if sales were made through existing retail outlets.²⁹ However, this complicated structure, though theoretically attractive seems unlikely to be a practical solution – indeed few states would want to take such responsibility for the harmful products. Like Kessler’s solution it might require compensating tobacco companies for reducing their tobacco sales and seeking to run down the business. This is an expensive project at any time and is particularly unlikely to appeal in times of economic austerity. Smokers could of course be made to pay through increased duties but this is unlikely to be politically palatable. It seems that stricter enforcement of traditional regulation may be the best way forward.³⁰

C Tobacco and Regulation

Before becoming too despondent about the continued existence of such a dangerous product on the market, it should be reflected that the desire to address the problems it causes is a recognition of the increased role public heath plays in our affluent society.³¹ In the long term the only effective means of reducing smoking will be by public health measures. Many of these will involve non-legal measures like education programmes and cessation programmes. This book nevertheless focuses on the legal controls, in particular those that might be described as relating to consumer protection. Chapter 6 analyses the various types of consumer protection controls, ranging from restrictions on advertising and marketing of tobacco products, age restrictions, controls on the presentation of the product including disclosure of tar, nicotine and carbon monoxide content and use of warnings.

This extensive list is not, however, exhaustive of the way the law promotes tobacco control. Taxation policy is a significant factor in affecting smoking rates.³² Price can particularly influence whether youths commence smoking, for since they are not yet addicted then can freely choose alternative ways to spend their limited disposable income. Price increases not only impact on individual decisions to smoke, but as it causes smoking to decrease amongst peers this has the knock-on effect of reducing peer pressure to smoke.³³ However, one negative impact of taxation is that it is regressive as low income consumers are affected most. This could be viewed as a positive in that it helps redress the overrepresentation of smokers amongst low income groups, but there is something inherently unfair about using price as a means to exclude poor people from the choice of smoking, even if most would characterise it as a bad choice. Many poor people view smoking as one of their few luxuries in life and it can be seen as paternalistic to use price to pressure this vulnerable group even if maintaining the habit will worsen their circumstances. More legitimate is the strong enforcement of customs and excise laws to ensure smuggled tobacco products do not reach the market since these are often a cheap source of tobacco which undermines the general taxation policy.

ETS controls would provide a wonderful case study in their own right. They fall strictly outside the scope of consumer protection rules, but brief mention of then is rightfully made in the next chapter as they form another important plank in the use of law to de-normalise tobacco use.

Underlying all these tobacco control efforts there is the simple truth that a powerful industry such as the tobacco industry can be expected to do nothing other than challenge, avoid and sidestep such laws.³⁴ Whilst breaking the law cannot be condoned any rational market driven firm would do its best within the limits of the law to influence the development of regulation and to apply the rules in a way which best reflects its interests. When a product has such serious health effects as tobacco one might hope for the companies to apply the spirit as well as the letter of the law, but the economic imperatives are likely to weigh heavily on the corporate mind.

There is an interesting debate between the tobacco companies as to their corporate approach to regulation. This is very evident in the US where Phillip Morris seems to be more positive about finding regulatory solutions, but the extent to which this goes and the motivations underpinning it remain subject to much debate.35 Its change to favour ‘reasonable regulation’ can be explained by its desire to improve both its corporate image and that of its products. Regulation of its products might give some consumers more confidence in their safety, but more fundamentally it allows the company to move the focus away from public health and to frame the debate as one of individual choice.³⁶ This is in many ways the central issue for modern tobacco policy. Does one work with the industry to provide safer products or simply countenance no truck with an industry that knows it is killing many of its consumers and seek to further de-normalise tobacco. It has been suggested that one part of Phillip Morris’s strategy is to exploit such divisions within the anti-tobacco movement.³⁷

A central question is what message should be put out about tobacco products. There is a lot of force is Kozlowski and Edwards’ argument that it is not enough to simply say there is ‘no safe cigarette’ or ‘no safe tobacco product’.³⁸ Indeed the fact this message can be used by both public health communities in promoting quitting and tobacco companies in defending its right to sell a product informed adults chose to smoke perhaps underlines that it has little value. Most people know smoking is unsafe; what they need is realistic evidence about the actual risks associated with particular products. Whilst some advocates may prefer the blanket ‘no safe tobacco product’ message for fear that consumers may easily misinterpret any more nuanced messages, if society is not able to ban the product it should leave it to adults to make an informed choice. This does not mean that strategies should not be adopted to make the product unappealing (through advertising and promotion bans and controls) and to deter smokers through measures such as extensive counter advertising. It does mean that a legal market should be required to operate in a transparent manner. This should not give succour to the tobacco industry for most of the news about all tobacco products is bad. Indeed convincing arguments can be made for ensuring that more information is given about the health risks so that potential consumers not only have a sound understanding of the risks but also accurately understand their personal chance of being affected.³⁹

Nevertheless, the natural tendency for corporations to find solutions within the rules that best enable it to sell more of its product does means that the regulatory framework needs to be flexible to allow the regulators to innovate and adapt. It also means that politicians need to have courage. They need to give themselves clear powers to regulate effectively and properly fund supervisory administrations. In turn, courts need to appreciate that society has given priority to the public health objective of reducing the harm caused by smoking. This should usually trump arguments based on competing rights in instances where interest have to be balanced as in the context of commercial free speech. The challenges are normally based on constitutional principles or human rights.

Traditionally Europe has a more effective regulatory environment for tobacco than the US. Regulation in the US has been restricted by First Amendment free speech restrictions on advertising controls and the lack of authority in the past of the FDA to regulate tobacco. The latter has been addressed by the FSPTCA 2009 and one can expect stricter regulation in the US in the future, even if takes some time, if ever, for them to reach the same level as the most protective in Europe. Indeed, the First Amendment means that total bans on advertising will simply not be allowed. Europe itself contains differing views on regulation as was emphasised by the challenges to various tobacco control directives, notably by Germany, and this is reflected in the variations in national tobacco control policy.40

D Competence to Regulate for Tobacco Control

There is a need for clear authority to regulate tobacco.⁴¹ This has been a problem in both the US and Europe for different reasons. The US Supreme Court refused to grant the FDA jurisdiction over tobacco.⁴² This concerned the allocation of responsibility within a state. Although the rights and wrongs of the legal reasoning of the Supreme Court can be debated, the problem could have been avoided if there had been the political will to grant the FDA jurisdiction over tobacco as has now been achieved by the FSPTCA 2009. At the other end of the spectrum the US has also seen industry challenges to local laws, often relating to ETS. It has been commented that, except where there is express pre-emption, industry has tended to be unsuccessful in running constitutional equal protection arguments or implied pre-emption arguments. One survey found the industry lost or dropped 60 per cent of such cases.43 Arguments in favour of local laws are that they are easier to pass (local politicians may be more responsive to electorates, less easily influenced by lobbyists and less dependent on campaign contributions); generally stricter than state or federal laws; have higher compliance rates and stronger community support.⁴⁴

By contrast the European Court of Justice’s decisions annulling the tobacco advertising directive and eventually upholding the Tobacco Products Directive concerned the allocation of competence between sovereign states and a supranational authority.⁴⁵ There is a political debate about how great the role of Europe should be in public health and tobacco policy. Many in the public health community would prefer national standards to dominate if the price of European harmonisation is the acceptance of products and advertising whose consumer protection standards are not as strict as in the most protective member states. Harmonisation it is argued should not be the occasion for a step backwards in protection. This is not an argument against harmonisation in the form of approximation based on minimum standards, but rather against the current vogue for favouring maximal harmonisation. Any concerns about an unduly restrictive interpretation of the Community’s powers to act in relation to tobacco could be removed if the EU Treaty was revised to give a more explicit basis for harmonisation of public health measures rather than forcing measures to be based on internal market rationales.

The World Health Organisation has taken on an increasingly prominent role in tobacco policy,⁴⁶ but is acting as a prompt to national initiatives and so competence issues do not arise at the international level, although there has been a political debate as to whether tobacco should be given such a high priority. There have been attempts to shift responsibility for tobacco to agencies within the UN seen as more sympathetic to the interests of the tobacco industry.⁴⁷

(i) FDA – No Competence Until Obama

When the federal Food and Drugs Act was originally proposed nicotine had been one of the drugs listed to be subject to the FDA’s jurisdiction. Some argue that the industry successfully lobbied for its exclusion,48 as it did in every consumer protection statute enacted that century that otherwise gave federal agencies increased jurisdiction over other consumer products. However, Pringle suggests there is no evidence of this on the congressional record or in the papers of Dr Wiley, who had been in charge of the Agricultural Department’s Division of Chemistry.⁴⁹ Instead it is suggested that tabacum was dropped from the US Pharmacopoeia because its curative properties had been superseded by other substances. Senator Frank Moss had persuaded a US district court that the US Consumer Product Safety Commission should assert jurisdiction over tobacco, but that was swiftly reversed by legislation excluding tobacco from the Consumer Product Safety Act.⁵⁰

After many years of denying it had jurisdiction over tobacco products the FDA changed its mind and in 1996 published ‘Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents’.⁵¹ It determined nicotine was a drug and that cigarettes and smokeless products were drug delivery devices intended to affect the structure or any function of the body. These Regulations contained advertising and promotion controls targeted at such conduct that might be aimed at or influence children, controls on access by minors and labelling rules that would have required packages to state ‘Nicotine-Delivery Device for Person 18 or Older’.⁵² David Kessler, the FDA Commissioner had been alerted to the tobacco problem and saw his chance to act when evidence came to light of nicotine manipulation so that it was possible to argue the companies intended to have an effect of the body.⁵³ Politically the tide was also turning and opinion polls, paid for by plaintiff lawyers, convinced President Clinton it was not a political risk so long as the regulation was aimed at preventing youths smoking.

The original ‘global settlement’ would have prevented the FDA from eliminating nicotine from tobacco, but it could have reduced it so long as it proved this significantly reduced health risks, was technologically feasible and would not create a black market. These restrictions were attacked by the public health lobby and did not figure in the MSA and the FDA pressed on with its regulations. The District Court upheld FDA jurisdiction except for the rules on advertising and promotion,54 but the Court of Appeal denied jurisdiction⁵⁵ and this was upheld by the Supreme Court in Food and Drug Administration v. Brown and Williamson Tobacco Corporation, et al.⁵⁶

It was significant that the FDA had previously denied it had jurisdiction and had even gone to court to defend that position.⁵⁷ Although the majority of the Supreme Court agreed an agency was entitled to change its mind (and the dissent pointed to new knowledge of what the industry intended and scientific advances), it nevertheless saw the history as important context. It also pointed to several factors that favoured there being no jurisdiction. An important argument was that under the scheme of the Food Drug and Cosmetics Act if tobacco was to be regulated the majority considered it would have to be banned and such a solution could not have been intended to be cryptically delegated to an agency. Congress had itself passed six pieces of legislation on the topic without expressly granting FDA jurisdiction;⁵⁸ there had been many congressional attempts to grant FDA express jurisdiction; and, the FDA had itself denied jurisdiction both in the political administrative arena and in the courts. When in 1978 the Consumer Product Safety Commission successfully claimed jurisdiction in a court action,⁵⁹ Congress had stepped in and removed jurisdiction.⁶⁰

The decision is now only of historic interest given the FSPTCA 2009 has granted the FDA jurisdiction over tobacco; it turned on US constitutional issues and matters of statutory interpretation. Nevertheless, the central argument that jurisdiction could not be granted as it would mean banning the product is interesting. The FDA was certainly aware of this potential objection and had tried to head it off by arguing that a ban was not appropriate as it would be more dangerous to remove the product because of the effects on those already addicted. The majority derided this position as implausible, but the dissent noted that the arguments can also lead ‘with similarly “inescapable” force to precisely the opposite conclusion, namely, that the FDA does have jurisdiction but that it must ban cigarettes’. It also commented sagely that the public health promotion context of the legislation should not be forgotten. It certainly seems strange that the majority felt able to oust jurisdiction without overturning the basic findings that nicotine is a drug and cigarettes are delivery devices. Surely some controls would be desirable based on those facts. The argument that no controls should be delegated as this would require a ban, which is considered too drastic, is unappealing given that regulation could at least have sought to improve the product or drawn its dangers to public attention more effectively. However, Congress always had the power to grant jurisdiction and that it had acquiesced with the FDA in withholding jurisdiction is telling.61 The 1996 Regulations have been described as ‘more a challenge to Congress than a circumvention of it’⁶² and it affected the public perception of the tobacco issue. Clarity of legal basis is always desirable and that has now been achieved when a political change allowed Congress to rise to the challenge by enacting the FSPTCA 2009. The 1996 Rule has now been reissued as the Regulation Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Children and Adolescents (March 2010).

(ii) US Non-Commercial Speech Challenges

Traditionally US courts have been viewed as reluctant to strike down tobacco control laws. Typical, outside the field of advertising is the Supreme Court decision in Austin v. Tennessee,⁶³ that held that the regulation of cigarette sales was within the powers of the states: ‘Without undertaking to affirm or deny their evil effects, we think it within the province of the legislature to say how far [cigarettes] may be sold or to prohibit their sale entirely … and there is no reason to doubt that the act in question is designed for the protection of the public health’.

The Cipollone decision assisted the tobacco companies by pre-empting state laws.⁶⁴ The tobacco companies have also encouraged state laws that pre-empted local powers,⁶⁵ but have been equally willing to challenge state laws. Advertising is considered below, but the industry had a notable success in challenging a Massachusetts’ law requiring disclosure of ingredients that could be made public. The US Court of Appeals for the First Circuit agreed this was against the takings clause as it deprived the companies of their property in their trade secret.66

Local laws on ETS have been struck down, for example because they did not provide equal protection as different types of premises were treated in different ways.⁶⁷ However, most courts seem to have upheld local laws properly promulgated.⁶⁸ The equal protection argument has often been rejected.⁶⁹ Such laws have also been found to be justified by the scientific evidence⁷⁰ and not to restrict smoker’s freedom of association.⁷¹ The Environmental Protection Agency Report of 1983 that had labelled ETS a human carcinogen was also challenged.⁷² Although initially successful this was overturned on appeal to the Court of Appeals for the Fourth Circuit.⁷³

(ii) EU – Internal Market Competence

(a) Treaty provisions  Several legal challenges have been made to the EUs efforts to regulate tobacco alleging that the EU did not have the legal powers to enact various regulations relating to tobacco. These have been launched by tobacco companies, but also by Germany, which was out voted when the Tobacco Advertising Directive was adopted. Everyone had suspected that the German challenge would have been dropped when Kohl’s CDU party lost the election and a SPD/Green coalition came to power with the Greens taking over the health ministry. However, at least the official the line was that the case would continue to test the underlying constitutional issue about the extent of EU powers. However, some commentators are suspicious of the relationship between tobacco and politics in Germany.⁷⁴

The reason why constitutional issues arise is because the EU has limited competence. It can only act to the extent that its Treaties provide it with competence. Some powers fall within the Community’s exclusive competence, others are shared with the Member States. In areas that do not fall within its exclusive competence the Community should adhere to the principle of subsidiarity and only act where the Community is the superior actor rather than the member states.75 The Community has no power to legislate in the field of public health.

Article 152 (ex. 129) of the Treaty dealt with public health at the time many of the relevant directives were adopted. It provided that a high level of human health protection shall be ensured in the definition and implementation of all Community policies and activities;⁷⁶ the Community shall encourage cooperation between member states and if necessary lend support to their actions;⁷⁷ and foster cooperation with third countries and competent international organisations in the sphere of public health.⁷⁸ The Council was authorised to adopt incentive measures to contribute to the achievement of these public health objectives, but the nub is that this power expressly excluded any harmonisation of the laws and regulations of the Member States.⁷⁹ It is also possible to adopt Recommendations, but these are non-binding.

The failed European Constitution had proposed adopting the same pattern for public health controls, but the word ‘tobacco’ was to have made its first appearance in an EU Treaty. This aspect has been retained in the Treaty of Lisbon which amended Art. 152(5) to provide,