The tobacco industry braces for the fallout of “Uruguay” and the recommendations about to be issued by the FDA’s tobacco products committee.
By George Gay
In a report to the executive board of the World Health Organization earlier this year, Director General Dr. Margaret Chan said the organization was not performing well enough across all of its activities because it was overextended and needed to trim the scope of its operations.
In fairness, this mea culpa took up only a small part of the report, and Chan talked also of instances where the WHO had enjoyed considerable success.
Nevertheless, Chan went on to say she believed that the level of WHO engagement should not be governed by the size of a health problem, but by the extent to which the WHO could have an impact on the problem. Others, she believed, might be positioned to do a better job.
I would be interested to know whether Chan would include in “others” the Framework Convention on Tobacco Control (FCTC). This body was born of the WHO but is often spoken of as existing independently of its parent. Perhaps it has just grown up and moved on, rather like a student going away to university. In fact, this is possibly a good analogy. The lifestyle choices of both leave something to be desired, and I don’t mean only that they both tend to live beyond their means, or what should be their means.
This is what British American Tobacco had to say in November in a note posted on its website: “Vague and partial guidelines on tobacco product regulation, including on the use of ingredients, were adopted last week by governments gathered in Uruguay for the World Health Organization’s tobacco control conference—despite the fact they offer little guidance on implementation of these recommendations.
“Delegates at the weeklong event, known as the Conference of the Parties [the FCTC’s fourth conference of the parties, COP4], were asked to consider far-reaching recommendations similar to legislation recently passed in Canada which bans the use of almost all ingredients in cigarettes—despite the fact there is no scientific evidence which supports the theory that cigarettes with ingredients are any more addictive or attractive than cigarettes without ingredients.
“Despite objections from many tobacco growing countries across the world, and a highly-charged debate culminating in a ten hour committee meeting, it was decided that the unfinished guidelines on this complex subject be accepted—regardless of the lack of clarification on key aspects and the absence of sound scientific evidence to support them.”
The Canadian model
Of course, since these comments came from a major international tobacco manufacturer, many people will dismiss them as just the automatic gainsaying of anything put out by the FCTC. But this would be wrong because BAT has been making strenuous efforts to reach out and publicly debate difficult issues, something that was reflected in a comment attributed within the website note to Michael Prideaux, director of corporate affairs, who said, in part: “However, we are encouraged by the newly included text in the partial guidelines that governments ‘should consider scientific evidence, other evidence and experience of other countries when determining new measures on ingredients of tobacco products’ and we urge governments to do just that.”
This is essential in fact if chaos is to be avoided. Canadian manufacturers, which serve largely a Virginia cigarette market, have been able to cope with the ban on most additives. But shortly after the COP4 meeting at Punta del Este, Uruguay, on Nov. 15-20, in a move that had been foreshadowed before that meeting, Brazil’s National Health Surveillance Agency (Anvisa) launched a public consultation on whether the country should ban additives from tobacco products. Submissions are due to be accepted until the end of March.
Despite the lack of evidence against the traditional ingredients added to tobacco products, the agency seems in no doubt about the effect of the use of flavors. “The flavors stimulate initiation of smoking in youth and adolescents and mask the unpleasant taste and odor of cigarettes,” said Anvisa’s manager of tobacco products, Humberto Martinez.
One thing that should be pointed out here is that though the second part of Martinez’s statement seems at first reading to be in line with what some in the tobacco industry might say, it is subtly different and, in my view, wrong. What Martinez is saying is the equivalent of claiming that sugar is used to mask the unpleasant taste of chocolate. In fact, I suppose, sugar is added to cocoa to mask the bitter taste of cocoa, so that it can be made into chocolate. And in the same way, flavors are added to tobacco to mask some of its unpleasant characteristics, so that it can be turned into cigarettes.
Mane’s Dr. Roger Penn put this more elegantly when he told me that what had to be remembered was that there were only two classical uses for tobacco flavors. One was to help level out the variation in the tobacco base and make a consistent product given variations in tobacco crops. The other was to put a “signature” on a product to create product differentiation on the market.
Anvisa, meanwhile, evokes the bans imposed in both Canada and the U.S., but it seems to be leaning toward a more extreme Canadian model. Additives are considered to be any substance or compound other than tobacco or water used in processing, manufacturing and packaging of a tobacco product.
Also, Anvisa is not confining itself to cigarettes. The ban would apply to products that use tobacco and that are smoked, inhaled or chewed.
One of the problems here is that Brazil’s market, unlike Canada’s, comprises modified blended products, and it seems highly unlikely that Brazilian manufacturers could produce such cigarettes without the use of some additives.
As Penn put it: “The unfortunate thing about Anvisa in Brazil is that they are advocating a ban, as per Canada, presumably because Brazil has been following Health Canada very closely for quite a few years.
“If it is a Virginia market, it is easier to sustain without flavorings because they are not used in the majority of products. But if you ban flavors in Brazil, for instance, or Germany, or France, or Switzerland, where there are modified blended products, you will wind up with harsh, irritating products that produce hot temperatures when smoked. People won’t buy them. So you kill that product, but, guess what, you get contraband shipped in from various parts of the world.”
At this point I asked Penn whether or not he had heard of any other countries planning to ban or regulate additives in tobacco products, and he said he had not. However, he is concerned that, depending on what happens in Brazil, there could be a domino effect.
Eduardo Berea, of Mother Murphy’s, also believes that Brazil could prove pivotal, at least among the countries of Latin America. Brazil was the first country to add delivery numbers to its packs, he said, and now you could find such information throughout Latin America.
Berea made the point that it would not be possible to make a reasonable product in Brazil without using casings, since local burleys had low levels of sugars that needed to be compensated for with the addition of casings.
He said it might be possible in Brazil to make a cigarette without top flavors, but a manufacturer would not be able to create a distinctive pack aroma, and it would be much more difficult to create distinctive products because there would need to be a different blend for every brand.
A note of explanation is needed here. We all tend to use the word flavor as shorthand, when what we are often talking about are casings, flavors or top flavors, or any combination of these. Casings, Berea explained, were used both in Virginia- and American-blend products, but the functionality was different. With Virginia (flue-cured) blends, the purpose of a casing was mainly to add humectants such as propylene glycol or glycerin—both of which are permitted even in Canada—with the objective of improving the humectation of the flue-cured tobacco, since sugar tended to bind to water and since, otherwise, flue-cured was not able to absorb too much liquid.
In the case of American-blend products and especially on the burley component, a casing was added that commonly comprised juice concentrates, chocolate, cocoa powder or cocoa extract, licorice and humectants. In this case the main objectives were to correct the sugar/nicotine ratio of the tobacco to make it a smokeable product, and to round—with the cocoa components and the licorice—the flavor.
Top flavors were used mainly to create a distinctive brand identity not only in the smoke but in the pack aroma as well.
Following the science?
Meanwhile, at an international level, Penn is hoping that the scientific argument wins out and that manufacturers continue to be allowed to use traditional tobacco additives. But, if not, he hopes that flavors are not banned but their application levels regulated.
And as reported by BAT, the tobacco industry’s position received something of a scientific lift when the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks recently acknowledged the lack of scientific evidence to support the idea that—“bearing in mind the broad meaning of ‘attractiveness’—a specific additive affected the attractiveness of tobacco products intended for smoking.”
Berea is greatly concerned about the science surrounding the tobacco flavors issue, or rather, he’s concerned with the lack of science. He sees the arguments put out by bodies such as the WHO’s FCTC and the U.S. Food and Drug Administration’s Center for Tobacco Products as being “infected” with the “quit or die” mentality.
Nevertheless, science is seen by some as the way forward and, in the middle of February, a senior executive of Lorillard—about 85 percent of whose sales are of menthol cigarettes—urged an FDA advisory panel not to lose sight of the congressional and FDA mandate to “follow the science” in developing its report and nonbinding recommendation regarding the use of menthol in cigarettes.
This sounds all well and good, but to my mind the idea that decisions on menthol can be made on the basis of science is wishful thinking. Congress’ exemption of menthol from its ban on characterizing flavors must have been based on economics and politics. And now, the rationale for that original decision is meeting science in a confluence that can result only in political expediency. This need not be a bad thing as far as the tobacco industry is concerned, however. Politics and economics exempted menthol in the first place, and it seems likely that they can come together with science to keep that exemption in place.
Currently, the FDA’s Tobacco Products Scientific Advisory Committee (TPSAC) is developing a report and recommendations on the impact on public health of the use of menthol in cigarettes that is due by March 23. And there are a number of aspects of this process that are encouraging. For instance, the FDA has asked tobacco industry representatives who serve on the committee to develop an industry perspective document on the public health impact of menthol cigarettes that will accompany the report.
Also, the TPSAC intends to discuss draft report chapters at open public meetings before they are finalized, and copies of these chapters are to be made available on the TPSAC website.
And there is no required deadline or timeline for the FDA to act on the recommendations provided by the TPSAC in the report.
But there are aspects of what the FDA says that makes me uneasy. For instance, it says that any actions that it might take that lead to restrictions on the sale of menthol products or the establishment of product standards would require formal rule making that would include public notice and comment. It seems to beggar belief that if the science on flavors is uncertain to the point where menthol is not banned, there could be any basis outside of the magic circle for, say, the reduction of levels of menthol in cigarettes.
But moving back to the international scene, there are other reasons to remain hopeful. Chan in her report made the point that many organizations involved in global health issues were facing serious funding shortfalls. I take no comfort in this where such shortfalls will cut meaningful health initiatives. But, clearly, it would seem to be reasonable that, given the current economic problems in many places, anti-tobacco organizations, like other bodies, should suffer cuts in respect of ideas that have no prospect of improving health and that could lead to severe economic losses in some of the countries least well able to withstand them. The additives issue is one such idea, and, as Chan says, the emphasis should be on what the WHO can achieve, not the
size—or, presumably, the perceived size—of the problem.