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| Technical Aspects of Tobacco Regulation |
| Source from:TJI 03/19/2010 |
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As governmental regulations of tobacco products are implied, few understand the technical complexities of developing meaningful regulations on product composition and deliveries.
Achieving satisfactory laboratory performance on those test methods is another key factor. Consequently, the purpose of this series of columns will be to address the technical issues involved in tobacco products regulation from a corporate management (including legal and regulatory) perspective, not from the view of the technical personnel in the laboratory. This perspective is needed because those at the corporate level are often those who interact with regulatory agencies, not those at the laboratory level. This is unfortunate, as those at the laboratory level have to get acceptable quality using test methods written by regulators who know relatively little about how to sample and test tobacco products. Where practical, important laboratory-level issues will be included in the discussion.
Co-operation is essential
In the early days of tobacco regulations, there was co-operation between the tobacco industry and the governmental agencies that were doing the regulation. This was, and still is, essential if the best quality data are to be obtained. Tobacco products are complex materials that are inherently variable and less stable than many other packaged consumer goods. Not all styles of tobacco products are amenable to the same conditions of test, and standard test methods such as the Coresta-recommended methods and the ISO standards do not cover every eventuality. Standard methods also assume that those in charge of the testing are well trained and know how to deal with atypical products and changes in the test methods mandated by regulatory agencies.
Furthermore, when novel products are developed in the tobacco companies' R&D laboratories, any difficulties in testing the product by the company's standard methods are worked out during the R&D process. The testing procedures for novel products could be passed onto the laboratories that were testing those products for regulatory compliance. For example, when novel cigarette products such as Eclipse were introduced, the Tobacco Institute Testing Laboratory (TITL), which was conducting tar, nicotine, and carbon monoxide tests on behalf of the US Federal Trade Commission, learned how to analyse the product and worked from a journal article written by the manufacturer's scientists.
Not only was there co-operation on novel products, but there was co-operation between TITL and the participating laboratories. This not only included making sure the firm employed by TITL to buy samples at retail (two packs per city for up to fifty cities) could find the brand styles to be tested, but also use of a monitor cigarette and frequent collaborative studies so each laboratory knew how it was performing versus the other laboratories. These frequent collaborative studies allowed participating laboratories to detect and correct performance issues before they resulted in serious data quality issues.
Minimised collaboration
Could that type of co-operation happen in today's environment? Not likely. Based on reports available from the WHO Framework Convention on Tobacco Control (FCTC), it appears that contact between laboratory personnel in regulatory agencies with laboratory personnel in the industry is to be minimised. Since expertise in the testing of tobacco products outside the industry is limited and concentrated in several commercial laboratories, there are few opportunities for regulatory personnel to obtain detailed information about tobacco products and how to analyse them. While many laboratories can obtain high-quality data on reference products [e.g., the KY3R4F reference cigarette (king size, normal circumference)] whose analytical values are well known, can they also get equal quality data on commercial products that require special care during analysis (e.g., an ultralight 120-mm long cigarette with ultra slim circumference)?
Inexperience and lack of training can lead to regulators making requests for information on product composition that are not only poorly stated but for which analytical methods do not exist. For example, in November 2009, the US FDA's Center for Tobacco Products (CTP) issued its final Guidance for the industry - Listing of ingredients in tobacco products.
In that document, the CTP asks each tobacco product manufacturer to identify reaction products used to formulate its products and also to identify each reaction product formed during processing. The form developed by the CTP to report such information also specifies that each tobacco manufacturer must give the quantities of the reaction products that can be found in a given tobacco product.
Many of the reaction products found in tobacco products come from the reactions of reducing sugars (e.g., glucose, fructose) with ammonia, ammonia-containing compounds (e.g., DAP, also known as diammonium phosphate) and/or amino acids. Such reactions do not yield single products, but tens of products ranging from very volatile compounds that have an odour reminiscent of chocolate, to very large polymeric molecules, which can break down when the tobacco is smoked to compounds that give smoke a burley character. The CTP did not provide any guidance on how to analyse tobacco products for such reaction products. Moreover, only a few scientists in the tobacco industry worldwide have the knowledge and access to the sophisticated scientific instrumentation needed to analyse some of the reaction products.
Furthermore, and most importantly, there has been little evidence found to date that the presence of reaction products in tobacco products increases the well-known health hazards associated with tobacco use.
Overcoming the costs
While the major tobacco manufacturers may have the scientific expertise, laboratories, and legal resources to deal with less than scientifically relevant information requests by the regulatory community and incorrect assertions from the regulatory laboratories of out-of-compliance product, the smaller tobacco product manufacturers do not have such resources.
Compliance with requests by regulators for ingredient information and analytical data that have little, if any, relevance to the toxicological properties of the product can become financially burdensome. In essence, the regulatory process is being used to eliminate the smaller manufacturers, not to reduce the hazards associated with tobacco use. One way the smaller manufacturers can partially overcome the costs of regulatory compliance is to pool their buying power to obtain better value when purchasing consulting and testing services needed to meet regulatory requirements. Another way to reduce the costs of regulatory compliance is to simplify products and processes. Complexity not only adds to costs but it increases the chances that non-conforming product will enter the marketplace.
Future columns will deal with ingredient reporting, testing, and reporting of analytical data, and good manufacturing practices. Suggestions for additional topics are most welcome. Enditem
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