People have died from tobacco-related diseases since the opening of the first FCTC working group on 28 October 1999.
Effective measures regulating the packaging and labelling of tobacco products are a key component of a comprehensive tobacco control strategy. As WHO recognizes, “despite overwhelming evidence of the dangers of tobacco, relatively few tobacco users worldwide fully understand the risks to their health”.  Package warnings are effective in increasing awareness of the health effects of tobacco use and exposure to tobacco smoke, and decreasing tobacco consumption.  Unless prohibited from doing so, tobacco companies use packaging and labelling to communicate misleading and deceptive messages about the harmfulness of products.
Regulations on packaging and labelling of tobacco products are highly cost-effective. Governments determine the regulatory requirements, and the tobacco industry pays the cost of implementation. A single national law affects every package of tobacco products sold in a country.
The most effective package warnings contain a rotating series of large, picture-based messages about the health effects of tobacco use, together with cessation information and other relevant messages, are located on both the front and back of each package (with the front more important), and are periodically updated to keep messaging fresh. Warnings that include pictures are far more effective than text-only warnings, and larger warnings are more effective than smaller warnings.  The use of pictures is especially beneficial for low-literacy populations and for people (including immigrants, speakers of a minority language, temporary workers and visitors) who speak a language other than a Party's official language(s). At least 19 jurisdictions in five WHO regions have finalized requirements for picture warnings,  while many other jurisdictions are in the process of doing so. A growing number of countries have adopted warnings larger than 50% as an average of the front and back of a package: these include Australia (60%), New Zealand (60%), Belgium (56%), Switzerland (56%) and Finland (52%). Surveys have consistently found that the majority of smokers (as well as the general population) support large warnings that include pictures. 
Effective regulatory requirements are also required to prevent the tobacco industry from communicating false, misleading or deceptive messages through tobacco product packaging and labelling. In many countries, the International Organization for Standardization (ISO) yield numbers appears on the side of packages for tar, nicotine and carbon monoxide. This may be as a result of a national law, or because of voluntary industry practice. There is a widespread mistaken consumer perception that a cigarette brand with a lower ISO tar yield is less dangerous for their health. However, it is now recognized that this is not the case. 
The ISO machine test method does not accurately reflect human smoking behaviour. Most people smoke because they are addicted to nicotine, and smokers, unlike machines, alter the way they smoke to achieve their preferred nicotine levels, a process known as compensation. Smokers can alter the way they smoke by taking more or deeper puffs or covering the ventilation holes. These holes are positioned in the filter where smokers place fingers or lips, and therefore are easy to block. The ISO method thus cannot be used to measure what smokers are actually taking in from their cigarettes and does not accurately reflect exposure of smokers to carcinogens and other toxins, largely underestimating exposure particularly with ‘lower tar' cigarettes. The WHO Scientific Advisory Committee on Tobacco Product Regulation has concluded that “Tar, nicotine and CO numerical ratings based upon current ISO/ U.S. Federal Trade Commission (FTC) methods and presented on cigarette packages and in advertising as single numerical values are misleading and should not be displayed.” 
A series of studies and reports are listed at the end of this document. For a summary, see generally: David Hammond, “Tobacco Labelling & Packaging Toolkit: A guide to FCTC Article 11” January 2008. http://www.igloo.org/community.igloo?r0=community&r0_script=/ scripts/folder/view.script&r0_pathinfo=%2F%7Bf0ce20c6-7a3c-409a-a5c9 -15e2b251a129%7D%2Ftobaccolab&r0_output=xml
For a fact sheet, see: David Hammond, “FCTC Article 11 Fact Sheet: Health Warnings on Tobacco Packages” February 2008. http://www.igloo.org/tobacco_labelling
Hammond, D., Fong, G.T., McDonald, P.W., Brown, S., & Cameron, R., “Graphic Canadian Cigarette Warning Labels and Adverse Outcomes: Evidence from Canadian Smokers. American Journal of Public Health , 2004;94, 8:1442-5; O'Hegarty, M., Pederson, L.L., Nelson, D.E., Mowery, P., Gable, J.M., Wortley, P. “ Reactions of young adult smokers to warning labels on cigarette packages” American Journal of Preventive Medicine , 2006;30(6): 467-473; Datafholha Instituto de Pesquisas, “76% são a favor que embalagens de cigarros tragam imagens que ilustram males provocadoes pelo fumo; 67% does fumantes que viram as imagens afirmam terem sentido vontade de parar de fumar” Opinião pública, 2002.
For further background, see: Framework Convention Alliance for Tobacco Control, “Tobacco Product Regulation” (Factsheet #4), available online at http://fctc.org/factsheets/4.pdf ; Framework Convention Alliance for Tobacco Control, “Developing Effective Product Regulation Under the FCTC” (Briefing Paper prepared for the first session of the Conference of the Parties to the WHO Framework Convention on Tobacco Control, February 2006), http://fctc.org/iwg_cops/COP1/bp5.pdf .
WHO Scientific Advisory Committee on Tobacco, “SACTob Conclusions on Health Claims Derived from ISO/FTC Method to Measure Cigarette Yield” (2002) 4, http://www.who.int/tobacco/global_interaction/tobreg/en/iso_ftc_en.pdf.
David Hammond, “FCTC Article 11 Fact Sheet: Prohibiting Misleading Information on Tobacco Packages” February 2008. http://www.igloo.org/tobacco_labelling.