Laws and regulations governing rotation of health warning labels on cigarette packs in the Region of the Americas.

Objectives: To provide detailed information about how countries in the Region of the Americas are fulfilling the requirements set out in the guidelines for the implementation of Article 11 of the WHO Framework Convention on Tobacco Control in relation to the rotation of health warning labels and to identify possible challenges in the implementation of the laws or regulations governing the rotation.
Methods: We first searched for and identified all the relevant laws or regulations pertaining to health warning labels on cigarette packs in 24 countries and territories in the Region of the Americas. We then analyzed these documents to see whether the requirements in the guidelines of the WHO Convention were being met, identifying similarities and differences across countries.
Results: We found that the majority of countries (18/24) rotate the warning labels within the 12-36 month period recommended by the WHO Convention, and about half (13/24) have sets of 8 to 12 warning labels, thus complying with the additional regional guidance, which adds other stipulations. Across the Region, there is variability regarding transition periods between sets, which range from 1 to 6 months. In the majority of countries, the leading authority in charge of warnings is the Ministry of Health. Conclusions: Our analysis shows that even when countries' laws meet the requirements of the WHO Convention, there are still challenges. Most countries' laws require future legislation or regulations to be adopted before new iterations of warnings can come into effect. If legal instruments are not adopted in a timely fashion - which is occurring in many countries - new warning labels are not implemented on time, and message fatigue becomes a risk.

Health warning labels (HWLs) are most effective at communicating the risks of tobacco use when they include both pictures and text, and are large and in color (1, 2). Evidence shows that HWLs must be rotated periodically to remain effective. Rotation allows for more targeted messaging for subgroups within a population (2).

There is limited evidence about the best time frame for rotating HWLs. The few studies conducted show that HWLs decline in effectiveness over time. One study found evidence of significant warning wear out in Canada and the United States during a 9-year period (3). Another study looking at 10 European countries found that periodically introducing new warnings helped maintain their effectiveness over time (4). Wear-out effects can be general (i.e. people get used to the presence of warnings) or specific to the actual content of the warning. Rotating warnings and changing their layout and design are vital to maintaining saliency and effectiveness (5).

Article 11 of the World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) establishes packaging and labeling requirements for tobacco products that reflect the evidence (6). While not offering in-depth detail, the accompanying Guidelines establish that warnings on tobacco products should be rotated and that rotation can be “implemented by having multiple health warnings and messages appearing concurrently or by setting a date after which the health warning and message content will change” (5).

The Guidelines establish a broad period for HWL rounds, suggesting that they should last for 12–36 months. This is in line with the literature that recommends rotation cycles of at least every 12–24 months and that cycles are not longer than every 48 months (7). The Guidelines do not establish how many warnings are ideal per set (i.e. a group of HWLs put into rotation at and for a specific period). An evidence-based tool kit on implementing HWLs suggests that a set should have 8–12 warnings that appear concurrently (7).

Additionally, the Guidelines advise that national legislation should: specify the number of HWLs to appear concurrently; for the HWLs in a specified set, each appear on an equal number of retail packages; establish two or more sets of HWLs to alternate after a specified period; during transition periods between sets, establish a phase-in period for rotation when both sets may be used concurrently (5).

Apart from the WHO Guidelines, countries in the Caribbean can use the CARICOM (Caribbean Community) Regional Standard for labeling tobacco products, which provides more specific requirements. The Regional Standard specifies that warnings should be divided into two distinct sets, each made up of eight different HWLs (8). Like the WHO FCTC Guidelines, the Regional Standard also mentions that the HWLs should be evenly distributed among each company’s tobacco products, with each specific HWL (pictogram or text, or both) appearing on an equal number of retail packages. Additionally, no set will be utilized for more than 16 months, and within those 16 months, transition periods will be determined by national legislation (8).

Globally, there is much variety in the number of warnings per set and the length of the rotation period. As of 2018, at least 118 countries or jurisdictions had finalized requirements for warnings (6, 8). One report lays out the number of HWLs in a rotation set and the rotation time for 14 low- and middle-income countries (7). A second report, the Canadian Cancer Society’s international status report on cigarette HWLs, indicates during which years in the 134 countries or jurisdictions in the report, “there have been two or more rounds of picture warnings” (9). Table 1 shows examples from these two reports with the number of sets and rotation periods for HWLs in 11 countries or areas.

TABLE 1.

Examples of international requirements for the numbers of sets and warnings and rotation periods for health warning labels on cigarette packs, 2010–2018

Country or area	No. of sets of warnings (no. of warnings, if applicable)	Rotation period[a]
Australia	2 sets (7 warnings)	12
European Union (countries following Directive 2014/40/EU)	3 sets (not specified)	12
Liechtenstein and Switzerland	3 sets (14 warnings)	24
New Zealand	2 sets (7 warnings)	16
Pakistan	0 sets (1 warning)	12
Philippines	1 set (12 warnings)	24
Russian Federation	1 set (13 warnings)	12
Türkiye	1 set (14 warnings)	14
Ukraine	1 set (10 warnings)	5 years
Viet Nam	1 set (6 warnings)	24

Rotation periods are months unless otherwise specified.

Countries that mandate more than one set of HWLs have rotation periods for the sets. During each rotation period, only one set of HWLs is present (except during transition times, when two sets may be in circulation). It is not always clear from the laws or regulations whether these sets are indefinitely rotated or if they rotate only once before two new sets are introduced. Some countries have sets in circulation only once before a new law or resolution is needed to issue a new iteration of warnings. In some countries, it is unclear how rotation periods work when only one set is mentioned in the law.

International reports, such as the Pan American Health Organization’s Report on tobacco control in the Region of the Americas 2018 (10) and the WHO report on the global tobacco epidemic, 2021 (11), broadly establish whether countries in the Region of the Americas have HWLs with pictograms and rotation. However, they do not provide details about the different components that the laws or regulations should set out (e.g. the number of sets, rotation times, transition rules and schedules, and penalties or fines) or whether regulations have been passed to update HWLs periodically. Without this information, it is difficult to establish whether HWLs are being properly implemented.

To fill in some of these gaps in knowledge, we describe the extent to which countries in the Region of the Americas are meeting the requirements for rotating HWLs on cigarette packs as laid out by the Guidelines for the implementation of Article 11 of the FCTC, as well as some of the key regulatory challenges related to HWL rotation.

MATERIALS AND METHODS

For this analysis, we examined the laws, regulations and ministerial resolutions in 24 countries and territories in the Region of the Americas. Initially, we included the same 23 countries designated as requiring pictograms and rotation periods as were in the WHO Report (11). From those 23 countries we eliminated two: Nicaragua, because although its regulation was adopted in 2010, it has not been implemented according to the WHO Report, and Paraguay, which had no official information available online. Finally, we added Antigua and Barbuda, Bermuda, and Turks and Caicos, which were missing from the WHO Report but have requirements for pictograms and rotation that were available online. The final list included 24 countries (Antigua and Barbuda, Argentina, Barbados, Bermuda, Bolivia [Plurinational State of], Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Guyana, Honduras, Jamaica, Mexico, Panama, Peru, Saint Lucia, Suriname, Turks and Caicos, Trinidad and Tobago, Uruguay and Venezuela [Bolivarian Republic of]).

From February to November 2021, FA identified all the relevant laws or regulations by reviewing official government websites and publicly available databases, such as the Campaign for Tobacco-Free Kids’ database of tobacco control laws. FA read the laws, regulations and resolutions, looking for components of the WHO FCTC Guidelines for implementation of Article 11. FA created a database with the following categories: the numbers of warnings and sets in rotation at one time; the rotation period and period for each iteration or round; transition schedules; notices to manufacturers or distributors; authority in charge of warnings; penalties or fines; and other relevant elements.

This database was reviewed with the coauthors. All documents were then reread to ensure database completeness. Finally, all the categories were analyzed to determine whether the information available fulfilled the requirements set out in the FCTC Guidelines and to identify similarities and differences across countries. Whenever there was a lack of clarity or ambiguity in the documents, the coauthors consulted until consensus on the meaning was decided. All information for each category extracted from the laws or regulations governing the rotation of HWLs is available as supplementary material (https://www.globaltobaccocontrol.org/paho-hwl-laws).

RESULTS

Number of warnings in rotation at one time

There is wide variety in the number of warnings required to be in rotation at one time, ranging from 4 (e.g. Guyana and Turks and Caicos) to 16 (Canada). There are two countries with less clarity about the number: in Honduras, none of the laws or regulations clarify how many warnings must be in place, and for Antigua and Barbuda, the laws or regulations set only a minimum number of six warnings. Mexico’s numbers vary depending on the iteration: ministerial resolutions that established the number of warnings created 10 iterations from December 24, 2009, to November 30, 2021, and these have included anywhere from 2 to 11 warnings.

Other countries have established rotation schedules and defined the number of sets and the specific HWLs when their initial rotation laws were passed. For example, some Caribbean countries (e.g. Barbados, Jamaica and Saint Lucia) follow the CARICOM Regional Standard and have 16 pictograms divided into two rotating sets. These countries alternate the two sets rather than developing new warnings every time the rotation period ends. Other countries have pairs of pictograms. A pair is two different warnings that go together on one pack, carton or product as part of the overall HWL (e.g. one HWL on the front and one on the back of the pack). For example, Chile has four pairs and Uruguay has eight images divided into four pairs, or series.

Rotation times

There is also a wide range of rotation times, ranging from 5 months (e.g. Brazil) to 24 months (e.g. Antigua and Barbuda, El Salvador). Of the 24 countries, 18 (75%) had rotation times within the 12–36 month period set by the FCTC Guidelines. The remaining six countries change the rotation more frequently (e.g. Brazil, 5 months) or do not specify rotation times (e.g. Bermuda, Bolivia [Plurinational State of], Canada, Turks and Caicos, Venezuela [Bolivarian Republic of]). Bolivian law does not state a rotation period, but it does state that future regulations must specify one. However, we could not find any regulations that contained this information.

In some instances, rotation periods may be longer if resolutions to introduce and implement new warnings are not passed. In many of these countries, the law specifies that resolutions establishing HWLs must be passed by the competent authorities every time new warnings are required. While the laws state the periods during which this should happen, these new provisions are not always introduced in time (or at all). For example, our analysis found that the law in Mexico states that rotation periods will last for 6 months for a set of two warnings and 12 months for a set of four warnings. However, in 10 rotation periods during the past 12 years, three lasted 6 months, four lasted 12 months, one lasted 20 months and one lasted 30 months. These times have not necessarily been consistent with the number of warnings in a set, nor do they seem to follow any specific pattern. Other countries, such as Suriname, foresaw that delays were possible and included provisions for HWLs to be extended for 18 months if resolutions for new warnings were not passed.

In most countries, it is unclear how many rounds of warnings have been passed in the legislation or implemented. There are some clear examples, such as Mexico, where there have been 10 rounds, and Ecuador, where 9 rounds have been implemented. In these two cases, each new regulation is available online. However, we could not find updated regulations for most countries. For example, the latest resolution we could find for the Bolivarian Republic of Venezuela was published in November 2013.

Transitions between sets

There is variability in the Region regarding when tobacco companies (including companies that produce, manufacture or import tobacco products) and other tobacco-related entities (including retailers who sell tobacco products and external companies that make the packaging) have to take products with old HWLs out of rotation. Several countries’ laws or regulations do not specify whether packs with old HWLs can stay on the shelf at retailers when new ones come into rotation. Other countries establish a number of days for the transition period, ranging from 30 to 90 days, or months, ranging from 2 months in Costa Rica and Honduras to 6 months in Antigua and Barbuda. Countries using the CARICOM Regional Standard as guidance define the transition periods in their schedules, as in the example of Barbados’ schedule (Table 2). In these instances, there are 4 months during which one set is introduced and the other is phased out.

TABLE 2.

Example of rotation of health warning labels on cigarette packages, Barbados, 2017

Rotation of Health Warnings Periods
Even Year	Month	Odd Year
(e.g. 2008)		(e.g. 2009)
Set B exclusively	January	Set A exclusively
Introduce Set A, phase out Set B	February	Introduce Set B, phase out Set A
Introduce Set A, phase out Set B	March	Introduce Set B, phase out Set A
Introduce Set A, phase out Set B	April	Introduce Set B, phase out Set A
Introduce Set A, phase out Set B	May	Introduce Set B, phase out Set A
Set A exclusively	June	Set B exclusively
Set A exclusively	July	Set B exclusively
Set A exclusively	August	Set B exclusively
Set A exclusively	September	Set B exclusively
Set A exclusively	October	Set B exclusively
Set A exclusively	November	Set B exclusively
Set A exclusively	December	Set B exclusively

In Chile and El Salvador manufacturers can request authorization to keep products with old HWLs in rotation for a certain period. For example, in Chile, if there are products in warehouses with the previous HWLs when the new HWLs come into force, authorization must be requested from the health authority to continue to distribute them. An exception may be granted only for an amount of product equivalent to that distributed during the previous month.

Notices to manufacturers and distributors

Most laws establish where new HWLs will be published and how manufacturers or distributors will be informed and what processes they must follow. In most cases, new HWLs are published through official government channels, such as official gazettes. New resolutions (e.g. from the Ministry of Health) are published in these daily publications for the general public and interested parties. Several laws mention that electronic annexes must accompany the gazette postings about HWLs. Tobacco companies must take the HWLs directly from the electronic files approved by the relevant authority. Some countries, such as Colombia and Honduras, go further to ensure that HWLs meet the appropriate criteria and maintain the same quality by specifying detailed timelines for obtaining government approval of proofs for the HWLs. Some laws also establish how long in advance the government has to inform manufacturers about new HWLs before they go into effect (e.g. Costa Rica, Peru).

Authority in charge of health warning labels

In more than 70% (17/24) of the countries analyzed, the authority in charge of providing the warnings and introducing the necessary resolutions is the health authority or the Ministry of Health. Some laws specify the departments within the Ministry of Health that oversee packaging and labeling, such as the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária) in Brazil. A few countries have other health-related offices, such as the Honduran Institute for the Prevention of Alcoholism, Drug Addiction and Drug Dependency (Instituto Hondureño para La Prevención Del Alcoholismo, Drogadicción y Farmacodependencia) or the Federal Commission for Protection against Health Risks in Mexico (Comisión Federal para la Protección contra Riesgos Sanitarios). Others have chosen authorities outside the health space for this role. These include the Barbados National Standard Institution, the Ministry of Health and Social Protection (Ministerio de Salud y Protección Social) in Colombia, and the Office of the Attorney General and Ministry of Legal Affairs in Trinidad and Tobago.

Penalties and fines

Some countries’ health laws set out general penalties or fines. Others establish general penalties or fines in their tobacco control laws: these are not specific to HWL rotation but are included in sections about violations of packaging and labeling standards. For example, Barbados’ legislation states that individuals who manufacture, distribute or sell a carton or package that fails to comply with labeling requirements (including rotation of HWLs) are liable to a fine of 5000 Barbados dollars or imprisonment for a term of 12 months, or both. In other instances, the regulations have sections governing packaging and health warnings that set out the penalties or fines specifically around rotation. For example, Antigua and Barbuda’s Tobacco Control Act states that “…at the end of the six months rotation period, in addition to any penalty to which the responsible person may be subject, any packaging and labeling with the warnings from the prior rotation period, along with the contents of the package, shall be subject to confiscation and destruction” (12).

Regardless of where the penalties or fines are defined in laws or regulations, it is not always clear who inspects packaging and enforces penalties for violations. Some laws name the office or authority that oversees control and enforcement (e.g. in Chile, there are the regional ministerial health secretariat and municipal inspectors) but do not describe more specific mechanisms. Other laws go a step further, setting out general action plans. Colombia’s law states that “police authorities will perform random inspection procedures, oversight and control of points of sale, with the purpose of guaranteeing compliance” (13). In Peru, the law states that municipalities, the Ministry of Health, and the Permanent National Commission on the Anti-Tobacco Fight (Comisión Nacional Permanente de Lucha Antitabáquica) will make the necessary inspections to ensure compliance within the sphere of their respective competencies. However, more detailed plans of action are unavailable. For 13 of the 24 (54%) countries analyzed, we could not find any information about the sanctioning body or the established penalties or fines.

In the countries that have established sanctions, penalties or fines include monetary penalties, imprisonment, the confiscation and destruction of products, possible cancellation of sales authorization for tobacco products, and temporary or permanent closure, suspension and revocation or limitation of licenses.

Distribution of images

Almost 60% of countries (14/24) require that each of the HWLs in each set appear on an equal number of retail packages for each brand during the rotation period.

DISCUSSION

The majority of the countries analyzed here are considered by the Pan American Health Organization and WHO to have the highest level of implementation for Article 11 (11). Our analysis shows that the majority of these countries have included in their national legislation most of the elements required by the FCTC Guidelines. For example, 75% of countries (18/24) have rotation periods within the recommended 12–36 months, and about half also have sets with 8–12 individual warnings, complying with regional guidelines and tool kits. However, our analysis shows that even when these 24 countries have HWLs with both pictograms and rotation, important challenges remain.

We identified two primary challenges. The first is unique to rotation and the second is found in the implementation of tobacco control more broadly. The need to continually update HWLs is a key and unique element not found in other tobacco control measures. As shown in the literature, one of the essential elements of warnings is that they must be revised or updated to maintain their effectiveness over time and to avoid message fatigue (7, 14). This means that passing an initial tobacco control law is not sufficient. For each new set or new iteration, or round, of HWLs, a new legal measure (typically a ministerial resolution) must be passed or introduced, and this must be done in perpetuity. What we observed is that even though all of these 24 countries passed an initial tobacco control law establishing the broad guidelines for rotation, few have passed the required subsequent measures.

This legislative review shows that many of the countries analyzed have not passed new legal measures since the first set of warnings, or at least none that could be found online. In some instances, this means that countries have had the same warnings for almost 10 years. In other cases, such as in Mexico and Panama, new rounds of HWLs have appeared, but the rounds have not been consistent in duration and have not followed the letter of the law. For example, on one occasion it took the Mexican government almost 3 years to pass a new resolution when, according to the law, this should happen every 6–12 months.

The second challenge refers to implementation more broadly. The legal measures that define HWLs and their rotation meet challenges similar to those faced by other tobacco control measures, for which implementation is only as good as its enforcement. For example, a weakness found by this analysis relates to penalties or fines. Fines specified in a country’s general health laws or even in general tobacco control laws do not provide enough specificity for implementation. Most of these laws do not indicate who will be in charge of inspection, how often this will occur and who will enforce any infractions. In the specific case of HWLs, inspection and enforcement are crucial to ensuring that cigarette packs are taken out of rotation at the required times and that old packs are no longer in circulation.

There are several limitations to this analysis. First, information is missing from the study because not all countries’ laws or regulations are available online. In some instances, it is unclear whether we were unable to find regulations or if they do not exist.

Second, the scope of this study does not allow us to determine whether all of the elements in these countries’ laws are being implemented. Future research should consider establishing in-country monitoring to observe whether rotation of HWLs is occurring, whether the number of images defined in law is available at retailers, whether transition times are being respected and old packs are no longer being sold, whether each warning appears on an equal number of packs and whether any entity has been fined or anyone is responsible for enforcing the laws.

Recommendations

The countries that do not currently comply with WHO FCTC Guidelines need to modify their laws or regulations to ensure that rotation occurs within the defined period of 12–36 months and that sets have 8–12 HWLs. Additionally, to ensure that HWLs are updated regularly, mechanisms must be put in place to guarantee that regulations are passed in a timely manner. Laws and regulations should specify clear penalties or fines and inspection agencies, and provide guidelines for enforcement.

Conclusions

Our analysis shows that most of the 24 countries analyzed have included all of the elements required by the WHO FCTC Guidelines in their national legislation or regulations. However, important challenges remain to ensure that the rotation of HWLs is successful. Implementation of tobacco control laws is generally challenging, given the lack of clear monitoring and enforcement mechanisms. In the case of HWLs and their rotation, implementation becomes even harder because there is a need to constantly update the warnings. If legal instruments are not passed or implemented when needed – which often happens in many countries in the Region of the Americas – then new warnings are not introduced on time. This puts the success of HWLs in danger, with a real risk of message fatigue.

Disclaimer.

Authors hold sole responsibility for the views expressed in the manuscript, which may not necessarily reflect the opinion or policy of the Revista Panamericana de Salud Pública/Pan American Journal of Public Health or those of the Pan American Health Organization (PAHO).