Regulatory framework for dietary supplements and the public health challenge / Marco regulatório dos suplementos alimentares e o desafio à saúde pública

ABSTRACT OBJECTIVE The new regulatory framework for dietary supplements in Brazil prompted this analysis of the current outlook of these products and the challenges posed by the new guidelines. METHODS We conducted a qualitative, observational and descriptive study of dietary supplements commercialized in Brazilian online stores with the help of the Google® search tool. We considered the ingredients on the labels, the effects attributed to these products and the commercial claims used as a means of promoting them to assess the necessary changes for the legal framework in the new guidelines. Finally, with the help of a database, we compared the effects declared by the manufacturers and attributed to certain ingredients with the scientific evidence described in literature. RESULTS In total, we purchased 44 dietary supplements from Brazilian online stores (n = 7). Of the samples studied, 34.2% could not be classified in the category Dietary Supplements, as recommended by the new regulation of the Brazilian Health Regulatory Agency due to the presence of prohibited substances; 16% of products should be commercialized as medicines. Regarding the commercial appeals, 97.7% had banned expressions. Numerous claims of effects attributed to certain products were characterized as consumer fraud because they have no scientific evidence. CONCLUSIONS The necessary changes represent a major regulatory and production challenge due to the wide range of dietary supplements and markets, an effort that aims to protect the consumers' health. Some previous gaps in the regulatory framework were not fully solved.

RESUMO OBJETIVO O novo marco regulatório para os suplementos alimentares no Brasil instigou a presente análise do panorama atual desses produtos e os desafios impostos pelas novas diretrizes. MÉTODOS Foi realizado um estudo qualitativo, observacional e descritivo dos suplementos alimentares comercializados em lojas virtuais brasileiras, com o auxílio da ferramenta de busca Google®. Os ingredientes declarados nos rótulos, bem como os efeitos atribuídos a esses produtos e as alegações comerciais utilizadas como forma de promovê-los foram levados em consideração a fim de avaliarmos as mudanças necessárias para o enquadramento legal nas novas diretrizes. Por fim, com o auxílio de base de dados, foram comparados os efeitos declarados pelos fabricantes e atribuídos a determinados ingredientes com as evidências científicas descritas na literatura. RESULTADOS No total, foram adquiridos 44 suplementos alimentares provenientes de lojas virtuais brasileiras (n = 7). Das amostras estudadas, 34,2% não poderiam ser enquadradas na categoria Suplementos Alimentares, conforme preconiza a nova regulação da Agência Nacional de Vigilância Sanitária, em decorrência de presença de substâncias não permitidas; 16% dos produtos deveriam ser comercializados como medicamentos. Quanto aos apelos comerciais, 97,7% apresentavam expressões não permitidas. Inúmeras alegações de efeitos atribuídos a determinados produtos, por não possuírem comprovação científica, foram caracterizadas como fraude contra o consumidor. CONCLUSÕES Dada a extensa gama de suplementos alimentares e pontos de comercialização, as mudanças necessárias representam um grande desafio regulatório e de produção, esforço este que visa a proteger a saúde dos consumidores. Algumas lacunas previamente existentes ao marco regulatório ainda não foram totalmente solucionadas.

Stability of antioxidant vitamins in commercial vitamin supplements

The stability of vitamins A, E, and C was determined in 12 brands of vitamin supplements over a 12-month storage period. The variations in concentrations of these vitamins across three different batches of five brands were measured. Vitamins A and E was determined by HPLC method, and vitamin C was measured by using potentiometric titration. All samples for stability studies were maintained at room temperature and protected from light. Measurements were carried out in the first semester of the expiration date and then every six months up to 12 months of storage. After this period, only one sample showed no significant decrease in vitamin A and E concentrations in relation to the concentrations measured at the beginning of the study. The concentration of vitamin C showed no significant decrease in 50% of the samples after 6 months of storage, although after 12 months, 92% had significant losses in concentration. The analysis of the different batches showed significant variations in the vitamin levels, which do not seem to be significant for inspection purposes considering the tolerance outlined in the legislation. Over-fortification of vitamin supplements during manufacture seems to be required, but the additional amount of supplementation will depend on each sample.

Políticas de etiquetado en los paquetes de cigarrillos: situación actual en América Latina y el Caribe / Cigarette labeling policies: current situation in Latin America and the Caribbean

En 2002, Brasil se convirtió en el primer país de la región en implementar etiquetas de advertencias sanitarias con pictogramas en los paquetes de cigarrillos. Desde la adopción del CMCT de la OMS en 2005, otros nueve países adoptaron advertencias con pictogramas y seis más aprobaron legislación cuya implementación está pendiente. El contenido del mensaje y el estilo del pictograma varían entre los países. Diecisiete países prohibieron descriptores de marca y nueve requieren una advertencia cualitativa con información de constituyentes y emisiones. Un importante progreso se ha alcanzado en la región desde 2005. Sin embargo, los países ratificantes del CMCT aún no han implementado todas las recomendaciones de las Directrices del Artículo 11.

In 2002, Brazil became the first country in the region to implement pictorial health warning labels on cigarette packages. Since the adoption of the FCTC/WHO in 2005, nine more countries adopted pictorial labels and six passed legislation that is pending of implementation. The message content and the picture style vary across countries. Seventeen countries have banned brand descriptors and nine require a qualitative label with information on constituents and emissions. Since 2005, important progress has been achieved in the region. However, countries that have ratified the FCTC have not yet implemented all the recommendations of Article 11 Guidelines.

Cigarette labeling policies in Latin America and the Caribbean: progress and obstacles / Políticas de etiquetado de cigarrillos en América Latina y el Caribe: progreso y obstáculos

Objetive. To describe cigarette labeling policies in Latin America and the Caribbean as of August 2010. Material and Methods. Review of tobacco control legislation of all 33 countries of the region; analysis of British American Tobacco (BAT)'s corporate social reports; analysis of information from cigarette packages collected in 27 countries. Results. In 2002, Brazil became the first country in the region to implement pictorial health warning labels on cigarette packages. Since then, six more countries adopted pictorial labels. The message content and the picture style vary across countries. Thirteen countries have banned brand descriptors and nine require a qualitative label with information on constituents and emissions. Tobacco companies are using strategies commonly used around the world to block the effective implementation of WHO Framework Convention on Tobacco Control (FCTC)'s Article 11. Conclusions. Since 2002, important progress has been achieved in the region. However, countries that have ratified the FCTC have not yet implemented all the recommendations of Article 11 Guidelines.

Objetivo. Describir las políticas de etiquetado de cigarrillos vigentes en América Latina y el Caribe en agosto de 2010. Material y métodos. Revisión de la legislación para el control del tabaco en vigencia en los 33 países de la región; análisis de reportes sociales corporativos del grupo BAT; análisis de información de paquetes de cigarrillos recolectados en 27 países. Resultados. En 2002, Brasil se convirtió en el primer país de la región en implementar etiquetas de advertencias sanitarias pictoriales en los paquetes de cigarrillos. Desde entonces, otros seis países adoptaron advertencias pictoriales. El contenido del mensaje y el estilo de la fotografía varía entre los países. Trece países prohibieron descriptores de marca y nueve requieren una advertencia cualitativa con información de constituyentes y emisiones. Las compañías tabacaleras están utilizando estrategias comúnmente usadas alrededor del mundo para bloquear la implementación efectiva del Artículo 11 del Convenio Marco para el Control del Tabaco (CMCT) de la OMS. Conclusiones. Desde 2002, se ha alcanzado un importante progreso en la región. Sin embargo, los países que han ratificado el CMCT aún no han implementado todas las recomendaciones de las directrices del Artículo 11.

Fluoride content of bottled water commercialized in two cities of northeastern Brazil

Aim: The objectives of this study were to evaluate the fluoride content of bottled water commercialized intwo cities of northeastern Brazil and to compare the fluoride values measured in the water to the ones printed on the bottle label, considering risks (dental fluorosis) and benefits (caries control) of systemic fluoride exposure. Methods: Fifty-six water samples were collected from 20 brands available in severalsupermarkets with high turnover in different regions of the municipalities of São Luís (State of Maranhão)and João Pessoa (State of Paraíba) in 2009. Fluoride concentrations were determined by triplicate analysisusing an ion-specific electrode. Results: The measured mean fluoride content varied from 0.001 to 0.270 ppmF with a mean (±SD) of 0.037 (±0.041) for the 56 samples. The majority of samples were found to contain less than 0.043 ppmF (92%). Conclusion: These results emphasize the importance of controllingthe fluoride levels in bottled water enforced by the Brazilian Sanitary Surveillance Agency. Concerning therisks and benefits, fluoride concentrations in the evaluated bottled water samples were below the suggested concentration (0.7 mg F/l), having neither preventive effect nor the potential for causing dental fluorosis.

Labelling of household products and prevention of unintentional poisoning

Intoxicações não-intencionais ocorrem principalmente na infância devido à ingestão de produtos de uso doméstico. Um fator determinante é a falta de conhecimento sobre a toxicidade destes produtos. Um estudo aleatório de 158 rótulos de produtos de limpeza foi realizado no Instituto Nacional de Controle de Qualidade em Saúde - Brasil. Advertência sobre os riscos à saúde, orientações para os primeiros-socorros em caso de envenenamento e instruções de armazenamento foram avaliadas para verificar a qualidade das informações fornecidas ao consumidor sobre os riscos inerentes ao uso destes produtos. Do total de produtos avaliados, 75 por cento foram considerados inadequados porque não forneciam todas as informações necessárias para prevenir danos à saúde decorrentes do seu uso. Instruções para os primeiros-socorros no caso de inalação foram omitidas em mais de 50 por cento dos rótulos estudados e 47 por cento não recomendavam levar o rótulo para o médico em caso de acidente. Além disto, os rótulos não forneciam outras importantes advertências como ler antes de usar e manter no frasco original. Os resultados indicam que a rotulagem dos produtos de limpeza de uso domiciliar não fornece todas as informações para garantir a segurança da população.

Unintentional poisoning occurs mainly in childhood due to ingestion of common household products. A decisive factor is the lack of knowledge concerning the potential toxicity of these products. A random study of 158 labels of cleaning products was conducted at the National Institute of Quality Control in Health - Brazil. Health hazard warnings, first aid in case of poisoning and storage instructions were evaluated to assess the quality of information provided to the consumer regarding the risks inherent in these products. Among these labels, 75 percent were considered inadequate since they did not provide all cautionary information necessary to avoid the health hazards associated with these products. First aid instructions in the case of inhalation were missing on more than 50 percent of labels studied and 47 percent did not recommend taking the label to a health professional in case of accident. Furthermore, the labels did not provide other important warnings such as read before use and keep in original container. The results indicate that the labelling of cleaning products does not provide all safety information recommended for consumers.

Comparative analysis of patient package inserts of local and imported anti-infective agents in Palestine

The patient package insert is an important source of drug information. The aim of this study was to evaluate and compare the PPI of the anti-infective agents manufactured in Palestine with the imported equivalents. The selection criteria generated 15 different anti-infective agents available as 36 locally manufactured products and 15 imported equivalents. The design of the patient package insert was evaluated in terms of the number of words used in eight main headings and the presence or absence of certain information regarding nine statements. Inserts of locally manufactured products have significantly fewer words than those of imported products with respect to warnings, dosage and administration, and side effects. The most significant difference was found in the warnings. Moreover, differences were found between inserts of local and imported products in terms of the presence of the nine informative statements. Locally manufactured products did not mention inactive ingredients, clinical pharmacology or date of last revision, but all of them provided information on the use of the drug during pregnancy and lactation and on the duration of therapy. However, in general they provided less information than the imported equivalents. Palestinian authorities and local manufacturers should implement appropriate measures to regulate the quality and quantity of information in the patient package insert of locally produced anti-infective agents. PPI improvement will better direct health practices to the benefit of the patients

The work of I-INCE Technical Study Group 2 on noise labels for consumer and industrial products.

In 1999 a new I-INCE Technical Study Group TSG 2 was formed on "Noise labels for consumer and industrial products". This was intended to survey current methods for labelling and otherwise characterizing the noise emissions of consumer and industrial products. Note that labelling can mean more than just a physical label - it might be details in a Technical Manual. The measurement methods used by testing authorities were to be included in the survey. The methodologies were to be compared, and an assessment made of their relative effectiveness. The study of noise labelling is part of an educational program to advise on how, and in what form such labelling should be implemented. There has been active participation in the TSG from UK, USA, Japan, Norway, Turkey, Belgium and Brazil, with email exchange of information and 3 meetings, at Internoise 2000 in Nice, 2001 in Den Haag and 2002 in Dearborn, USA. More recently the survey questionnaire has been sent to all the 46 Member Societies of I-INCE. This paper explains the survey and summarises current results.

Solid waste from beverage package in Egypt

Production of beverages has been expanded to cover the growing demands of soft drink. There are 30 plants filling 15 million returnable glass bottles in Egypt. Those plants discharge washing effluent without any treatment. The strength of the wastewater effluent exceeds the maximum permissible level for wastewater discharges into water streams or into municipal sewer. Most of them are confronted with either clean up or close down. Filling plastic bottles is an alternative to cut down the washing effluent. For that alternative, extra loads of solid wastes will be added to the local sanitary system. This alternative was studied through comparing two types of beverage containers, i.e., filling beverage into returnable glass bottles or into plastic bottles. The life cycles of the containers were studied. Also the involved factors in the product life cycle were identified. The results is a guide to replace our traditional approach of satisfying our needs in terms of production by the more basic approach of a clean product. Also, it addresses a sustainable solid waste system in Egypt