Strategic and contested use of food laws to ban smokeless tobacco products in India: a qualitative analysis of litigation.

OBJECTIVE: To understand how food laws are used, contested and interpreted to ban certain forms of chewing tobacco in India. METHODS: A qualitative study analysing all the tobacco-related litigation under the food laws in India. We used an inductive thematic analysis of the litigation contents. RESULTS: The tobacco industry systematically deployed litigation to (1) challenge the categorisation of smokeless tobacco products as food, and hence, questioned the use of food laws for regulating these products; (2) challenge the regulatory power of the state government in banning tobacco products via the food laws; and (3) challenge the applicability of the general food laws that enabled stricter regulations beyond what is prescribed under the tobacco-specific law. CONCLUSION: Despite facing several legal challenges from the tobacco industry, Indian states optimised food laws to enable stricter regulations on smokeless tobacco products than were feasible through use of a tobacco-specific law.

The current use and evolving landscape of nutraceuticals.

The nutraceutical market is currently a high-impact multi-billion-dollar industry, and it is anticipated to grow rapidly over the next decade. Nutraceuticals comprise diverse food-derived product categories that have become widespread due to increased consumer awareness of potential health benefits and the need for improved wellness. This targeted review is designed to identify the current global trends, market opportunities, and regulations that drive the nutraceutical industry. Safety and efficacy concerns are also explored with a view to highlighting areas that necessitate further research and oversight. Key drivers of the nutraceutical market include aging populations, consumer awareness, consumer lifestyle, increasing cost of healthcare, and marketing channels. Although some nutraceuticals hold promising preventive and therapeutic opportunities, there is a lack of a universal definition and regulatory framework among countries. Moreover, there is a lack of adequate evidence for their efficacy, safety, and effectiveness, which was even further highlighted during the ongoing coronavirus pandemic. Future prospective epidemiological studies can delineate the health impact of nutraceuticals and help set the scientific basis and rationale foundation for clinical trials, reducing the time and cost of trials themselves. Together, an understanding of the key drivers of the nutraceutical market alongside a consistent and well-defined regulatory framework will provide further opportunities for growth, expansion, and segmentation of nutraceuticals applications.

The need for European harmonization of Nutrivigilance in a public health perspective: a comprehensive review.

According to the European Union regulation, some countries have established a pre-market notification system for food supplements while others have not. As this regulation is unfulfilled, a notified and marketed food supplement ingredient in one country may be forbidden in another. Even though food supplements shall not be placed on the market if unsafe, some products may still expose the consumers to risks. The risk is increased by easier access due to worldwide dissemination fostered by the internet and free movement of goods in the European Union. The Rapid Alert System for Food and Feed and the Emerging Risks Exchange Network are described. To date, the European Union legislation does not include a provision to establish a dedicated vigilance system for food supplements (Nutrivigilance). Six European Union countries have nevertheless set up national systems, which are presented. The present lack of European Union data collection harmonization, does not allow easy cooperation between countries. This article advocates for creating a coordinated European Nutrivigilance System to detect and scrutinize adverse effects of food supplements. This, to help in directing science-based risk assessments and reinforce the science-based decision of policy makers to improve public health safety.

Unacceptable failures: the final report of the Lancet Commission into liver disease in the UK.

This final report of the Lancet Commission into liver disease in the UK stresses the continuing increase in burden of liver disease from excess alcohol consumption and obesity, with high levels of hospital admissions which are worsening in deprived areas. Only with comprehensive food and alcohol strategies based on fiscal and regulatory measures (including a minimum unit price for alcohol, the alcohol duty escalator, and an extension of the sugar levy on food content) can the disease burden be curtailed. Following introduction of minimum unit pricing in Scotland, alcohol sales fell by 3%, with the greatest effect on heavy drinkers of low-cost alcohol products. We also discuss the major contribution of obesity and alcohol to the ten most common cancers as well as measures outlined by the departing Chief Medical Officer to combat rising levels of obesity-the highest of any country in the west. Mortality of severely ill patients with liver disease in district general hospitals is unacceptably high, indicating the need to develop a masterplan for improving hospital care. We propose a plan based around specialist hospital centres that are linked to district general hospitals by operational delivery networks. This plan has received strong backing from the British Association for Study of the Liver and British Society of Gastroenterology, but is held up at NHS England. The value of so-called day-case care bundles to reduce high hospital readmission rates with greater care in the community is described, along with examples of locally derived schemes for the early detection of disease and, in particular, schemes to allow general practitioners to refer patients directly for elastography assessment. New funding arrangements for general practitioners will be required if these proposals are to be taken up more widely around the country. Understanding of the harm to health from lifestyle causes among the general population is low, with a poor knowledge of alcohol consumption and dietary guidelines. The Lancet Commission has serious doubts about whether the initiatives described in the Prevention Green Paper, with the onus placed on the individual based on the use of information technology and the latest in behavioural science, will be effective. We call for greater coordination between official and non-official bodies that have highlighted the unacceptable disease burden from liver disease in England in order to present a single, strong voice to the higher echelons of government.

A regulatory relic: After 60 years of research on cancer risk, the Delaney Clause continues to keep us in the past.

The Delaney Clause of the Federal Food, Drug, and Cosmetic Act became law in 1958 because of concerns that potentially harmful chemicals were finding their way into foods and causing cancer. It states, "[n]o additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal." The United States Food and Drug Administration (US FDA) and United States Environmental Protection Agency (US EPA, prior to implementation of the Food Quality Protection Act) were charged with implementing this clause. Over 60 years, advances in cancer research have elucidated how chemicals induce cancer. Significant advancements in analytical methodologies have allowed for accurate and progressively lower detection limits, resulting in detection of trace amounts. Based on current scientific knowledge, there is a need to revisit the Delaney Clause's utility. The lack of scientific merit to the Delaney Clause was very apparent when recently the US FDA had to revoke the food additive approvals of 6 synthetic flavoring substances because high dose testing in animals demonstrated a carcinogenic response. However, US FDA determined that these 6 synthetic flavoring substances do not pose a risk to public health under the conditions of intended use. The 7th substance, styrene, was de-listed because it is no longer used by industry. The scientific community is committed to improving public health by promoting relevant science in risk assessment and regulatory decision making, and this was discussed in scientific sessions at the American Association for the Advancement of Science (AAAS) 2020 Annual Meeting and the Society of Toxicology (SOT) 2019 Annual Meeting. Expert presentations included advances in cancer research since the 1950s; the role of the Delaney Clause in the current regulatory paradigm with a focus on synthetic food additives; and the impact of the clause on scientific advances and regulatory decision making. The sessions concluded with panel discussions on making the clause more relevant based on 21st-century science.

Using the rapid alert system for food and feed: potential benefits and problems on data interpretation.

The Rapid Alert System for Food and Feed (RASFF), where competent authorities in each Member State (MS) submit notifications on the withdrawal of unsafe or illegal products from the market, makes a significant contribution to food safety control in the European Union. The aim of this paper is to frame the potential challenges of interpreting and then acting upon the dataset contained within the RASFF system. As it is largest cause of RASFF notifications, the lens of enquiry used is mycotoxin contamination. The methodological approach is to firstly iteratively review existing literature to frame the problem, and then to interrogate the RASFF system and analyze the data available. Findings are that caution should be exercised in using the RASFF database both as a predictive tool and for trend analysis, because iterative changes in food law impact on the frequency of regulatory sampling associated with border and inland regulatory checks. The study highlights the variability of engagement by MSs with the RASFF database, influencing generalisability of the trends noted. As importing countries raise market standards, there are wider food safety implications for the exporting countries themselves. As this is one of the first studies articulating the complexities and opportunities of using the RASFF database, this research makes a strong contribution to literature.

Food recalls associated with foodborne disease outbreaks, United States, 2006-2016.

About 800 foodborne disease outbreaks are reported in the United States annually. Few are associated with food recalls. We compared 226 outbreaks associated with food recalls with those not associated with recalls during 2006-2016. Recall-associated outbreaks had, on average, more illnesses per outbreak and higher proportions of hospitalisations and deaths than non-recall-associated outbreaks. The top confirmed aetiology for recall-associated outbreaks was Salmonella. Pasteurised and unpasteurised dairy products, beef and molluscs were the most frequently implicated foods. The most common pathogen-food pairs for outbreaks with recalls were Escherichia coli-beef and norovirus-molluscs; the top pairs for non-recall-associated outbreaks were scombrotoxin-fish and ciguatoxin-fish. For outbreaks with recalls, 48% of the recalls occurred after the outbreak, 27% during the outbreak, 3% before the outbreak, and 22% were inconclusive or had unknown recall timing. Fifty per cent of recall-associated outbreaks were multistate, compared with 2% of non-recall-associated outbreaks. The differences between recall-associated outbreaks and non-recall-associated outbreaks help define the types of outbreaks and food vehicles that are likely to have a recall. Improved outbreak vehicle identification and traceability of rarely recalled foods could lead to more recalls of these products, resulting in fewer illnesses and deaths.

False and misleading health-related claims in food supplements on Spanish radio: an analysis from a European Regulatory Framework.

OBJECTIVE: The excessive growth of the food supplements' industry highlights the need to focus attention on all aspects involved in their proper consumption; one that takes centre stage is advertising. The aim of this research is to analyse the presence of false and misleading claims in food supplements advertising. To this end, a relationship is established between the different types of health-related claims and the substances on which they are based, whether authorised or not by European Food Safety Authority (EFSA). DESIGN: This empirical work conducts a content analysis of all radio mentions broadcast throughout 2017 on news/talk radio stations. SETTING: Spain. PARTICIPANTS: All radio mentions broadcast on news/talk commercial radio stations in Spain with the highest audience levels. The corpus is composed of 437 advertisements. RESULTS: Results indicate that 80·3 % of function claims included in the analysed advertisements are not authorised by EFSA, while 20·4 % of disease claims are not allowed by EU regulation. Likewise, almost half of the substances referred to (43·7 %) are illicit: 54·1 % in function claims, 57·3 % in disease claims and 73·7 % in the case of reduction of disease risk claims. CONCLUSIONS: This work reveals consistent failures to comply with European regulation on food supplements advertising. The widespread use of unauthorised health claims and substances is aggravated by the indirect recourse of illness as a persuasive argument, descriptions of alleged benefits as product attributes and the omission of essential information. This leads to dangerous misinformation and can pose serious health risks. Stronger legal mechanisms are needed for effective consumer protection.

Health-related claims in food supplements endorsements: a content analysis from the perspective of EU regulation.

OBJECTIVES: Based on the legal framework regulating the advertisement of food supplements in the EU, the aim of this article is to analyse the relationship between the presence of endorsers, the different types of health-related claims (H-RCs) and product content information. STUDY DESIGN: We applied a quantitative approach based on the content analysis of all radio spots broadcast throughout 2017 on full-service radio stations in Spain. METHODS: A corpus of 10,556 radio spots was obtained of the three radio stations with the highest audience levels (165 without repetitions). We incorporated data on the accumulated broadcast frequencies to supplement the content analysis specific to each radio spot with its weight in relation to the overall advertising discourse. We developed a coding scheme to assess the type of endorser, the types of H-RCs, and the product content information. RESULTS: Results show that European directives are breached in different ways. Healthcare experts prevail in disease claims, although they are prohibited. Celebrities are the most widely used endorsers (25%) in the function and reduction of disease risk claims. In addition, although these types of claims require substantiation by authorised ingredient, 73% of H-RCs lack this information. CONCLUSIONS: The high presence of illicit H-RCs and endorsers, such as physicians, and the omission of compulsory product information suggest that public administrations must apply stricter monitoring and sanctioning mechanisms to dissuade advertisers from further breaches of the law and to protect consumers. Implications for public health policy are made.

Current regulatory guidelines and resources to support research of dietary supplements in the United States.

The U.S. Dietary Supplement Health and Education Act (DSHEA) established the regulatory framework for dietary supplements as foods through the Food and Drug Administration (FDA). DSHEA outlined the legal definition, labeling requirements, and process for adverse event reporting for dietary supplements. FDA also issued formal guidance on current Good Manufacturing Practice to ensure that processes for preparation, packaging, labeling, and storage of supplements and ingredients are documented and meet specifications to ensure purity, composition, and strength. However, efficacy of dietary supplements is not required under U.S. law. Despite regulations to improve the marketplace, many challenges remain; as a result, the quality and safety of products available can be highly variable, especially for botanical and herbal products. The ability of regulators to successfully carry out their mission is hampered by the sheer number of products and manufacturing facilities and a lack of analytical methods for all ingredients and products in the marketplace, this is especially difficult for herbal and botanical dietary supplements. Safety issues continue to exist such as adulteration and contamination, especially with specific product types (i.e. body building, sexual enhancement). Thus, a need remains for continued efforts and improved techniques to assess the quality of dietary supplements, especially with regard to purity, bioavailability, and safety. This review will highlight the existing American regulatory framework for dietary supplements and will describe the remaining regulatory barriers to ensuring that safe and high-quality dietary supplements are offered in the marketplace.

Translation of EU Food Law and Nutrient Reference Values Into Practice: the German Dietary Scheme for the First Year of Life.

OBJECTIVES: European dietary regulations affect national dietary guidelines for child nutrition. The update of the German Dietary Scheme for the first year of life is used to examine the translation of European nutrient references into food-based guidelines while maintaining traditional habits. METHODS: Within the Dietary Scheme, intake of energy and nutrients was calculated in the complementary feeding period for each of the 3 daily recommended complementary meals (a vegetable-potato-meat meal, a milk-cereal meal, a cereal-fruit meal) in addition to the daily liquid-milk servings (breast milk or follow-on formula). Pureed-home-made complementary meals were assumed. The adequacy of nutrient intake was evaluated by comparison with the European Food Safety Authority (EFSA) Dietary Reference Values. Macronutrient content of meals was compared to the European complementary food directive. RESULTS: Daily intake of most nutrients following the scheme was well in line with EFSA values, whereas the commonly 'critical' nutrients iron and iodine remained far below EFSA values. Substituting breast milk or whole cow's milk with follow-on formula had only a small impact on nutrient supply. Although the different nutrient profiles of meals were not fully in line with European regulations, they add up to an overall balanced daily diet. CONCLUSIONS: Taken together, European dietary reference values for energy and nutrients can mostly be met by the modular system of the Dietary Scheme as a total diet concept for infant nutrition in Germany. The different proposed meals generally agree with EU regulations for complementary food.

Changes in nutrition content and health claims post-implementation of regulation in Australia.

OBJECTIVE: To determine whether there were changes in the prevalence or healthiness of products carrying claims post-implementation of Standard 1.2.7: Nutrition, Health and Related Claims in the Australia New Zealand Food Standards Code. DESIGN: Observational survey of claims on food packages in three categories: non-alcoholic beverages, breakfast cereals and cereal bars. Nutrient profiling was applied to products to determine their eligibility to carry health claims under Standard 1.2.7. The Standard came into effect in 2013. The proportion of products carrying claims and the proportion of those not meeting the nutrient profiling criteria were calculated. A comparative analysis was conducted to determine changes between 2011 and 2016. SETTING: Three large metropolitan stores from the three major supermarket chains in Sydney, Australia were surveyed in 2011 and 2016. PARTICIPANTS: All claims on all available products in 2016 (n 1737). Nutrition composition and ingredients were collected from the packaging. RESULTS: Overall in 2016, 76 % of products carried claims and there were 7367 claims identified in the three food categories. Of products in 2016 with health claims, 34 % did not meet nutrient profiling criteria. These may breach Standard 1.2.7. Comparison of 2011-2016 showed a significant increase in the number of products carrying claims (66 v. 76 %, P < 0·001). CONCLUSIONS: The proportion of products carrying claims that do not meet nutrient profiling and consumers' tendency to infer health benefits from nutrition content claims warrants the regulation of all claims using the nutrient profiling. This will ensure consumers are not misled by claims on unhealthy food products.

"Natural" is not synonymous with "Safe": Toxicity of natural products alone and in combination with pharmaceutical agents.

During the 25 years since the US Congress passed the Dietary Supplement Health and Education Act (DSHEA), the law that transformed the US Food and Drug Administration's (FDA's) authority to regulate dietary supplements, the dietary supplement market has grown exponentially. Retail sales of herbal products, a subcategory of dietary supplements, have increased 83% from 2008 to 2018 ($4.8 to $8.8 billion USD). Although consumers often equate "natural" with "safe", it is well recognized by scientists that constituents in these natural products (NPs) can result in toxicity. Additionally, when NPs are co-consumed with pharmaceutical agents, the precipitant NP can alter drug disposition and drug delivery, thereby enhancing or reducing the therapeutic effect of the object drug(s). With the widespread use of NPs, these effects can be underappreciated. We present a summary of a symposium presented at the Annual Meeting of the Society of Toxicology 2019 (12 March 2019) that discussed potential toxicities of NPs alone and in combination with drugs.

How the 62-year old Delaney Clause continues to thwart science: Case study of the flavor substance ß-myrcene.

The Delaney Clause is a provision of the 1958 Food Additive Amendment to the Food, Drug and Cosmetic Act of 1938 which stipulates that if a substance is found by the Food and Drug Administration to be carcinogenic in any species of animal or in humans, then it cannot be used as a food additive. This paper presents a case study of ß-myrcene, one of seven synthetic substances that was challenged under the Delaney Clause, ultimately resulting in revocation of its regulatory approval as a food additive despite a lack of safety concern. While it is listed as a synthetic flavor in 21 CFR 172.515, ß-myrcene is also a substance naturally occurring in a number of dietary plants. The exposure level to naturally-occurring ß-myrcene is orders of magnitude higher (estimated to be 16,500 times greater) than the exposure via ß-myrcene added to food as a flavoring substance. The National Toxicology Program conducted genotoxicity testing (negative), a 13-week range-finding study, and a two-year cancer bioassay in B6C3F1 mice and F344/N rats. An increase in liver tumors was seen in male mice and kidney tumors in male rats, ultimately resulting in ß-myrcene being classified by IARC as a Class 2B carcinogen and being listed on California Proposition 65; in contrast, ß-myrcene is not classified as a carcinogen by any other regulatory authority. The doses administered in the NTP bioassay were five-six orders of magnitude higher than human exposures, and the FDA concluded after a thorough evaluation that there was no safety concern associated with the use of ß-myrcene as a flavor substance at the current use level. The Delaney Clause, however, does not consider the exposure potential or the human health relevance of effects observed in animals. The lack of options available to the US FDA led to the 2018 decision to remove ß-myrcene from the list of approved food additives. This revocation has contributed to the ongoing erosion of trust in regulatory agencies (and industry), which has both economic implications for food manufacturers and consumers alike, and implications for consumer perception of safety of the US food supply. It is time for us to reconsider the rationale behind any legislation that relies on classification alone, and whether there is, in fact, a reason to still classify nongenotoxic carcinogens at all.

Science-based regulatory approach for safe nutraceuticals.

Food safety is a very complex issue. The food that reaches the plate from the farm is exposed to many hazards in processing methods and each of those steps is likely to contribute, indirectly or directly, to contaminants and pathogens that ultimately make the food unsafe. Consumers would always wish for 100% product safety; even regulators want to ensure 100% safety of the product and protect consumers. Every country has its own food safety regulations, but the application of food safety management in the plant and prescription of standards with a clear network of organising the risk analysis in the chain is lacking. However, with the wide array of new health products - nutraceuticals, nutritional supplements, functional foods, dietary supplements, foods for special medical purposes and foods for special dietary uses - safety draws the attention consumers to a much greater extent. Foods may contain herb/plant or animal extracts that perhaps were not previously ingredients, making health claims a very challenging and difficult task for manufacturers and regulators in the food industry. This Mini-Review attempts to address this issue from a science-based viewpoint. © 2018 Society of Chemical Industry.

Why for feed and not for human consumption? The black soldier fly larvae.

With the surge in consumption of insects, the search continues to find ways to increase the popularity of insect-based products in the Western world. The black soldier fly larvae (BSFL), which is mainly utilized for animal feed, has great potential to provide a sustainable source of nutrients for human food. This review aims to discuss some of the key benefits and challenges of BSFL and their potential role as a food ingredient and/or product for human consumption. Few articles specifically discuss BSFL as a food source, therefore a comprehensive literature search strategy consisted of collecting and evaluating published data about BSFL as animal feed that could be relevant to its use in food. The hurdles that need to be overcome in order to introduce BSFL as a viable food option include safety concerns, technofunctional properties, nutritional aspects, consumer attitudes, and product applications for BSFL.

Sulfites in meat: Occurrence, activity, toxicity, regulation, and detection. A comprehensive review.

Sulfites are a class of chemical compounds, SO2 releasers, widely used as additives in food industry, due to their antimicrobial, color stabilizing, antibrowning, and antioxidant properties. As the results of these pleiotropic functions they can be added to a broad range of products including dried fruits and vegetables, seafood, juices, alcoholic and nonalcoholic beverage, and in few meat products. Sulfites ingestion has been correlated with several adverse and toxic reactions, such as hypersensitivity, allergic diseases, vitamin deficiency, and may lead to dysbiotic events of gut and oral microbiota. In many countries, these additives are closely regulated and in meat products the legislation restricts their usage. Several studies have been conducted to investigate the sulfites contents in meat and meat products, and many of them have revealed that some meat preparations represent one of the main sources of SO2 exposure, especially in adults and young people. This review discusses properties, technological functions, regulation, and health implications of sulfites in meat-based foods, and lays a special emphasis on the chemical mechanisms involved in their interactions with organic and inorganic meat components.

[Novel food sources: from GMO to the broadening of Russia's bioresource base].

The modern strategy of humanity food providing is aimed at finding the exit from the food crisis in the shortest possible time, by the end of XXI century food and feed production should increase by at least 70%. These tasks solution implies not only the use of science-oriented technologies, but also the expansion of the food base by means of novel food sources, which don't have a history of safe use. In the Russian Federation the formation of novel food's safety assessment approaches is regulated at the state level and is the most important requirement for the possibility of usage. Russian experience of the second half of the XX century in the area of novel food sources' biomedical research unites two stages. The first of them dates back to the middle of the 1960s', when the Soviet scientists, in particular, the workforce of the Institute of Nutrition of the USSR Academy of Medical Sciences, under the leadership of Academician A.A. Pokrovskii, have developed the evaluation approaches of the biological value and safety of microbial synthesized protein. The second stage of the safety assessment research development was the work with the genetically modified organisms of plant origin (GMO), that begun in the middle of the 1990s'. Since the moment of formation in 1995-1996, 9 methodical guidelines that regulate methods of safety assessment and control over GMO have been developed. Comprehensively formed by 2020, safety assessment system has been used in the framework of 27 GMO lines state registration that passed a whole cycle of medical and biological research and were allowed for use in nutrition of the population of the Eurasian Economic Union. Within the framework of these research a considerable amount of factual material has been accumulated, a regulatory and methodological basis has been built, and a substantial background for further fundamental and applied scientific research in the field of development and safety assessment of novel food has been created.