Science and claims of the arena of food bioactives: comparison of drugs, nutrients, supplements, and nutraceuticals.

The scientific community and lay press are participating in a heated debate over the usefulness of food bioactives when used as dietary supplements. This debate often ignores hard scientific evidence and the outcomes of proper research in either direction. Some propose that health claims should be awarded based on classic pharmacological parameters of efficacy and safety. Others suggest that a botanical history of their safe use and basic biological evidence in support of their effects should suffice to allow their marketing. The current regulatory impasse does not help solve this conundrum. It is time for scientists, regulators, and legislators to open an epistemological debate on the appropriateness of using classic pharmacological methods for substances that do not share the usual drug profiles and which are, consequently, difficult to study in humans.

Review: Bioavailability of trace elements in farm animals: definition and practical considerations for improved assessment of efficacy and safety.

Currently, the authorisation procedure of trace elements as feed additives in the European Union according to Regulation (EC) No. 1831/2003 does not consider the bioavailability of trace element sources. This manuscript provides framework conditions for in vivo experiments that aim to estimate differences in the relative bioavailability between supplements of essential trace elements. Framework conditions encompass necessary technical information on the test substance, the experimental design and diet composition as well as the suitability of status parameters that allow for relative comparisons of regression variables. This manuscript evolves recommendations for researchers to conduct solid and reliable experiments on the matter as well as decision makers to interpret the value of studies submitted with authorisation applications regarding a certain trace element supplement.

Regional Codex Guidelines and Their Potential To Impact Food Safety in Traditional Food Markets.

ABSTRACT: Traditional food markets frequently have inadequate infrastructure, limited access to potable water, unsanitary conditions, and inadequate storage facilities, making them especially risky places for the growth and spread of foodborne pathogens. Traditional markets also often lack effective government oversight. Government programs are important for providing a foundation to manage food safety by setting and enforcing minimum food safety and quality standards and by establishing uniform standards for the conduct of food businesses. Four regional guidelines developed by the Codex Alimentarius to improve the safety of street-vended food were examined for their application to traditional food markets. These guidelines provide important standards that can be used to improve food safety in traditional food markets in many countries, including advice to governments and market authorities in the areas of policy and regulation, infrastructure, food handling, vendor health and hygiene, and training and education. The guidelines can be supplemented with additional material from the World Health Organization and the Food and Agriculture Organization of the United Nations. However, given the gaps identified in the individual regional guidelines, a uniform international standard is needed for national, regional, and local governments to use when managing food safety in traditional markets.

Assessment of the Impact of Scientific Reports Published by EFSA and GIS on Functional Foods Newly Placed on the Market in Poland.

Dietary supplements are health-promoting products. The legal categorization of dietary supplements as foods does not raise concerns, but a general understanding of how they work in the human body seems to deviate from the official definition. Thus, it is necessary to establish effective methods of market control related to dietary supplements. This research aims at assessing the impact of recommendations by various food safety authorities on ingredients used in newly registered products. It probes how the proportions of utilized product ingredients were modified after the European Food Safety Authority (EFSA) and Chief Sanitary Inspector in Poland (GIS) published their recommendations. Research data on the composition of products comes from the Polish national register of dietary supplements and covers the period from 2012 to 28 November 2021. Note that 103,102 products were analysed for the presence of thirty-seven ingredients, and the joinpoint regression method was applied to assess changing trends related to the use of ingredients. As our research points out, most often, changes in the trend appeared in product ingredients for which the European Food Safety Authority and Chief Sanitary Inspector in Poland issued the recommendation of having the safest level of consumption. However, these changes seem to emerge randomly and should not be unquestionably considered as the result of the published recommendations.

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.

A Graded Approach for Evaluating Health Claims about Plant-Based Food Supplements: Application of a Case Study Methodology.

The implementation of REGULATION (EC) No 1924/2006 has led to the formation of a list of health claims that can be used in food supplements (EU 432/2012). However, such supplements are often composed of plant preparations with claims omitted from this list. The peculiarity of plants is related to their long history of use, that could allow claims based on traditionally recognized health effects. In addition, the scientific literature has been enriched over the years through clinical studies that have assessed the bioavailability and efficacy of bioactive components, and investigated their mechanisms of action. Based on existing recognized models which aim to classify research according to the level of scientific evidence, Synadiet developed a three-grade model (A, B or C) for assessing plants health claims. In this paper, the applicability of the model is illustrated through an example for which a Grade B health claim attesting the possible contribution of red clover isoflavones to the improvement of blood lipid levels in postmenopausal women has been attributed. The model appears able to be easily extrapolated to claims pertaining to other plants. If adopted by consensus at European level, this model could initiate the implementation of a positive list of health claims on plant preparations.

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.

Accidental Consumption of Aspartame in Phenylketonuria: Patient Experiences.

Aspartame is a phenylalanine containing sweetener, added to foods and drinks, which is avoided in phenylketonuria (PKU). However, the amount of phenylalanine provided by aspartame is unidentifiable from food and drinks labels. We performed a cross-sectional online survey aiming to examine the accidental aspartame consumption in PKU. 206 questionnaires (58% female) were completed. 55% of respondents (n = 114) were adults with PKU or their parent/carers and 45% (n = 92) were parents/carers of children with PKU. 74% (n = 152/206) had consumed food/drinks containing aspartame. Repeated accidental aspartame consumption was common and more frequent in children (p < 0.0001). The aspartame containing food/drinks accidentally consumed were fizzy drinks (68%, n = 103/152), fruit squash (40%, n = 61/152), chewing gum (30%, n = 46/152), flavoured water (25%, n = 38/152), ready to drink fruit squash cartons (23%, n = 35/152) and sports drinks (21%, n = 32/152). The main reasons described for accidental consumption, were manufacturers' changing recipes (81%, n = 123/152), inability to check the ingredients in pubs/restaurants/vending machines (59%, n = 89/152) or forgetting to check the label (32%, n = 49/152). 23% (n= 48/206) had been prescribed medicines containing aspartame and 75% (n = 36/48) said that medicines were not checked by medics when prescribed. 85% (n = 164/192) considered the sugar tax made accidental aspartame consumption more likely. Some of the difficulties for patients were aspartame identification in drinks consumed in restaurants, pubs, vending machines (77%, n = 158/206); similarities in appearance of aspartame and non-aspartame products (62%, n = 127/206); time consuming shopping/checking labels (56%, n = 115/206); and unclear labelling (55%, n = 114/206). These issues caused anxiety for the person with PKU (52%, n = 106/206), anxiety for parent/caregivers (46%, n = 95/206), guilt for parent/carers (42%, n = 87/206) and social isolation (42%, n = 87/206). It is important to understand the impact of aspartame and legislation such as the sugar tax on people with PKU. Policy makers and industry should ensure that the quality of life of people with rare conditions such as PKU is not compromised through their action.

A Review of Hemp as Food and Nutritional Supplement.

The term "hemp" refers to Cannabis sativa cultivars grown for industrial purposes that are characterized by lower levels of tetrahydrocannabinol (THC), the active principle responsible for Cannabis psychotropic effects. Hemp is an extraordinary crop, with enormous social and economic value, since it can be used to produce food, textiles, clothing, biodegradable plastics, paper, paint, biofuel, and animal feed, as well as lighting oil. Various parts of the hemp plant represent a valuable source of food and ingredients for nutritional supplements. While hemp inflorescence is rich in nonpsychoactive, yet biologically active cannabinoids, such as cannabidiol (CBD), which exerts potent anxiolytic, spasmolytic, as well as anticonvulsant effects, hempseed has a pleasant nutty taste and represents a valuable source of essential amino acids and fatty acids, minerals, vitamins, and fibers. In addition, hempseed oil is a source of healthy polyunsaturated fatty acids, and hemp sprouts are rich in antioxidants. This review article aims to provide a comprehensive outlook from a multidisciplinary perspective on the scientific evidence supporting hemp beneficial properties when consumed as food or supplement. Marketing of hemp-derived products is subjected to diversified and complex regulations worldwide for several reasons, including the fact that CBD is also the active principal of pharmaceutical agents and that regulatory bodies in some cases ban Cannabis inflorescence regardless of its THC content. Some key regulatory aspects of such a complex scenario are also analyzed and discussed in this review article.

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.

Contaminação microscópica por matérias estranhas em noz-moscada, cúrcuma, gengibre, colorífico, pimenta-do-reino e páprica comercializados no estado de São Paulo, Brasil. (Parte I) / Microscopic contamination by foreign matter in nutmeg, turmeric, ginger, colorific, black pepper and paprika marketed in the State of Sao Paulo, Brazil. (Part I)

O objetivo deste trabalho foi avaliar a presença de matérias estranhas em noz-moscada, (Myristica fragrans Houttuyn), cúrcuma (Curcuma longa Linnaeus), gengibre (Zingiber officinale Roscoe), colorífico (mistura de urucum [Bixa orellana Linnaeus] com fubá), pimenta-do-reino (Piper nigrum Linnaeus) e páprica (Capsicum annuum Linnaeus) conforme a legislação sanitária. Foram analisadas 180 amostras empregando os métodos preconizados pela AOAC International, de maio de 2018 a maio de 2020. A presença de ao menos uma matéria estranha foi observada em 80% das amostras. Pelos animais foram observados em todos os produtos e fragmentos de insetos foram encontrados na maioria das amostras. Ácaro, inseto inteiro, larva de inseto, bárbula e exúvia também foram encontrados, além de fibras sintéticas e fragmentos de microplásticos. Quanto à legislação, 47,8% das amostras estavam acima dos limites de tolerância, destas, 90,7% por conterem matérias estranhas indicativas de falhas na aplicação das boas práticas e 9,3% por matérias estranhas indicativas de risco à saúde. Os resultados obtidos denotam ineficiência da aplicação das medidas de boas práticas na cadeia produtiva e alertam para a intensificação da fiscalização direcionada ao cumprimento das normas sanitárias, além de provocarem a reflexão sobre a necessidade de alterações na legislação referente às matérias estranhas. (AU)

The aim of this work was to evaluate the presence of foreign matter in nutmeg, (Myristica fragrans Houttuyn), turmeric (Curcuma longa Linnaeus), ginger (Zingiber officinale Roscoe), colorific (mixture of annatto [Bixa orellana Linnaeus] with cornmeal), black pepper (Piper nigrum Linnaeus) and paprika (Capsicum annuum Linnaeus) according to the health legislation. A total of 180 samples were analyzed using the methods recommended by AOAC International, from May 2018 to May 2020. The presence of at least one foreign matter was observed in 80% of the samples. Animal's hairs were observed in all the evaluated products and insect's fragments were found in the most of the samples. Mites, whole insects, insect larvae, barbules and exuvia were also found, as wellas synthetic fibers and microplastic fragments. About legislation, 47.8% of the samples were above the tolerance limits, of these, 90.7% for containing foreign matters indicating failure of good practices and 9.3% for foreign matters indicating health risk. The results obtained show inefficiency in the application of good practice measures in production chain and advertise for the intensification of inspection directed to fulfillment of sanitary norms, besides provoking the reflection on the necessity of alterations in the legislation about foreign matter in foods. (AU)

Designing an Effective Front-of-Package Warning Label for Food and Drinks High in Added Sugar, Sodium, or Saturated Fat in Colombia: An Online Experiment.

Policies to require warnings on the front of food and drinks high in nutrients of concern (e.g., added sugar, sodium, or saturated fat) are becoming increasingly common as an obesity prevention strategy. Colombia, a country with growing prevalence of obesity, is considering implementing a similar policy. The objective of this study was to assess perceptions and reactions to different warning designs. We conducted a randomized experiment in an online panel of adults age > 18y (n = 1997). Participants were randomized to view one of four labels: a control label (barcode), an octagon warning, a circle warning, and a triangle warning. Participants viewed their randomly assigned label on a series of products and answered questions (continuous outcomes ranged from 1-4). Compared to the control, all warnings led to higher perceived message effectiveness (increase in mean from 1.79 in the control to 2.59-2.65 in the warning conditions, p < 0.001), a higher percentage of participants who correctly identified products high in nutrients of concern (from 48% in the control condition to 84-89% in the warning conditions, p < 0.001), and reduced intentions to purchases these products (decrease in mean from 2.59 to 1.99-2.01 in the warning conditions, p < 0.001). Relative to the control, warnings performed similarly across education levels, suggesting this policy would be equitable in Colombia. Looking at differences by warning type, the pattern of results suggested that the octagon warnings performed best. After viewing all label types, 49% of participants selected the octagon warning as the one that most discouraged them from consuming products high in nutrients of concern, while 21% and 27% selected the circle and triangle warning. Colombian policymakers should consider the octagon warning as part of a front-of-package labeling policy to help consumers identify and reduce consumption of foods and drinks high in nutrients of concern.

Culinary and nutritional value of edible wild plants from northern Spain rich in phenolic compounds with potential health benefits.

Wild edible plants (WEPs) have been consumed since ancient times. They are considered as non-domesticated plants that grow spontaneously in nature, particularly in forests and bushlands, where they can be found and collected to be incorporated into human nutrition. Increasingly, WEPs are gaining importance as they are potential sources of food due to their nutritional value, besides showing positive health effects and offer innovative applications in haute cuisine. As these autochthonous plants grow naturally in the environment, they are more suitable to adapt to different climatic conditions as well as biotic and abiotic factors. Therefore, a door has been opened for their possible cultivation as they seem to require fewer expenses than other commercially cultivated plants. Moreover, the consumers demand for new products of natural origin that are sustainable and ecologically labeled have also boosted WEPs' recovery and incorporation into the market. In addition, they are considered as promising sources of essential compounds needed not only in human diet including carbohydrates, proteins, and lipids but also of other minor compounds as phenols, vitamins, or carotenoids that have shown numerous beneficial bioactivities such as antioxidants, anti-inflammatory, or anti-tumor activity. The use of these plants rich in bioactive molecules could be beneficial from the health point of view as the human body is not always capable of producing enough defenses, for instance, preventing oxidative damage. In particular, the presence of phenolic compounds in these vegetal matrices is supposed to provide a prophylactic effect against further pathogenesis and disorders related to aging or oxidative stresses. Regarding all this information based on traditional knowledge and ethnobotanical data, different WEPs found in the Northwestern region of Spain were selected, namely, Mentha suaveolens, Glechoma hederacea, Prunus spinosa, Apium nodiflorum, Artemisia absinthium, Silybum marianum, Picris hieracioides, Portulaca oleracea, Crithmum maritimum, and the genus Amaranthus. However, even though tradition and popular knowledge are excellent tools for the exploitation of these plants, it is necessary to develop regulations in this aspect to assure safety and veracity of food products. This article aims to review the main aspects of their bioactive properties, their traditional use, and the possibility of their incorporation into the market as new functional foods, looking at innovative and healthy gastronomic applications.

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.

Cannabis sativa L. and Its Extracts: Regulation of Cannabidiol in the European Union and United Kingdom.

The lawful sale of Cannabis sativa L. and its extracts including Cannabidiol is not harmonized under European Union law. Such products have in the most part been classified as novel foods and thus illegal for sale in Europe without prior authorization. The regulation of such substances not only spans EU and Member State food laws but also international conventions on illicit drug and psychoactive substances. An understanding of the laws governing the sale of these compounds can help business and academia better understand the challenges consumers may face in selecting products lawfully placed on the market, whilst identifying the unique challenges imposed from the marketing of Cannabis-based foods.

Special Low Protein Foods in the UK: An Examination of Their Macronutrient Composition in Comparison to Regular Foods.

Special low protein foods (SLPFs) are essential in a low phenylalanine diet for treating phenylketonuria (PKU). With little known about their nutritional composition, all SLPFs on UK prescription were studied (n = 146) and compared to equivalent protein-containing foods (n = 190). SLPF nutritional analysis was obtained from suppliers/manufacturers. Comparable information about regular protein-containing foods was obtained from online UK supermarkets. Similar foods were grouped together, with mean nutritional values calculated for each subgroup (n = 40) and percentage differences determined between SLPFs and regular food subgroups. All SLPF subgroups contained 43-100% less protein than regular foods. Sixty-three percent (n = 25/40) of SLPF subgroups contained less total fat with palm oil (25%, n = 36/146) and hydrogenated vegetable oil (23%, n = 33/146) key fat sources. Sixty-eight percent (n = 27/40) of SLPF subgroups contained more carbohydrate, with 72% (n = 105/146) containing added sugar. Key SLPF starch sources were maize/corn (72%; n = 105/146). Seventy-seven percent (n = 113/146) of SLPFs versus 18% (n = 34/190) of regular foods contained added fibre, predominantly hydrocolloids. Nine percent of SLPFs contained phenylalanine > 25 mg/100 g and sources of phenylalanine/protein in their ingredient lists. Stricter nutritional composition regulations for SLPFs are required, identifying maximum upper limits for macronutrients and phenylalanine, and fat and carbohydrate sources that are associated with healthy outcomes.

Nutraceuticals: A Comparative Analysis of Regulatory Framework in Different Countries of the World.

BACKGROUND: Nutraceutical is a term that is a combination of nutrition and pharmaceutical. They are believed to improve physical and mental health and provide therapeutic benefit in disease conditions. Nutraceuticals are claimed to be beneficial in several disease conditions which include cardiovascular disorder, neurodegenerative disorders, metabolic disorders and cancer prevention. OBJECTIVE: In the current review, we will study the current regulatory framework in some of the major countries of the world by comparing different parameters of these regulations. FINDINGS: Global nutraceutical market is currently expanding at a rapid pace but there are some restraints to the market growth which include poor quality manufacturing and unharmonized regulations leading to trade barriers across the globe. Although there are laws and regulations in place which govern nutraceutical products in different countries, these regulations lack harmonization and differ from country to country. Some of the countries follow stringent regulations, whereas, in some of the countries, well-structured and stern regulations for nutraceuticals are lacking. CONCLUSION: The development of a well regulated, harmonized and research-driven approach can help boost the confidence of consumers in nutraceutical products in the world thereby driving the nutraceutical market.

"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.