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.

Regulatory Framework of Fortified Foods and Dietary Supplements for Athletes: An Interpretive Approach.

A varied and well-planned diet can meet the nutritional needs of an athlete; however, in certain cases, it could be advisable to increase the intake of some vitamins, minerals or other components through the controlled intake of fortified foods or dietary supplements. In the European Union, a high number of sport foods and supplements are marketed; athletes could at times consume them indiscriminately or even choose products that have not been evaluated and approved by scientific evidence. In this sense, it is necessary to know and interpret the specific regulations for these products in order to make adequate use of them. The aim of this manuscript is to describe the current status of the European regulatory framework, focusing on: (1) regulation of the marketing and labelling of both fortified foods and supplements; (2) regulation of the use of substances used as ingredients in fortified foods; and (3) regulation of nutritional claims and/or health properties associated with nutrients, ingredients and other related substances. This review can facilitate knowledgeable decision making by sports nutrition professionals in order to counsel or manage adequate food choices as well as help consumers make better-informed food decisions. Other experts, such as producers who ensure food safety, might also be interested in this review.

Examining the Prevalence, Nutritional Quality and Marketing of Foods with Voluntary Nutrient Additions in the Canadian Food Supply.

Foods with voluntary nutritional additions are a fast-growing sector of the global food industry. In Canada, while the addition of nutrients to foods has been regulated through fortification regulations, parallel policies which aim to encourage product innovation have also allowed for the voluntary addition of nutrients and other novel ingredients to 'supplemented' and 'functional' foods. Concerns have been raised that the consumption of these products may have negative repercussions on population health, such as high nutrient intakes inappropriate for certain population subgroups (e.g., children) and the shifting of dietary patterns to include more unhealthy foods. The aim of this study was to evaluate the prevalence, nutritional quality, and marketing characteristics of foods with added nutrients in the Canadian market. We found many nutritionally-enhanced foods contained high levels of nutrients beyond recommended intakes, despite these nutrients having no evidence of inadequacy in the Canadian population. Additionally, a large proportion of foods with added nutrients had poor nutrient profiles (were deemed 'less healthy' than their non-enhanced counterparts) and carried heavy marketing on their labels, regardless of their nutritional quality. Taken together these findings raise concerns about foods with voluntary nutrient additions and suggest the need to further investigate consumer attitudes and decision-making towards these foods.

Plants: A natural solution to enhance raw milk cheese preservation?

Plants have been traditionnally used for centuries in cheese manufacturing, either for their aromatic properties or as technological auxiliaries (e.g. milk-clotting enzyme preparations, cheese wrappers). Some of these plants are known to have antimicrobial and/or antioxidant properties and could also act as natural preservatives for raw milk and derived dairy products. This review examined the traditional uses of plants in dairy processing, and then focuses on known antimicrobial and antioxidant properties of their extracts (e.g. maceration, decoction, essential oil). Known effects of theses plants on technological flora (starter cultures and microorganisms implicated in cheese ripening) were also summarized, and the potential for plant extracts used in combination with hurdle technologies was explored. Then, legal restriction and bioactivity variations from a culture media to a food matrix was reviewed: non-toxic bioactive molecules found in plants, extract preparation modes suitable with foodgrade processing restrictions, the role of the food matrix as a hindrance to the efficiency of bioactive compounds, and a review of food legislation. Finally, some commercial plant extracts for milk preservation were discussed.

Report on the SCRA Nuts and Bolts Workshop II: case studies of citrus greening, Ultra-low Gossypol Cotton, and blight tolerant, low-acrylamide potato.

To be commercialized and grown in the US, genetically engineered (GE) crops typically go through an extensive food, feed, and environmental safety assessment process which, in certain instances, requires complex consultations with three different US regulatory agencies. Many small market, niche, and specialty crops have been genetically engineered using the modern tools of recombinant DNA but few have been commercialized due to real or perceived regulatory constraints. This workshop discussed the practical aspects of developing dossiers on GE specialty, niche, or small-market crops/products for submission to US regulatory agencies. This workshop focused on actual case studies, and provided an opportunity for public or private sector scientists and crop developers to spend time with regulatory officials to learn the specifics of compiling a dossier for regulatory approval. The objective of the workshop was to explain and demystify data requirements and regulatory dossier compilation by small companies, academics, and other developers.

Is multi-level marketing of nutrition supplements a legal and an ethical practice?

BACKGROUND: Multi-level marketing (MLM) of nutrition products has experienced dramatic growth in recent decades. 'Wellness' is the second most popular niche in the MLM industry and represents 35% of sales among all the products in 2016. This category includes dietary supplements, weight management and sports nutrition products. The aim of this paper is to analyse whether this practice is legal and ethical. METHODS: An analysis of available documentary information about the legal aspects of Multi-level marketing business was performed. Ethical reflexion was based on the "principlism" approach. RESULTS: We argue that, while being a controversial business model, MLM is not fraudulent from a legal point of view. However, it is an unethical strategy obviating all the principles of beneficence, nonmaleficence and autonomy. What is at stake is the possible economic scam and the potential harm those products could cause due to unproven efficacy, exceeding daily nutrient requirements and potential toxicity. The sale of dietary and nutrition supplements products by physicians and dieticians presents a conflict of interests that can undermine the primary obligation of physicians to serve the interests of their patients before their own. CONCLUSION: While considering that MLM of dietary supplements and other nutrition products are a legal business strategy, we affirm that it is an unethical practice. MLM products that have nutritional value or promoted as remedies may be unnecessary and intended for conditions that are unsuitable for self-prescription as well.

Why Americans Need Information on Dietary Supplements.

Until a decade ago, no dietary supplement (DS) databases with open access for public use existed in the United States. They were needed by researchers, since half of American adults use dietary DSs and, without information on supplement use and composition, exposures could not be estimated. These articles on Challenges and Future Directions for Dietary Supplement Databases describe subsequent progress. They begin by describing why information on DSs is needed by the government and how it is used to ensure the health of the public. Current developments include: application of DS information to meet public health needs; research efforts on DS quality, efficacy, and safety (as conducted by the Office of Dietary Supplements and other federal agencies); enhanced regulatory activities implemented by the FDA Office of Dietary Supplement Programs, the FDA Office of Enforcement, and the Federal Trade Commission; and initiatives for broader development and dissemination of DS databases for commercial and public use. Other contributions in this journal supplement describe the challenges of working with DSs and the progress that has been made. Additional articles describe surveys of DS use among the general US population and also among special groups such as high supplement users, illustrating why there is a need in the United States for information on supplements. Likely directions for the future of DS science are summarized.

Trans-Fatty Acids and Cardiovascular Disease: Urgent Need for Legislation.

Hydrogenated oils containing trans-fatty acids (TFA) are used to produce margarine and various processed foods. TFA affect serum lipid levels, fatty acid metabolism, and endothelial function. High TFA intake is linked to increased all-cause mortality, coronary heart disease mortality, and cardiovascular disease (CVD) incidence. Denmark was the first country to introduce a law that limited TFA content in food; this action led to lower CVD mortality. So far 7 European countries have followed this practice, in a few others the food industry voluntarily reduced TFA use. The issue remains mostly unaddressed in the rest of the world. Legal TFA limits should be commonly established as they are the optimal solution considering both CVD prevention and the associated cost savings in public healthcare.

The Benefits of Regulatory Friction in Shaping Policy.

The regulation of food, drugs, and controlled substances in this country is exceedingly complex. Local, state, and federal regulation coexist, and common law remedies supplement positive law. Strata of regulation are necessary because patterns of production and consumption vary by region and demographic, while federal regulation provides regulatory uniformity across the United States. As localities struggle to sustain autonomy in response to local preference while working within a centralized system, and federal agencies struggle to maintain regulatory uniformity to foster a national marketplace, we see interaction and friction between regulatory spheres. While this friction usually becomes apparent through a lens of adversity, it is also a space of foment for policy change and democratic engagement. In this Paper I explore this productive space by looking at several recent instances of action by states in food, dietary supplements, and controlled substances regulation that highlight this friction. An analysis of these actions and the challenges to them provides an opportunity to view the interaction between different levels of regulatory authority and to discuss implications of the judicial review of these enactments. We see complex and shifting alliances working to change policy, and we see benefits in the push and pull caused by these actions.

Scientific, economic, regulatory, and ethical challenges of bringing science-based pediatric nutrition products to the U.S. market and ensuring their availability for patients.

Many nutrition products and related drugs are unavailable or not consistently available to clinicians despite a body of clinical data and experience supporting their use. Many of these can be related to drug shortages that have increased since 2009. In addition, there are potentially useful products that are not approved for a specific use or are no longer being manufactured. This review broadly examines the product availability gap from the perspectives of a clinician/former nutrition industry medical director and an economist. The process of pediatric nutrition product and related drug innovation, as well as its drivers and the steps involved in bringing a product to market, is first described. This is followed by an assessment of factors influencing product availability beyond the innovation process, including regulatory issues, manufacturing compliance, purchasing practices, and other factors related to drug and nutrition product pricing and reimbursement. Three pediatric case examples are reviewed and placed in the context of the prior review. Last, recent and future possible steps toward closing the product availability gap are discussed.

Effect of increasing voluntary folic acid food fortification on dietary folate intakes and adequacy of reproductive-age women in New Zealand.

OBJECTIVE: Mandatory folic acid fortification of breads in New Zealand was put on hold in 2009. At this time, bread manufacturers were requested to adopt greater voluntary fortification and agreed to add folic acid to approximately one-third of their bread range. We sought to evaluate the impact of increased voluntary fortification of bread and the proposed mandatory fortification programme on folate intake adequacy of reproductive-age women. DESIGN: Cross-sectional study conducted in 2008. Dietary data were collected using 3 d weighed food records and usual folate intakes were generated by modifying the food composition table as follows: (i) voluntary fortification of bread as of 2008 (six breads); (ii) increased voluntary fortification of bread as of 2011 (thirty-four breads); and (iii) mandatory fortification of all breads. The prevalence of inadequate folate intake was calculated for all three scenarios using the Estimated Average Requirement (320 µg dietary folate equivalents/d) cut-point method. SETTING: New Zealand. SUBJECTS: Healthy non-pregnant women (n 125) aged 18-40 years. RESULTS: Usual folate intake in 2008 was 362 µg dietary folate equivalents/d. Increased voluntary bread fortification led to a marginal increase in folate intakes (394 µg dietary folate equivalents/d) and a decline in inadequacy from 37 % to 29 %. Mandatory fortification resulted in an increase of 89 µg folic acid/d, which substantially shifted both the proportion of women with folic acid intakes above 100 µg/d and the distribution of overall folate intakes, producing a marked reduction in inadequacy to 5 %. CONCLUSIONS: Increased voluntary bread fortification efforts are far inferior to mandatory fortification as a reliable public health intervention.

Reformulating partially hydrogenated vegetable oils to maximise health gains in India: is it feasible and will it meet consumer demand?

BACKGROUND: The consumption of partially hydrogenated vegetable oils (PHVOs) high in trans fat is associated with an increased risk of cardiovascular disease and other non-communicable diseases. In response to high intakes of PHVOs, the Indian government has proposed regulation to set limits on the amount of trans fat permissible in PHVOs. Global recommendations are to replace PHVOs with polyunsaturated fatty acids (PUFAs) in order to optimise health benefits; however, little is known about the practicalities of implementation in low-income settings. The aim of this study was to examine the technical and economic feasibility of reducing trans fat in PHVOs and reformulating it using healthier fats. METHODS: Thirteen semi-structured interviews were conducted with manufacturers and technical experts of PHVOs in India. Data were open-coded and organised according to key themes. RESULTS: Interviewees indicated that reformulating PHVOs was both economically and technically feasible provided that trans fat regulation takes account of the food technology challenges associated with product reformulation. However, there will be challenges in maintaining the physical properties that consumers prefer while reducing the trans fat in PHVOs. The availability of input oils was not seen to be a problem because of the low cost and high availability of imported palm oil, which was the input oil of choice for industry. Most interviewees were not concerned about the potential increase in saturated fat associated with increased use of palm oil and were not planning to use PUFAs in product reformulation. Interviewees indicated that many smaller manufacturers would not have sufficient capacity to reformulate products to reduce trans fat. CONCLUSIONS: Reformulating PHVOs to reduce trans fat in India is feasible; however, a collision course exists where the public health goal to replace PHVOs with PUFA are opposed to the goals of industry to produce a cheap alternative product that meets consumer preferences. Ensuring that product reformulation is done in a way that maximises health benefits will require shifts in knowledge and subsequent demand of products, decreased reliance on palm oil, investment in research and development and increased capacity for smaller manufacturers.

Regulatory monitoring systems of fortified salt and wheat flour in selected ASEAN countries.

BACKGROUND: Considerable efforts have been made over the past decade to address vitamin and mineral deficiencies. An increasing number of countries in the Association of Southeast Asian Nations (ASEAN) are adopting mandatory food fortification as one of the primary strategies to overcome these deficiencies. Experience shows that fortified foods can reach large parts of the population, including the poor, if the fortification is done on a mandatory rather than a voluntary basis and if the food vehicle is widely consumed. OBJECTIVE: To review the importance of regulatory monitoring as an essential component of food fortification efforts in selected ASEAN countries, with special focus on the available information on regulatory monitoring systems for iodized salt and fortified wheat flour. METHODS: The role of regulatory monitoring in strengthening food fortification programs was discussed during a joint regional meeting of the World Health Organization, UNICEF, the Flour Fortification Initiative, the Global Alliance for Improved Nutrition, the Micronutrient Initiative, and the World Bank on regulatory monitoring of salt and wheat flour fortification programs in Asia, which took place in Manila, Philippines, on 27-29 September 2011. This paper reviews the regulatory monitoring systems of selected ASEAN countries that participated in this meeting. RESULTS: Problems and challenges in regulatory monitoring systems for iodized salt and fortified wheat flour in selected ASEAN countries are identified, and a description of the role of regulatory monitoring in strengthening food fortification initiatives, particularly of salt and flour, and highlights of areas for improvement are presented. CONCLUSIONS: Regulatory monitoring consists of monitoring activities conducted at the production level, at customs warehouses, and at retail stores by concerned regulatory authorities, and at the production level by producers themselves, as part of quality control and assurance efforts. Unless there are appropriate enforcement and quality assurance mechanisms in place to stimulate compliance by food producers, i.e., regulatory monitoring, having national legislation will not necessarily lead to increased coverage of fortified products and associated outcomes.

Legal framework for food fortification: examples from Vietnam and Indonesia.

BACKGROUND: Food fortification is a cost-effective, powerful, and sustainable strategy to combat micronutrient deficiency, with the potential to reach large sections of the population with minimal cost and effort. However, the implementation of food fortification on a systematic and large scale, for instance in national programs, has often been challenging. OBJECTIVE: This paper takes a closer look at food fortification efforts and legislation mechanisms in Vietnam and Indonesia in order to determine specific factors and components in the legal framework that are crucial to the success of fortification programs. METHODS: Fortification efforts in Indonesia and Vietnam are evaluated using published data as well as unpublished data from detailed evaluation reports, and compared with respect to the specific circumstances, constraints, objectives and results in each country. RESULTS: The legal framework is a crucial factor for the success of food fortification programs, as it shapes to a large extent the implementation of food fortification. The legal framework is instrumental to ensure the quality, safety, availability, cost-effectiveness, and sustainability of food fortification. In the first place, the legal framework should specify the fortificants and fortification levels, as well as the food vehicles and the fortification procedures. In addition, it should ensure the commitment of policy makers and producers to fortification, regulate the costing, describe and ensure information and communication such as product labeling integrate social marketing into the implementation, and provide the means to monitor and enforce fortification. A clear public health objective, together with careful consideration of the choices and restrictions dictated by the specific national environments, will help to develop legal frameworks that optimize the potential success of food fortification strategies. CONCLUSIONS: The lessons from these experiences show that a mandatory approach to fortification, with costing, monitoring and enforcement, and social marketing clearly defined and well embedded in the legal framework and in the implementation structures, is the best foundation for an effective, sustainable, and feasible food fortification program.

Gazing into the crystal ball: future considerations for ensuring sustained growth of the functional food and nutraceutical marketplace.

Over the last decade the concept of functional foods and nutraceuticals (FFN) has gained support from various stakeholders including the food industry, scientific and academic community, government institutions or regulators, producers and consumers. However, as one begins to evaluate the global FFN industry, several issues emerge including (i) a lack of consensus across jurisdictions for acknowledging safe and efficacious FFN, (ii) challenges regarding the classification of novel food-derived bioactives as FFN or drugs, and (iii) a disconnect between nutrient requirements and dosages of FFN required to facilitate health benefits. The objectives of the present review are to discuss the role of existing stakeholders within the FFN marketplace and identify performance indicators for growth within the FFN sector. In addition, the following report provides feasible resolutions to present and future challenges facing the global FFN industry to ensure sustained long-term growth.

The regulation of protein content and quality in national and international food standards.

Food regulation aims to protect public health through a safe and nutritious food supply produced by a compliant food industry. Food standards of developed countries generally do not regulate protein content or protein quality because the risk of dietary protein inadequacy in their national populations is very low. Protein is nevertheless regulated for reasons of product quality or protein labelling or to minimise assessed health risks associated with consumption of certain animal- and vegetable-protein foods; analogue products that extend or simulate commonly available animal-protein foods; and special purpose foods such as infant formula and foods, supplementary and medical foods, and foods for weight loss. The extent and approach to protein regulation varies greatly among jurisdictions but where it occurs, it is applied through minimum and sometimes maximum limits on protein content or quality measures or both using an inter-related approach. Protein quality measures range from amino acid profiles and digestibility corrected scores to protein rating, a rat bioassay and reference proteins not further described. Regulatory methods for protein quality determination are referenced to the published scientific literature or developed nationally. Internationally, the Codex Alimentarius regulates the protein content and quality of some foods. The Codex approach varies according to the food but is similar to the approaches used in national and regional food regulation. This paper provides a comparison of the regulation of protein in foods using examples from the food regulations of Australia New Zealand, Canada, the European Union, the United States of America and the Codex Alimentarius.

[Enriched and functional foodstuffs: similarities and differences].

A comparison of fortified and functional foods on such parameters as destination, food group, the principles of enrichment with vitamins and/or macro- and micronutrients, doses and forms of vitamins and minerals, hygienic regulations of micronutrients usage and content in the final product, regulatory and technical documentation, duration of application, effectiveness, labeling, information for consumers has been carried out. Insufficiency and the need to improve the regulatory framework for functional foods are noted.