Therapeutic food claims: a global perspective.

PURPOSE OF REVIEW: Medical foods in the United States, and foods for special medical purposes in other countries, are food formulations used to manage specific chronic diseases or conditions under medical or physician supervision. The process of reviewing and approving food claims for health benefits varies widely from country to country. RECENT FINDINGS: CODEX Alimentarius, a 187-country and one-member (European Union) organization, has standardized not only nutrition labeling and food safety worldwide but has also recently taken on a prominent role in analyzing therapeutic and health claims for food in member countries by providing a framework to study these issues. Two recent activities at CODEX - analyzing foods for special dietary uses and foods for special medical purposes therapeutic food claims - have focused on both how these food categories are formulated for patients with specific conditions and diseases. SUMMARY: Food and specially formulated foods can play a role in preventing or mitigating disease and other health-related conditions. This article will examine the means by which regulatory authorities across the globe address health claims for foods and food-derived products to alter human physiology and disease outcome.

Keeping mycotoxins away from the food: Does the existence of regulations have any impact in Africa?

Following the discovery of aflatoxins in the early 1960s, there have been many studies leading to the uncovering of many mycotoxins and the understanding of associated health effects in animals and humans. Consequently, there has been a global increase in the number of countries with mycotoxin regulations in foods. However, many African countries have only regulations for aflatoxins (or a few other mycotoxins) in specific foods, or no regulations at all. This paper critically reviews the challenges thwarting the establishment of mycotoxin regulations and their impacts on human dietary mycotoxin exposure in Africa. Mycotoxin regulatory limits for different countries are compared with mycotoxin tolerable daily intakes established by international food safety bodies taking into account consumption patterns. The agrarian setup, food insecurity, and mycotoxin analytical challenges in African countries are discussed; and more feasible mycotoxin dietary exposure reduction strategies are proposed.

Important Regulatory Aspects in the Receipt of Animal Products by Food Services.

The aim of this study was to review the current legislation and rules in Brazil that involve quality assurance of animal products during food service reception. Published federal legislation and technical regulations were verified to present a broad general approach to raw material reception. Food service determinations included specifications of the criteria for evaluating and selecting suppliers, verifying the transport system, reception area requirements, and inspecting raw material. For product approval, the packaging, labeling, and temperature should be evaluated. However, periodic microbiological, physicochemical, and sensory support assessment analyses are not required for receiving animal products. For the safety of the raw material, it was concluded that the largest impacts came from the regulation and supervision of the food sector provider because of the challenges of food service and a lack of requirements to use more complex evaluation methods during the reception of raw materials.

Food Labeling: Revision of the Nutrition and Supplement Facts Labels. Final rule.

The Food and Drug Administration (FDA or we) is amending its labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the label to assist consumers in maintaining healthy dietary practices. The updated information is consistent with current data on the associations between nutrients and chronic diseases, health-related conditions, physiological endpoints, and/or maintaining a healthy dietary pattern that reflects current public health conditions in the United States, and corresponds to new information on consumer understanding and consumption patterns. The final rule updates the list of nutrients that are required or permitted to be declared; provides updated Daily Reference Values and Reference Daily Intake values that are based on current dietary recommendations from consensus reports; amends requirements for foods represented or purported to be specifically for children under the age of 4 years and pregnant and lactating women and establishes nutrient reference values specifically for these population subgroups; and revises the format and appearance of the Nutrition Facts label.

Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments. Final rule.

The Food and Drug Administration (FDA or we) is issuing a final rule to define a single-serving container; require dual-column labeling for certain containers; update, modify, and establish several reference amounts customarily consumed (RACCs); amend the label serving size for breath mints; and make technical amendments to various aspects of the serving size regulations. We are taking this action to provide consumers with more accurate and up-to-date information on serving sizes.

National School Lunch Program and School Breakfast Program: Nutrition Standards for All Foods Sold in School as Required by the Healthy, Hunger-Free Kids Act of 2010. Final rule and interim final rule.

This rule adopts as final, with some modifications, the National School Lunch Program and School Breakfast Program regulations set forth in the interim final rule published in the Federal Register on June 28, 2013. The requirements addressed in this rule conform to the provisions in the Healthy, Hunger-Free Kids Act of 2010 regarding nutrition standards for all foods sold in schools, other than food sold under the lunch and breakfast programs. Most provisions of this final rule were implemented on July 1, 2014, a full year subsequent to publication of the interim final rule. This was in compliance with section 208 of the Healthy, Hunger-Free Kids Act of 2010, which required that State and local educational agencies have at least one full school year from the date of publication of the interim final rule to implement the competitive food provisions. Based on comments received on the interim final rule and implementation experience, this final rule makes a few modifications to the nutrition standards for all foods sold in schools implemented on July 1, 2014. In addition, this final rule codifies specific policy guidance issued after publication of the interim rule. Finally, this rule retains the provision related to the standard for total fat as interim and requests further comment on this single standard.

Local School Wellness Policy Implementation Under the Healthy, Hunger-Free Kids Act of 2010. Final rule.

This final rule requires all local educational agencies that participate in the National School Lunch and School Breakfast Programs to meet expanded local school wellness policy requirements consistent with the requirements set forth in section 204 of the Healthy, Hunger-Free Kids Act of 2010. The final rule requires each local educational agency to establish minimum content requirements for the local school wellness policies, ensure stakeholder participation in the development and updates of such policies, and periodically assess and disclose to the public schools' compliance with the local school wellness policies. These regulations are expected to result in local school wellness policies that strengthen the ability of a local educational agency to create a school nutrition environment that promotes students' health, well-being, and ability to learn. In addition, these regulations will increase transparency for the public with regard to school wellness policies and contribute to integrity in the school nutrition program.

A proposed framework for an appropriate evaluation scheme for microorganisms as novel foods with a health claim in Europe.

This paper concerns the procedure and the scientific approach to obtain market authorization for a microorganism to be recognized as a novel food with a health claim. Microorganisms that have not been traditionally used during food production in Europe prior to 1997 are considered as novel foods, which should undergo an in-depth characterization and safety assessment before being authorized on the European market. If a novel food bacterium is claimed to provide a beneficial effect on health, these claims must also be investigated before they can be authorized. Some requirements to obtain novel food certification are shared with those required to obtain a health claim. Although regulation exists that deals with these issues for foods in general, bacteria in food raise a specific set of questions that are only minimally addressed in official documentation. We propose a framework and suggest a list of criteria that should be assessed to obtain marketing authorization and health claim for a bacterium in accordance with European health policy.

Regulatory aspects of nanotechnology in the agri/feed/food sector in EU and non-EU countries.

Nanotechnology has the potential to innovate the agricultural, feed and food sectors (hereinafter referred to as agri/feed/food). Applications that are marketed already include nano-encapsulated agrochemicals or nutrients, antimicrobial nanoparticles and active and intelligent food packaging. Many nano-enabled products are currently under research and development, and may enter the market in the near future. As for any other regulated product, applicants applying for market approval have to demonstrate the safe use of such new products without posing undue safety risks to the consumer and the environment. Several countries all over the world have been active in examining the appropriateness of their regulatory frameworks for dealing with nanotechnologies. As a consequence of this, different approaches have been taken in regulating nano-based products in agri/feed/food. The EU, along with Switzerland, were identified to be the only world region where nano-specific provisions have been incorporated in existing legislation, while in other regions nanomaterials are regulated more implicitly by mainly building on guidance for industry. This paper presents an overview and discusses the state of the art of different regulatory measures for nanomaterials in agri/feed/food, including legislation and guidance for safety assessment in EU and non-EU countries.

Food allergy, a summary of eight cases in the UK criminal and civil courts: effective last resort for vulnerable consumers?

Food allergy has a forensic context. The authors describe eight cases in the UK courts involving fatalities, personal injury or criminal non-compliance with food law from mainly 'grey' literature sources. The potentially severe consequences for people with food allergy of contraventions of labelling law have led to enforcement action up to criminal prosecution for what might otherwise be regarded as 'trivial' non-compliance. The authors suggest there should be central collation of such cases. Non-compliances should be followed up in a more rapid and robust manner. Evidence of fraud in the catering supply chain supports recent calls for zero tolerance of food fraud. Businesses must guard against gaps in allergen management, for which there are readily available sources of training and guidance, but also against fraudulent substitution in the supply chain, about which training and guidance should be developed. New allergen labelling legislation and case law appear to place responsibility on food businesses even for the forensically problematic area of allergen cross-contamination. The courts can be an effective last resort for vulnerable consumers; however, there is evidence of knowledge and skill gaps in both the investigation and prosecution of potentially serious incidents of food allergen mismanagement and mislabelling. Thorough investigation of food allergy deaths is required with a tenacious and skilled approach, including early realisation that samples of the food and/or stomach contents from a post mortem examination should be retained and analysed. The supply chain must be rigorously examined to find out where adulteration or contamination with the fatal allergen occurred.

Acrylamide: formation, occurrence in food products, detection methods, and legislation.

This review aims at summarizing the most recent updates in the field of acrylamide (AA) formation (mechanism, conditions) and the determination of AA in a number of foods (fried or baked potatoes, chips, coffee, bread, etc). The methods applied for AA detection [Capillary Electrophoresis-Mass Spectrometry (CE-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), Non-Aqueous Capillary Electrophoresis (NACE), High Performance Liquid Chromatography-Mass Spectrometry (HPLC-MS), Pressurized Fluid Extraction (PFE), Matrix Solid-Phase Dispersion (MSPD), Gas Chromatography-Mass Spectrometry (GC-MS), Solid-Phase MicroExtraction-Gas Chromatography (SPME-GC), Enzyme Linked Immunosorbent Assay (ELISA), and MicroEmulsion ElectroKinetic Chromatography (MEEKC) are presented and commented. Several informative figures and tables are included to show the effect of conditions (temperature, time) on the AA formation. A section is also included related to AA legislation in EU and US.

Attitudes and beliefs on the establishment of a national food safety authority in Cyprus. A population-based survey.

Cyprus does not have a National Food Safety Authority (NFSA), but a multi-level, fragmented system with responsibilities divided among different ministries and governmental agencies, frequently impeding efforts to effectively manage food risks by duplication and overlapping of responsibilities. A population-based survey was carried out to determine the beliefs and attitudes of interested parties concerning the establishment of a NFSA in Cyprus. Information was collected using a random stratified sampling design and a structured questionnaire. A total of 868 questionnaires were collected (704 from regular consumers, 154 from food businesses' representatives, and 10 from public services' directors or acting head officers). About 11% of food businesses' representatives and 45% of consumers reported that they did not know which public authorities are responsible for food control. Moreover, 2 out of 10 (17%) of responders from public agencies, 70% from food businesses and 91% from consumers, although not aware of ongoing efforts to establish a food safety authority in Cyprus (currently under consideration), were supportive of the idea [8 out of 10 (83%) of responders from public services, 93% from food businesses, and 89% of consumers]. Finally, 7 out of 10 (67%) from the public agencies and 84% of representatives from food businesses agreed with the separation of risk assessment from risk management activities. Public opinion in Cyprus as well as public agencies and food businesses' representatives support the establishment of a single independent national food safety authority in Cyprus based on the European paradigm including the division of risk activities.

[Legislative regulation of production and turnover of products for people with different diseases].

This article presents results of analysis of existing regulatory documents and approaches to the legislative regulation of production and turnover of special dietary products for people with specific diseases in EU, Ukraine and Russian Federation. According to the EU legislation, production and turnover of food products for nutritional support of people during specific diseases and the rehabilitation period are regulated by the Commission Directive 1999/21/EC, 2009/39/ES, by Regulation Commission (EU) No 953/2009 and documents of Codex Committee. Special food products for people with specific diseases in Ukrainian legislation are classified as nutrition products for special dietary use and are regulated by the following Laws of Ukraine "On the safety and quality of food", "On ensuring of sanitary and epidemiological welfare of the population", "On Consumer Rights Protection", "On advertising" and by other non-legislative acts. According to the current legislation of the Russian Federation, the products for people with specific diseases are classified as healthy dietary food products. The basis of the legal framework are federal laws "On the quality and safety of food", "On the sanitary-epidemiological welfare of the populations", "On technical regulations and technical regulations of the Customs Union "On Food Safety" and "On the safety of certain types of specialized food products, including healthy dietary food products and therapeutic dietary food products". There is no common approach to the legal regulation of production and turnover of products for people with specific diseases in the world. The proposals for further harmonization of regulatory control in this area have been developed.

[Tolerance in the substantiation of the maximum allowable content of antibiotics in food products].

Provides the ability to use the principle of tolerance in substantiation of the maximum permissible levels (MDU) residual amounts of antibiotics of tetracycline group (ATG) in meat and dairy products. Using the data of monitoring research of food products, carried out in 2005-2011, in the system of Rospotrebnadzor was conducted analysis of the levels of tolerance of residual quantities of ATG in the meat, meat by-products, chicken eggs, milk, dairy and other products. The conclusion weas made that the Russian Federation hygienic norm MDU of ATG of meat and dairy products - 0.,01 mg/kg (SanPiN2.3.2.2804-10) - justified, consistent with the principle of tolerance and reduces the risk of negative consequences for the population.

[On the implementation by Rospotrebnadzor (Federal service for the oversight of consumer protection and welfare) common principles and rules of technical regulation within the agreement of the Customs Union].

In accordance with the Agreement of the Customs Union on sanitary measures between the Government of the Russian Federation, the Republic of Belarus and the Republic of Kazakhstan in the customs territory of the Customs Union the Uniform sanitary and epidemiological and hygienic requirements for goods subject to sanitary-epidemiological control are applied. Common sanitary requirements are binding for executive authorities of the Member States of the Customs union, local authorities, legal persons, whatever legalform, individual entrepreneurs, individuals. Currently, out of 47 planned to take priority technical regulations of the Customs Union 31 regulation, including the safety of railway rolling stock, production of perfumery and cosmetics, toys and products for children and teenagers, food products, grain, and other furniture products was adopted.

[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.

[The analysis of international legislation in the field of regulation of functional foods claims].

It is known that manufacturers quite often put into foodstuff marking or advertisement the information about its beneficial action into the consumers health, i.e. about its functional qualities. However in Russian Federation the rules are regulated using of term "functional foods" doesn't established. In the review of legislation acts which are regulated of using claims in the foodstuff marking or advertisement in the different countries have been shown that claims concerning of energy and nutritional values of foods (beneficial nutrition claims) should be used in compliance with established rules without additional investigations. Food health claims referring to the reduction of disease risk and (or) functional foods claims for children must maintain in compliance with established procedure. Only claims that have scientific evidence about its beneficial for health could be recommended for approval. Thereupon insistent necessity in development, discussion and approval regulation in the field of using Claims concerning the functional qualities of foods (described rules of using beneficial nutrition claims and claims referring to the reduction of disease risk and to children's development and growth) in Russian Federation and United Customs Union (EurAsEU) are obvious.

Food standards: the cacophony of governance.

Although long distance trade in food goes back at least as far as Columbus, the recent wave of food globalization is unprecedented in human history. But despite the existence of the Codex Alimentarius, the Food and Agriculture Organization, and the World Trade Organization, there is no central authority that governs the many facets of food. Instead, we have arrived at a food network that is governed by a plethora of public and private standards including those for productivity, food safety, food quality, packaging, and nutritional value. However, standards are both epistemological and ontological devices; they make the realities that they claim to describe. Moreover, once accepted they tend to become 'second nature,' often obscuring growing problems and conflicts, including (perhaps especially) those arising out of the very standards themselves. On the one hand, standards for productivity obscure the weak and rapidly eroding premises on which current productivity is based. On the other hand, standards for quality tend to rigidify production regimes. Both tend to inhibit innovations of the sort necessary for us to realize food security globally.

Banning front-of-package food labels: first Amendment constraints on public health policy.

In recent months, the FDA has begun a crackdown on misleading nutrition and health claims on the front of food packages by issuing warning letters to manufacturers and promising to develop stricter regulatory standards. Leading nutrition policy experts Marion Nestle and David Ludwig have called for an even tougher approach: a ban on all nutrition and health claims on the front of food packages. Nestle and Ludwig argue that most of these claims are scientifically unsound and misleading to consumers and that eliminating them would 'aid educational efforts to encourage the public to eat whole or minimally processed foods and to read the ingredients list on processed foods'. Nestle and Ludwig are right to raise concerns about consumer protection and public health when it comes to front-of-package food labels, but an outright ban on front-of-package nutrition and health claims would violate the First Amendment. As nutrition policy experts develop efforts to regulate front-of-package nutrition and health claims, they should be mindful of First Amendment constraints on government regulation of commercial speech.