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.

Time for Change: Stepping Up the FDA's Regulation of Dietary Supplements to Promote Consumer Safety and Awareness.

People are often looking for that quick fix when it comes to their health. With dietary supplements so readily available on the market, the public assume that they have been through rigorous testing. Dietary supplements are not tested as much as consumers believe. The Food and Drug Administration (FDA) does not initiate the same type of testing and analysis for supplements as it does for food, drink and medication. Given that people are now choosing supplemental meal replacements and the like, as opposed to whole foods, regulations drastically need to be stepped up in an effort to emphasise public safety. An authoritative body needs to stop manufacturers from taking advantage of an already vulnerable marketplace. I suggest a new form of regulation that takes the pressure away from the FDA and into the hands of someone who wholly focuses on the supplement market. Dietary supplements have revolutionised the "health" world; however, the only way that the market can keep growing is through enacting more stringent rules and regulations--at the same time allowing consumers to maintain their autonomy and freedom when purchasing.

Regulating the South African sport supplement industry: 'Whey' overdue.

The South African sport supplement industry has experienced rapid growth in recent years. Despite the massive market demand, this industry remains poorly regulated. From raw ingredient contamination to label compliance discrepancies, the sport supplement industry is an area of growing concern and warrants further public debate.

Which type of tobacco product warning imagery is more effective and sustainable over time? A longitudinal assessment of smokers in Canada, Australia and Mexico.

OBJECTIVE: This study examined smokers' responses to pictorial health warnings (PHWs) with different types of imagery under natural exposure conditions. METHODS: Adult smokers from online panels in Canada (n=2357), Australia (n=1671) and Mexico (n=2537) were surveyed every 4 months from 2012 to 2013. Participants were shown PHWs on packs in their respective countries and asked about: (1) noticing PHWs; (2) negative affects towards PHWs; (3) believability of PHWs; (4) PHW-stimulated discussions; and (5) quit motivation due to PHWs. Country-specific generalised estimating equation models regressed these outcomes on time (ie, survey wave), PHW imagery type (ie, symbolic representations of risk, suffering from smoking and graphic depictions of bodily harm) and interactions between them. RESULTS: In all countries, PHW responses did not significantly change over time, except for increased noticing PHWs in Canada and Mexico, increased negative affect in Australia and decreased negative affect in Mexico. For all outcomes, symbolic PHWs were rated lower than suffering and graphic PHWs in Canada (the only country with symbolic PHWs). Graphic PHWs were rated higher than suffering PHWs for negative affect (all countries), discussions (Canada) and quit motivation (Australia). Suffering PHWs were rated higher than graphic PHWs for noticing PHWs (Canada), believability (all countries), discussions (AustraliaandMexico) and quit motivation (Mexico). Changes in noticing, believability and discussions varied somewhat by imagery type across countries. CONCLUSIONS: The different PHW imagery appears to have different pathways of influence on adult smokers. Reactions to specific PHWs are similar over 1-2 years, suggesting that wear-out of PHW effects is due to decreased attention rather than the diminishing effectiveness of content.

Dietary Supplements: Regulatory Challenges and Research Resources.

Many of the scientific and regulatory challenges that exist in research on the safety, quality and efficacy of dietary supplements are common to all countries as the marketplace for them becomes increasingly global. This article summarizes some of the challenges in supplement science and provides a case study of research at the Office of Dietary Supplements at the National Institutes of Health, USA, along with some resources it has developed that are available to all scientists. It includes examples of some of the regulatory challenges faced and some resources for those who wish to learn more about them.

[Marketability of food supplements - criteria for the legal assessment]. / Kriterien zur Beurteilung von Nahrungsergänzungsmitteln.

To be placed on the market legally, food supplements have to meet national and European food law regulations. This is true for all substances used as well as for the labeling on the packaging of and the advertising for food supplements. The food business operator is responsible for its compliance with all regulations. Therefore, in this article, a concise step-by-step assessment is presented, covering all necessary legal requirements to market food supplements. Additionally, all steps are visualized in a flow chart. All vitamins, minerals and other substances used have to meet the legal conditions. Food business operators have to make sure that their products do not contain medicinal ingredients based on their pharmacologic effect. It is prohibited to place medicinal products as food supplements on the market. Furthermore, food business operators have to make sure that their products are not non-authorized novel foods according to the novel food regulation (EC) no. 258/97. Also, food supplements have to meet the requirements of article 14 of Regulation (EC) No. 178/2002 concerning the safety of foodstuff. Food shall not be placed on the market if it is unsafe. For food supplements that fail the German food-related legal standards but are legally manufactured in another EU member state or are legally put into circulation, the importer requires the so-called general disposition, which must be applied for at the BVL according to § 54 of the German Food and Feed Act. Another possibility for food which fails to meet German food law is to apply for a certificate of exemption according to § 68 of the Food and Feed Act. The food business operator has to meet the harmonized regulations concerning maximum and minimum levels of additives, flavors and enzymes. The packaging has to meet the compulsory labeling as well the voluntary labeling, like health claims. The BVL is also the relevant authority for other tasks concerning food supplements. A figure shows all notifications since 2005 of food supplements in Germany at the BVL. Additionally, an overview for notifications in the rapid alert system for food and feed concerning food supplements is given as well as a brief introduction into the survey of food supplements marketed on the internet.

[Food supplements : Legal requirements, borderline issues and other aspects]. / Nahrungsergänzungsmittel : Rechtliche Grundlagen, Abgrenzung zu Arzneimitteln, sonstige Fragestellungen.

Food supplements are classified as foods. They are concentrated sources of vitamins and minerals or other substances with a nutritional or physiological effect. Their purpose is to supplement the normal diet. Food supplements have to comply with the applicable legal provisions of the food law. In order to ensure the health protection of consumers, food supplements that will be put on the market must be safe. For food supplements, regulations exist at the EU level as well as at the national level. Specific requirements are regulated in the Ordinance on Food Supplements, with which the European Directive on Food Supplements was transposed into German law. The European and German legal provisions applicable to food supplements are outlined. Important aspects regarding the delimitation between food supplements and medicinal products are addressed. These borderline issues are of special importance to food supplements which are marketed in dose forms such as capsules, tablets etc., the typical forms of medicinal products. Problems resulting from the lack of harmonized rules are described. The European harmonization of the rules is still incomplete for substances with a nutritional or physiological effect other than vitamins and minerals for use in food supplements. The setting of maximum amounts of vitamins and minerals present in food supplements as envisaged in the Directive on Food Supplements has not yet been implemented.

Leveraging corporate social responsibility to improve consumer safety of dietary supplements sold for weight loss and muscle building.

The potential dangers associated with dietary supplements sold for weight loss and muscle building are well documented and increasingly garnering the attention of the media, public, and government leaders. Public health professionals have an opportunity to improve population health in the context of dietary supplement use by translating scientific evidence into action. In this commentary, we discuss the potential to motivate corporate social responsibility (CSR) among manufacturers and retailers of dietary supplements sold for weight loss and muscle building. We examine levers available to public health professionals for generating voluntary corporate self-regulation by reviewing examples from successful CSR initiatives in other domains of public health and offering recommendations highlighting effective advocacy strategies. We encourage public health professionals to use one or multiple advocacy strategies to improve consumer protections for dietary supplements sold for weight loss and muscle building.

Nutrition: ethical issues and challenges.

For nutrition and its associated disciplines, ethical considerations related to research are often complicated by factors that range from the use of experimental research designs that are overly holistic to inextricable links between nutrition research and marketing. As a consequence, there is the need for constant vigilance to assess and deal with apparent conflicts of interest. Also, there are few scientific disciplines that are defined by cultural, religious, or political codifications as is nutrition. Accordingly, examples of historical, cultural, and political events are described that have influenced ethical approaches related to nutrition research. Furthermore, nutrition research questions are often multifaceted and require dealing with complex variables. In this regard, ethical principles and perspectives that have relevance to data acquisition, the publication and translation of nutrition research, and the marketing of nutritional products and concepts are highlighted.

Safety Assessment of Alumina and Aluminum Hydroxide as Used in Cosmetics.

This is a safety assessment of alumina and aluminum hydroxide as used in cosmetics. Alumina functions as an abrasive, absorbent, anticaking agent, bulking agent, and opacifying agent. Aluminum hydroxide functions as a buffering agent, corrosion inhibitor, and pH adjuster. The Food and Drug Administration (FDA) evaluated the safe use of alumina in several medical devices and aluminum hydroxide in over-the-counter drugs, which included a review of human and animal safety data. The Cosmetic Ingredient Review (CIR) Expert Panel considered the FDA evaluations as part of the basis for determining the safety of these ingredients as used in cosmetics. Alumina used in cosmetics is essentially the same as that used in medical devices. This safety assessment does not include metallic or elemental aluminum as a cosmetic ingredient. The CIR Expert Panel concluded that alumina and aluminum hydroxide are safe in the present practices of use and concentration described in this safety assessment.

Safety Assessment of Achillea millefolium as Used in Cosmetics.

Cosmetic ingredients derived from Achillea millefolium function in cosmetics as skin-conditioning agents-miscellaneous, skin-conditioning agents-humectants, and fragrance ingredients. The Cosmetic Ingredient Review Expert Panel (Panel) reviewed relevant animal and human data to determine their safety in cosmetics and raised concerns about cosmetics containing linalool, thujone, quercetin, hydroquinone, or α-peroxyachifolid. Because final product formulations may contain multiple botanicals, each containing similar constituents of concern, formulators are advised to be aware of these components and to avoid reaching levels that may be hazardous to consumers. Additionally, industry was advised to use good manufacturing practices to limit impurities. The Panel concluded that achillea millefolium extract, achillea millefolium flower extract, and achillea millefolium flower/leaf/stem extract are safe in the present practices of use and concentration in cosmetics when formulated to be nonsensitizing.

STOPPING DECEPTIVE HEALTH CLAIMS: THE NEED FOR A PRIVATE RIGHT OF ACTION UNDER FEDERAL LAW.

This Article offers a thorough analysis of an important public health issue, namely how to confront the growing problem of deceptive claims regarding foods and dietary supplements, including increasingly prevalent but unverifiable claims. The authors call for the creation of a limited private right of action under the Federal Trade Commission (FTC) Act for deceptive health-related claims for these products. The proposal responds to the growing market for these products and the inadequacy of current laws and enforcement actions to prevent such claims. In crafting the limited private right of action, the authors attempt to enhance consumer protection without undermining federal agency primacy in enforcement. The Article ends with an appendix setting forth proposed language for a statutory amendment to the FTC Act incorporating the authors' proposal.

Rapid methodology to screen flame retardants in upholstered furniture for compliance with new California labeling law (SB 1019).

In response to concerns regarding the widespread use of flame retardants, the California Legislature passed a law (SB1019) requiring labels on furniture products to indicate whether they do or do not contain flame retardants. To support the enforcement of the new law, our laboratory developed a step-wise, screening approach to test for brominated (BFR) and phosphorus-based flame retardants (OPFRs) in several types of furniture components (foam, fabric, batting, plumage, etc.). We used X-Ray Fluorescence (XRF) to screen for the presence of Br (and other elements) and Inductively Coupled Plasma - Optical Emission Spectrometry (ICP-OES) to identify and measure the concentration of P (and other elements). The same samples were also extracted by dichloromethane using sonication and analyzed by a single injection into a Gas Chromatograph - Tandem Mass Spectrometer to obtain concentrations of specific BFRs and OPFRs. Our approach showed excellent screening potential for Br and Sb by XRF and for P by ICP-OES, with both tests having predictive values of a negative equal to 1. To explore and screen for flame retardants in products not included in our current list of target chemicals, we used Liquid Chromatography/Time-of-Flight Mass Spectrometry operated with electrospray ionization, to identify additional flame retardants to be incorporated in quantitative methods. We are making all our methodologies public to facilitate simple and low cost methods that can help manufacturers and suppliers have their products tested and correctly labeled, ultimately benefitting the consumer.