New food safety law: effectiveness on the ground.

The demand for safety in the US food supply from production to consumption necessitates a scientific, risk-based strategy for the management of microbiological, chemical, and physical hazards in food. The key to successful management is an increase in systematic collaboration and communication and in enforceable procedures with all domestic and international stakeholders. The enactment of the Food Safety Modernization Act (FSMA) aims to prevent or reduce large-scale food-borne illness outbreaks through stricter facility registration and records standards, mandatory prevention-based controls, increased facility inspections in the United States and internationally, mandatory recall authority, import controls, and increased consumer communication. The bill provisions are expected to cost $1.4 billion over the next four years. Effective implementation of the FSMA's 50 rules, reports, studies, and guidance documents in addition to an increased inspection burden requires further funding appropriations. Additional full-time inspectors and unprecedented foreign compliance is necessary for the full and effective implementation of the FSMA.

Principles for building public-private partnerships to benefit food safety, nutrition, and health research.

The present article articulates principles for effective public-private partnerships (PPPs) in scientific research. Recognizing that PPPs represent one approach for creating research collaborations and that there are other methods outside the scope of this article, PPPs can be useful in leveraging diverse expertise among government, academic, and industry researchers to address public health needs and questions concerned with nutrition, health, food science, and food and ingredient safety. A three-step process was used to identify the principles proposed herein: step 1) review of existing PPP guidelines, both in the peer-reviewed literature and at 16 disparate non-industry organizations; step 2) analysis of relevant successful or promising PPPs; and step 3) formal background interviews of 27 experienced, senior-level individuals from academia, government, industry, foundations, and non-governmental organizations. This process resulted in the articulation of 12 potential principles for establishing and managing successful research PPPs. The review of existing guidelines showed that guidelines for research partnerships currently reside largely within institutions rather than in the peer-reviewed literature. This article aims to introduce these principles into the literature to serve as a framework for dialogue and for future PPPs.

How experts are chosen to inform public policy: can the process be improved?

The ever-increasing complexity of the food supply has magnified the importance of ongoing research into nutrition and food safety issues that have significant impact on public health. At the same time, ethical questions have been raised regarding conflict of interest, making it more challenging to form the expert panels that advise government agencies and public health officials in formulating nutrition and food safety policy. Primarily due to the growing complexity of the interactions among government, industry, and academic research institutions, increasingly stringent conflict-of-interest policies may have the effect of barring the most experienced and knowledgeable nutrition and food scientists from contributing their expertise on the panels informing public policy. This paper explores the issue in some depth, proposing a set of principles for determining considerations for service on expert advisory committees. Although the issues around scientific policy counsel and the selection of advisory panels clearly have global applicability, the context for their development had a US and Canadian focus in this work. The authors also call for a broader discussion in all sectors of the research community as to whether and how the process of empaneling food science and nutrition experts might be improved.

A research model for investigating the effects of artificial food colorings on children with ADHD.

The United Kingdom and European Union recently restricted the use of artificial food colorings (AFCs) to improve the health of children. These decisions provide an interesting case study of the role of scientific evidence in the assessment of food additives and risk to children's health and formulation of food policy. Although there continues to be uncertainty concerning the link between AFCs and attention-deficit/hyperactivity disorder (ADHD), policy decisions have been made that have far-reaching implications. In addition, publicity surrounding the policy changes may shape public perceptions concerning effective management of ADHD. We believe that the balance of existing evidence neither refutes nor supports the link between AFCs and ADHD, which highlights the need for carefully designed studies to further investigate the link between AFCs and ADHD. In this article we describe a model for such studies. In developing our model, we drew from current investigative standards in ADHD research, such as those used in the landmark Multimodal Treatment Study of Children With ADHD. These standards encompass methodologic considerations including sample selection, outcome assessment, and data analyses. It is our hope that this model research methodology may prove valuable in addressing design considerations in future studies of AFCs and ADHD with the goal of producing reliable data that will enable policy-makers to better formulate effective, evidence-based food-policy decisions.

Funding food science and nutrition research: financial conflicts and scientific integrity.

There has been substantial public debate about the susceptibility of research to biases of various kinds. The dialogue has extended to the peer-reviewed literature, scientific conferences, the mass media, government advisory bodies, and beyond. While biases can come from myriad sources, the overwhelming focus of the discussion, to date, has been on industry-funded science. Given the critical role that industry has played and will continue to play in the research process, the International Life Sciences Institute (ILSI) North America Working Group on Guiding Principles has, in this paper, set out proposed conflict-of-interest guidelines regarding industry funding for protecting the integrity and credibility of the scientific record, particularly with respect to health, nutrition, and food safety science. Eight principles are enumerated, specifying ground rules for industry-sponsored research. The paper, which issues a challenge to the broader scientific community to address all bias issues, is only a first step; the document is intended to be dynamic, prompting ongoing discussion and refinement.

Funding food science and nutrition research: financial conflicts and scientific integrity.

There has been significant public debate about the susceptibility of research to biases of various kinds. The dialogue has extended to the peer-reviewed literature, scientific conferences, the mass media, government advisory bodies, and beyond. While biases can come from myriad sources, the overwhelming focus of the discussion, to date, has been on industry-funded science. Given the critical role that industry has played and will continue to play in the research process, the International Life Sciences Institute (ILSI) North America Working Group on Guiding Principles has, in this paper, set out proposed conflict-of-interest guidelines, regarding industry funding, for protecting the integrity and credibility of the scientific record, particularly with respect to health, nutrition, and food-safety science. Eight principles are enumerated, specifying ground rules for industry-sponsored research. The paper, which issues a challenge to the broader scientific community to address all bias issues, is only a first step; the document is intended to be dynamic, prompting ongoing discussion and refinement. The Guiding Principles are as follows. In the conduct of public/private research relationships, all relevant parties shall: 1) conduct or sponsor research that is factual, transparent, and designed objectively; according to accepted principles of scientific inquiry, the research design will generate an appropriately phrased hypothesis and the research will answer the appropriate questions, rather than favor a particular outcome; 2) require control of both study design and research itself to remain with scientific investigators; 3) not offer or accept remuneration geared to the outcome of a research project; 4) prior to the commencement of studies, ensure that there is a written agreement that the investigative team has the freedom and obligation to attempt to publish the findings within some specified time-frame; 5) require, in publications and conference presentations, full signed disclosure of all financial interests; 6) not participate in undisclosed paid authorship arrangements in industry-sponsored publications or presentations; 7) guarantee accessibility to all data and control of statistical analysis by investigators and appropriate auditors/reviewers; and 8) require that academic researchers, when they work in contract research organizations (CRO) or act as contract researchers, make clear statements of their affiliation; require that such researchers publish only under the auspices of the CRO.

Funding food science and nutrition research: financial conflicts and scientific integrity.

There has been significant public debate about the susceptibility of research to biases of various kinds. The dialogue has extended to the peer-reviewed literature, scientific conferences, the mass media, government advisory bodies, and beyond. Whereas biases can come from myriad sources, the overwhelming focus of the discussion to date has been on industry-funded science. Given the critical role that industry has played and will continue to play in the research process, the International Life Sciences Institute (ILSI) North America Working Group on Guiding Principles has, in this article, proposed conflict-of-interest guidelines regarding industry funding to protect the integrity and credibility of the scientific record, particularly with respect to health, nutrition, and food-safety science. Eight principles are enumerated, which specify the ground rules for industry-sponsored research. This article, which issues a challenge to the broader scientific community to address all bias issues, is only a first step; the document is intended to be dynamic, prompting ongoing discussion and refinement. In the conduct of public/private research relationships, all relevant parties shall 1) conduct or sponsor research that is factual, transparent, and designed objectively, and, according to accepted principles of scientific inquiry, the research design will generate an appropriately phrased hypothesis and the research will answer the appropriate questions, rather than favor a particular outcome; 2) require control of both study design and research itself to remain with scientific investigators; 3) not offer or accept remuneration geared to the outcome of a research project; 4) ensure, before the commencement of studies, that there is a written agreement that the investigative team has the freedom and obligation to attempt to publish the findings within some specified time frame; 5) require, in publications and conference presentations, full signed disclosure of all financial interests; 6) not participate in undisclosed paid authorship arrangements in industry-sponsored publications or presentations; 7) guarantee accessibility to all data and control of statistical analysis by investigators and appropriate auditors/reviewers; 8) require that academic researchers, when they work in contract research organizations (CRO) or act as contract researchers, make clear statements of their affiliation; and require that such researchers publish only under the auspices of the CRO.

A review of childhood and adolescent obesity interventions.

Obesity is one of the largest health problems facing Americans. Figures produced by the National Center for Health Statistics show that in 1999-2002, 15.8% of 6-11-year-olds were overweight as were 16.1% of adolescents aged 12-19. Some have proposed that interventions in childhood may be the best place to focus efforts to reduce the growing obesity epidemic. This paper examines several of the popular intervention strategies that have been proposed for youth and assesses the potential of these interventions for meaningful public health impacts. Findings show that most childhood obesity interventions completed to date produced only meager results, creating need for more well-designed studies that are tailored to the needs of specific age, ethnic and economic groups.

Effect of Varying Concentrations of Phytate, Calcium, and Zinc on the Solubility of Protein, Calcium, Zinc, and Phytate in Soy Protein Concentrate.

The phytate x Ca:Zn millimolar ratio was varied in a number of soy protein concentrates and subjected to a sequential pH treatment to simulate gastrointestinal conditions. In two independent studies, calcium was either decreased incrementally from 4.94 to 0.25 mmol or zinc was increased from 0.0036 to 0.55 mmol. At the lowest level of calcium, a significant increase (P < 0.01) in soluble zinc and soluble phytate was Observed at pH 5.5, due to the possible formation of a soluble calcium-phytate-zinc complex. Soluble zinc significantly increased (P < 0.01) only when the level of zinc was raised to 0.55 mmol. Neither soluble calcium nor soluble phytate was altered at this level.

Solubility of Iron in Model Systems Containing Organic Acids and Lignin.

The effect of six organic acids, ascorbic, citric, fumaric, lactic, malic, and succinic, alone and in combination, at a 1:1.9 molar ratio (Fe+2:ligand) on the solubility of iron was evaluated in the presence of lignin under simulated gastrointestinal pH conditions. The enhancing effect, evaluated under two systems of preparation at two pH values, was in the following order: citric>malic>ascorbic>lactic,fumaric>succinic. Citric acid solubilized 80 and 81% of iron under both pH conditions. When ascorbic acid was mixed with fumaric, lactic, and succinic acids, a higher percentage of soluble iron was retained than with these three acids alone. In the case of citric and malic acids, the addition of ascorbic acid reduced the soluble iron. The percentage of soluble iron obtained when prepared at the endogenous pH (2.5-3.1) was higher than that at pH 5.5. These results indicated that ascorbate bound less iron in a soluble form than citrate or malate but more than fumarate, lactate, or succinate. Also, combinations of citric with malic acid did not demonstrate a synergistic effect.

In Vitro Solubility Characteristics of Six Calcium Salts.

Six calcium salts (lactate, carbonate, citrate, gluconate, phosphate, and citrate malate) were evaluated for ionic and total soluble calcium content utilizing a sequential pH treatment to simulate gastrointestinal pH conditions. At pH 2.0 (gastric pH), 80-90% of all soluble calcium present was in the ionic form. However, when the pH was brought to 7.0 (intestinal pH), a unique solubility pattern for each calcium source was evident. Both calcium citrate and calcium citrate malate formed significantly higher levels of a soluble complex. By contrast, calcium phosphate precipitated extensively under the same conditions. These results indicate the importance of pH adjustment during in vitro testing of calcium bioavailability.