Guidance and perspectives on highly processed foods.

Guidance from Health Canada to limit highly processed foods (HPF) seeks to ensure that Canadians remain within intake recommendations for nutrients of concern. However, HPF can contribute to dietary requirements of specific populations. The Canadian Nutrition Society and Institute for the Advancement of Food and Nutritional Sciences convened speakers for a Food for Health workshop in 2021 to provide evidence and perspectives from government, industry, and healthcare on reasons for advocating limits and potential unintended consequences of limiting HPF, and implications and necessity of HPF in clinical settings. This paper discusses advantages and disadvantages of HPF explored at this workshop.

An Updated Framework for Industry Funding of Food and Nutrition Research: Managing Financial Conflicts and Scientific Integrity.

Although the food and beverage industry plays a critical role in advancing food and nutrition science, industry-funded research is subject to intense scrutiny as a result of various perceived and real biases related to funding sources. To address this, the Institute for the Advancement of Food and Nutrition Sciences (IAFNS) Assembly on Scientific Integrity has updated its Guiding Principles for Funding Food Science and Nutrition Research to provide a modernized framework for minimizing bias and promoting integrity in industry-funded research. Existing best practices for managing conflicts and maintaining trust in science, as well as coverage related to conflicts in industry-funded research, were reviewed to inform the development of the updated Guiding Principles. The updated Guiding Principles continue to provide conflict-of-interest guidelines to protect the integrity and credibility of the scientific record. These updates provide clarification, strengthen the guardrails that separate the funding from the science, and reflect the shift within the scientific community toward increased transparency and open science. If the principles are followed as intended, there should be little reason to dispute the results of industry-funded studies, other than to debate the science itself. This article issues a challenge to the research community to strive for just that.

Trends in Food Allergy Research, Regulations and Patient Care.

This review provides an overview of food allergies, their impact on affected individuals and caregivers, regulatory activities, and current research efforts to improve allergen management and patient care. Food allergies have been reported to affect up to 32 million Americans, including approximately 6 million children. The Centers for Disease Control and Prevention reported that food allergies in children have clearly increased by 50% between 1997 and 2011. Recent years have seen significant advances in the understanding of responses to food allergens such as the development of response thresholds that hold promise for developing more informative labels on food packaging. Staying current on advances in food allergy research will allow healthcare and nutrition practitioners to provide evidence-based guidance to individuals they serve.

[Agricultural biotechnology safety assessment].

Genetically modified (GM) crops were first introduced to farmers in 1995 with the intent to provide better crop yield and meet the increasing demand for food and feed. GM crops have evolved to include a thorough safety evaluation for their use in human food and animal feed. Safety considerations begin at the level of DNA whereby the inserted GM DNA is evaluated for its content, position and stability once placed into the crop genome. The safety of the proteins coded by the inserted DNA and potential effects on the crop are considered, and the purpose is to ensure that the transgenic novel proteins are safe from a toxicity, allergy, and environmental perspective. In addition, the grain that provides the processed food or animal feed is also tested to evaluate its nutritional content and identify unintended effects to the plant composition when warranted. To provide a platform for the safety assessment, the GM crop is compared to non-GM comparators in what is typically referred to as composition equivalence testing. New technologies, such as mass spectrometry and well-designed antibody-based methods, allow better analytical measurements of crop composition, including endogenous allergens. Many of the analytical methods and their intended uses are based on regulatory guidance documents, some of which are outlined in globally recognized documents such as Codex Alimentarius. In certain cases, animal models are recommended by some regulatory agencies in specific countries, but there is typically no hypothesis or justification of their use in testing the safety of GM crops. The quality and standardization of testing methods can be supported, in some cases, by employing good laboratory practices (GLP) and is recognized in China as important to ensure quality data. Although the number of recommended, in some cases, required methods for safety testing are increasing in some regulatory agencies, it should be noted that GM crops registered to date have been shown to be comparable to their nontransgenic counterparts and safe . The crops upon which GM development are based are generally considered safe.

Applying the biopharmaceutics classification system to veterinary pharmaceutical products. Part I: biopharmaceutics and formulation considerations.

The complexity of multiple species approvals continues throughout the life of a product as post-approval manufacturing changes, as well as all generic versions of approved products, are evaluated for each of the approved target animal species. In comparing product bioavailability across animal species, it is not unusual to observe marked interspecies differences. For many compounds, these differences reflect species-specific presystemic metabolism. However, a host of other variables must also be considered, including in vivo drug solubility, gastric transit time, intestinal permeability, diet, and species-by-formulation interactions. To predict potential species-by-formulation interactions, one must consider the solubility and intestinal permeability of the drug entity, the type of formulation, nature of the excipients, and the physiological characteristics of the animal recipient. In this paper, we examine manufacturing and formulation variables that can affect drug bioavailability, and the potential for species-specific differences in the responses to these formulations.

Applying the biopharmaceutics classification system to veterinary pharmaceutical products. Part II. Physiological considerations.

In comparing product bioavailability across animal species, it is not unusual to observe marked interspecies differences. For many compounds, these differences reflect presystemic drug metabolism. However, a host of other variables must also be considered such as in vivo drug solubility, gastric transit time, intestinal permeability, diet, and species-by-formulation interactions. By combining information on drug solubility and intestinal permeability with an understanding of the interrelationship between pH, product dissolution and gastrointestinal physiology, we attempt to define those conditions under which in vitro dissolution data may be used as a surrogate for data on in vivo bioavailability. We consider the likely physiological causes for species-related differences in the absolute and relative bioavailability of orally administered pharmaceuticals, and examine the potential for these normal interspecies differences to reflect bioavailability changes that can occur with various human pathologies.