Food irradiation: a public health opportunity. (33/1514)

Public health scientists have had an interest in food irradiation for a hundred years and more. The first investigations occurred within a few years of the discovery of x-ray and short wavelength by the German physicist Roentgen, in 1895. German and French scientists carried on studies on pasteurization of food by radiation until 1914 and the war years. The problem was an unacceptable taste following irradiation. In 1921, the x-ray was reported by the scientists of the United States Department of Agriculture (USDA) to be effective in killing Trichinella cysts in pork and that it could kill disease-causing organisms and halt food spoilage.  (+info)

An interactive CD-ROM for nutrition screening and counseling. (34/1514)

OBJECTIVES: The goal of this project was to develop an interactive CD-ROM for nutrition screening and counseling, designed to produce dietary behavior change in fat and fruit and vegetable intake. METHODS: The design was based on principles of relevance to the learner, readiness for change, feedback, individualization, facilitation of skills, and goal setting. It was tested in community settings such as libraries, senior centers, and Women, Infants, and Children clinics. RESULTS: Nearly 80% of the respondents (n = 284), including numerous low-income persons, reported learning something new about nutrition and health or their own dietary habits. More than 50% of those recontacted 2 to 4 weeks later had put some of their dietary goals into practice. CONCLUSIONS: This program is useful for dietary screening, feedback, skill building, and motivation in settings in which in-person counseling by nutrition professionals is not feasible.  (+info)

Functional foods: the Food and Drug Administration perspective. (35/1514)

Because the Federal Food, Drug, and Cosmetic Act (FFDCA) does not provide a statutory definition of functional foods, the Food and Drug Administration has no authority to establish a formal regulatory category for such foods. The primary determinant of the regulatory status of a food is its intended use, which is determined largely by the label and labeling information accompanying the product. This information includes nutrient information, nutrient content claims, and various types of health claims. In marketing these foods, manufacturers may come under one of several existing regulatory options. The first decision manufacturers will make that will help determine their product's regulatory status is whether the product is a food or a drug. Thus, manufacturers and retailers have a range of legal and regulatory categories in which their products may be classified. This article describes the definitions provided in the FFDCA for a drug and a food, the safety and labeling requirements of various food categories, and types of possible claims for dietary supplements.  (+info)

US FDA "Redbook II" immunotoxicity testing guidelines and research in immunotoxicity evaluations of food chemicals and new food proteins. (36/1514)

The rapid advances in the field of immunology and an understanding of the potential adverse effects of xenobiotics on the immune system have resulted in the development of a discipline in toxicology now referred to as immunotoxicology. This discipline has evolved steadily over the last 2 decades as a result of research in the national and international communities. Various US, European, and Japanese regulatory agencies have recognized a need to promulgate testing guidelines for immunotoxicity in support of the approval process involving toxicological testing. The US Food and Drug Administration "Redbook II" guidelines and some of the research conducted in support of the concepts and testing strategies are presented here. Concerns raised with regard to these guidelines are included, as are on-going initiatives in development of experimental approaches for assessing allergic potential and/or hypersensitivity responses to new foods and food constituents.  (+info)

Moving new vaccines for tuberculosis through the regulatory process. (37/1514)

The development of novel vaccines for the prevention of tuberculosis is an area of intense interest for scientific researchers, public health agencies, and pharmaceutical manufacturers. Development of effective new vaccines directed against tuberculosis for use in target populations will require close cooperation among several different international organizations, including regulatory agencies responsible for evaluating the safety and effectiveness of new biologics for human use.  (+info)

Selected herbals and human exercise performance. (38/1514)

Herbs have been used throughout history to enhance physical performance, but scientific scrutiny with controlled clinical trials has only recently been used to study such effects. The following herbs are currently used to enhance physical performance regardless of scientific evidence of effect: Chinese, Korean, and American ginsengs; Siberian ginseng, mahuang or Chinese ephedra; ashwagandha; rhodiola; yohimbe; CORDYCEPS: fungus, shilajit or mummio; smilax; wild oats; Muira puama; suma (ecdysterone); Tribulus terrestris; saw palmetto berries; beta-sitosterol and other related sterols; and wild yams (diosgenin). Controlled studies of Asian ginsengs found improvements in exercise performance when most of the following conditions were true: use of standardized root extracts, study duration (>8 wk, daily dose >1 g dried root or equivalent, large number of subjects, and older subjects. Improvements in muscular strength, maximal oxygen uptake, work capacity, fuel homeostasis, serum lactate, heart rate, visual and auditory reaction times, alertness, and psychomotor skills have also been repeatedly documented. Siberian ginseng has shown mixed results. Mahuang, ephedrine, and related alkaloids have not benefited physical performance except when combined with caffeine. Other herbs remain virtually untested. Future research on ergogenic effects of herbs should consider identity and amount of substance or presumed active ingredients administered, dose response, duration of test period, proper experimental controls, measurement of psychological and physiologic parameters (including antioxidant actions), and measurements of performance pertinent to intended uses.  (+info)

Medical, legal and ethical considerations in the use of drugs having undesirable side effects.(39/1514)

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Biotech pharmaceuticals and biotherapy: an overview. (40/1514)

Broadly, the history of pharmaceutical biotechnology includes Alexander Fleming"s discovery of penicillin in a common mold, in 1928, and the subsequent development-prompted by World War II injuries-of large-scale manufacturing methods to grow the organism in tanks of broth. Pharmaceutical biotechnology has since changed enormously. Two breakthroughs of the late 1970s became the basis of the modern biotech industry: the interspecies transplantation of genetic material, and the fusion of tumor cells and certain leukocytes. The cells resulting from such fusion-hybridomas-replicate endlessly and can be geared to produce specific antibodies in bulk. Modern pharmaceutical biotechnology encompasses gene cloning and recombinant DNA technology. Gene cloning comprises isolating a DNA-molecule segment that corresponds to a single gene and synthesizing ("copying") the segment. Recombinant DNA technology, or gene splicing, comprises altering genetic material outside an organism-for example, by inserting into a DNA molecule a segment from a very different DNA molecule-and making the altered material (recombinant DNA) function in living things. Recombinant DNA technology enables modifying microorganisms, animals, and plants so that they yield medically useful substances, particularly scarce human proteins (by giving animals human genes, for example). This review, however, focuses not on pharmaceutical biotechnology"s methods but on its products, notably recombinant pharmaceuticals. It describes various types of biotech pharmaceuticals, their safety and effectiveness relative to the safety and effectiveness of conventionally produced pharmaceuticals, and the regulation of biotech pharmaceuticals.  (+info)