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1. Microbiology of Mayonnaise and Salad Dressing: A Review

Author:
Richard B. Smittle
Source:
Journal of food protection 1977 v.40 no.6 pp. 415-422
ISSN:
0362-028X
Subject:
Food and Drug Administration; Lactobacillus; Staphylococcus; acetic acid; bacteria; food pathogens; health hazards; mayonnaise; microbial growth; public health; salads; spoilage; sugars; yeasts; United States
Abstract:
... Mayonnaise and salad dressing commercially produced in the United States are defined in accordance with the Food and Drug Administration Standard of Identity. The microbiological content of these products is dictated primarily by the high acetic acid concentration found in their aqueous phase. The overall microbiological content of mayonnaise and salad dressing is low with a very low incidence of ...
DOI:
10.4315/0362-028X-40.6.415

2. Update on control of olive oil adulteration and misbranding in the United States

Author:
Firestone, D.; Carson, K.L.; Reina, R.J.
Source:
Journal of the American Oil Chemists' Society 1988 v.65 no.5 pp. 788-792
ISSN:
0003-021X
Subject:
olive oil; adulterated products; surveys; esterification; food inspection; laws and regulations; Food and Drug Administration; United States
DOI:
10.1007/BF02542533

3. Mutagenic potential of ammonia-related aflatoxin reaction products in a model system

Author:
Haworth, S.R.; Lawlor, T.E.; Zeiger, E.; Lee, L.S.; Park, D.L.
Source:
Journal of the American Oil Chemists' Society 1989 v.66 no.1 pp. 102-104
ISSN:
0003-021X
Subject:
mutagenicity; cottonseed meal; Aspergillus flavus; aflatoxins; decontamination; pressure treatment; Food and Drug Administration; USDA; United States
DOI:
10.1007/BF02661794

4. The brave new world of FDA nutrition regulation--some thoughts about current trends and long-term effects

Author:
McNamara, S.H.
Source:
Critical reviews in food science and nutrition 1994 v.34 no.2 pp. 215-221
ISSN:
1040-8398
Subject:
health claims; nutrient content; Food and Drug Administration; health promotion; agricultural law; nutrition policy; standards of identity; nutrition labeling
Abstract:
... This article reviews long-term trends at the U.S. Food and Drug Administration (FDA) concerning regulation of nutrition, and considers how these trends may affect products of the food industry in the decades ahead. Among the topics discussed are the FDA's rules concerning the provision of basic, standard format nutrition information ("nutrition labeling") on food products. These rules have changed ...
DOI:
10.1080/10408399409527659
PubMed:
8011146

5. The regulatory environment past and future--incentive or impediment to developments in food science and technology: a perspective from FDA

Author:
Shank, F.R.; Carson, K.
Source:
Critical reviews in food science and nutrition 1994 v.34 no.2 pp. 207-214
ISSN:
1040-8398
Subject:
Food and Drug Administration; food industry; agricultural law; food technology; food safety
Abstract:
... The best system for protecting public health is one that involves two layers of control before food reaches the consumer. The first layer of control is the industry's clear responsibility to prepare food that is safe. The second layer of control is the monitoring that is provided by government to ensure that the industry is doing its job and is in fact producing safe food. While some may view this ...
DOI:
10.1080/10408399409527658
PubMed:
8011145

6. Update on migration research and regulatory initiatives

Author:
Schwartz, P.S.
Source:
Food additives & contaminants 1994 v.11 no.2 pp. 261-270
ISSN:
0265-203X
Subject:
laws and regulations; food analysis; Food and Drug Administration; food contamination; food packaging; food policy; heat treatment; food additives; United States
Abstract:
... The Food and Drug Administration's (FDA) current research programme on migration from food packaging materials focuses on high-temperature packaging applications. Results from two studies conducted by Arthur D. Little, Inc., under contract to the FDA, are presented as well as highlights of the FDA's research programme on migration from microwave heat susceptor packaging. Some regulatory policy iss ...
DOI:
10.1080/02652039409374224
PubMed:
8039586

7. Regulation of Medical Foods: Toward a Rational Policy

Author:
Charles Mueller; Marion Nestle
Source:
Nutrition in clinical practice 1995 v.10 no.1 pp. 8-15
ISSN:
0884-5336
Subject:
Food and Drug Administration; adults; clinical trials; health foods; infant formulas; issues and policy; medical foods; morbidity; mortality; nutrients; nutrition; patients; processed foods; therapeutics; United States
Abstract:
... Medical foods are enterally administered formulas used as complete or supplemental nutrition support in the treatment of diseases and clinical disorders of hospitalized or incapacitated adult patients. Because clinical trials have failed to demonstrate a consistent benefit of these products on morbidity and mortality rates, it has been difficult to reach consensus on their primary role. Are medica ...
DOI:
10.1177/011542659501000108

8. Effective regulatory approval process for food ingredient technologies

Author:
Kirschman, J.C.
Source:
Critical reviews in food science and nutrition 1998 v.38 no.6 pp. 465-510
ISSN:
1040-8398
Subject:
laws and regulations; costs and returns; structure-activity relationships; food composition; artificial colors; food additives; history; public health; Food and Drug Administration; agricultural law; food quality; risk assessment; toxicology; ingredients; toxins; case studies; food chain; federal government; environmental exposure; food chemistry; food safety; caffeine; testing; solvents
Abstract:
... Most sciences and technologies related to food safety have advanced exponentially over the 40 years since passage in the U.S. of the Food Additive Amendment of 1958 to the Federal Food, Drug and Cosmetic (FD&C) Act. Effective regulatory decision making places a high premium on competent professional and administrative judgement applied to sound scientific data. This review discusses changes and le ...
DOI:
10.1080/10408699891274282
PubMed:
9759560

9. Herbal and Related Remedies

Author:
Cathy L. Bartels; Sarah J. Miller
Source:
Nutrition in clinical practice 1998 v.13 no.1 pp. 5-19
ISSN:
0884-5336
Subject:
Dietary Supplement Health and Education Act of 1994; Food and Drug Administration; dietary supplements; drugs; United States
Abstract:
... Herbal and related remedies are becoming increasingly popular in the United States. Although some of these products have been promoted as panaceas with little scientific data to support their use, clinical data are starting to accumulate showing the benefit of specific products. For the herbal products, English translation of the German Commission E monographs greatly increases the availability of ...
DOI:
10.1177/088453369801300102

10. U.S. Regulatory Oversight of Agricultural and Food-Related Biotechnology

Author:
DONALD L. UCHTMANN; GERALD C. NELSON
Source:
American behavioral scientist 2000 v.44 no.3 pp. 350-377
ISSN:
0002-7642
Subject:
Animal and Plant Health Inspection Service; Food and Drug Administration; biotechnology; environmental protection; farmers; genetic engineering; industry; risk; United States
Abstract:
... Genetic engineering has both risks and the potential to provide significant benefits. The Coordinated Framework for Regulation of Biotechnology relies on existing federal laws and agencies to assure that genetically engineered products are safe. The goal is to balance the need for safety with the need to avoid impeding the biotech industry. This article reviews U.S. laws of greatest significance t ...
DOI:
10.1177/00027640021956251

11. Comment: regulatory environment for dietary supplements and botanicals targeted to weight loss

Author:
Lewis, C.J.
Source:
Critical reviews in food science and nutrition 2001 v.41 no.1 pp. 43-44
ISSN:
1040-8398
Subject:
laws and regulations; consumer protection; federal government; health claims; risk; human health and safety; Food and Drug Administration; alternative medicine; medical treatment; medicinal plants; weight loss; dietary supplements; diet therapy; adverse effects
DOI:
10.1080/20014091091724
PubMed:
11152046

12. Dietary supplements: an advertising guide for industry

Source:
Critical reviews in food science and nutrition 2001 v.41 no.1 pp. 71-85
ISSN:
1040-8398
Subject:
laws and regulations; health claims; Food and Drug Administration; industry; consumer information; guidelines; data analysis; research; dietary supplements; federal government; experts
DOI:
10.1080/20014091091742
PubMed:
11221600

13. Folic Acid Intake from Fortification in United States Exceeds Predictions

Author:
Choumenkovich, Silvina F.; Selhub, Jacob; Wilson, Peter W.F.; Rader, Jeanne I.; Rosenberg, Irwin H.; Jacques, Paul F.
Source:
Journal of nutrition 2002 v.132 no.9 pp. 2792-2798
ISSN:
0022-3166
Subject:
Estimated Average Requirement; Food and Drug Administration; Tolerable Upper Intake Level; cohort studies; confidence interval; folic acid; foods; nutrient intake; progeny; United States
Abstract:
... In 1996, the U.S. Food and Drug Administration issued a regulation requiring that all enriched cereal-grain products be fortified with folic acid by January 1998. An average increase in folic acid intake of 100 μg/d was projected as a result of this fortification. The objective of the present study was to estimate the effect of this fortification on the intake of folic acid and total folate, and o ...
PubMed:
12221247

14. Hazard analysis and critical control point––original “spin”

Author:
Adams, Catherine E.
Source:
Food control 2002 v.13 no.6-7 pp. 355-358
ISSN:
0956-7135
Subject:
Codex Alimentarius; Food and Drug Administration; HACCP; USDA; hazard characterization; juices; poultry meat; seafoods; trade; United States
Abstract:
... It may be a reflection of age, but I hope it is a reflection of age and wisdom that we have been invited to present a "retrospection" on hazard analysis and critical control point (HACCP) as a regulatory tool. HACCP has become a regulatory tool of choice for many countries, advanced through its adoption by the Codex Alimentarius Commission in the early 1990s. HACCP has been defined as a method for ...
DOI:
10.1016/S0956-7135(02)00041-5

15. Soluble fiber intake at a dose approved by the US Food and Drug Administration for a claim of health benefits: serum lipid risk factors for cardiovascular disease assessed in a randomized controlled crossover trial

Author:
Jenkins, David J.A.; Kendall, Cyril W.C.; Vuksan, Vladimir; Vidgen, Edward; Parker, Tina; Faulkner, Dorothea; Mehling, Christine C.; Garsetti, Marcella; Testolin, Giulio; Cunnane, Stephen C.; Ryan, Mary Ann; Corey, Paul N.
Source:
American journal of clinical nutrition 2002 v.75 no.5 pp. 834-839
ISSN:
0002-9165
Subject:
health claims; dietary fiber; blood lipids; energy; foods; gastrointestinal system; high fiber diet; Food and Drug Administration; soluble fiber; risk factors; fasting; cholesterol; beta-glucans; palatability; risk reduction; blood; blood pressure; adults; United States
Abstract:
... Background: The US Food and Drug Administration (FDA) approved health claims for 2 dietary fibers, β-glucan (0.75 g/serving) and psyllium (1.78 g/serving), on the assumption that 4 servings/d would reduce cardiovascular disease risk. Objective: We assessed the efficacy of this dose of fibers in reducing serum lipid risk factors for cardiovascular disease. Design: Sixty-eight hyperlipidemic adults ...
PubMed:
11976156

16. Soy Isoflavones Increase Latency of Spontaneous Mammary Tumors in Mice

Author:
Jin, Zeming; MacDonald, Ruth S.
Source:
Journal of nutrition 2002 v.132 no.10 pp. 3186-3190
ISSN:
0022-3166
Subject:
Food and Drug Administration; Mouse mammary tumor virus; adulthood; breast neoplasms; carcinogenesis; cardioprotective effect; daidzein; foods; gene overexpression; genistein; health claims; hormone replacement therapy; humans; mammary neoplasms (animal); mice; models; oncogenes; perinatal period; plant estrogens; soy protein; women; United States
Abstract:
... Soy protein, with and without isoflavones, is being added to foods by manufacturers in response to the Food and Drug Administration (FDA)-approved health claim for cardiovascular protection. Furthermore, soy isoflavones are increasingly consumed by women in the United States as an alternative to hormone replacement therapy. The role of these phytoestrogens in breast cancer is controversial. Althou ...
PubMed:
12368416

17. Antibiotic residues in poultry tissues and eggs: human health concerns?

Author:
Donoghue, D.J.
Source:
Poultry science 2003 v.82 no.4 pp. 618-621
ISSN:
0032-5791
Subject:
growth promotion; vitamin B12; drug toxicity; no observed adverse effect level; antibiotic residues; toxicity testing; broiler chickens; medical history; veterinary drugs; Food and Drug Administration; agricultural history; monitoring; feed additives; feed conversion; ducks; coccidiostats; USDA; food safety; human health and safety; antibiotics; turkeys; consumer attitudes; poultry meat
DOI:
10.1093/ps/82.4.618
PubMed:
12710482

18. Contaminants and levels of occurrence in washed and shredded poly(ethylene terephthalate) from curbside collection. Part 1: Extraction conditions

Author:
Konkol, L.M.; Cross, R.F.; Harding, I.H.; Kosior, E.
Source:
Food additives and contaminants : Analysis, surveillance, evaluation Control 2003 v.20 no.9 pp. 859-874
ISSN:
1944-0049
Subject:
benzophenones; ethylene; dodecanoic acid; polyethylene terephthalates; monitoring; Food and Drug Administration; methylene chloride; methyl salicylate; particle size; limonene; solvents; food additives; gas chromatography-mass spectrometry; United States
Abstract:
... The aim was to determine which contaminants were present in washed and dried shredded poly(ethylene terephthalate) (PET, flake) obtained from curbside collection and whether the concentrations were above the US FDA threshold of 215 ppb. Thirty-two semivolatile contaminants were extracted from the treated flake by Soxhlet extraction using dichloromethane as a PET swelling solvent and gas chromatogr ...
DOI:
10.1080/0265203031000156088

19. Dietary phytoestrogens – a role in women’s health

Author:
Jefferson, Angie
Source:
Nutrition and food science 2003 v.33 no.1 pp. 16-22
ISSN:
0034-6659
Subject:
Food and Drug Administration; antioxidant activity; blood; bone density; cholesterol; diet; health claims; health foods; isoflavones; menopause; plant estrogens; women; United Kingdom; United States
Abstract:
... Interest into the role of dietary phytoestrogens and their potential effects on women’s health has dramatically increased over the past decade. Phytoestrogens, and in particular isoflavone-rich soya foods, are now believed to play a role in alleviating symptoms of the menopause, maintaining bone density, reducing blood cholesterol levels, protecting against cancer development. In addition they exh ...
DOI:
10.1108/00346650310459527

20. Effectiveness of polypropylene film as a barrier to migration from recycled paperboard packaging to fatty and high-moisture food

Author:
Song, Y.S.; Begley, T.; Paquette, K.; Komolprasert, V.
Source:
Food additives and contaminants : Analysis, surveillance, evaluation Control 2003 v.20 no.9 pp. 875-883
ISSN:
1944-0049
Subject:
benzophenones; risk; pentachlorophenol; monitoring; Food and Drug Administration; anthracenes; stearic acid; food packaging; food additives; isopropyl alcohol; flame ionization; paper; polypropylenes; recycled paper; solvents; ethanol; paperboard; United States
Abstract:
... The capability of a polypropylene (PP) film barrier to prevent migration of residual contaminants from recycled paperboard into food simulants was studied. Anthracene, benzophenone, methyl stearate and pentachlorophenol were chosen as chemical surrogates to represent classes of contaminants likely to be found in recycled paper/paperboard. Each surrogate was spiked into a test specimen made of seve ...
DOI:
10.1080/02652030310001597592

21. Isoflavone supplements do not affect thyroid function in iodine-replete postmenopausal women

Author:
Bruce, Bonnie; Messina, Mark; Spiller, Gene A.
Source:
Journal of medicinal food 2003 v.6 no.4 pp. 309-316
ISSN:
1096-620X
Subject:
Food and Drug Administration; animals; blood serum; cholesteremic effect; goiter; health claims; hormone replacement therapy; infants; iodine; isoflavones; postmenopause; soy protein; soybeans; thyroid function; thyrotropin; triiodothyronine; women; United States
Abstract:
... Despite the safety review conducted by the U.S. Food and Drug Administration in the process of awarding a health claim for the cholesterol-lowering properties of soy protein, concerns about the possible goitrogenic effects of soybean isoflavones persist. Concerns are based primarily on in vitro research, animal studies, and older reports of goiter in infants fed soy formula not fortified with iodi ...
DOI:
10.1089/109662003772519859
PubMed:
14977438

22. Residue Depletion Study and Withdrawal Period for Flunixin-N-methyl Glucamine in Bovine Milk Following Intravenous Administration

Author:
Ngoh, Maureen A.; Wislocki, Peter G.; Thompson, Kenneth; Katz, Terry; Weingarten, Allan; TerHune, Terry; Hurshman, Bret
Source:
Journal of agricultural and food chemistry 2003 v.51 no.16 pp. 4701-4707
ISSN:
0021-8561
Subject:
Food and Drug Administration; body weight; dairy cows; drugs; guidelines; intravenous injection; lactation; mass spectrometry; milk; veterinary medicine; United States
Abstract:
... The objective of this study was to establish a withdrawal period for flunixin in milk by quantifying 5-hydroxyflunixin, the marker residue, in bovine milk as a function of time, following intravenous treatment of lactating dairy cows with flunixin-N-methyl glucamine (Banamine or Finadyne). Lactating dairy cows were dosed on three consecutive days at 2.2 mg of flunixin free acid/kg of body weight/d ...
DOI:
10.1021/jf026219+

23. Safe food from a consumer perspective

Author:
DeWaal, Caroline Smith
Source:
Food control 2003 v.14 no.2 pp. 75-79
ISSN:
0956-7135
Subject:
foods; public health; Food and Drug Administration; food contamination; HACCP; safety standards; food availability; animal production; food policy; experts; United States
Abstract:
... Food-safety experts believe that contaminated food causes up to 76 million illnesses, 325,000 hospitalizations and 5000 deaths each year in the US alone. These estimates underline the fact that foodborne-illnesses pose a significant public-health burden. CSPI recommends strengthening the safety of the food supply by setting farm and animal production food-safety standards, by improving Hazard Anal ...
DOI:
10.1016/S0956-7135(02)00114-7

24. Source of Arsenic in Licorice Confectionery Products

Author:
Carbonell-Barrachina, Angel Antonio; Aracil, Pedro; Garcia, Elena; Burlo, Francisco; Martinez-Sanchez, Francisco
Source:
Journal of agricultural and food chemistry 2003 v.51 no.6 pp. 1749-1752
ISSN:
0021-8561
Subject:
Food and Drug Administration; arsenic; atomic absorption spectrometry; glycyrrhizin; high performance liquid chromatography; licorice; pearls; sweets; throat; United States
Abstract:
... Spanish legislation sets a maximum level for total arsenic (As) in confectionery products at 0.1 μg g-1. The U.S. Food and Drug Administration limitations for glycyrrhizic acid in hard and soft candies are 160 and 31 mg g-1, respectively. Arsenic and glycyrrhizic acid were determined in 22 different confectionery products: 9 throat pearls, 4 hard candies, and 9 soft candies. Arsenic and glycyrrhiz ...
DOI:
10.1021/jf026057h

25. The effects of fiber enrichment of pasta and fat content on gastric emptying, GLP-1, glucose, and insulin responses to a meal

Author:
Frost, G.S.; Brynes, A.E.; Dhillo, W.S.; Bloom, S.R.; McBurney, M.I.
Source:
European journal of clinical nutrition 2003 v.57 no.2 pp. 293-298
ISSN:
0954-3007
Subject:
Food and Drug Administration; Plantago; absorption; acetaminophen; blood; blood sampling; cholesterol; coronary disease; cross-over studies; diabetes; gastric emptying; glucagon-like peptide 1; glucose; health claims; hunger; insulin; lipid content; long term effects; metabolism; nausea; nutrients; pasta; risk factors; saturated fats; sodium propionate; soluble fiber; sunflower oil; tomato sauce; unsaturated fats; United States
Abstract:
... Objective: To assess whether the addition of viscous fiber at an amount recommended by the US FDA to allow a 'low saturated fat, cholesterol, soluble fiber and coronary heart disease', health claim label on a food package (1.7 g psyllium) and/or fat (30 g sunflower oil and 3 g sodium propionate) to a pasta meal would affect gastric emptying, postprandial glucose, insulin and GLP-1 concentrations. ...
DOI:
10.1038/sj.ejcn.1601520

26. Whole grain health claims in the USA and other efforts to increase whole-grain consumption

Author:
Marquart, Len; Wiemer, Kathryn L.; Jones, Julie M.; Jacob, Brenda
Source:
Proceedings of the Nutrition Society 2003 v.62 no.1 pp. 151-160
ISSN:
0029-6651
Subject:
Food and Drug Administration; Nutrition Labeling and Education Act of 1990; chronic diseases; color; diet; dietary recommendations; experts; hardness; health claims; health information; heart diseases; industry; modernization; national surveys; prices; public health; purchasing; risk; taste; texture; value added; water content; whole grain foods; United States
Abstract:
... In response to the 1990 Nutrition Labeling and Education Act, the Food and Drug Administration approved seven health claims that addressed the relationship between broad food categories and risk of certain chronic diseases. These claims are based on scientific consensus that includes epidemiological, animal and clinical research. The Food and Drug Administration also established a process to petit ...
DOI:
10.1079/PNS2003242

27. Effect of Delayed Processing on Changes in Histamine and Other Quality Characteristics of 3 Commercially Canned Fishes

Author:
R. Jeya Shakila; Geevarethinam Jeyasekaran; S. Aunto Princy Vyla; R. Saravana Kumar
Source:
Journal of food science 2005 v.70 no.1 pp. M24
ISSN:
0022-1147
Subject:
Food and Drug Administration; Katsuwonus pelamis; Sardinella; Scomberomorus; ambient temperature; canned fish; canning; histamine; odors; sardines; toxicity; tuna; United States
Abstract:
... Changes in histamine and other quality characteristics were examined in 3 commercially important fishes, tuna (Katsuwonus pelamis), seerfish (Scomberomorus commersonii), and sardines (Sardinella gibbosa) through the canning process, at 3 different stages (raw, precooked, and canned) immediately on receipt and also after a delay of 6 h at ambient temperature (30 ± 2 °C). Tuna and seerfish remaine ...
DOI:
10.1111/j.1365-2621.2005.tb09042.x

28. FDA's regulation of genetically engineered foods: Scientific, legal and political dimensions

Author:
Pelletier, D.L.
Source:
Food policy 2006 v.31 no.6 pp. 570-591
ISSN:
0306-9192
Subject:
food policy; food biotechnology; food safety; developing countries; Food and Drug Administration; genetically modified foods; risk; United States
Abstract:
... The controversy over genetically engineered (GE) food during the southern Africa drought in 2002/03 raised questions concerning the safety of GE foods and the basis for the safety assurances issued by national and international agencies. In the case of foods grown in the US, these assurances must be interpreted in relation to the Food and Drug Administration's (FDA) 1992 policy, which remains in e ...
DOI:
10.1016/j.foodpol.2006.03.010

29. Lutein and zeaxanthin intakes and risk of age-related macular degeneration and cataracts: an evaluation using the Food and Drug Administration's evidence-based review system for health claims

Author:
Trumbo, Paula R.; Ellwood, Kathleen C.
Source:
American journal of clinical nutrition 2006 v.84 no.5 pp. 971-974
ISSN:
0002-9165
Subject:
at-risk population; age; validity; tissue degeneration; dietary supplements; nutrition labeling; nutrient intake; health claims; Food and Drug Administration; human health; zeaxanthin; cataract; product evaluation; human diseases; lutein; human nutrition; antioxidant activity; antioxidants
Abstract:
... The labeling of health claims that meet the significant scientific agreement standard and of qualified health claims on conventional foods and dietary supplements requires premarket approval by the Food and Drug Administration (FDA). The FDA conducts an evidence-based review to ascertain whether sufficient evidence exists to support a significant scientific agreement standard or a qualified health ...
PubMed:
17093145

30. New and Existing Oils and Fats Used in Products with Reduced Trans-Fatty Acid Content

Author:
Tarrago-Trani, M.T.; Phillips, K.M.; Lemar, L.E.; Holden, J.M.
Source:
Journal of the American Dietetic Association 2006 v.106 no.6 pp. 867-880
ISSN:
0002-8223
Subject:
fats and oils industry; novel foods; food labeling; fatty acid composition; cooking fats and oils; Food and Drug Administration; adverse effects; human health; physicochemical properties; food processing; trans fatty acids; ingredients; hydrogenated oils; product development; chemical structure; United States
Abstract:
... The US Food and Drug Administration's final ruling on trans-fatty acid labeling issued in 2003 has caused a rapid transformation in the fat and oil industries. Novel ingredients and improved technologies are emerging to replace partially hydrogenated fats in foods. We present an overview of the structure and formation of trans fatty acids in foods, and a comprehensive review of the newly formulate ...
Handle:
10113/34489
DOI:
10.1016/j.jada.2006.03.010
PubMed:
16720128

31. Wildlife contraceptives: a regulatory hot potato

Author:
Eisemann, John D.; Fagerstone, Kathleen A.; O'Hare, Jeanette R.
Source:
Proceedings - Vertebrate Pest Conference 2006 no.22 pp. 63-66
ISSN:
0507-6773
Subject:
Food and Drug Administration; goose eggs; wildlife management; vaccines; urban areas; geese; fertility agents; fish and wildlife law; United States
Handle:
10113/39044

32. A comparison of the chemical properties of drugs and FEMA/FDA notified GRAS chemical compounds used in the food industry

Author:
Sprous, D.G.; Salemme, F.R.
Source:
Food and chemical toxicology 2007 v.45 no.8 pp. 1419-1427
ISSN:
0278-6915
Subject:
Food and Drug Administration; GRAS substances; food industry; safety testing; pharmacology; toxicity testing; molecular weight; beverages
DOI:
10.1016/j.fct.2007.02.004
PubMed:
17368904

33. A review of the occurrence, formation and analysis of furan in heat-processed foods

Author:
Crews, C.; Castle, L.
Source:
Trends in food science & technology 2007 v.18 no.7 pp. 365-372
ISSN:
0924-2244
Subject:
sugar products; chemical reactions; furans; food composition; carcinogens; genotoxicity; soy sauce; heat treatment; cooking; coffee (beverage); Food and Drug Administration; headspace analysis; dietary nutrient sources; quantitative analysis; canned meat; processed foods; gravy; food safety; metabolic detoxification; coffee beans; United States; Europe
DOI:
10.1016/j.tifs.2007.03.006

34. Comparison of different nutrient profiling schemes to a new reference method using dietary surveys

Author:
Quinio, Caroline; Biltoft-Jensen, Anja; De Henauw, Stefaan; Gibney, Michael J.; Huybrechts, Inge; McCarthy, Sinéad N.; O'Neill, Jennifer L.; Tetens, Inge; Turrini, Aida; Volatier, Jean-Luc
Source:
European journal of nutrition 2007 v.46 no.2 pp. 37-46
ISSN:
1436-6207
Subject:
health claims; foods; Food and Drug Administration; European Union; healthy diet; national surveys; dietary surveys; adults; United Kingdom; United States
Abstract:
... A new EU regulation on nutrition and health claims made on foods has entered into force in January 2007. The regulation provides for the use of nutrient profiles to determine which foods may bear claims but does not specify what the profiles should be or how they should be developed. Several nutrient profiling schemes have already been established. Therefore, it is necessary to develop approaches ...
DOI:
10.1007/s00394-007-2005-4

35. Evaluation of gas chromatographic methods for the determination of trans fat

Author:
Delmonte, Pierluigi; Rader, Jeanne I.
Source:
Analytical and bioanalytical chemistry 2007 v.389 no.1 pp. 77-85
ISSN:
1618-2642
Subject:
Food and Drug Administration; Fourier transform infrared spectroscopy; chemists; cholesterol; coronary disease; gas chromatography; nutrition labeling; oils; risk; trans fatty acids; United States
Abstract:
... Consumption of trans fat has been associated with increased risk of coronary heart disease. For nutrition labeling purposes, the US Food and Drug Administration (FDA) defines trans fat as the sum of all the fatty acids with at least one nonconjugated double bond in the trans configuration. The FDA regulation states that label declarations of trans fat are not required for products that contain les ...
DOI:
10.1007/s00216-007-1392-y
PubMed:
17572885

36. The US FDA and animal cloning: Risk and regulatory approach

Author:
Rudenko, L.; Matheson, J.C.
Source:
Theriogenology 2007 v.67 no.1 pp. 198-206
ISSN:
0093-691X
Subject:
livestock; cloning (animals); laws and regulations; agricultural law; animal law; Food and Drug Administration; risk management process; risk assessment; risk communication; animal health; food safety; United States
Abstract:
... The Food and Drug Administration's (FDA's) Center for Veterinary Medicine issued a voluntary request to producers of livestock clones not to introduce food from clones or their progeny into commerce until the agency had assessed whether production of cattle, swine, sheep, or goats by somatic cell nuclear transfer (SCNT) posed any unique risks to the animal(s) involved in the process, humans, or ot ...
DOI:
10.1016/j.theriogenology.2006.09.033

37. US-FDA's revised consumption factor for polystyrene used in food-contact applications

Author:
Cassidy, K.; Elyashiv-Barad, S.
Source:
Food additives & contaminants 2007 v.24 no.9 pp. 1026-1031
ISSN:
0265-203X
Subject:
polystyrenes; packaging materials; public health; Food and Drug Administration; packaging materials migration; food packaging; dietary exposure; food consumption; food contact surfaces; United States
Abstract:
... US FDA's continual effort to evaluate the safety of food-contact materials includes periodically re-examining our established packaging factors, such as consumption and food-type distribution factors. The use of polystyrene in food-contact and disposable food-packaging applications has expanded and is expected to continue to increase in the future. Therefore, it is important to revise the polystyr ...
DOI:
10.1080/02652030701313797
PubMed:
17691017

38. An analysis of trends in food import refusals in the United States

Author:
Allen, A.J.; Myles, A.E.; Shaik, S.; Yeboah, O.
Source:
Journal of food distribution research 2008 v.39 no.1 pp. 5-10
ISSN:
0047-245X
Subject:
horticultural crops; Food and Drug Administration; compliance; trade regulations; agricultural law; food quality; imports; plant-based foods; United States

39. Are Non-prescription Medications Needed for Weight Control

Author:
Bray, George A.
Source:
Obesity 2008 v.16 no.3 pp. 509-514
ISSN:
1930-7381
Subject:
portion size; body mass index; exercise; women; low carbohydrate diet; Food and Drug Administration; health care workers; weight control programs; dietary supplements; weight loss; herbal medicines
DOI:
10.1038/oby.2007.100
PubMed:
18239604

40. Development and validation of a high-throughput zwitterionic hydrophilic interaction liquid chromatography solid-phase extraction-liquid chromatography-tandem mass spectrometry method for determination of the anti-influenza drug peramivir in plasma

Author:
Lindegardh, N.; Hanpithakpong, W.; Phakdeeraj, A.; Singhasivanon, P.; Farrar, J.; Hien, T.T.; White, N.J.; Day, N.P.J.
Source:
Journal of chromatography 2008 v.1215 no.1-2 pp. 145-151
ISSN:
0021-9673
Subject:
Food and Drug Administration; blood proteins; drugs; guidelines; humans; hydrophilic interaction chromatography; peramivir; phospholipids; quality control; solid phase extraction; tandem mass spectrometry; zwitterions; United States
Abstract:
... An assay for the analysis for the quantification of the anti-influenza drug peramivir in human plasma using high-throughput zwitterionic (ZIC) hydrophilic interaction liquid chromatography (HILIC) solid-phase extraction (SPE) in a 96-wellplate format and liquid chromatography coupled to positive tandem mass spectroscopy has been developed and validated. The ZIC-HILIC SPE efficiently removed source ...
DOI:
10.1016/j.chroma.2008.11.009

41. Enantioselective HPLC resolution of synthetic intermediates of armodafinil and related substances

Author:
Nageswara Rao, Ramisetti; Shinde, Dhananjay D.; Kumar Talluri, Murali V.N.
Source:
Journal of separation science 2008 v.31 no.6-7 pp. 981-989
ISSN:
1615-9306
Subject:
1-propanol; Food and Drug Administration; amylose; cellulose; drugs; enantiomers; ethanol; high performance liquid chromatography; isopropyl alcohol; solutes; solvents; temperature; United States
Abstract:
... Armodafinil is a unique psychostimulant recently approved by the US Food and Drug Administration for the treatment of narcolepsy. The chromatographic resolution of its chiral intermediates including related substances in the total synthesis of armodafinil was studied on polysaccharide-based stationary phases, viz. cellulose tris-(3,5-dimethylphenylcarbamate) (Chiralcel OD-H) and amylose tris-(3,5- ...
DOI:
10.1002/jssc.200700545
PubMed:
18381701

42. How changes affecting wholesale drug distribution can impact veterinary practitioners

Author:
Lust, Elaine
Source:
Journal of the American Veterinary Medical Association 2008 v.233 no.7 pp. 1081-1082
ISSN:
0003-1488
Subject:
product authenticity; consumer protection; veterinary drugs; product safety; pet care; animal well-being; Food and Drug Administration; product quality standards; wholesale marketing; adulterated products; pets; qualitative analysis; veterinarians; veterinary clinics; distribution (economics); United States
DOI:
10.2460/javma.233.7.1081

43. Innovative regulatory approaches to reduce sodium consumption: could a cap-and-trade system work?

Author:
Forshee, R.A.
Source:
Nutrition reviews 2008 v.66 no.5 pp. 280-285
ISSN:
0029-6643
Subject:
sodium; nutrient intake; public health; economic impact; laws and regulations; food safety; foods; taxes; risk communication; Food and Drug Administration; United States
Abstract:
... Many regulatory and professional organizations are calling for strict new regulations to reduce sodium consumption on a population basis. New regulations on sodium may have significant public health and economic impacts. This article explores five regulatory options to reduce sodium consumption: 1) maintaining the status quo, 2) improving risk communication and information, 3) revoking generally r ...
DOI:
10.1111/j.1753-4887.2008.00033.x
PubMed:
18454814

44. Multi-targeted therapy by curcumin: how spicy is it

Author:
Goel, Ajay; Jhurani, Sonia; Aggarwal, Bharat B.
Source:
Molecular nutrition & food research 2008 v.52 no.9 pp. 1010-1030
ISSN:
1613-4125
Subject:
Food and Drug Administration; clinical trials; curcumin; curry; genes; humans; ingestion; mechanism of action; powders; therapeutics; traditional medicine; tumor necrosis factors; vascular endothelial growth factors; United States
Abstract:
... Although traditional medicines have been used for thousands of years, for most such medicines neither the active component nor their molecular targets have been very well identified. Curcumin, a yellow component of turmeric or curry powder, however, is an exception. Although inhibitors of cyclooxygenase-2, HER2, tumor necrosis factor, EGFR, Bcr-abl, proteosome, and vascular endothelial cell growth ...
DOI:
10.1002/mnfr.200700354
PubMed:
18384098

45. Nutrient profiling of foods: creating a nutrient-rich food index

Author:
Drewnowski, A.; Fulgoni, V. III
Source:
Nutrition reviews 2008 v.66 no.1 pp. 23-39
ISSN:
0029-6643
Subject:
rating scales; nutrient content; humans; Food and Drug Administration; nutritional adequacy; health status; nutrient density; plant-based foods; Reference Daily Intakes
Abstract:
... Nutrient profiling of foods, described as the science of ranking foods based on their nutrient content, is fast becoming the basis for regulating nutrition labels, health claims, and marketing and advertising to children. A number of nutrient profile models have now been developed by research scientists, regulatory agencies, and by the food industry. Whereas some of these models have focused on nu ...
DOI:
10.1111/j.1753-4887.2007.00003.x
PubMed:
18254882

46. Regulatory considerations related to stem cell treatment in horses

Author:
Yingling, G.L.; Nobert, K.M.
Source:
Journal of the American Veterinary Medical Association 2008 v.232 no.11 pp. 1657-1661
ISSN:
0003-1488
Subject:
laws and regulations; bioethics; veterinary law; bone diseases; musculoskeletal system; Food and Drug Administration; immunotherapy; biotechnology; guidelines; stem cells; joint diseases; cell lines; horse diseases; federal government; horses; United States
DOI:
10.2460/javma.232.11.1657

47. Surrogate endpoints and emerging surrogate endpoints for risk reduction of cardiovascular disease

Author:
Rasnake, C.M.; Trumbo, P.R.; Heinonen, T.M.
Source:
Nutrition reviews 2008 v.66 no.2 pp. 76-81
ISSN:
0029-6643
Subject:
pathophysiology; Center for Food Safety and Applied Nutrition; blood lipids; humans; cardiovascular diseases; biomarkers; cholesterol; low density lipoprotein; risk reduction; blood pressure
Abstract:
... This article reviews surrogate endpoints and emerging biomarkers that were discussed at the annual "Cardiovascular Biomarkers and Surrogate Endpoints" symposium cosponsored by the US Food and Drug Administration (FDA) and the Montreal Heart Institute. The FDA's Center for Food Safety and Applied Nutrition (CFSAN) uses surrogate endpoints in its scientific review of a substance/disease relationship ...
DOI:
10.1111/j.1753-4887.2007.00010.x
PubMed:
18254873

48. US Governmental Interagency Programs, Opportunities, and Collaboration

Author:
H. Chen; M. Perchonok
Source:
Food science and technology international 2008 v.14 no.5 pp. 447-453
ISSN:
1082-0132
Subject:
educational institutions; stakeholders; Agricultural Research Service; Food and Drug Administration; extension education; Food Safety and Inspection Service; food processing; food availability; cooperative research; nonthermal processing; curriculum; food safety; National Institute of Food and Agriculture; United States
Abstract:
... Improving the quality, value, and safety of national food supplies is the common mission of several Federal agencies. Under different authorities, these agencies conduct basic and applied research, develop curriculum at higher educational institutions, and disseminate new scientific knowledge about food processing, formulation, and preservation to a broad range of stakeholders. Emerging food proce ...
DOI:
10.1177/1082013208098817

49. US regulatory system for genetically modified [genetically modified organism (GMO), rDNA or transgenic] crop cultivars

Author:
McHughen, Alan; Smyth, Stuart
Source:
Plant biotechnology journal 2008 v.6 no.1 pp. 2-12
ISSN:
1467-7644
Subject:
Food and Drug Administration; USDA; United States Environmental Protection Agency; agricultural biotechnology; crops; cultivars; issues and policy; laws and regulations; politics; ribosomal DNA; transgenic plants; United States
Abstract:
... This paper reviews the history of the federal regulatory oversight of plant agricultural biotechnology in the USA, focusing on the scientific and political forces moulding the continually evolving regulatory structure in place today. Unlike most other jurisdictions, the USA decided to adapt pre-existing legislation to encompass products of biotechnology. In so doing, it established an overarching ...
DOI:
10.1111/j.1467-7652.2007.00300.x
PubMed:
17956539

50. Vitamin D discovery outpaces FDA decision making

Author:
Marshall, Trevor G.
Source:
BioEssays 2008 v.30 no.2 pp. 173-182
ISSN:
0265-9247
Subject:
DNA; Food and Drug Administration; adults; autoimmune diseases; calcium; children; chronic diseases; decision making; disease outbreaks; food chain; foods; gene expression; genes; grains; homeostasis; milk; molecular biology; neoplasms; obesity; osteoporosis; rickets; risk reduction; transcription (genetics); transcription factors; vitamin D; vitamin supplements; United States
Abstract:
... The US FDA currently encourages the addition of vitamin D to milk and cereals, with the aim of reducing rickets in children and osteoporosis in adults. However, vitamin D not only regulates the expression of genes associated with calcium homeostasis, but also genes associated with cancers, autoimmune disease, and infection. It does this by controlling the activation of the vitamin D receptor (VDR) ...
DOI:
10.1002/bies.20708

51. Was It Something I Ate? Implementation of the FDA Seafood HACCP Program

Author:
Anna Alberini; Erik Lichtenberg; Dominic Mancini; Gregmar I. Galinato
Source:
American journal of agricultural economics 2008 v.90 no.1 pp. 28-41
ISSN:
0002-9092
Subject:
laws and regulations; Food and Drug Administration; compliance; seafoods; HACCP; food industry; food inspection; sanitation standard operating procedures; econometric models; food sanitation; law enforcement; United States
Abstract:
... We develop a theoretical model of enforcement and compliance under HACCP regulation and use the FDA's seafood inspection records to examine: (1) if the FDA has targeted its inspections under HACCP regulation; (2) the effects of inspections on compliance with HACCP and plant sanitation standards; and (3) the relationship between compliance with HACCP and preexisting sanitation standards. There is s ...
DOI:
10.1111/j.1467-8276.2007.01038.x

52. Automated determination of venlafaxine in human plasma by on-line SPE-LC-MS/MS. Application to a bioequivalence study

Author:
Suenaga, Eunice Mayumi; Ifa, Demian R.; Cruz, Alessandro Carvalho; Pereira, Renata; Abib, Eduardo; Tominga, Mineko; Nakaie, Clovis Ryuichi
Source:
Journal of separation science 2009 v.32 no.4 pp. 637-643
ISSN:
1615-9306
Subject:
Food and Drug Administration; absorption; blood plasma; confidence interval; hexanols; humans; liquid chromatography; liquid-liquid extraction; mass spectrometry; solid phase extraction; solvents; volunteers; Brazil; United States
Abstract:
... A new automated SPE-LC-ESI-MS/MS method was developed and validated to quantify venlafaxine in human plasma using fluoxetine as an internal standard. The analytes were automatically extracted from plasma by C18 SPE cartridges, separated on a C8 RP column and analyzed by MS in the multiple reaction-monitoring (MRM) mode. The method has a chromatographic run time of 4.0 min and a linear calibration ...
DOI:
10.1002/jssc.200800629
PubMed:
19212975

53. Comparison of pesticide exposure from consumption of domestic and imported fruits and vegetables

Author:
Katz, J.M.; Winter, C.K.
Source:
Food and chemical toxicology 2009 v.47 no.2 pp. 335-338
ISSN:
0278-6915
Subject:
food analysis; Food and Drug Administration; food contamination; imports; pesticide residues; dietary exposure; provenance; food composition; vegetables; pesticides; United States
DOI:
10.1016/j.fct.2008.11.024
PubMed:
19059451

54. FDA Regulation of Stem Cell-Based Products

Author:
Fink, Donald W. Jr.
Source:
Science 2009 v.324 no.5935 pp. 1662-1663
ISSN:
0036-8075
Subject:
Food and Drug Administration; clinical trials; humans; risk; stem cells; tissues; United States
Abstract:
... Cell self-renewal and the capacity to differentiate into multiple cell types (pluripotency) are biological attributes casting stem cells as attractive candidates for development of therapies targeting indications that involve functional restoration of damaged tissues. In the United States, clinical trials designed to demonstrate the safety and effectiveness of stem cell-based products are regulate ...
DOI:
10.1126/science.1173712

55. Food Safety Regulations under Ambiguity

Author:
Melkonyan, Tigran A.; Schubert, Jens
Source:
American journal of agricultural economics 2009 v.91 no.5 pp. 1389-1396
ISSN:
0002-9092
Subject:
food law; foodborne illness; HACCP; Food and Drug Administration; Food Safety and Inspection Service; economics; United States
DOI:
10.1111/j.1467-8276.2009.01353.x

56. Garlic intake and cancer risk: an analysis using the Food and Drug Administration's evidence-based review system for the scientific evaluation of health claims

Author:
Kim, Ji Yeon; Kwon, Oran
Source:
American journal of clinical nutrition 2009 v.89 no.1 pp. 257-264
ISSN:
0002-9165
Subject:
humans; garlic; health foods; food intake; neoplasms; risk reduction; risk assessment; Food and Drug Administration; meta-analysis; health claims
Abstract:
... BACKGROUND: Numerous animal and in vitro studies provided evidence for a relation between garlic intake and cancer risk reduction. Several studies also reported an inverse association in humans. However, no claims have been made about garlic intake and cancer risk reduction with respect to food labeling. OBJECTIVE: The objective of this study was to evaluate the scientific evidence for garlic inta ...
DOI:
10.3945/ajcn.2008.26142
PubMed:
19056580

57. New Therapeutic Horizons: Mapping the Future of Glycemic Control With Incretin-based Therapy

Author:
Campbell, R. Keith; Miller, Sara
Source:
diabetes educator 2009 v.35 no.5 pp. 731-747
ISSN:
0145-7217
Subject:
Food and Drug Administration; adults; agonists; children; glucagon-like peptide 1; glycemic control; guidelines; lifestyle; metformin; noninsulin-dependent diabetes mellitus; patients; teachers; therapeutics; United States
Abstract:
... Purpose More than 24 million adults and children in the United States are living with diabetes, and the vast majority of those individuals have type 2 diabetes. The clinical benefits of good glycemic control have been well established. Most patients eventually require the use of multiple hyperglycemic drugs in combination to approach or achieve the American Diabetes Association's recommended targe ...
DOI:
10.1177/0145721709342900
PubMed:
19783765

58. Nonparametric Estimation in a Markov “Illness–Death” Process from Interval Censored Observations with Missing Intermediate Transition Status

Author:
Halina Frydman; Michael Szarek
Source:
Biometrics 2009 v.65 no.1 pp. 143-151
ISSN:
0006-341X
Subject:
Food and Drug Administration; algorithms; biometry; clinical trials; death; models; patients
Abstract:
... In many clinical trials patients are intermittently assessed for the transition to an intermediate state, such as occurrence of a disease‐related nonfatal event, and death. Estimation of the distribution of nonfatal event free survival time, that is, the time to the first occurrence of the nonfatal event or death, is the primary focus of the data analysis. The difficulty with this estimation is th ...
DOI:
10.1111/j.1541-0420.2008.01056.x
PubMed:
18505421

59. Overlap of US FDA residue tests and pesticides used on imported vegetables: Empirical findings and policy recommendations

Author:
Galt, Ryan E.
Source:
Food policy 2009 v.34 no.5 pp. 468-476
ISSN:
0306-9192
Subject:
environmental fate; maximum residue limits; Food and Drug Administration; imports; pesticide residues; import policies; plant-based foods; vegetables; agricultural policy; pesticide use reduction; United States; Costa Rica
Abstract:
... In the United States, the Environmental Protection Agency (EPA) registers pesticides and sets crop-specific tolerances while the Food and Drug Administration (FDA) enforces EPA regulations by testing plant-based foods for pesticide residues. Pesticide treatment histories are almost always unknown, especially on imported produce, posing an empirical question: to what extent do FDA’s residue testing ...
DOI:
10.1016/j.foodpol.2009.05.005

60. Qualified Health Claims for Calcium and Colorectal, Breast, and Prostate Cancers: The U.S. Food and Drug Administration's Evidence-Based Review

Author:
Kavanaugh, Claudine J.; Trumbo, Paula R.; Ellwood, Kathleen C.
Source:
Nutrition and cancer 2009 v.61 no.2 pp. 157-164
ISSN:
0163-5581
Subject:
health claims; dietary mineral supplements; Food and Drug Administration; calcium; anticarcinogenic activity; prostatic neoplasms; colorectal neoplasms; dietary minerals; breast neoplasms; United States
Abstract:
... In 2003, the United States Food and Drug Administration (FDA) received a health claim petition for calcium supplements and reduced risk of colorectal, breast, and prostate cancers. Health claims characterize the relationship between a substance (food or food component) and disease (e.g., cancer or cardiovascular disease) or health-related condition (e.g., hypertension) and require premarket approv ...
DOI:
10.1080/01635580802395741
PubMed:
19235032

61. Rapid identification and quantification of methamphetamine and amphetamine in hair by gas chromatography/mass spectrometry coupled with micropulverized extraction, aqueous acetylation and microextraction by packed sorbent

Author:
Miyaguchi, Hajime; Iwata, Yuko T.; Kanamori, Tatsuyuki; Tsujikawa, Kenji; Kuwayama, Kenji; Inoue, Hiroyuki
Source:
Journal of chromatography 2009 v.1216 no.18 pp. 4063-4070
ISSN:
0021-9673
Subject:
Food and Drug Administration; acetylation; amphetamine; anion exchange; evaporation; gas chromatography; humans; mass spectrometry; methanol; microextraction; sodium carbonate; temperature; United States
Abstract:
... We developed a rapid identification and quantification method for the toxicological analysis of methamphetamine and amphetamine in human hair by gas chromatography/mass spectrometry coupled with a novel combination of micropulverized extraction, aqueous acetylation and microextraction by packed sorbent (MEPS) named MiAMi-GC/MS. A washed hair sample (1-5mg) was micropulverized for 5min in a 2mL pla ...
DOI:
10.1016/j.chroma.2009.02.093

62. Safety of Imported Foods

Author:
Doyle, M. Ellin; Zach, Lorna
Source:
Food protection trends 2009 v.29 no.10 pp. 642-643
ISSN:
1541-9576
Subject:
Food and Agriculture Organization; Food and Drug Administration; compliance; food contamination; HACCP; microbial contamination; imports; adulterated products; melamine; United States; Mexico; Europe

63. Scientific substantiation of claims in the USA: focus on functional foods

Author:
Lupton, Joanne R.
Source:
European journal of nutrition 2009 v.48 no.1 pp. 27-31
ISSN:
1436-6207
Subject:
Daily Values; Food and Drug Administration; bioactive properties; diet; food law; functional foods; health claims; markets; nutrient content; nutritive value; odors; people; taste; United States
Abstract:
... Although functional foods are currently regulated the same as conventional foods by the US Food and Drug Administration (FDA) there is some concern that they should not be. One concern is whether functional foods can/should carry the same type of health and nutrition labeling claims as conventional foods. For example, the type of nutrient content claim that describes a level of the nutrient such a ...
DOI:
10.1007/s00394-009-0073-3

64. VEGF inhibition: insights from preclinical and clinical studies

Author:
Crawford, Yongping; Ferrara, Napoleone
Source:
Cell and tissue research 2009 v.335 no.1 pp. 261-269
ISSN:
0302-766X
Subject:
Food and Drug Administration; angiogenesis; blood vessels; clinical trials; macular degeneration; metastasis; mice; models; neoplasms; vascular endothelial growth factors
Abstract:
... Angiogenesis, the growth of new blood vessels, is required for a variety of normal proliferative processes. Furthermore, angiogenesis is well established as also playing an important role in neoplastic growth and metastasis. Numerous regulators of angiogenesis have been identified and characterized over the last few decades. Among these, vascular endothelial growth factor (VEGF)-A appears especial ...
DOI:
10.1007/s00441-008-0675-8
PubMed:
18766380

65. Aluminum contamination in products used in parenteral nutrition: Has anything changed

Author:
Gura, Kathleen M.
Source:
Nutrition 2010 v.26 no.6 pp. 585-594
ISSN:
0899-9007
Subject:
at-risk population; bioaccumulation; Food and Drug Administration; food contamination; parenteral feeding; dietary exposure; aluminum; patients; toxicity; pharmacokinetics; United States
Abstract:
... In July 2004, the U.S. Food and Drug Administration issued a mandate that required manufacturers to include the aluminum content on the labels of the additives commonly used in the compounding of parenteral nutrition solutions. It was the hope that practitioners would use this information to minimize the amount of aluminum exposure provided by parenteral nutrition to less than the 5 mCg/kg/d, the ...
DOI:
10.1016/j.nut.2009.10.015
PubMed:
20363591

66. Bacterial and Viral Pathogens in Live Oysters: 2007 United States Market Survey

Author:
DePaola, Angelo; Jones, Jessica L.; Woods, Jacquelina; Burkhardt, William III.; Calci, Kevin R.; Krantz, Jeffrey A.; Bowers, John C.; Kasturi, Kuppuswamy; Byars, Robin H.; Jacobs, Emily; Williams-Hill, Donna; Nabe, Khamphet
Source:
Applied and environmental microbiology 2010 v.76 no.9 pp. 2754-2768
ISSN:
0099-2240
Subject:
bacteriophages; shellfish; Food and Drug Administration; risk assessment; pollution; Vibrio parahaemolyticus; pathogens; harvesting; coliform bacteria; Escherichia coli; indicator species; sanitation; plate count; control methods; Norovirus; markets; oysters; Salmonella; Hepatovirus A; surveys; United States; Mid-Atlantic region
Abstract:
... Two samples of market oysters, primarily from retail establishments, were collected twice each month in each of nine states during 2007. Samples were shipped refrigerated overnight to five U.S. Food and Drug Administration laboratories on a rotating basis and analyzed by most probable number (MPN) for total and pathogenic Vibrio parahaemolyticus and V. vulnificus numbers and for the presence of to ...
DOI:
10.1128/AEM.02590-09
PubMed:
20190085
PubMed Central:
PMC2863423

67. Changes in Glitazone Use Among Office-Based Physicians in the U.S., 2003-2009

Author:
Cohen, Andrew; Rabbani, Atonu; Shah, Nilay; Alexander, G. Caleb
Source:
Diabetes care 2010 v.33 no.4 pp. 823-825
ISSN:
0149-5992
Subject:
Food and Drug Administration; physicians; time series analysis; United States
Abstract:
... OBJECTIVE: Little is known regarding recent changes in glitazone use. RESEARCH DESIGN AND METHODS: Interrupted time series analyses of nationally representative office-visit data using IMS Health's National Disease and Therapeutic Index. RESULTS: From 2003 through 2005, glitazone use increased steadily. From February 2005 to January 2007, rosiglitazone use decreased by 16% (95% CI -20 to -11) annu ...
DOI:
10.2337/dc09-1834
PubMed:
20103549
PubMed Central:
PMC2845035

68. Characterization of Listeria monocytogenes Recovered from Imported Cheese Contributed to the National PulseNet Database by the U.S. Food and Drug Administration from 2001 to 2008

Author:
Babgaleh B. Timbo; Christine Keys; Karl Klontz
Source:
Journal of food protection 2010 v.73 no.8 pp. 1511-1514
ISSN:
0362-028X
Subject:
Centers for Disease Control and Prevention; Food and Drug Administration; Food and Drug Administration Food Code; Listeria monocytogenes; cheeses; compliance; databases; epidemiological studies; food pathogens; foodborne illness; foods; genetic relationships; genetic variation; human diseases; imports; listeriosis; monitoring; pulsed-field gel electrophoresis; Colombia; Greece; Israel; Italy; Mexico; Portugal; Spain; United States
Abstract:
... Imported foods must meet the same U.S. Food and Drug Administration (FDA) standards as domestic foods. The FDA determines whether an imported food is in compliance with the Federal Food, Drug, and Cosmetic Act. Pursuant to its regulatory activities, the FDA conducts compliance surveillance on imported foods offered for entry into the U.S. commerce. The National PulseNet Database is the molecular s ...
DOI:
10.4315/0362-028X-73.8.1511

69. Detection and Confirmation of Clostridium botulinum in Water Used for Cooling at a Plant Producing Low-Acid Canned Foods

Author:
Sachdeva, Amita; Defibaugh-Chávez, Stephanie L.H.; Day, James B.; Zink, Donald; Sharma, Shashi K.
Source:
Applied and environmental microbiology 2010 v.76 no.22 pp. 7653-7657
ISSN:
0099-2240
Subject:
Clostridium botulinum; Food and Drug Administration; antibodies; bioassays; canning; enzyme-linked immunosorbent assay; low acid foods; mice; polymerase chain reaction; screening; United States
Abstract:
... Our laboratory tested water samples used for cooling low-acid canned foods at a canning facility under investigation by the U.S. Food and Drug Administration. We used an enzyme-linked immunosorbent assay with digoxigenin-labeled antibodies (DIG-ELISA) and real-time PCR as screening methods and confirmed the presence of neurotoxin-producing Clostridium botulinum in the samples by mouse bioassay. ...
DOI:
10.1128/AEM.00820-10
PubMed:
20889791
PubMed Central:
PMC2976179

70. Determination of Deoxynivalenol in Infant Cereal by Immunoaffinity Column Cleanup and High-Pressure Liquid Chromatography–UV Detection

Author:
Mary Ann Dombrink-Kurtzman; Stephen M. Poling; David F. Kendra
Source:
Journal of food protection 2010 v.73 no.6 pp. 1073-1076
ISSN:
0362-028X
Subject:
Food and Drug Administration; Fusarium graminearum; barley; cleaning; deoxynivalenol; diarrhea; gastrointestinal system; immunoaffinity chromatography; immunomodulation; infant foods; infants; inflammation; oatmeal; vomiting; wheat products; United States
Abstract:
... The presence of deoxynivalenol (DON) in cereal-based baby food, a primary source of the first solid food for infants, was studied in order to develop a method to detect its presence at low concentrations. DON, produced primarily by Fusarium graminearum, is commonly isolated from grains and feed around the world and affects both animal and human health, producing diarrhea, vomiting, gastrointestina ...
DOI:
10.4315/0362-028X-73.6.1073

71. Determination of Sample Sizes for Demonstrating Efficacy of Radiation Countermeasures

Author:
Ralph L. Kodell; Shelly Y. Lensing; Reid D. Landes; K. Sree Kumar; Martin Hauer‐Jensen
Source:
Biometrics 2010 v.66 no.1 pp. 239-248
ISSN:
0006-341X
Subject:
Food and Drug Administration; Institutional Animal Care and Use Committee; Monte Carlo method; adverse effects; drug therapy; ethics; humans; irradiation; laboratory animals; lethal dose 50; models; new drugs; radiation injury; terrorism; toxicity testing; animal use reduction; United States
Abstract:
... In response to the ever increasing threat of radiological and nuclear terrorism, active development of nontoxic new drugs and other countermeasures to protect against and/or mitigate adverse health effects of radiation is ongoing. Although the classical LD50 study used for many decades as a first step in preclinical toxicity testing of new drugs has been largely replaced by experiments that use fe ...
DOI:
10.1111/j.1541-0420.2009.01236.x
PubMed:
19432769
PubMed Central:
PMC3036987

72. Environmental risk assessment for food-related substances

Author:
Smith, M.R.; König, A.
Source:
Food control 2010 v.21 no.12 pp. 1588-1600
ISSN:
0956-7135
Subject:
public health; genetically modified foods; Food and Drug Administration; drugs; risk assessment; veterinary medicine; European Union; environmental impact; environmental assessment; food safety; United States; Europe
DOI:
10.1016/j.foodcont.2009.12.032

73. Establishing Efficacy of Human Products Using Animals : The US Food and Drug Administration’s “Animal Rule”

Author:
P. J. Snoy
Source:
Veterinary pathology v.47 no.5 pp. 774-778
ISSN:
1544-2217
Subject:
Food and Drug Administration; animal pathology; clinical trials; drugs; human diseases; humans; United States
Abstract:
... In 2002, the US Food and Drug Administration issued regulations to allow the approval of human drugs and biological products based on animal efficacy studies when human efficacy studies would be unethical or not feasible. These regulations are intended to assist in the approval process for products aimed at preventing or treating human diseases caused by nuclear, radiological, biological, and chem ...
DOI:
10.1177/0300985810372506

74. Functional Claims: Antioxidants and Claims

Author:
Artik, N.
Source:
Acta horticulturae 2010 v. no.877 pp. 105-119
ISSN:
0567-7572
Subject:
Codex Alimentarius; Food and Drug Administration; antioxidants; dietary supplements; food industry; food labeling; food safety; fruit juices; health claims; vegetable juices; Turkey (country); United States
Abstract:
... Health claims that characterize the relationship between a substance (e.g., a food or food component) and a disease (e.g., cancer or cardiovascular disease) or health-related condition (e.g., hypertension) require premarket approval by organizations as the Turkey Agriculture and Rural Affairs Ministry, Europena Food Safety Authority (EFSA), the US Food and Drug Administration (FDA) and Codex Alime ...
DOI:
10.17660/ActaHortic.2010.877.7

75. Gluten Contamination of Grains, Seeds, and Flours in the United States: A Pilot Study

Author:
Thompson, Tricia; Lee, Anne Roland; Grace, Thomas
Source:
Journal of the American Dietetic Association 2010 v.110 no.6 pp. 937-940
ISSN:
0002-8223
Subject:
Food and Drug Administration; consumer protection; enzyme-linked immunosorbent assay; flour; food labeling; gliadin; gluten; gluten-free foods; millets; seeds; United States
Abstract:
... Under the Food Allergen and Consumer Protection Act, the Food and Drug Administration (FDA) must issue a rule for the voluntary labeling of food as gluten-free. In the proposed rule, many single-ingredient foods, such as millet, are considered inherently free of gluten. Inherently gluten-free grains will be considered misbranded if they carry a gluten-free label and do not also state that all food ...
DOI:
10.1016/j.jada.2010.03.014
PubMed:
20497786

76. Identification of select glucocorticoids as Smoothened agonists: Potential utility for regenerative medicine

Author:
Wang, Jiangbo; Lu, Jiuyi; Bond, Michael C.; Chen, Minyong; Ren, Xiu-Rong; Lyerly, H. Kim; Barak, Larry S.; Chen, Wei
Source:
Proceedings of the National Academy of Sciences of the United States of America 2010 v.107 no.20 pp. 9323-9328
ISSN:
0027-8424
Subject:
Food and Drug Administration; agonists; cell proliferation; drugs; glucocorticoids; medicine; plasma membrane; receptors; stem cells; tissues; United States
Abstract:
... Regenerative medicine holds the promise of replacing damaged tissues largely by stem cell activation. Hedgehog signaling through the plasma membrane receptor Smoothened (Smo) is an important process for regulating stem cell proliferation. The development of Hedgehog-related therapies has been impeded by a lack of US Food and Drug Administration (FDA)-approved Smo agonists. Using a high-content scr ...
DOI:
10.1073/pnas.0910712107
PubMed:
20439738
PubMed Central:
PMC2889058

77. Nonessential Metals in Striped Marlin and Indo-Pacific Sailfish in the Southeast Gulf of California, Mexico: Concentration and Assessment of Human Health Risk

Author:
Soto-Jiménez, M. F.; Amezcua, F.; González-Ledesma, R.
Source:
Archives of environmental contamination and toxicology 2010 v.58 no.3 pp. 810-818
ISSN:
0090-4341
Subject:
European Union; Food and Drug Administration; Istiophorus platypterus; Makaira; Tetrapturus; World Health Organization; adults; child development; children; guidelines; human health; infants; metals; nervous system; pregnancy; pregnant women; risk; Gulf of California; Mexico; United States
Abstract:
... Seventeen sailfish (Istiophorus platypterus; 166-246 cm long) and 13 striped marlin (Tetrapturus audax; 159-254 cm long) specimens from the southern Gulf of California were analyzed for As, Cd, Hg, and Pb concentrations. More than 20% of the As and Cd levels exceeded the guideline levels of the World Health Organization (WHO), the U.S. Food and Drug Administration, and the European Union. About 65 ...
DOI:
10.1007/s00244-009-9452-2
PubMed:
20101402

78. Review of Adverse Events Associated With False Glucose Readings Measured by GDH-PQQ-Based Glucose Test Strips in the Presence of Interfering Sugars

Author:
Frias, Juan P.; Lim, Christine G.; Ellison, John M.; Montandon, Carol M.
Source:
Diabetes care 2010 v.33 no.4 pp. 728-729
ISSN:
0149-5992
Subject:
Food and Drug Administration; analytical kits; databases; death; glucose; hypoglycemia; intravenous injection; monitoring; patients; risk; United States
Abstract:
... OBJECTIVE: To assess the implications of falsely elevated glucose readings measured with glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) test strips. RESEARCH DESIGN AND METHODS: We conducted a review of the Food and Drug Administration's Manufacturer and User Facility Device Experience database and medical literature for adverse events (AEs) associated with falsely elevated glucose readin ...
DOI:
10.2337/dc09-1822
PubMed:
20351227
PubMed Central:
PMC2845013

79. Testing computational toxicology models with phytochemicals

Author:
Valerio, Luis G. Jr.; Arvidson, Kirk B.; Busta, Emily; Minnier, Barbara L.; Kruhlak, Naomi L.; Benz, R. Daniel
Source:
Molecular nutrition & food research 2010 v.54 no.2 pp. 186-194
ISSN:
1613-4125
Subject:
Food and Drug Administration; active ingredients; carcinogenicity; computer software; environmental assessment; food additives; metabolites; models; phytochemicals; prediction; public health; quantitative structure-activity relationships; risk assessment; rodents; safety assessment; statistics; toxicology
Abstract:
... Computational toxicology employing quantitative structure-activity relationship (QSAR) modeling is an evidence-based predictive method being evaluated by regulatory agencies for risk assessment and scientific decision support for toxicological endpoints of interest such as rodent carcinogenicity. Computational toxicology is being tested for its usefulness to support the safety assessment of drug-r ...
DOI:
10.1002/mnfr.200900259
PubMed:
20024931

80. Analytical determination of hydroxytyrosol in olive extract samples by micellar liquid chromatography

Author:
M. Rambla-Alegre; S. Marco-Peiró; J. Peris-Vicente; B. Beltrán-Martinavarro; M.A. Collado-Sánchez; S. Carda-Broch; J. Esteve-Romero
Source:
Food chemistry 2011 v.129 no.2 pp. 614-618
ISSN:
0308-8146
Subject:
Food and Drug Administration; absorbance; antioxidant activity; detection limit; guidelines; liquid chromatography; methanol; olives; pH; quantitative analysis; sodium sulfate; United States
Abstract:
... Hydroxytyrosol is a well-known natural phenolic component obtained from olive extract samples with antioxidant effects. A micellar liquid chromatography method to detect and quantify hydroxytyrosol in olive extract samples is described. Matrix resolution was performed using a Kromasil C18 column and a micellar mobile phase of sodium dodecyl sulphate (SDS) 0.05M and 4% methanol buffered at pH 7. De ...
DOI:
10.1016/j.foodchem.2011.04.075

81. Attributes, knowledge, beliefs, and behaviors relating to prevention of heartworm in dogs among members of a national hunting dog club

Author:
Barton W. Rohrbach; Amanda Lutzy; Sharon Patton
Source:
Veterinary parasitology 2011 v.176 no.4 pp. 324-332
ISSN:
0304-4017
Subject:
Dirofilaria immitis; Food and Drug Administration; Internet; compliance; disease control; drug therapy; guidelines; heartworms; pets; pharmacokinetics; puppies; veterinary medicine
Abstract:
... The Food and Drug Administration Center for Veterinary Medicine (FDA/CVM) has cited an increasing number of reports of failure of heartworm prophylaxis in dogs. Failures may be due to resistance of L₃–L₄ stage Dirofilaria immitis to the macrocyclic lactone class of compounds used for prophylaxis, lack of compliance with and understanding of administration of prophylactics, individual differences i ...
DOI:
10.1016/j.vetpar.2011.01.017
PubMed:
21310533

82. Awareness and knowledge of methylmercury in fish in the United States

Author:
Amy M. Lando; Yuanting Zhang
Source:
Environmental research 2011 v.111 no.3 pp. 442-450
ISSN:
0013-9351
Subject:
Food and Drug Administration; United States Environmental Protection Agency; Xiphias gladius; adults; breast feeding; children; education; environmental protection; food consumption; food safety; foodborne illness; income; lakes; mackerel; males; mercury; methylmercury compounds; parents; pregnant women; regression analysis; risk; rivers; sharks; surveys; tuna; Great Lakes region; United States
Abstract:
... In the 1970s several states in the Great Lakes region became concerned about mercury contamination in lakes and rivers and were the first to issue local fish consumption advisories. In 2001, the Food and Drug Administration (FDA) advised pregnant women, nursing mothers, young children, and women who may become pregnant not to consume shark, swordfish, king mackerel, and tilefish and recommended th ...
DOI:
10.1016/j.envres.2011.01.004

83. Ciprofibrate quantification in human plasma by high-performance liquid chromatography coupled with electrospray tandem mass spectrometry for pharmacokinetic studies

Author:
Fabiana D. Mendes; Lu Shi Chen; André Borges; Tainah Babadópulos; Jaime O. Ilha; Khalid M. Alkharfy; Gustavo D. Mendes; Gilberto De Nucci
Source:
Journal of chromatography 2011 v.879 no.24 pp. 2361-2368
ISSN:
1570-0232
Subject:
Food and Drug Administration; absorption; acetic acid; acetonitrile; confidence interval; energy; ethyl ether; formic acid; high performance liquid chromatography; humans; liquid-liquid extraction; methylene chloride; pharmacokinetics; solvents; tandem mass spectrometry; volunteers; United States
Abstract:
... A rapid, sensitive and specific method for quantifying ciprofibrate in human plasma using bezafibrate as the internal standard (IS) is described. The sample was acidified prior extraction with formic acid (88%). The analyte and the IS were extracted from plasma by liquid–liquid extraction using an organic solvent (diethyl ether/dichloromethane 70/30 (v/v)). The extracts were analyzed by high perfo ...
DOI:
10.1016/j.jchromb.2011.05.055

84. Concentration of polychlorinated biphenyls and organochlorine pesticides in some edible fish species from the Shadegan Marshes (Iran)

Author:
Morteza Davodi; Abbas Esmaili-Sari; Nader Bahramifarr
Source:
Ecotoxicology and environmental safety 2011 v.74 no.3 pp. 294-300
ISSN:
0147-6513
Subject:
Barbus; Cyprinus carpio; DDT (pesticide); European Union; Food and Drug Administration; HCH (pesticide); diet; edible species; feeding behavior; fish; food safety; guidelines; hexachlorobenzene; isomers; lipids; marshes; polychlorinated biphenyls; Iran; United States
Abstract:
... Concentrations of polychlorinated biphenyls (PCBs), and organochlorine pesticides (OCPs), such as dichlorodiphenyltrichloroethane (DDT) and analogs, hexachlorocyclohexanes (HCHs) and hexachlorobenzene (HCB), were determined in 8 fish species collected during October and November 2007 from the largest Iranian wetland, the Shadegan Marshes. Fishes were selected on the basis of their importance in th ...
DOI:
10.1016/j.ecoenv.2010.07.045

85. Consumer Perceptions of “Functional Food” in the United States

Author:
Nina Urala; Howard Schutz; Julie Spinks
Source:
Journal of food products marketing 2011 v.17 no.4 pp. 407-419
ISSN:
1540-4102
Subject:
Food and Drug Administration; carrots; consumer attitudes; food industry; functional foods; green tea; information sources; marketing; nutrition; surveys; vegetable juices; wheat; United States
Abstract:
... There is a strong trend to market products that promise improved health in the United States. Functional food is a rather new concept promoting the healthfulness of foods. Functional food manufacturers should provide motivating and trustful marketing messages. However, since the term “functional foods” lacks definition, communication to consumers is challenging and can be confusing. This study inv ...
DOI:
10.1080/10454446.2011.583181

86. Determination of hexamethylene bisacetamide, an antineoplastic compound, in mouse and human plasma by LC–MS/MS

Author:
Kerri M. Smith; Wannarasmi Ketchart; Xiang Zhou; Monica M. Montano; Yan Xu
Source:
Journal of chromatography 2011 v.879 no.23 pp. 2206-2212
ISSN:
1570-0232
Subject:
Food and Drug Administration; acetonitrile; adverse effects; antineoplastic agents; breast neoplasms; chromatography; clinical trials; guidelines; humans; leukemia; mice; sodium chloride; tandem mass spectrometry; thrombocytopenia; United States
Abstract:
... Hexamethylene bisacetamide (HMBA) is a polar compound which has recently been discovered to have antineoplastic activity by up-regulating the expression of an endogenous antiproliferative breast cancer protein, HEXIM1 (hexamethylene bisacetamide inducible protein 1) in vivo. HMBA has been shown in the past to induce terminal differentiation in multiple leukemia types at a concentration of 2–5mM, b ...
DOI:
10.1016/j.jchromb.2011.06.002
PubMed:
21723208
PubMed Central:
PMC4068250

87. Determination of histamine in Mahi-Mahi fillets (Coryphaena hippurus) implicated in a foodborne poisoning

Author:
Chen, H.C.; Lee, Y.C.; Hwang, D.F.; Chiou, T.K.; Tsai, Y.H.
Source:
Journal of food safety 2011 v.31 no.3 pp. 320-325
ISSN:
0149-6085
Subject:
Bacillus subtilis; Coryphaena hippurus; Enterobacter aerogenes; Food and Drug Administration; fish; fish fillets; histamine; ingestion; nucleotide sequences; poisoning; polymerase chain reaction; ribosomal DNA; scombroid poisoning; seafoods; sequence analysis; temperature; Taiwan; United States
Abstract:
... An incident of foodborne poisoning causing illness in 53 victims due to ingestion of fish fillets occurred in January, 2009, in Kaohsiung city, southern Taiwan. The two suspected fish samples contained 11.3 and 37.7 mg/100 g of histamine, which is greater than the 5.0 mg/100 g allowable limit suggested by the United States Food and Drug Administration. Given the allergy-like symptoms of the victim ...
DOI:
10.1111/j.1745-4565.2011.00303.x

88. Determination of sugammadex in human plasma, urine, and dialysate using a high-performance liquid chromatography/tandem mass spectrometry assay

Author:
Marcel A.H. de Zwart; Jolanda ten Bruggencate-Broeders; Henk J.M. van Hal; René (H) J.J.J. Megens; Helma (W) L.H. Frasa
Source:
Journal of chromatography 2011 v.879 no.19 pp. 1573-1586
ISSN:
1570-0232
Subject:
Food and Drug Administration; ambient temperature; clinical trials; formic acid; gamma-cyclodextrin; guidelines; high performance liquid chromatography; humans; monitoring; solid phase extraction; tandem mass spectrometry; urine; Netherlands; United States
Abstract:
... Sugammadex (Bridion®, Merck Sharp & Dohme Corp., Oss, The Netherlands) is a modified γ-cyclodextrin which has the ability to reverse the neuromuscular blockade induced by the steroidal neuromuscular blocking agents rocuronium and vecuronium. The objective of the current study is to describe the bioanalytical methods that have been developed and validated according to US Food and Drug Administratio ...
DOI:
10.1016/j.jchromb.2011.03.050

89. Determining the viability of marine protists using a combination of vital, fluorescent stains

Author:
Mia K. Steinberg; Edward J. Lemieux; Lisa A. Drake
Source:
Marine biology 2011 v.158 no.6 pp. 1431-1437
ISSN:
0025-3162
Subject:
Food and Drug Administration; ballast water; guidelines; invasive species; management systems; manufacturing; marine science; plankton; ships; viability; United States
Abstract:
... Determining the viability of protists and small microzooplankton has long been a focus of studies in marine biology and ecology. It is especially relevant in the issue of shipborne invasive species, and impending international guidelines and various national regulations on the allowable concentrations of organisms in discharged ballast water have spurred the growth of an industry that develops and ...
DOI:
10.1007/s00227-011-1640-8

90. Diminished immunogenicity to pandemic H1N1 2009 influenza vaccine in subjects with severe motor and intellectual disability

Author:
Megumi Hara; Tomoyuki Hanaoka; Takashi Mizushima; Junya Honma; Kazuhiro Maeda; Satoko Ohfuji; Keitaro Tanaka; Yoshio Hirota
Source:
Vaccine 2011 v.29 no.46 pp. 8323-8329
ISSN:
0264-410X
Subject:
Food and Drug Administration; adverse effects; confidence interval; health care workers; hemagglutination; influenza; long term care; multivariate analysis; odds ratio; pandemic; risk; seroconversion; vaccination; vaccines; United States
Abstract:
... Subjects with severe motor and intellectual disability (SMID) are considered to be debilitated and at high risk of influenza infection. However, the safety and immunogenicity of pandemic H1N1 (pH1N1) vaccine in these subjects have not been reported. We measured the hemagglutination inhibition antibody titer and calculated the geometric mean titer ratio (GMTR), seroprotection rate, and seroconversi ...
DOI:
10.1016/j.vaccine.2011.08.097

91. Economic Impacts of Zilmax Adoption in Cattle Feeding

Author:
Ted C. Schroeder; Glynn T. Tonsor
Source:
Journal of agricultural and resource economics 2011 v.36 no.3 pp. 521-535
ISSN:
1068-5502
Subject:
Food and Drug Administration; beef; cattle; cattle feeding; consumer surplus; cow-calf operations; economic impact; market prices; markets; technology; zilpaterol hydrochloride; United States
Abstract:
... The Food and Drug Administration recently approved the feeding of Zilmax for cattle in the United States. This study determines direct net return benefits for early-adopting cattle feeders and beef packers. In addition, longer-run producer and consumer surplus measures are estimated as adoption impacts market prices and quantities. After markets adjust, cow-calf producers, cattle feeders, and cons ...

92. Estimated portion sizes of snacks and beverages differ from reference amounts and are affected by appetite status in non-obese men

Author:
Brogden, Nina; Almiron-Roig, Eva
Source:
Public health nutrition 2011 v.14 no.10 pp. 1743-1751
ISSN:
1475-2727
Subject:
Food and Drug Administration; bananas; beverages; breakfast; cross-over studies; data collection; equipment; health care workers; hunger; men; portion size; snacks; United Kingdom; United States
Abstract:
... Objective To explore the extent to which appetite status influences portion size estimation in men under laboratory conditions and to quantify how much participants' portion estimates differed from the recommended portion sizes defined by authoritative bodies (i.e. government and health professionals’ reference amounts). Design Repeated, randomized cross-over trial with each participant attending ...
DOI:
10.1017/S1368980011000528
PubMed:
21466743

93. Evaluation of Heavy Metal Pollution in the Arabian Gulf Using the Clam Meretrix meretrix Linnaeus, 1758

Author:
Alyahya, Hamad; El-Gendy, Amel H.; Al Farraj, Saleh; El-Hedeny, Magdy
Source:
Water, air, and soil pollution 2011 v.214 no.1-4 pp. 499-507
ISSN:
0049-6979
Subject:
acute toxicity; bioaccumulation; Food and Drug Administration; absorption; heavy metals; clams; human health; deuterium oxide; pollutants; summer; coasts; Meretrix meretrix; United States; Persian Gulf; Saudi Arabia
Abstract:
... The present study is an attempt to assess the heavy metal contamination in the marine environment of the Arabian Gulf of Saudi Arabia. The concentrations of heavy metals in water and the soft tissues of the bivalve species Meretrix meretrix Linnaeus, 1758, from different stations along the Arabian Gulf coastline, were determined during the summer season of 2008. Bioaccumulation of some heavy metal ...
DOI:
10.1007/s11270-010-0441-x

94. International Guidelines for Bioanalytical Method Validation: A Comparison and Discussion on Current Scenario

Author:
Kollipara, Sivacharan; Bende, Girish; Agarwal, Nitin; Varshney, Brijesh; Paliwal, Jyoti
Source:
Chromatographia 2011 v.73 no.3-4 pp. 201-217
ISSN:
0009-5893
Subject:
Food and Drug Administration; anticoagulant activity; chromatography; guidelines; ions; pharmacokinetics; United States
Abstract:
... US FDA released guidelines for bioanalytical method validation in 2001 and it became the basis for guidelines such as ANVISA and EMA. Even though there is a general agreement between these guidelines in terms of evaluation of validation parameters, significant diversity exists with respect to methodology employed. Present review compares and summarizes the regulatory guidelines issued by US FDA, A ...
DOI:
10.1007/s10337-010-1869-2

95. Ivermectin and Milbemycin Oxime in Experimental Adult Heartworm (Dirofilaria immitis) Infection of Dogs

Author:
Snyder, D.E.; Wiseman, S.; Cruthers, L.R.; Slone, R.L.
Source:
Journal of veterinary internal medicine 2011 v.25 no.1 pp. 61-64
ISSN:
0891-6640
Subject:
Dirofilaria immitis; Food and Drug Administration; adults; clinical trials; dog diseases; dogs; heartworms; ivermectin; larvae; medicine; necropsy; United States
Abstract:
... Background: The US Food and Drug Administration reports an increase in the frequency of reports of lack of effectiveness claims for heartworm (HW) prevention products. Hypothesis: At their labeled doses, single doses of commercially available HW prevention products are not completely effective against all field isolates of HW. Animals: Forty-two HW-free dogs experimentally inoculated with a recent ...
DOI:
10.1111/j.1939-1676.2010.0657.x

96. Linking farmers to community stores to increase consumption of local produce: a case study of the Navajo Nation

Author:
Setala, Ashley; Gittelsohn, Joel; Speakman, Kristen; Oski, Jane; Martin, Tammy; Moore, Regina; Tohannie, Marcella; Bleich, Sara N.
Source:
Public health nutrition 2011 v.14 no.9 pp. 1658-1662
ISSN:
1475-2727
Subject:
Food and Drug Administration; case studies; certification; childhood obesity; crops; farm to fork; farmers; farming systems; fruits; pest control; prices; traditions; vegetables; United States
Abstract:
... Objective: To understand the barriers to farmer participation in Farm-to-Table (F2T) programmes and to identify possible solutions to these obstacles. Design: Cross-sectional analysis of farmer perspectives on F2T programmes. Setting: Three service units on the Navajo Nation (Chinle, Tuba City and Fort Defiance). Subjects: Forty-four Navajo farmers. Results: Most participants reported that farming ...
DOI:
10.1017/S1368980011000334
PubMed:
21450136

97. Metabolic profiling of Actaea species extracts using high performance liquid chromatography coupled with electrospray ionization time-of-flight mass spectrometry

Author:
Chunhui Ma; Adam R. Kavalier; Bei Jiang; Edward J. Kennelly
Source:
Journal of chromatography 2011 v.1218 no.11 pp. 1461-1476
ISSN:
0021-9673
Subject:
Actaea racemosa; Food and Drug Administration; adulterated products; good manufacturing practices; hepatotoxicity; high performance liquid chromatography; ionization; markets; mass spectrometry; medicinal plants; metabolomics; principal component analysis; United States
Abstract:
... Despite persistent questions about the safety of black cohosh (Actaea racemosa L., syn. Cimicifuga racemosa L.), its products continue to be one of the most popular botanical supplements in the United States market. Black cohosh products have been associated with cases of liver toxicity, but subsequent evaluation found some products to be adulterated with other related plants from the same genus. ...
DOI:
10.1016/j.chroma.2011.01.033
PubMed:
21316686
PubMed Central:
PMC3389552

98. Organic and total mercury levels in bigeye tuna, Thunnus obesus, harvested by Taiwanese fishing vessels in the Atlantic and Indian Oceans

Author:
M.H. Chen; P.Y. Teng; C.Y. Chen; C.C. Hsu
Source:
Food additives & contaminants 2011 v.4 no.1 pp. 15-21
ISSN:
1939-3229
Subject:
Food and Drug Administration; Thunnus obesus; World Health Organization; adults; body weight; fishing boats; men; mercury; oceans; tuna; women; Atlantic Ocean; Indian Ocean; Taiwan; United States
Abstract:
... Muscle samples of 121 and 110 bigeye tuna (Thunnus obesus) caught by Taiwanese long-line fishing vessels in the Atlantic and Indian Oceans, respectively, were used to analyze total mercury (THg) and organic mercury (OHg) content. The overall THg and OHg concentrations were 0.786 ± 0.386 (0.214–3.133) and 0.595 ± 0.238 (0.143–2.222) mg kg⁻¹ wet weight, respectively, similar to the results of previo ...
DOI:
10.1080/19393210.2010.535908
PubMed:
24779657

99. Parenteral Iron Therapy in the Pediatric Patient : A Review

Author:
Kathleen Gura; Esther Chang; Ashley Casey; Erin Roach
Source:
Infant, child & adolescent nutrition 2011 v.3 no.3 pp. 145-151
ISSN:
1941-4072
Subject:
Food and Drug Administration; adverse effects; dextran; health care workers; iron; patients; repletion; therapeutics; United States
Abstract:
... For more than 50 years, iron dextran has been the mainstay of parenteral iron therapy in the United States. In October 2009, the Food and Drug Administration expanded its existing black box warning that cautioned practitioners to administer a test dose first because of the risk of anaphylactic, often fatal adverse reactions. It further modified the warning, stating that fatal reactions can still o ...
DOI:
10.1177/1941406411408600

100. Preliminary assessment of the nutritional composition of underexploited wild legumes from semi-arid Caatinga and moist forest environments of northeastern Brazil

Author:
Ana Fontenele Urano Carvalho; Davi Felipe Farias; Lady Clarissa Brito da Rocha-Bezerra; Nathanna Mateus de Sousa; Mariana Giovenardi Cavalheiro; Geórgia Sampaio Fernandes; Isabel Cristiane Façanha Brasil; Andréa Agaciana Bessa Maia; Daniele Oliveira Bezerra de Sousa; Ilka Maria Vasconcelos; Sandro Thomaz Gouveia; Olga Lima Tavares Machado
Source:
Subtropical plant science 2011 v.24 no.4-5 pp. 487-493
ISSN:
0485-2044
Subject:
Food and Drug Administration; Reference Daily Intakes; amino acid composition; body weight; crude protein; dietary fiber; erythrocytes; flour; forests; lethal dose 50; malnutrition; minerals; nutrition assessment; nutrition labeling; seeds; soybeans; urease; Brazil; United States
Abstract:
... The seeds of 14 wild legume species from Brazil were analyzed to assess their potential as food. The seeds showed high levels of crude protein (10.9–50.0%), dietary fiber (0.8–52.3%) and energy (905–1804kJ 100g⁻¹), and the amino acid composition (mgg⁻¹ N) was comparable to that of soybeans, but with higher amounts of lysine (456–10,884) and histidine (199–918). The seeds showed lec ...
DOI:
10.1016/j.jfca.2011.01.013