Safety studies on products from whole coffee fruit.

The fruit of the coffee plant, Coffea arabica, has high phenolic antioxidant and phytonutrient content and could be a beneficial food ingredient. However, the fruit has historically been discarded for the favored harvesting of the coffee bean alone. CoffeeBerry products are derived from the whole fruit and include a ground whole powder, a water extract, and a more recently developed water-ethanol extract. The safety of CoffeeBerry products was evaluated in three genotoxicity studies, three short-term oral toxicity studies, and a 90-day dietary toxicity study. Bacterial mutagenicity studies and a micronucleus test using murine peripheral cells demonstrated that none of the three products showed mutagenic or genotoxic potential. In the short-term studies, despite palatability issues, female rats showed a tolerance for whole powder and ethanol extract at doses up to 8800 mg/kg bw/day. Male rats also exhibited palatability issues and tolerated lower doses of approximately 4000 mg/kg bw/day ethanol extract via gavage and approximately 2100 mg/kg bw/day whole powder or water extract in the diet. When fed in the diet to Sprague-Dawley rats for 90 days, ethanol extract showed no adverse effects at dietary concentrations of up to 5% (approximately 3446 and 4087 mg/kg bw/day for male and female rats, respectively).

Twenty eight-day dietary toxicity study of Luo Han fruit concentrate in Hsd:SD rats.

A 28-day dietary study was conducted in Hsd:SD rats to evaluate the safety of PureLo, a non-caloric powdered concentrate of the Chinese fruit Luo Han Guo, which derives its sweetening properties from triterpene glycosides called mogrosides. Groups of 20 rats (10/sex/group) were fed diets containing 0, 10,000, 30,000, or 100,000 ppm PureLo for 28 days (OECD, Redbook 2000). PureLo was well tolerated and produced no significant adverse effects. Reduced body weight and body weight gain in high-dose animals of both sexes were related to sporadic reductions in food consumption; there were no overall differences in feed efficiency. Statistically significant changes in clinical chemistry (decreased bilirubin, increased total protein) and relative organ weights of liver, adrenals, ovaries and/or testes, and epididymides were not correlated with any histopathological findings and were not considered adverse. Although a few clinical and pathological findings suggest possible treatment-related effects, particularly in the high-dose group, these findings were transient, not dose-dependent, non-adverse, inconsistent, occurred only in one sex, and/or not supported by histopathological findings. Under the conditions of this study and based on the toxicological endpoints evaluated, the NOAEL for PureLo was 100,000 ppm in the diet, the highest level tested, equivalent to 7.07 and 7.48 g/kg bw/day for male and female rats, respectively.

Weight of evidence needed to substantiate a health effect for probiotics and prebiotics: regulatory considerations in Canada, E.U., and U.S.

Successful and responsible introduction of probiotic and prebiotic products into the worldwide marketplace requires labelling for health benefits that meets consumer needs, adheres to regulatory standards and does not overextend scientific evidence. Regulations differ among countries, but underlying all is an emphasis on scientific credibility of any statements of health benefits. This paper considers the value of different types of evidence offered in substantiation of efficacy and reviews different regulatory approaches to labelling for health claims. Limitations of in vitro, animal and different types of human studies used for efficacy substantiation for probiotics and prebiotics are discussed.

Dietary exposures to mineral hydrocarbons from food-use applications in the United States.

Food-use applications of mineral hydrocarbons (MHC) derived from petroleum sources result in dietary exposure to these compounds by consumers. Food applications of MHC, including white mineral oils, paraffin waxes, microcrystalline waxes and petrolatum, include both direct-additive uses in which the MHC is intentionally applied to the food and indirect-additive uses in which the MHC become components of the food due to migration from food-contact surfaces. A key consideration in evaluating the safety of these uses of MHC is the level of exposure that results. We estimated exposures to MHC in the US from food applications based primarily on a food-consumption approach, in which MHC concentrations in foods were multiplied by the amount of these foods consumed. This was a conservative estimate, because it assumes that all foods that might contain MHC in fact do so at maximum possible concentrations. A "poundage approach", in which the amount of MHC used in food applications was divided by the US population to determine maximum potential per capita exposures, was used to validate the consumption-based estimates. Exposures to MHC from food-packaging applications were estimated using the FDA's food-factor approach, which takes into account the volume and kinds of food packaged with specific types of materials. A conservative estimate of mean exposure to all MHC types combined is 0.875 mg/kg BW/day. Half of this, 0.427 mg/kg BW/day, is white mineral oils used as pan-release lubricants in baking, for de-dusting of stored grain, in confectioneries, and in coatings for fruits and vegetables. Nearly all of the remainder, 0.404 mg/kg BW/day, is petrolatum, primarily from its use as trough grease in bakery applications. Exposure to paraffin and microcrystalline waxes combined is only 0.044 mg/kg BW/day.

Using the national nutrition monitoring system to profile dietary supplement use.

The National Nutrition Monitoring and Related Research Program (NNMRRP) was defined by Congress in 1990 as "the set of activities necessary to provide timely information about the role and status of factors that bear on the contribution that nutrition makes to the health of the people of the United States" (7 U.S.C. section sign5302). The NNMRRP includes nearly 100 components at both the national and state level; the keystone components are the National Health and Nutrition Examination Surveys (conducted by the National Center for Health Statistics) and the Continuing Surveys of Food Intakes by Individuals (conducted by the Agricultural Research Service). These surveys were designed to measure individuals' consumption of foods and beverages and the nutrient intakes resulting from this consumption; expansion of these surveys to include dietary supplements and their nutrient contributions has been and continues to be a significant challenge. This article identifies the data needs regarding consumer use of dietary supplements in terms of the analytical demands to address the contribution dietary supplements make to "the health of the people of the United States." Important gaps in the data currently available are discussed. Current efforts to address dietary supplements are described along with recommendations regarding efficient use of the keystone surveys as well as other components of the NNMRRP.

Estimated intakes of trans fatty and other fatty acids in the US population.

OBJECTIVE: To estimate mean level of trans fatty acid intakes using a representative sample of the US population. DESIGN: The study used food intake data from the 1989-1991 Continuing Survey of Food Intakes by Individuals (CSFII) and the trans fatty acid contents of specific foods calculated from a database compiled by the US Department of Agriculture (USDA) to estimate the mean level and deciles of trans fatty acid intake of the representative US population. SUBJECTS/SETTING: Trans fatty acid intakes were estimated for each subject (N = 11,258) in the CSFII data who completed both a 24-hour recall and a 2-day food record. STATISTICAL ANALYSES PERFORMED: Weights developed by USDA for the survey were used for all data analyses. The Technical Assessment Systems (TAS) International Diet Research System (TAS-DIET), software developed by TAS, was used to derive weighted estimates of the mean and percentiles of the intake distribution. PC CARP, software designed by Iowa State University, was used to estimate standard errors. RESULTS: Mean percentage of energy ingested as trans fatty acids was 2.6% and the mean percentage of total fat ingested as trans fatty acids was 7.4%. Across all age and gender groups examined, estimates ranged from 2.6% to 2.8% and 7.1% to 7.9%, respectively. APPLICATIONS/CONCLUSIONS: Dietetics practitioners can use the representative data of this study to help clients achieve desired changes in consumption levels of trans fatty acids.

Consumption of calcium in the U.S.: food sources and intake levels.

Calcium intake is one of a number of factors that affect peak bone mass. Low bone mass is related to increased incidence of osteoporotic fractures. Data from the USDA 1987-88 Nationwide Food Consumption Survey were used to determine populations most at risk of less than optimal calcium intake and food sources of calcium intake. Mean per capita daily consumption of calcium for the total U.S. population was 737 mg and varied by region of the country, household income, ethnic group, sex, and age. For most groups of females, intake was substantially less than the RDA. About 50% of total dietary calcium was supplied by milk and milk products. Milk and cheese used as ingredients in meat, grain, and vegetable mixtures contributed another 20% of dietary calcium. The remaining 30% of calcium was provided by grains and grain products, meat, poultry, fish, vegetables, fruits, eggs, legumes, nuts, and seeds.

Change in public perspective on cholesterol and heart disease. Results from two national surveys.

The National Heart, Lung and Blood Institute, Bethesda, Md, and the Food and Drug Administration, Washington, DC, sponsored two national probability telephone surveys (N = 4000) of adults to assess attitudes and knowledge about heart disease risk from high blood cholesterol levels and the public's efforts to lower blood cholesterol levels. The first survey was conducted in 1983, before release of the results from the Lipid Research Clinics Coronary Primary Prevention Trial, which showed that a reduction in the blood cholesterol level reduced coronary heart disease; the second survey was conducted in 1986. The percentage of adults who believed that reducing high blood cholesterol levels would have a large effect on heart disease increased from 64% in 1983 to 72% in 1986, so that the importance attached to reducing high blood cholesterol levels approached that attributed to reducing smoking and high blood pressure. In 1983, 35% of adults reported that they had their cholesterol level checked vs 46% in 1986. In both years, diet changes were most frequently chosen (greater than 60%) as ways to control the blood cholesterol level; reducing dietary fat was believed to be as important as reducing dietary cholesterol. By 1986, 23% of adults reported that they made dietary changes specifically to lower their blood cholesterol level, up from 14% in 1983. These comparative data show gains in public awareness and action relating to high blood cholesterol level risk. The data can be used to develop education programs.

Cardiovascular disease and diet: the public view.

A national probability sample of the public was asked questions dealing with perceived relationships between diet (especially sodium, cholesterol, and saturated fats) and cardiovascular disease (CVD). More than half of the respondents were aware of the suspected relationship between sodium and hypertension, and nearly half were aware that saturated fats and cholesterol may be factors in other types of CVD. Majorities expressed concern about these substances, and substantial minorities claimed to be making efforts to reduce consumption of them. The data provide a baseline against which future developments may be measured.