HHS and EPA announce new scientific assessments and actions on fluoride

The U.S. Department of Health and Human Services (HHS) and the U.S. Environmental Protection Agency (EPA) today are announcing important steps to ensure that standards and guidelines on fluoride in drinking water continue to provide the maximum protection to the American people to support good dental health, especially in children. HHS is proposing that the recommended level of fluoride in drinking water can be set at the lowest end of the current optimal range to prevent tooth decay, and EPA is initiating review of the maximum amount of fluoride allowed in drinking water.

These actions will maximize the health benefits of water fluoridation, an important tool in the prevention of tooth decay, while reducing the possibility of children receiving too much fluoride. The Centers for Disease Control and Prevention named the fluoridation of drinking water one of the ten great public health achievements of the 20th century.

“One of water fluoridation’s biggest advantages is that it benefits all residents of a community—at home, work, school, or play,” said HHS Assistant Secretary for Health Howard K. Koh, MD, MPH. “Today’s announcement is part of our ongoing support of appropriate fluoridation for community water systems, and its effectiveness in preventing tooth decay throughout one’s lifetime.”

“Today both HHS and EPA are making announcements on fluoride based on the most up to date scientific data,” said EPA Assistant Administrator for the Office of Water, Peter Silva. “EPA’s new analysis will help us make sure that people benefit from tooth decay prevention while at the same time avoiding the unwanted health effects from too much fluoride.”

HHS and EPA reached an understanding of the latest science on fluoride and its effect on tooth decay prevention and the development of dental fluorosis that may occur with excess fluoride consumption during the tooth forming years, age 8 and younger. Dental fluorosis in the United States appears mostly in the very mild or mild form – as barely visible lacy white markings or spots on the enamel. The severe form of dental fluorosis, with staining and pitting of the tooth surface, is rare in the United States.

There are several reasons for the changes seen over time, including that Americans have access to more sources of fluoride than they did when water fluoridation was first introduced in the United States in the 1940s. Water is now one of several sources of fluoride. Other common sources include dental products such as toothpaste and mouth rinses, prescription fluoride supplements, and fluoride applied by dental professionals. Water fluoridation and fluoride toothpaste are largely responsible for the significant decline in tooth decay in the U.S. over the past several decades.

HHS’ proposed recommendation of 0.7 milligrams of fluoride per liter of water replaces the current recommended range of 0.7 to 1.2 milligrams. This updated recommendation is based on recent EPA and HHS scientific assessments to balance the benefits of preventing tooth decay while limiting any unwanted health effects. These scientific assessments will also guide EPA in making a determination of whether to lower the maximum amount of fluoride allowed in drinking water, which is set to prevent adverse health effects.

The new EPA assessments of fluoride were undertaken in response to findings of the National Academies of Science (NAS). At EPA’s request, in 2006 NAS reviewed new data on fluoride and issued a report recommending that EPA update its health and exposure assessments to take into account bone and dental effects and to consider all sources of fluoride. In addition to EPA’s new assessments and the NAS report, HHS also considered current levels of tooth decay and dental fluorosis and fluid consumption across the United States.

The notice of the proposed recommendation will be published in the Federal Register soon and HHS will accept comments from the public and stakeholders on the proposed recommendation for 30 days at CWFcomments@cdc.gov. HHS is expecting to publish final guidance for community water fluoridation by spring 2011. You may view a prepublication version of the proposed recommendation at ­­­­­­­­­­­­­­­­­­­ http://www.hhs.gov/news/press/2011pres/01/pre_pub_frn_fluoride.html. Comments regarding the EPA documents, Fluoride: Dose-Response Analysis For Non-cancer Effects and Fluoride: Exposure and Relative Source Contribution Analysis should be sent to EPA at FluorideScience@epa.gov. The documents can be found at http://water.epa.gov/action/advisories/drinking/fluoride_index.cfm

For more information about community water fluoridation, as well as information for health care providers and individuals on how to prevent tooth decay and reduce the chance of children developing dental fluorosis, visit http://www.cdc.gov/fluoridation. For information about the national drinking water regulations for fluoride, visit: http://water.epa.gov/drink/contaminants/basicinformation/fluoride.cfm


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Fewer U.S. Schools Selling Less Nutritious Food and Beverages

/PRNewswire/ -- Fewer secondary schools in the United States are selling less nutritious foods and beverages, such as candy and soda, according to a survey from the Centers for Disease Control and Prevention.

The greatest improvements were seen in states that have adopted strong school nutrition standards and policies for foods and beverages sold outside school meal programs.

The report, "Availability of Less Nutritious Snack Foods and Beverages in Secondary Schools - Selected States, 2002-2008," was published today in CDC's Morbidity and Mortality Weekly Report.

The report shows that among the 34 states that collected data in 2006 and 2008, the median percentage of secondary schools that did not sell soda or fruit drinks that are not 100 percent juice increased from 38 percent to 63 percent. The median percentage of secondary schools in these states that did not sell candy or salty snacks not low in fat increased from 46 percent in 2006 to 64 percent in 2008.

"The school environment is a key setting for influencing children's food choices and eating habits," said Howell Wechsler, Ed.D, M.P.H., director of CDC's Division of Adolescent and School Health. "By ensuring that only healthy food options are available, schools can model healthy eating behaviors, help improve students' diets, and help young people establish lifelong healthy eating habits."

Mississippi and Tennessee made the greatest progress in improving the nutrition environment in their schools. In Mississippi, the percentage of secondary schools that did not sell soda or fruit drinks that are not 100 percent juice increased from 22 percent in 2006 to 75 percent in 2008, while in Tennessee the percentage increased from 27 percent to 74 percent. These two states are national leaders in implementing strong statewide school nutrition standards.

"Efforts to improve the school nutrition environment are working, and Mississippi and Tennessee are excellent examples of this progress. However, there are still far too many schools selling less nutritious foods and beverages," said Wechsler.

The School Health Profiles Survey is conducted among a representative sample of secondary schools in a state, large urban school district, or territory. The data are collected from self-administered questionnaires from the principal and the lead health education teacher at each sampled school. The 2008 report includes data from 47 states, 20 cities, and four territories.

The 2008 study results varied dramatically across states.
-- In Hawaii, Connecticut, California, and Maine, more than two-thirds of
secondary schools did not sell baked goods, salty snacks not low in
fat, candy, soda or fruit drinks that were not 100 percent juice.

-- In Utah, Kansas, Idaho, and Nebraska, less than one-third of secondary
schools did not sell these items.

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FDA Alert: New USP Standards for Heparin Products Will Result in Decreased Potency

The U.S. Food and Drug Administration today alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common blood-clotting drug.

To ensure the quality of heparin and to guard against potential contamination, the United States Pharmacopeia (USP), a nonprofit standards-setting organization, adopted new manufacturing controls for heparin. These changes include a modification of the reference standard for the drug’s unit dose.

Manufacturers in the United States label the amount of heparin included in their products based on USP standards. The changes adopted by the USP for the heparin unit dose match the World Health Organization’s International Standard (IS) unit dose definition that has been in use in Europe for many years. The revised USP reference standard and unit definition for heparin is about 10 percent less potent than the former USP unit.

A unit is the measure of a drug’s activity in the body. For heparin, a unit dose is the measure of the drug’s ability to block the blood’s natural clotting ability (anticoagulation). Heparin’s potency is determined by the dose of the drug required to produce a specific level of anticoagulation.

Manufacturers for the U.S. market have begun to make heparin using the new USP standard. While the USP manufacturing controls take effect Oct. 1 for production, the FDA has asked that they not ship this new product to customers until Oct. 8, 2009, or later. The delay will give health care providers and facilities time to learn about the changes and to make adjustments to their pharmacy procedures and dosing practices, according to John Jenkins, M.D. director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research.

“Although the FDA-approved labeling for heparin has not changed, including the recommended doses, it is essential that health care professionals be aware of the potential difference in potency between the old and new vials of heparin when administering the drug,” said Jenkins.

Four companies market heparin in the United States. APP, the largest manufacturer, markets heparin in vials; Hospira markets heparin in intravenous bags, vials, and syringes; Baxter markets heparin in intravenous bags, and B. Braun markets heparin in intravenous bags. The FDA has asked that all manufacturers identify their new products to help pharmacies and health care professionals differentiate it from the former product.

Prescription and over–the–counter medicines available in the United States must generally meet USP's public standards, when such standards exist. The revised standards for heparin are contained in a new USP monograph.

The monograph was revised, in part, in response to a 2007- 2008 incident of heparin contamination involving a manufacturing step in China. The contaminated heparin was associated with deaths and other adverse events in the United States. The monograph was changed to include a test for the contaminant.

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