FDA outlines proposed rules for food and cosmetics containing tiny nanoparticles
nike Zoom Kobe shoesRegulators are proposing that food companies that want to use tiny engineered particles in their packaging may have to provide extra testing data to show the products are safe.The Food and Drug Administration issued tentative guidelines Friday for food and cosmetic companies interested in using nanoparticles, which are measured in billionths of a meter. Nanoscale materials are generally less than 100 nanometers in diameter. A sheet of paper, in comparison, is 100,000 nanometers thick. A human hair is 80,000 nanometers thick.The submicroscopic particles are increasingly showing up in FDA-regulated products like sunscreens, skin lotions and glare-reducing eyeglass coatings. Some scientists believe the technology will one day be used in medicine, but the FDA’s announcement did not address that use.The draft guidance suggests the FDA may require food companies to provide data establishing the safety of any packaging using nanotechnology.Under longstanding regulations, companies aren’t required to seek regulatory approval before launching products containing established ingredients and materials, such as caffeine, spices and various preservatives.But FDA officials said Friday that foods and packaging containing nanoparticles may require more scrutiny. “At this point, in terms of the science, we think it’s likely the exemption does not apply and we would encourage folks to come in and talk to us,” said Dennis Keefe, director of FDA’s office of food additive safety.
nike HyperDunk basketball shoesKeefe said companies are studying whether nanoparticles can reduce the risk of bacterial contamination in certain foods. He said the agency is aware of just one food package currently on the market that uses nanoparticles but did not identify it. He said more are expected in coming years.The FDA has previously stated its position that nanotechnology is not inherently unsafe; however, materials at the nano scale can pose different safety issues than do things that are far larger. “This is an emerging, evolving technology and we’re trying to get ahead of the curb to ensure the ingredients and substances are safe,” Keefe said.In a separate guidance, the FDA laid out suggestions for the use of nanotechnology in cosmetics, a practice which has been in use since the 1990s. Nanoparticles are used in skin moisturizer, mineral make up and other cosmetics.The FDA has less authority over cosmetics than food additives. Generally, the FDA does not review cosmetics before they launch, and companies are responsible for assuring the safety of their products.The FDA will take comments on both proposals for 90 days. There is no deadline for finalizing the documents.The Food and Drug Administration said the agency now provides as much effort in monitoring the safety of approved drugs as it does during the pre-market drug review processThe FDA released three reports on Saturday that outline the steps its Center for Drug Evaluation and Research has taken to enhance the agency's postmarket drug safety program.“Our oversight of the safety of marketed drugs has changed significantly over the past few years,” said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, in a news release. “This report shows that the quality, accountability, and timeliness of postmarket drug safety decisions have been enhanced, and our public communication of this information is more effective.”
fake nike air jordansSince the Food and Drug Administration Amendments Act was passed in 2007, the FDA has focused on four factors to strengthen the postmaket drug safety program. The FDAAA also updated the drug industry's five-year user-fee program, which expires this year. Congress is currently reviewing legislation for user-fee programs for the drug, device, generic and biosimilar industries.According to the “Advances in FDA's Safety Program for Marketed Drugs” report, the areas of focus include developing new capabilities for detecting and responding quickly to postmarket drug safety issues; enhancing the quality, speed, and transparency of the agency's decisions about how to address specific drug safety issues; provider earlier and more effective drug safety communication to the public; and developing stronger protection of patients from preventable medication errors.The FDA said it has increased the number of drug safety communications to consumers, from 68 in 2011 compared to 39 in 2010. Other actions taken by the FDA since 2008 include requiring 65 safety-related labeling changes, doubling the staff in CDER's Office of Surveillance and Epidemiology, and introducing the Safety First, Sentinel and Safe Use programs. More than 170 people in the country's central province of Quang Ngai have reported symptoms.The disease begins with a rash on the hands and feet: it can progress to liver problems and multiple organ failure. Vietnamese health ministry tests have failed to pinpoint the cause.
discount nike air yeezy shoes"This disease is challenging as we have not identified the root causes. If it is just an external skin disease why is it causing deaths and failures inside internal organs?" Deputy Health Minister Thanh Long said on Friday.The mystery illness was first reported between April and December 2011 and then subsided, but broke out again last month.Health workers say it responds well to early intervention but is difficult to treat once established.Frightened residents of Reu village in an impoverished, mountainous part of Quang Ngai, have laid branches across the path to the houses of infected people to try to isolate the outbreak."We have to block the entrances here to stop patients from getting out and spreading the disease," one resident, Pham Van Tray, told Vietnamese TV."Since we don't know what caused the disease, we will have to rely on our rituals and prayers."Vietnamese media quoted officials in Quang Ngai as saying that the condition might be caused by chemicals.But the health ministry said it had yet to draw conclusions from its own tests: it hoped to have preliminary results within 10 days.Dozens of people are being treated at a leprosy hospital in the neighbouring province of Binh Dinh. The government has said it will ask the World Health Organization and the US Centers for Disease Control and Prevention to join its investigation. Those organisations have yet to comment on the disease: a WHO spokesman told the Associated Press news agency it had not yet received a request from Vietnam for help.
discount nike running shoesUnlike some states pushing for the Supreme Court to overturn the 2010 health-care reform law, Colorado is doing a lot to provide medical care to its 829,000 uninsured residents, experts say. "We have a very robust health-care safety net that's currently providing care to many of our uninsured," said Gretchen Hammer, executive director of the Colorado Coalition for the Medically Underserved. "Just because one does not have health insurance does not mean that they don't have a medical home." The biggest impediment to getting more people in the state to buy insurance is the high cost of policies, which average about $12,000 a year for a family plan. Colorado is one of 26 states that have sued to overturn the Affordable Care Act. Even if the Supreme Court decides to do that, state lawmakers "continue to work toward state-focused solutions to improve our health-care system," said state Rep. John Kefalas, D-Fort Collins. Fifty-eight percent of Coloradans lacking health coverage are employed, according to the Colorado Trust, a nonprofit that wants every state resident to have insurance by 2018. They either can't afford their share of employer-sponsored plans or the full cost of private plans, experts say. Michael Gervasi told his office staff that if it collected $1,000 for the Komen Race for the Cure in January, he'd run the race on Flagler Drive in West Palm Beach in a grass skirt and coconut-shell brassiere - a promise he kept.
nike basketball shoes on saleBut will he run in the 2013 race given Komen's initial decision to discontinue funding of Planned Parenthood?After attending an event where Susan G. Komen for the Cure founder Nancy Brinker spoke, Gervasi, a physician, said he is confident in the overall soundness of the organization, and he and his staff will try to raise more money next year."I tried to stay out of the political debate," he said. "I have learned not to form an opinion too early in the game."That's not the case in Indianapolis, Arizona and Southwest Florida, where there has reportedly been a 15 percent to 30 percent decline in sign-ups for the Race for the Cure. Those 5K runs and walks account for most of the charity's fundraising.Komen South Florida, the local affiliate, seems unaffected by the national uproar that erupted Jan. 31 when news broke that Brinker had withdrawn funding from Planned Parenthood, which was under a congressional investigation launched at the urging of anti-abortion activists.The West Palm Beach race, held Jan. 28, was the first of 140 races around the world in 2012. A few days later, several high-ranking Komen employees resigned in protest when the news leaked .Then, after a three-day national barrage of criticism, Brinker, a part-time Palm Beach resident, decided to restore the money to Planned Parenthood.Soon after, national Komen Vice President Karen Handel resigned. A conservative, Handel was seen as promoting the original decision to cut off money to Planned Parenthood.
nike shoes store Only nine races have been held since the controversy, but an Associated Press survey showed a downward trend - a month before a southern Arizona race, the number of people registered was about half as many as last year."There's no getting around the fact that the controversy did have an impact," said Leslie Aun, a spokeswoman for Susan G. Komen for the Cure. "We're not back where we were. We know that it's going to take a while." For Penny Westberry, who leads the Komen South Florida affiliate, it was Brinker's change of heart that saved the national Komen organization even more grief.During the first two days of the controversy, Komen South Florida was getting both positive and negative feedback from the public."But when Komen (the national organization) reconsidered, most of our email turned to being supportive," Westberry said.Her group ended its fiscal year in March slightly up in revenue, she said, while this fiscal year is too new to suggest any trends.She said she was pleased that there were 10 applications for five open positions on Komen South Florida's board of directors, an indicator that local support has not decreased.