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December 24, 2015

US FDA allows gay and bisexual men to donate blood with restrictions

US FDA allows gay and bisexual men to donate blood with restrictions

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Thursday, December 24, 2015

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On Monday, the Food and Drug Administration (FDA) announced a decision to allow gay and bisexual men in the United States to donate blood. To be allowed, the men must avoid sexual intercourse with the same sex for at least one year.

Men have been asked whether they had sex with men since 1977. During the HIV/AIDS crisis, in 1983, the FDA started banning the men from donating their blood. Since then, medical and gay rights groups, like The National Gay Blood Drive, advocated lifting the blood donation federal ban on the men.

In May 2015, the FDA first proposed allowing gay and bisexual men to donate if they do not make sexual contact with the same sex for the minimum of twelve months. About half of 700 comments on the proposal suggested upholding the ban. This month the FDA repeals the ban and approves the proposal.

Activists criticize the FDA’s restrictions as “discriminatory”. Nonetheless, other countries like Australia, Japan, and the United Kingdom enforce similar restrictions on gay and bisexual men. Australia has enforced the rule for more than a decade.

Annually, about 15.7 million units of blood have been donated in the U.S. According to a 2010 UCLA study, lifting the ban will increase annual U.S. blood donations by 2–4%.

The FDA has screened the donations for transmissible diseases like HIV before shipment. Australia has done the same.



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U.S. now allows gay and bisexual men to donate blood with restrictions

U.S. now allows gay and bisexual men to donate blood with restrictions

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Thursday, December 24, 2015

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On Monday, the Food and Drug Administration (FDA) announced a decision to allow gay and bisexual men in the United States to donate blood. To be allowed, the men must avoid sexual intercourse with the same sex for at least one year.

Men have been asked whether they had sex with men since 1977. During the HIV/AIDS crisis, in 1983, the FDA started banning the men from donating their bloods. Since then, medical and gay rights groups, like The National Gay Blood Drive, advocated lifting the blood donation federal ban on the men.

In May 2015, the FDA first proposed allowing gay and bisexual men to donate if they do not make sexual contact with the same sex for the minimum of twelve months. This month the FDA repeals the ban and approves the proposal.

Activists criticize the FDA’s restrictions as “discriminatory”. Nonetheless, other countries like Australia, Japan, and the United Kingdom enforce similar restrictions on gay and bisexual men. Australia has enforced the rule for more than a decade.

Annually, about 15.7 million units of blood have been donated in the U.S. According to a 2010 UCLA study, lifting the ban will increase annual U.S. blood donations by 2–4%.

Even with the restriction, the FDA raises concerns about contaminated U.S. blood donations. The FDA has screened the donations for transmissible diseases like HIV before shipment.



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May 2, 2012

Poison control centers educate public on hand sanitizer consumption

Poison control centers educate public on hand sanitizer consumption

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Wednesday, May 2, 2012

Cquote1.svg Teens may ingest hand sanitizer recreationally, and one or two swallows could get a child visibly drunk. Cquote2.svg

—Cyrus Rangan

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Poison control centers across the US are monitoring a recent increase in the trend of teenagers getting drunk by consuming hand sanitizer. In an effort to educate the public about the trend’s detrimental effects, these centers will be publicizing preventative methods, according to James Mowry, director of Indiana Poison Center.

“We are going to keep a close watch on this trend,” said Mowry. “We will be posting information on our Facebook page so our public will be aware of what could happen.”

Sixteen cases have been reported in California since March 1, according to the California Poison Control System. This amount raises California’s total to 60 cases reported since 2010.

Since the system “only receives the reported cases,” said Stuart E. Heard, executive director at CPCS, “… we suspect there are much more that go unreported.”

Ingesting the product can cause severe internal damage. The US Food and Drug Administration considers hand sanitizer a drug because the active ingredient in the product is alcohol. Low numbers of reported cases will not stop poison control centers from educating the public on the trend’s harmful effects, according to Mowry.

Hand sanitizer contains 62 percent ethyl alcohol.

Hand sanitizer contains 62 percent ethyl alcohol and, when ingested, produces the same effects of consuming a 120-proof alcoholic beverage or 50 percent more alcohol than hard liquor, according to Mowry. These effects range from dizziness to slurred speech. Ingesting the product can also lead to severe internal damage including alcohol poisoning. Alcohol poisoning symptoms include confusion, vomiting, seizures, slow or irregular breathing, blue-tinged or pale skin, low body temperature, and unconsciousness, according to a report from the American Association of Poison Control Centers.

“Teens may ingest hand sanitizer recreationally, and one or two swallows could get a child visibly drunk. The larger the bottle, the greater the potential for poisoning,” said Cyrus Rangan, a medical toxicology consultant at the Children’s Hospital Los Angeles and an assistant medical director at CPCS.

Hand Sanitizer Ingredients

Teenagers learn how to extract the alcohol from the product through various sources, like YouTube tutorials. A common method of distilling hand sanitizer involves using salt to isolate the alcohol. Other teens boil the product to separate the ethanol.

“Methods to distill it can be found through friends and the Internet, but straight ingestion of the product without distillation is also common,” said Rangan. Another concern with this trend is the product’s availability. “Hand sanitizer is readily available,“ said Heard. “Teens can buy it anywhere.”

Officials suggest parents keep hand sanitizer out of children’s sight and reach. Also, purchasing hand sanitizer in foam form instead of gel makes drinking the substance less appealing. However, education is critical. “The main preventative focus should be education,” said Heard. “Teens need to thoroughly understand the effects of consuming large amounts of alcohol in a short amount of time.”



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December 23, 2011

Walmart recalls infant formula after baby death

Walmart recalls infant formula after baby death

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Friday, December 23, 2011

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Trypticase containing Cronobacter sakazakii bacteria.
Image: Centers for Disease Control and Prevention.

Retail store group Walmart has removed an infant formula from over three thousand of their stores in the United States. The decision was taken in the aftermath of the death of a baby who suffered from Cronobacter sakazakii, an infection which is extremely rare but poses a significant risk to babies born recently and those born prematurely should they contract it. A second newborn baby has also contracted the infection, which is most frequently discovered in plants like rice and wheat.

Ongoing tests are now attempting to establish whether or not the powdered infant formula is connected to the bacterial infection the two babies suffered from in the US state of Missouri. A statement from Walmart says that the company is taking the product Enfamil Newborn Formula off their shelves “out of an abundance of caution”. Speaking on behalf of Walmart, Dianna Gee stated that the group express their “deepest condolences” to the family of Avery Cornett, who died after removal from life support. Gee informed Agence France-Presse that lot number ZP1K7G had been removed and “Walmart customers who may have purchased the item at our stores can return it for a full refund or exchange it for another brand of formula”.

The manufacturer of Enfamil Newborn Formula has also stated that tests made before shipment of the product came back as negative. Chris Perille, a spokesperson for Enfamil manufacturer Mead Johnson Nutrition, has said: “The batch of our product used by the child’s family tested negative for Cronobacter when it was produced and packaged, and that has been reconfirmed from our batch records following this news”. Mead Johnson are “highly confident in the safety and quality of our products — and the rigorous testing we put them through” and is “working with the health authorities to support their efforts to identify the source or cause of this infant’s infection,” according to Perille. The U.S. government has reportedly made no recall of the product.

The Missouri Department of Health and Senior Services has referred the infant formula to the Centers for Disease Control and Prevention and the Food and Drug Administration for examination and has advised parents that “powdered infant formulas are not commercially sterile products” and destroying bacteria amongst the production process may not be possible, while “no exclusively breastfed infants have been reported to have” contracted Cronobacter sakazakii. Pending test completion, “it cannot be determined whether the illness is linked to Enfamil Newborn Formula 12.5 oz. cans lot #ZP1K7G or an outside source”, according to a statement from the Missouri Department of Health and Senior Services. The department has also suggested that parents observe the World Health Organisation’s ‘Guidelines for the safe preparation, storage and handling of powdered infant formula’, which recommends “washing your hands with soap and water, thoroughly sterilizing all feeding equipment in hot, soapy water and preparing enough formula for only one feeding at a time”.



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June 19, 2011

US Food and Drug Administration proposes new regulations on sunscreen labeling

US Food and Drug Administration proposes new regulations on sunscreen labeling

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The FDA wants sunscreen labels to clarify how effective the product is at protecting against UV rays.
Image: Axel Bührmann.

The US Food and Drug Administration (FDA) has proposed new regulations, set to come into effect next year, to clarify sunscreen labels regarding the product’s effectiveness against ultraviolet (UV) rays.

The regulations, which the FDA has been considering since 1978, would prohibit claims that a sunscreen is “waterproof” or “sweatproof”, since the FDA believes these terms are misleading. Instead, the word “water-resistant” must be used, and the label must specify how long the product lasts in water. Sunscreens that are not water-resistant must include a warning.

Only sunscreens that protect against both UV-A and UV-B rays could be labeled “broad spectrum”. Currently, the SPF reflects protection against only UVB, not UVA. If the SPF is less than 15, then the label also must warn the consumer that the product is less effective at protecting against skin cancer or sunburn. Labels would not be able to claim an SPF higher than 50, since there is little evidence that suggests that anything higher offers significantly better protection against UV. Dermatologist Dr. Neil Korman supports this regulation, saying that it would reduce consumers’ inclination towards buying products with unnecessarily high SPFs.

The FDA is also investigating the safety of aerosol-spray sunscreen, until more is known about its effects on breathing. The Environmental Working Group (EWG) warns that the spray could cause lung damage. The EWG also discourages the use of sunscreens with bug repellant, and recommends practices that avoid substantial exposure to UV rays.



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June 14, 2011

Apples top most contaminated produce list

Apples top most contaminated produce list

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Tuesday, June 14, 2011

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File photo of a red apple.
Image: Abhijit Tembhekar.

According to the United States-based Environmental Working Group (EWG), apples rank as the most contaminated fruit and vegetable produce.

The consumer advocacy group’s Dirty Dozen list, released Monday, ranks fruit and vegetables most highly contaminated by pesticides and fungicides. Apples are followed by celery, strawberries, peaches, spinach, nectarines, grapes, sweet bell peppers, potatoes, blueberries, lettuce and kale or collard greens.

Cquote1.svg Pesticides are toxic. They are designed to kill things and most are not good for you. The question is, how bad are they? Cquote2.svg

—Sonya Lunder, EWG analyst.

The Dirty Dozen list is part of the EWG’s seventh annual Shopper’s Guide to Pesticides in Produce along with the Clean 15 list, headed by onions, corn, pineapple, asparagus and watermelon. Consumers taking the recommended five-a-day from the Dirty Dozen were predicted by EWG to consume an average of 14 different pesticides; in contrast, those choosing from the Clean 15 could be expected to be exposed to two or less contaminants—a claimed reduction of 92 percent.

For the report, EWG synthesized data from the U.S Department of Agriculture and Food and Drug Administration collected between 2000 and 2009. Produce was washed and peeled, if necessary, and then each was given a score based on the the level, type and number of pesticides found in the produce.

Cquote1.svg […] crops are shown to have either no residues at all or with residues 10 times to 100 times below already stringent safety limits. Cquote2.svg

—Teresa Thorne, Alliance for Food and Farming

The lists are meant to aid consumers in making safer choices as they shop for produce. “Pesticides are toxic,” said EWG analyst Sonya Lunder, “[t]hey are designed to kill things and most are not good for you. The question is, how bad are they?”

“A growing body of scientific evidence shows pesticide consumption can cause lasting harm to children’s brain development,” wrote a group of leading physicians and public health experts in a May 6 letter to the U.S. Department of Agriculture, the U.S. Environmental Protection Agency and the Food and Drug Administration. “Three recently published studies have all shown that early life exposure of children to pesticides can cause persistent problems in learning, memory and behavior.”

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The pesticides that coat produce have been linked to various health problems says Alex Formuzis, spokesperson for EWG. Although pesticides remained after washing and peeling, Formuzis said the health benefits of eating fruits and vegetables make them a better choice than most other snack foods: “If it’s a choice between an apple and potato chips, choose the apple”.

Pesticides and fungicides are used by farmers to kill insects, other pests, and to extend produce shelf life. The Alliance for Food and Farming (AFF), a trade group, criticized the new report. Teresa Thorne of the AFF said, “Not only are farmers of fruits and vegetables meeting requirements set by the U.S. Environmental Protection Agency for pesticide residues, but their crops are shown to have either no residues at all or with residues 10 times to 100 times below already stringent safety limits.”

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April 3, 2011

FDA issues proposed rules requiring calorie content on menus

FDA issues proposed rules requiring calorie content on menus

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Sunday, April 3, 2011

File photo of McDonald’s in Times Square
Image: Sallicio..

The US Food and Drug Administration (FDA) has issued proposed calorie labeling rules requiring most retail food vendors to display the calorie counts in items on their menus and menu boards. The proposed rules, issued Friday and expected to be finalized in 2012, would apply to most restaurants, snack bars, vending machines, coffee shops, drive-through restaurants, and convenience and grocery stores.

The US Congress required the rules in the health-care reform law passed in 2010. The rules proposed by the FDA must undergo a public comment period before they are finalized and take effect, said Michael R. Taylor, Deputy Director for Foods at the FDA.

The proposed regulations pertain to businesses devoting more than 50 percent of their floor space to the sale of food or that consider themselves restaurants, specifically food-selling chains with at least 20 stores nationally. Included are candy stores, bakeries, and ice-cream parlors.

The FDA’s proposed guidelines specify that chains post the calorie counts of foods and drinks on menus and menu boards or next to the food item, such as at a salad bar. The menu is to prominently exhibit the calorie content of each item in a way customers can see easily, giving them the same information packaged foods prepared at home currently provide. The information must be displayed in “clear and conspicuous” print and colors.

Cquote1.svg Giving consumers clear nutritional information makes it easier for them to choose healthier options that can help fight obesity and make us all healthier. Cquote2.svg

—Kathleen Sebelius, Secretary of Health and Human Services

Many cities and states have passed laws requiring calorie labeling on menus, beginning with New York City in 2008. California implemented a similar law in January, although many counties are waiting for the release of the federal guidelines before they begin enforcement. Some fast-food chains there, such as McDonald’s and Starbucks, are displaying calorie counts on menus in some of their stores.

The rules are intended to curb the national obesity epidemic since, according to FDA estimates, one third of the calories people consume yearly come from food eaten out. In a statement issued yesterday, Kathleen Sebelius, Secretary of Health and Human Services said, “Giving consumers clear nutritional information makes it easier for them to choose healthier options that can help fight obesity and make us all healthier.”

Excluded from the rules are businesses whose primary product is not food sales but that sell it, such as bowling alleys, airports and airplanes, amusement parks, hotels and movie theaters. Alcohol is also excluded.

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August 20, 2010

US food regulators recall 380 million eggs after salmonella outbreak

US food regulators recall 380 million eggs after salmonella outbreak

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Friday, August 20, 2010

380 million eggs have been recalled for salmonella in the US.
Image: Schnee.

The United States Food and Drug Administration (FDA) has recalled 380 million eggs and the number is expected to grow, after around 300 in Colorado, California, and Minnesota and 2,000 nationwide became infected with salmonella after eating eggs distributed by Wright County Eggs.

The contaminated eggs were sold under the labels Lucerne, Albertson, Mountain Dairy, Ralph’s, Boomsma’s, Sunshine, Hillandale, Trafficanda, Farm Fresh, Shoreland, Lund, Dutch Farms, Kemps, Bayview, Mountain Dairy, NuLay and Sun Valley. Eggs have been sold in seventeen states.

Wright County Egg’s owner has been previously cited for breaking environmental laws.

Cquote1.svg They [birds] defecate in the feed, which the chickens then eat and can become infected. Cquote2.svg

—Nancy Bufano, FDA egg safety expert

In response to the outbreak the FDA deployed an initial team of ten investigators to Wright County Egg in Iowa to inspect the farms and determine the source of the contamination. Although no official statement has been issued, it is believed animals including birds and rodents defecated where food for chickens is stored.

The outbreak is believed to have started in early July, around the time new federal regulations to prevent salmonella contamination of eggs took effect.

According to the FDA, the symptoms of salmonella infection includes fever, diarrhea, nausea, vomiting, and abdominal pain.

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August 14, 2010

Wikinews Shorts: August 14, 2010

Wikinews Shorts: August 14, 2010 – Wikinews, the free news source

Wikinews Shorts: August 14, 2010

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A compilation of brief news reports for Saturday, August 14, 2010.

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Tamil migrant boat bound for Canada sparks debate

Hundreds of Sri Lanka Tamils seeking asylum in Canada unboarded their cargo ship that they used to sail from Sri Lanka to Vancouver. Some of the people who were on board the MV Sun Sea needed medical treatment, but officials have said that they were not aware of major medical problems.

The landing of the 490 refugees, however, has raised concerns that some onboard might have been members of the Tamil Tigers Sri Lankan rebel group. The Tigers, who fought a civil war against the Sri Lankan government for over two decades and lost in 2009, have been designated a terrorist group by the Canadian government since 2006. “Our goal is to ensure that our refugee system is not hijacked by criminals or terrorists,” Public Safety Minister Vic Toews said. Toews also said that the governnment would be taking a tough line with the ship’s passengers.

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South Carolina Senate candidate Alvin Greene indicted on felony charge

Alvin Greene, the Democratic candidate for the South Carolina US senate seat, has been indicted on a felony charge of showing pornography to a female college student. The 32 year-old Greene was arrested last November after allegedly showing a female student obscene photos on his laptop and then asking to come to her dorm room. Greene shot to instant fame after he won the South Carolina Democratic senate primary with 58% of the vote despite not campaigning or raising funds for his US senate bid.

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FDA approves of ‘morning after’ pill

The US FDA (Food and Drug administration) has approved a new, longer lasting ‘morning after’ pill that works for up to five days after unprotected sex. The FDA approved the pill, called ella, has stated that the birth-control pill will be prescription-only. The FDA said that the drug “is not intended for routine use as a contraceptive.” The pill is made by the French medical company HRA Pharma and will be marketed in the US by Watson Pharmaceuticals.

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May 5, 2010

FDA report criticizes conditions in factory that produced recalled medications

FDA report criticizes conditions in factory that produced recalled medications

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Wednesday, May 5, 2010

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Logo of the FDA.

The US Food and Drug Administration released a report today harshly criticizing the conditions at a Johnson & Johnson factory that produced medications recalled this weekend.

The report, the result of an FDA inspection conducted at the facility, said that the plant in question, located in Fort Washington, Pennsylvania, had upwards of 20 documented manufacturing problems, including both quality and security issues.

According to the report, material used in the medicines produced were contaminated with a type of bacteria not yet identified, and the factory had not had sufficient quality control procedures or facilities for testing the quality of products. The report also noted that employees had received insufficient training in safe manufacturing procedures.

The FDA’s inspection of the plant had begun in mid April, and concluded last Friday. A recall of the drugs, which included Tylenol, Motrin, Zyrtec and Benadryl, was issued by Johnson & Johnson later on Friday. The products affected were sold in twelve countries worldwide, including the US

According to McNeil Consumer Healthcare, a division of J&J, the recalled medications can include higher than indicated amounts of active ingredients, foreign particles, or ingredients that don’t meet requirements for testing. The recalls followed at least 46 consumer complaints in the last year of “black or dark specks” found in J&J Tylenol products.

According to a senior FDA official, “[t]his is yet another example of when a company has to take full accountability for the quality of its drugs [with] severe consequences for not doing so.”

In a response, J&J said in a statement that “we have no higher concern than providing parents with the highest quality products for their children” and “the quality issues that the FDA has observed, many of which we had recently identified in our own quality reviews and communicated to the FDA, are unacceptable to us.” The company said the plant affected has temporarily ceased all production.



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