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Posts Tagged ‘FDA

Trans fat levels are declining in the bloodstreams of Americans

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The intense battle that public health advocates have waged against trans fats appears to be working: A new report shows that since 2000, levels of trans fats in Americans’ bloodstreams have plummeted nearly 60 percent.

Once widely found in fried, baked and packaged foods, trans fats have been slowly removed from the food supply after studies linked them to heart disease and obesity. Many cities have banned their use in restaurants, and public health experts have pressed companies to strip them from processed foods like cookies, soups, crackers and frozen foods.

In a research letter published in the latest issue of The Journal of the American Medical Association today, researchers found that as trans fats have disappeared from supermarket shelves and restaurant kitchens, they have also been disappearing from Americans’ bloodstreams. The study showed that in a nationally representative sample of middle-aged Americans, levels of trans fats fell 58 percent from 2000 to 2009…

Trans fats have been widely vilified since the late 1990s, when large studies showed that even slight increases in their intake could significantly elevate heart risks. Advocacy groups like the Center for Science in the Public Interest, one of the most vocal opponents of trans fats, sued fast food companies that used them in their foods, and cities including New York and Philadelphia have prohibited restaurants from cooking with them.

As controversy grew, many food manufacturers and restaurants gave in to pressure to remove trans fats — also known as partially hydrogenated oils — and began using alternatives like canola or sunflower oil.

In the new study…trans fat levels fell 58 percent, but there were also improvements in cholesterol and triglycerides. Levels of LDL, or “bad” cholesterol, fell almost 10 units on average, to 119.2 milligrams per deciliter of blood from 128.2 milligrams. Meanwhile, levels of HDL, or “good” cholesterol, rose to 55.8 milligrams from an average of 49.6 milligrams.

At the same time, triglyceride levels, a measure of fat in the blood, fell on average about 20 units, to 109 milligrams from roughly 131 milligrams. The American Heart Association considers triglyceride levels of 100 milligrams to be “optimal.” Health authorities say HDL should be above 40 milligrams in men and higher than 50 milligrams in women, while LDL levels in men and women should ideally be lower than 100 milligrams…

Partially hydrogenated oils could be removed pretty much entirely from supermarkets, processed foods – and our bloodstreams – by an order from the FDA. I know every one has kept the heat on this medical/political enclave since the election of Obama. But, the pressure hasn’t been sufficient. Maybe we relented too soon when we started to get some movement on food quality, food safety.

Maybe it’s time to ask questions, try to turn the attention of our elected representative from oil-bearing sands in Canada to those partially-hydrogenated oils still being stuffed into our circulatory systems?

Written by eideard

February 9, 2012 at 2:00 am

Import OJ samples passing tests for fungicide — so far!

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Testing of imported orange juice for a banned fungicide has not turned up any product with dangerous levels of the chemical since Jan. 4, U.S. regulators said today.

The Food and Drug Administration has collected 45 samples of imported orange juice, the agency reported. 19 have proven to be safe, and 26 are awaiting analysis, according to a weekly update from the FDA posted online. Regulators have released 12 of the 19 samples back to companies.

The safe samples came from Canada, Mexico, Honduras, Costa Rica and Belize, the FDA said. The agency began temporarily holding and testing orange juice samples after trace levels of the fungicide carbendazim were detected in products from Brazil.

“If the FDA collects and analyzes three shipments of orange juice products from the same manufacturer and all samples are found to be in compliance, products from that manufacturer will no longer be sampled under the current assignment,” the agency said in its report.

Carbendazim is banned in use in U.S. oranges and has been linked to liver tumors in animals. U.S. regulators were alerted to use of the chemical in December by Atlanta-based Coca Cola Co., which owns the Minute Maid brand…

The U.S. is the biggest single importer of orange juice…

The serious part of the problem is that most of the time you don’t know whether or not some imported OJ has been mixed in with domestic product. And Carbendazim not only isn’t banned in most of Central and South America – its use is pretty common.

Written by eideard

January 20, 2012 at 10:00 pm

FDA takes baby step reducing antibiotics pumped into cattle

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Home on the Range

Federal drug regulators announced Wednesday that farmers and ranchers must restrict their use of a critical class of antibiotics in cattle, pigs, chickens and turkeys because such practices may have contributed to the growing threat of bacterial infections in people that are resistant to treatment.

The medicines belong to a class of antibiotics known as cephalosporins and include such brands as Cefzil and Keflex. They are among the most common antibiotics prescribed to treat strep throat, bronchitis, skin infections and urinary tract infections. Surgeons also often use them before surgery to prevent bacterial infections.

The drugs’ use in agriculture has, according to many microbiologists, led to the development of bacteria that are resistant to the drugs’ effects, a development that many doctors say has endangered the lives of patients.

Antibiotics are often added to animal feed and are used routinely to encourage rapid growth of livestock, but officials at the Food and Drug Administration have been increasingly vocal in their concerns that overuse of antibiotics in agriculture is endangering human health. The agency proposed rules in 2010 to slow the use of penicillin, tetracycline and other antibiotics simply to promote growth or prevent disease in feed animals, but those rules have yet to be made final…

Perish the thought we offend a drug company or the owners of cattle feed lots.

Read the rest of this entry »

Written by eideard

January 4, 2012 at 6:00 pm

Unsanitary equipment blamed for deadly listeria outbreak

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Cantaloupes rotting in the Jensen Farms fields in Colorado
Daylife/AP Photo used by permission

Potentially contaminated processing equipment and problems with packing and storage of whole cantaloupes at a Colorado farm likely led to the deadliest listeria outbreak in the United States in 25 years, which has so far claimed 25 lives in a dozen states…

Pools of water on the floor of the Jensen Farms packing facility in Granada, Colo., equipment that was not easily cleaned and sanitized and failure to cool newly harvested cantaloupes before sending them to cold storage all contributed to the outbreak, the first-ever listeria contamination blamed on whole melons, federal Food and Drug Administration officials said Wednesday…

Investigators tested fruit samples and equipment from Jensen Farms and confirmed the presence of four outbreak strains of the listeria monocytogenes bacteria confirmed in the illnesses and deaths.

The FDA said Jensen Farms, which is based in Holly, Colo., had recently bought used equipment that was corroded and hard to clean. For example, the equipment used to wash and dry cantaloupe showed signs of dirt and product build-up, even after it had been disassembled, cleaned and sanitzed, the FDA’s report said. The equipment had been previously used to process raw potatoes, officials said, which could have left listeria bacteria behind.

In addition, a truck used to haul culled cantaloupe to a cattle operation was parked near the facility and could have introduced contamination to the facility, investigators said. Low levels of listeria in the field also could have introduced the bacteria into the packing facility. And the design of the plant allowed stagnant water to pool on the floor. The FDA had not inspected the farm before the Sept. 10 session that first detected listeria problems…

The outbreak has claimed lives in a dozen states, the Centers for Disease Control and Prevention said. They include six in Colorado, five in New Mexico, two each in Kansas, Louisiana, New York and Texas and one each in Indiana, Maryland, Missouri, Nebraska, Oklahoma and Wyoming…

Four illnesses were related to pregnancy, including a newborn who fell ill. One miscarriage has been reported.

Rest assured our elected officials are on top of the situation. Between Congress, the White House, the bureaucrats within the Food and Drug Administration and the US Department of Agriculture — the company has been mailed a warning letter detailing violations.

WTF?

Written by eideard

October 19, 2011 at 2:00 pm

China bans unsafe chemical from baby bottles. Good news to see them catch up to advanced countries like the United States. Oh.

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Last month, China banned companies from manufacturing, importing or selling baby bottles that contain bisphenol A (BPA), a potentially dangerous chemical routinely added to everyday plastic products.

China joins Canada, France, Denmark and the European Union in recognizing that this chemical is linked to a number of harmful health effects like breast cancer, heart disease, obesity, hyperactivity and other disorders.

Unfortunately, BPA is still routinely used in hundreds of consumer products sold in the United States…

BPA is a known endocrine disruptor, which means it interferes with how hormones work in the body by blocking their normal function. This chemical is so widespread that it has actually been detected in the bodies of 93% of Americans…

Despite a BPA investigation by the Environmental Protection Agency, and other numerous studies, the United States still does not have a nationwide ban of the chemical. Even though BPA has been linked to so many harmful health effects, it is still used in American products — most notably in infant and children’s feeding products.

Just this summer, the American Medical Association adopted a new policy recognizing that BPA is an endocrine-disrupting chemical and urged a ban on the sale of these products. The AMA also urges the development and use of safe alternatives to BPA for the linings of infant formula cans and other food can linings…

There is no good reason this country should continue to expose our children to a chemical that is known to disrupt the way our hormones work when there are safe, BPA-free alternatives available for baby bottles, sippy cups, and baby food and infant formula packaging.

We’ve blogged about these studies before. Some would be hilarious in the Darwinian sense – if these materials weren’t so harmful. But we live in a nation where lobbyists hold a lot more dollars – and therefore a lot more power – than scientists and regulatory agencies. You might consider voting for someone who thinks this is another useful change.

Written by eideard

July 15, 2011 at 6:00 am

Lazy Cakes send kids to hospital

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Two towns in the state of Massachusetts are moving to ban sales of a “relaxation” brownie named Lazy Cakes, laced with melatonin and sold in food markets, after children who ate them required hospitalization.

The mellowing chocolate treats, which sell for $3 to $5 at food stores and some night clubs, are legal but contain nearly 8 milligrams of the supplemental sleep aid, which is about 25 times the usual amount prescribed for adults.

Melatonin is a hormone produced naturally by the body. Standard doses in the Unites States, where it is available over the counter, and in Europe, where a prescription is typically required, range from 0.3 mg to 3 mg.

Considered a dietary supplement rather than a drug, melatonin is not regulated by the Food and Drug Administration. Doctors say an adult dosage could be dangerous to a child, effectively acting as a strong drug akin to Valium that can cause extreme drowsiness…

In the Massachusetts cities of New Bedford and nearby Fall River, efforts are underway to ban their sales, largely because of their appeal to children. Purple packaging features Lazy Larry, a cartoonish brownie with a big grin on its face…

National poison control centers receive more calls regarding melatonin than for any other herbal supplement – about 5,000 calls in 2009…

Should we just let the Free Market determine our response in the name of capitalism and not let the government question the safety of mood-altering, sleep-inducing chemicals?

Why not ask the parents of those kids who spotted a great looking brownie with good old Lazy Larry smiling at them – and ended up in the hospital?

Written by eideard

May 18, 2011 at 6:00 pm

It’s salmonella time for tomatoes!

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A nice pasta primavera

A California firm has been notified that the grape tomatoes supplied for its salads may be contaminated with salmonella…

The U.S. Food and Drug Administration said the prepackaged salads from Taylor Farms Pacific, Inc. of Tracy, Calif. were sold to Albertson’s, Raley’s, Safeway, Sam’s Club and Walmart.

The salads have “use by” dates of late April and early May and were distributed to stores in California, Nevada, Oregon, Washington, Arizona, New Mexico, Montana and Utah.

The suspect grape tomatoes were supplied to Taylor Farms Pacific by a California grower, Six L’s, the FDA said. No illnesses have been reported but Six L’s issued a voluntary recall of the tomatoes.

Questions about the recall? Contact the company directly at 209-835-6300.

Crap! One of my favorite items for a spring salad. I think I’ll stick to the organic varieties from the Mennonite farms down in Mexico.

Written by eideard

May 3, 2011 at 2:00 pm

Medical study left patients riddled with tungsten particles

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X-ray shows tiny particles of tungsten in breast tissue

Women participating in a study of patients with breast cancer have been inadvertently left with hundreds of tiny particles of the heavy metal tungsten in their breast tissue and chest muscles. The particles came from a device used during surgery. The device has since been recalled.

It is not known if the metal is dangerous to health because relatively little research has been done on its long-term effects in the body. But it shows up on mammograms, and may make them difficult to read, an especially troubling effect for women who have already had breast cancer and worry about recurrences. (The particles resemble calcium deposits, which can indicate cancer.)

About 30 women have been affected, according to the manufacturer of the device that caused the problem, the Axxent FlexiShield Mini. The women are in a quandary. At least one, fearing that the tungsten could cause cancer or another illness, is trying to decide whether to get rid of the particles by having her breast and its underlying tissue removed in a radical and disfiguring operation…

The episode casts doubt on the safeguards for people who participate in medical research and on the Food and Drug Administration’s ability to protect the public from flawed medical devices…

Karen Riley, FDA spokeswoman, said the 510(k) process was used to avoid “reinventing the wheel” for products that were essentially the same as others that had already passed muster with the agency.

RTFA as a cautionary tale. An accepted procedure for passing medical devices as safe – and has a fine track record – failed a number of women. They are left with years of wondering just what medical issues may follow the tests of the Flexishield.

Written by eideard

March 27, 2011 at 2:00 pm

Recall issued for Skippy reduced-fat peanut butter

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The possible discovery of salmonella has prompted a limited recall of Skippy reduced-fat peanut butter spreads sold in 16 states.

Unilever issued a press release detailing a voluntary recall of Skippy’s “Reduced Fat Creamy” and “Reduced Fat Super Chunk” brands. The recall applies only to these branded items distributed in Arkansas, Connecticut, Delaware, Illinois, Iowa, Maine, Minnesota, Missouri, Nebraska, New Hampshire, New Jersey, New York, North Dakota, Pennsylvania, Virginia and Wisconsin.

While there have been no known illnesses, the recall was issued for fear that some of the peanut butter now in stores had salmonella…

The recalled products are sold in 16.3-ounce plastic jars, have UPC codes of 048001006812 or 048001006782 and have best-if-used-by-dates of May 16-21, 2012, on the top, the company statement said. Those with such jars should throw them away and call Skippy at 1-800-453-3432 to get a replacement coupon, according to Unilever…

Salmonella is a bacterial infection that usually lasts four to seven days. About 40,000 cases of salmonellosis are reported each year in the United States, according to the CDC.

Those who get it typically develop fever, abdominal cramps and diarrhea between 12 and 72 hours after becoming infected. Most people recover on their own, without needing significant treatment. But salmonella in very young and very old people, as well as those with weakened immune systems, can lead to severe illness and even death.

Cripes. This prompts a couple of thoughts.

I ate a ton of Skippy peanut butter growing up. The only change in my adult peanut butter life is switching to organic brands from markets I know run their own checks on food quality.

Wonder if there were as many or more – or fewer – instances of salmonella and other food poisonings in the good old days. Are they just better reported nowadays? Is it only the increase in production servicing a larger population that seems to include a calculated risk of food poisoning?

Hmmm?

Written by eideard

March 6, 2011 at 2:00 pm

Study shows HPV vaccine works for boys

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“Doc, I have this funny wart on my whatsis”

The vaccine for human papillomavirus (HPV) can prevent 90 percent of genital warts in men when offered before exposure to the four HPV strains covered by the vaccine, according to a new multi-center study led by H. Lee Moffitt Cancer Center and UCSF.

The four-year, international clinical trial, which also found a nearly 66 percent effectiveness in the general population of young men regardless of prior exposure to these strains, provides the first reported results of using the HPV vaccine as a prophylactic in men.

Initial data from this study informed the Food and Drug Administration’s decision to approve the vaccine for boys in 2009 to prevent warts, while results from a substudy led the FDA to expand approval late last year to prevent anal cancer.

While the HPV vaccine was approved in 2006 for girls to prevent cervical cancer, the vaccine’s benefit for young men was not initially addressed. Yet infection and diseases caused by HPV are common in men, the researchers said, including genital warts, which are one of the leading sexually transmitted diseases (STD) for which treatment is sought nationwide. The Centers for Disease Control and Prevention estimate that half of all sexually active Americans will get HPV at some point in their lives…

The authors noted that while they find it likely that the prevention of HPV infection and disease in men will have additional benefits, such as preventing anal, genital and throat cancers, these benefits need to be directly demonstrated through further clinical trials.

More good reasons for expanded trials. If we could get Congress and the FDA to discuss the question without special permission from someone in the Old Testament.

Written by eideard

February 7, 2011 at 6:00 pm

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