Posts Tagged ‘Food and Drug Administration’

New Study Claims FDA Review of GM Salmon Is Incomplete

November 25, 2010 Leave a comment

Wednesday 24 November 2010

by: Mike Ludwig, t r u t h o u t | Report


(Photo: Mark Benger)

The process used by the Food and Drug Administration (FDA) to review genetically modified (GM) salmon presents “an incomplete picture” of the risks and benefits of what could be the first GM animal food approved for human consumption, according to a recent Duke University study.

The FDA’S preliminary conclusions, announced in September, found that the GM salmon were as safe to eat as any other salmon. A comment period on whether the FDA can require GM salmon to be labeled as GM expired on Monday, putting the agency one step closer to a final decision.

The Duke Study, published in the latest issue of Science magazine, echoes the concerns of anti-GM activists, who argue in public hearings that the FDA has not considered enough data on the potential health and environmental consequences of farming GM salmon.

“Instead of focusing on the safety of a food taken one portion at a time, or whether it was produced through genetic modifications or through classic breeding, a more useful approach would be to evaluate whether society is better off overall with the new product on the market than without it,” said Jonathan B. Wiener, one of the study’s co-authors.

Members of Congress have also expressed concern about the review process, and last week, senators from Alaska introduced legislation that would ban GM salmon if the FDA approves the fish.

The salmon have DNA from other organisms that cause the fish to grow faster and larger. The FDA is specifically reviewing the DNA, which is considered a “new animal drug.” Duke environmental economics professor Martin Smith said the review process has ignored broad effects that large, fast-growing salmon could have on the environment and society, like how cheaper salmon might lower prices and increase consumption.

“These market impacts could dwarf any small differences in nutritional content,” Smith said.

Smith said the review process has only compared the nutritional value of GM salmon to regular salmon and screened for known toxins and allergens.

Smith and his team argue a full review would consider broader definitions of environmental safety and public health. The FDA should also make a fuller assessment of potential economic and environmental impacts, such as the amount of pollution created by salmon farms and the increased harvesting of the wild fish used to feed farmed salmon.

FDA spokesperson Siobhan DeLancey said the FDA did not receive a copy of the Duke study and the review process is still under way.

Smith and his team also argued the FDA should have put more thought into the potential threat GM salmon could pose to native salmon if the fish escaped into the wild.

Last week, watchdog group Food and Water Watch released internal documents from the Department of the Interior to Truthout showing that federal wildlife officials are concerned about the GM salmon proposal and the FDA’s failure to consult the Fish and Wildlife Service about the potential for the salmon to escape and threaten endangered populations in the wild.

“The approval of genetically modified salmon will set an important precedent for other transgenic animals intended for human consumption,” Smith said in a statement. “It’s essential that FDA establishes an approval process that assesses the full portfolio of impacts to ensure that such decisions serve society’s best interests.”

AquaBounty Technologies, the company that spent a decade developing the GM salmon, has proposed to breed the fish in inland tanks in Canada and then grow them in Panama.

Some activists are concerned that a decision on the salmon is imminent, but DeLancey said the agency is still reviewing comments from the industry and the public.

The FDA also has to decide whether to prepare a Finding of No Significant Impact or an Environmental Impact Statement, a preliminary decision that would be subject to a 30-day comment period.

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An assault on salt?

November 19, 2010 Leave a comment

Salt mounds in Salar de Uyuni, Bolivia. The Sa...

Salt mounds in Salar de Uyuni, Bolivia. The Salar de Uyuni is the world's largest (12 000 km²) and h...

Help may be on the way for cutting back on salt in a way your taste buds won’t notice but your heart and arteries will appreciate. In a long-awaited study and report commissioned by Congress, the Institute of Medicine has recommended that the FDA decrease the amount of salt in commercially prepared food. The proposal aims to rein in the overabundance of sodium (which is one of two components of table salt, along with chloride) in the American diet. Too much sodium helps usher in high blood pressure and damages arteries. By the Institute of Medicine’s reckoning, reducing Americans’ salt intake could save at least 100,000 lives a year.
The proposal isn’t a Big Brother approach to watch how much salt you use at home. For most people, that’s small potatoes — under 25% of daily salt intake. Instead, the institute recommends that the FDA take a step-down approach that would gradually lower the amount of salt in prepared foods in the next 10 years (2010 to 2020). Such a move could make a big difference, since most of the salt in the American diet is put there by someone else — a food company, chef, or cook.
How much is too much?
Every day, the average American takes in about 1½ teaspoons, or 8,500 milligrams (mg), of salt — which translates to about 3,400 mg of sodium. That’s 50% higher than the 5,700 mg of salt (2,300 mg of sodium) recommended for healthy people by the federal Dietary Guidelines for Americans, and double what the American Heart Association recommends (3,800 mg of salt, or 1,500 mg of sodium) for older people or those with borderline high blood pressure, heart conditions, kidney trouble, or diabetes.
Most of this is “hidden” salt, which is everywhere — breakfast cereals (1 cup of Raisin Bran, 354 mg of sodium), a tuna sandwich (1,300 mg), a cup of cottage cheese (900 mg), prepared cookies (3 Oreos, 190 mg). Salt plays many roles in food, from acting as a preservative or a binder to helping yeast rise. It is also a cheap way to make food tastier.
Some companies have a head start
The Institute of Medicine’s proposal would codify a move that some food companies began voluntarily several years ago. Campbell’s, for example, has slowly reduced the amount of sodium in its regular V8 drink by one-third since 1992. Sales during that period held steady, suggesting that consumers didn’t notice the change.
If efforts like this work, why bring in the FDA? Because most of the food industry has gone in the other direction, gradually increasing the amount of salt in prepared foods. The more salt we eat, the more our taste buds get used to it, making low-sodium foods taste bland.
A little is good, a lot isn’t
The assault against salt comes after decades of scientific bickering about whether too much sodium in the diet is harmful and whether cutting back is beneficial. The consensus today is yes and yes.
No one is looking to ban salt. It occurs naturally in many foods, and the human body needs some sodium to make muscles contract, to help nerves conduct impulses, and to maintain a healthy balance of fluids in the body. Instead, the Institute of Medicine and other public health organizations just want to reduce salt consumption to a less harmful level. Targeting prepared foods is one way to do this.
Predictably, the Institute of Medicine’s proposal drew immediate support from public health officials and criticism from the Salt Institute, a trade group of salt producers. The Salt Institute has long fought both the idea that excess sodium in the diet contributes to heart disease and restrictions on salt use.
Whether the FDA adopts the Institute of Medicine’s proposal remains to be seen. In the meantime, there are many things you can do to reduce your salt intake. The Department of Nutrition at the Harvard School of Public Health teamed up with the Culinary Institute of America, a leader in teaching chefs and other food service workers, to create 25 science-based strategies for cutting back on salt. They include commonsense tips from reading food labels and tasting food before you salt it to discovering and using umami — the so-called fifth taste, along with salty, sweet, bitter, and sour.

Harvard Medical School offers special reports on over 50 health topics. Visit our Web site at to find reports of interest to you and your family.

Copyright © 2010 by Harvard University.


BPA destroys sperm

November 18, 2010 Leave a comment

Bottles of Coca-Cola Zero a Coca-Cola Light

Bottles of Coca-Cola Zero a Coca-Cola Light

Talk about a kick in the you-know-where: A new study finds that a common chemical can destroy sperm.And you’re exposed to this chemical nearly every day. In fact, there’s probably far too much of it inside you right now, as you read this.

It’s bisphenol A, or BPA, the hormone-like chemical used in plastics and can linings, and researchers say men exposed to it have a higher risk of problems with their contribution to the baby-making process.

In the new study, researchers examined urine and semen samples provided by 218 Chinese factory workers over a five-year period.

When compared to men with no detectable levels of BPA in their urine, the workers who had detectable levels of the chemical had a dramatically higher risk of sperm problems, including:
Four times the risk of a lower sperm count;
Triple the risk of lowered sperm concentration;
Triple the risk of lower sperm vitality; and
Double the risk of lower sperm motility.
On the bright side, BPA didn’t seem to have an impact on sperm shape or volume, according to the study in the journal Fertility and Sterility.

And that’s not the only bad news on BPA. Studies have also linked the estrogen-like chemical to other sexual problems, diabetes, heart disease, developmental issues and much, much more.

Despite all that, the Food and Drug Administration passed on a chance to take action on BPA earlier this year. They said they want to see more research.

But while the feds dither, others are taking action.

The Canadian government recently declared BPA to be toxic to humans and the environment, a move that will enable them to place tighter controls on the chemical, or ban it outright.

But for now, the best way to protect yourself and your sperm from BPA is by avoiding anything in a plastic container or a metal can–and that’s good advice no matter where you live.

And for maximum defense for your sperm, skip the soda too. One study earlier this year out of Denmark found that young men who drank a quart of soda each day averaged 35 million sperm per milliliter of semen… while those who drank little to no soda averaged 50 million.

Since Coca-Cola says its cans are lined with BPA and they have no intent to change them, maybe there’s a connection.

And for more reasons to skip soda, stay tuned later this week–I’ll tell you about a frightening new link between sugar-sweetened drinks and diabetes, even among people who aren’t overweight.

But for now, let’s get back to saving your sperm–because for many men, it’s as easy as making some careful, healthy choices. A diet rich in selenium, zinc and folic acid, or a supplement that can boost those nutrients, can help improve sperm quality and quantity.


Tests Now Being Conducted for Corexit and Oil … Results Not Very Reassuring

November 3, 2010 4 comments

Source article

Real testing is starting to be conducted on dispersant and oil in the Gulf, the results are not looking so good:

* U.S. Government press release says NOAA, FDA now testing for dispersant: Corexit ingredient DOSS found in 13 samples — Up to 500 ppm allowed in shrimp, crabs, oysters [“DOSS” stands for Dioctyl Sulfosuccinate Sodium Salt – which might be nastier than BP is telling us]

* Crab containing 8,815 ppm of hydrocarbons had NO smell or sight of oil — “We were astonished there were levels like that”

* Research team “uncovered a PAH bonanza” — And just 190 parts per BILLION of PAHs is “considered pretty toxic” says professor at NASA installation

* Scott Milroy, a marine scientist at the University of Southern Mississippi, said seafood samples he gathered in September along the Mississippi coast showed levels… hundreds of times higher than the levels the government tests found

* TV report on shrimp with nearly 200 ppm oil in digestive system (VIDEO)

* LSU professor: Crude oil in seafood NOT detectable by ‘smell test’ — “We are being lied to”

* Fish organs are NOT the same color as they used to be, says BP/P2S worker — “You cut them open and they’re not the same” (VIDEO)

* Photo surfaces of black substance inside large fish caught by Florida man in late September

* 193 ppm of oil found inside shrimp purchased on Oct. 22 (Lab Results)

* EPA “BP Spill” testing across Gulf finds highest amount of heavy metal INSIDE FLORIDA BAYS — Raises “Level of Concern” (Lab Results)

In related news:

* “World renowned” scientist says currents WILL transport oil throughout Gulf — Florida’s EAST & WEST coasts under threat (VIDEO)

* “As deep as you could go”: No matter how far they dig at beach, the oil is already there — BP dissolved the oil in the water and it seeped into sand

* Head of cleanup on MS island: “Finding more and more and more oil” — “And this is like the fifth time we have come through here” (VIDEO)

* Reconnaissance flight over Gulf finds wetlands surrounded by oil (PHOTOS)

* BP cleanup worker: Oil “really hasn’t even been touched” — It’s “rolling in as we speak” (VIDEO)

* 60 percent have “NO TRUST” for BP’s information or the Feds’ response (Mobile, AL Survey)

* Clean up workers say that BP is limiting how much oil cleanup workers can clean up, and instead just covering oil up with sand, and that Corexit is still being sprayed at night:


Herbs, Supplements To Go In EU – US Is Next

October 29, 2010 Leave a comment

herbal supplementsIn less than a year, virtually all medicinal herbs will be illegal in the European Union.

In their take-no-prisoners strategy to wipe out every penny of competition and gain complete control of the health of the people, Big Pharma and Agribusiness have scored a major win in Europe. Similar, potentially devastating battles are also underway in the U.S.

How can this be happening?

The secret weapon used by drug companies is trade law. According to Gaia Health:

“Rather than treating food and traditional medicines as human rights issues, they have been treated as trade issues. That makes the desires of large corporations the focus of food and herbal law, rather than the needs and desires of people.

It’s this twisting that has resulted in the FDA‘s making outrageously absurd statements, such as claiming that Cheerios and walnuts quite literally become drugs simply because of health claims made for them.”


Diabetes drug linked to cancer risk

October 7, 2010 1 comment

There’s no such thing as a safe diabetes drug–just different degrees of risk.

While the spotlight has been on Avandia‘s heart risk, the FDA now says it’s putting the drug’s main rival, Actos, under review after new data linked it to an increased risk of bladder cancer.

And naturally, the feds are telling diabetics to make sure they keep right on taking this drug anyway.

In fact, they’re sending some dangerously mixed signals: First, they say the interim analysis of data on 193,000 California diabetics collected between 1997 and 2008 did not show an increase in bladder cancer risk.

Second, they say that patients who took the highest cumulative dose for the longest periods did have a higher risk–one that reached statistical significance after just 2 years.

Confused? Don’t be–because other studies have also found a link, including two clinical trials that found patients who took this med had a higher risk of bladder cancer than patients on other drugs.

In addition, rats given the rodent equivalent of a human dose have developed bladder tumors.

Not exactly encouraging… but the drug’s maker, Takeda Pharmaceuticals, is urging caution, saying we’re only halfway through a 10-year trial that should answer more questions.

But of course they’d say that.

They have drugs to sell, after all–and Actos has never been in a better position than it is now.

In fact, Actos is the unofficial “better than Avandia” choice for diabetics, since most of the studies that linked Avandia to heart risk compared it to Actos. And with Avandia sales now severely restricted, Takeda stands to earn a quick burst of cash before Actos faces generic competition next year.

But as I’ve written before, being “better” is not the same as being “good,” so even if Actos is better than Avandia, that doesn’t make it a good choice for you.

In fact, none of the diabetes meds are good choices, because they all come with risks–and those risks start with the illusion they create.

That’s the illusion that a diabetic can take a pill, and then enjoy a slice of double chocolate pound cake.

But that’s all it is–an illusion.

Do yourself a favor and take control of your diet, your body and your disease–because diabetics who commit to basic lifestyle changes–and I mean really commit to them, from a strict low-carb diet to daily exercise–find they no longer need dangerous drugs or even insulin.

And that’s the best way to avoid the drug risks… and the illusions.