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Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Tuesday, September 20, 2011

Modern Milk is Frankenfood

Sadly, what we consume today as "milk" is not your grandmother's milk. Like most of the other overly processed foods available on grocery shelves today, milk has been altered, stripped and reconstituted. There are so many additives and processes involved that buying a gallon of milk (or a cup of yogurt) at your grocery store guarantees that you'll get a mixture of substances from all over the country - possibly the world. When all is said and done, the product that you actually purchase is a far cry from what actually came from the cow.

Homogenization - John Bunting, a dairy farmer who researches and writes about dairy for The Milkweed, says "homogenization is not good". "The milk is pumped under high pressure which smashes the milk molecules so hard. Homogenization splits and exposes the molecules." The hard science goes like this: A raw milk molecule is surrounded by a membrane, which protects it from oxygen. Homogenization decreases the average diameter of each fat globule and significant;ly increases the surface area. Because there's now not enough membrane to cover all of this new surface area, the molecules are easily exposed to oxygen, and the fats  become oxidized.

Milk Solids - Critics believe that milk solids, which are sometimes added back into the milk, contain oxidized, or damaged, forms of fat and cholesterol. Nonfat milk solids are created through a process of evaporation and high heat drying which removes the moisture from skim milk. Exposure to high heat and oxygen causes fats to oxidize. And oxidized cholesterol has been shown in numerous studies to lead to atherosclerosis, or hardening of the arteries, and to raise LDL, aka "bad" cholesterol. One study from 2004 found that oxidized dietary fats are a "major cause" in the development of atherosclerosis.

This phenomenon worries Nina Planck, author of Real Food. "This damaged cholesterol is much different than what I call "fresh cholesterol," which is found in egg yolks, whole milk, and butter," she said. "We know that fresh cholesterol has one main effect and that is to raise HDL [or ‘good' cholesterol]. On the other hand, oxidized cholesterol raises LDL." What's more, Planck says that the law does not require manufacturers to tell consumers when milk solids are in food or milk. "It's a [potential] scandal because it's unlabeled," she says.

Michael Pollan writes about this as well in In Defense of Food: "In the case of low-fat or skim milk, that usually means adding powdered milk. But powdered milk contains oxidized cholesterol which scientists believe is much worse for your arteries than ordinary cholesterol." In California, where the industry reports the ingredients on its website, all industrially produced milk contains nonfat milk solids. Even "whole milk" is a product of reconstitution; it contains at least 3.5 percent milk fat and 8.7 percent nonfat milk solids. This is also true for (industrially produced) organic milk.

Are these milk solids really as big of a problem as Planck and others in her camp believe them to be?  Lloyd Metzger is doubtful. He says there's virtually no fat left in the milk to oxidize. Bunting agrees, "If it's skim milk, there might be small amounts - but that's not a real concern. If you're worried about oxidized fat, it's homogenization that is the real culprit." Has Bunting seen evidence of the health impacts associated with oxidized fats in milk? "No," he says. "But who's going to fund it? The USDA is the largest funder of dairy research in this country and they're not going to fund a study they don't want to hear about."

Milk Protein Concentrates (MPCs) - MPCs are made using ultra-filtration - milk is forced through a membrane to remove some of the lactose. MPCs have less carbohydrates and more protein than other milk solids and are often used in protein bars and drinks as well as in some processed cheeses Nonfat milk solids are approved for food use, but MPCs are not considered GRAS (generally regarded as safe) by the FDA. "MPCs have undergone a change," says Bunting. "They cannot be reconstituted into anything called milk." He suspects that the protein in MPCs is not as digestible as that in milk, but it has never been tested. He says Kraft, in particular, uses a lot of MPCs.

Lorraine Lewandrowski, a fourth-generation dairy farmer in Newport, N.Y., is also concerned about MPCs. "MPCs are derived from milk, but they're not really milk," she said. "There have been a lot of complaints by farmers concerned about MPCs being added to cheese to boost production." She says that typically around 10 pounds of milk yields one pound of cheese. MPCs - many of which come from overseas - can increase yields considerably. The MPC's are being imported from countries such as New Zealand, Mexico and China and "we cannot trust foreign governments with the safety of these ingredients", says Planck.

Milk doesn't have to contain nonfat milk solids, MPCs, or any other additives. Mark McAfee, founder of Organic Pastures, offers an alternative in California. "What is in our bottle comes straight from grass-fed, pasture-grazed cows. All we do is chill it and test it," he said.

In the New York region, where the sale of raw milk is illegal, small dairies leave their milk unhomogenized and pasteurize it at low temperatures to avoid damaging the milk molecules. "The real issue is trust," Bunting said. "If people could buy from someone they trusted, we wouldn't even need pasteurization. It extends shelf life, but it's not a safer product."


I don't know about you, but I want my milk (butter, cream, cheese, yogurt, etc.) to come from that cow right there...




SOURCES:
Grist.org
RealMilk.com
Why Modern Milk is Bad for You

This post was shared at Real Food Wednesday.

Thursday, August 25, 2011

Major Drug Research Company Fakes Documents to Get Drugs Approved - FDA Shrugs it's Shoulders

It is truly astounding to witness the utter corruption that takes place - and practically in plain sight - within the pharmaceutical drug industry. The FDA has announced that drug firm, Cetero Research, for many years knowingly forged thousands of clinical trial documents for drug companies in order for them to gain drug approval. The FDA's response to this was basically to shrug it's shoulders -this massive, years long corruption is basically NO BIG DEAL.

It is no secret that the FDA routinely works in illicit tandem with drug companies to get dangerous drugs on the market in exchange for lining their pockets with cash. The FDA's own scientists have even publicly indicted the agency for censoring truthful scientific data, intimidating and unfairly targeting supplement companies and using the drug approval system to extort cash from drug companies in exchange for its rubber stamp of approval. The entire racket between the FDA and Big Pharma is mind-bogglingly extensive and crooked. In truth, the FDA is really not interested in regulating the drug industry and, like with Big Ag, has told Big Pharma to go regulate itself.

As evidenced by the FDA's recent announcement "against" Cetero, where initially it appears that the FDA is upset at Cetero for lying via its clinical trial documents. But what does the FDA do, it tells the drug companies to go back and redo the clinical trials themselves. The FDA declared that both an internal company investigation and a third-party audit revealed "significant instances of misconduct and violations in conducting clinical trials". Between April 2005 and June 2009 there were at least 1,900 instances of fraud and falsified studies. And each of the studies were falsely used to prove that a drug was safe before it went on the market.  "The pattern of misconduct was serious enough to raise concerns about the integrity of the data Cetero generated during the five-year time frame," said the FDA.

Here, in the real world, the FDA's solution to tell the fox to go guard the hen house, while simultaneously reassuring the world that the fox itself is safe and would never hurt anybody, is outrageous. In fact, the agency is actually alleging that all approved drugs - even those that were approved with falsified Cetero data - are perfectly safe and "unlikely to be affected" by this massive criminal cover up.

Need more, how about this? One would assume that the nation's food and drug regulatory agency would, at the very least, have records of which drug companies used Cetero for their early clinical trials. Such information is standard on any drug application, right? Apparently not. The FDA actually has no idea which drug companies used Cetero's services and it is now asking drug companies to search their records and determine whether or not they contracted with Cetero. HA! Does the FDA really think the drug companies that used Cetero are going to willingly participate in this? Of course not!!! It would mean the companies would have to go back and redo their clinical trials if they fess up.

So........
- Why doesn't the FDA itself have records of the research companies used for the drugs that it approves?

- Why is the FDA apparently unconcerned about the safety of these drugs, considering they were approved using falsified data?

- Why is the FDA not attempting to hold Cetero accountable for its actions, other than to make an announcement about them?

Despite the nonchalant way in which the mainstream media is reporting on this issue, what Cetero has done is nothing short of high-profile crime. By falsifying drug trial data, Cetero has willingly put millions of people's lives at risk. The only right thing to do is immediately shut down the company and order a full investigation. Followed closely by pulling every drug, that had falsified data, off the market immediately!!!! All parties involved must be held accountable, including those at the FDA that may have been complicit as well.

But the real kicker is that the FDA also stated that this is not really that big of a deal. Millions of people's lives are on the line as potentially fatal drugs were approved with false data - but according to the FDA, nobody should be concerned. In fact, the FDA has known for years that Cetero has been falsifying data and has done absolutely nothing about it.

So there you have it. The truth, the whole truth and nothing but the truth as only the FDA can shovel it. It is absolutely insane, but the FDA expects you, me and the world to take it seriously.

SOURCES:
NaturalNews.com
Reuters.com

Tuesday, August 23, 2011

GMO Labeling Wars Continue

The FDA and USDA are at it again...not only do they want to prohibit the labeling of products that contain GMO ingredients, they also want to prohibit the labeling of products that don't contain GMO ingredients. Basically, they are trying to outlaw truth in labeling and openly working to deceive the public. In a draft of their written position, the FDA and USDA stated that mandatory labeling of GMOs is "false, misleading [and] deceptive" because it implies that there is a difference between GMO ingredients and non-GMO ingredients.
Fortunately, science and pure common sense, which are both lacking at the FDA and USDA, indicates that GMOs are different than non-GMOs and that the public has a right to know the types of ingredients that are in the products they buy. Not only are GMOs structurally different than non-GMOs, but GMOs are actually toxic. Several studies have shown they are harmful to the body. For more information regarding the dangers of GMOs, check out the following website: http://www.seedsofdeception.com/.

The labeling matter is further complicated because the FDA has maintained a tough stance for food makers who don't use genetically engineered ingredients and want to promote their products as an alternative. The agency allows manufacturers to label their products as not genetically engineered as long as those labels are accurate and do not imply that the products are therefore more healthful.

The dairy industry was warned in 1994 that it could not use "Hormone Free" labeling on milk from cows that are not given engineered hormones because all milk contains some hormones.

A flurry of enforcement letters have been sent to food makers, including B&G Foods, who was told it could not use the phrase "GMO-free" on its Polaner All Fruit strawberry spread label because GMO refers to genetically modified organisms and strawberries are produce, not organisms.

Spectrum Canola Oil was told that it could not use a label that included a red circle with a line through it and the words "GMO," saying the symbol suggested that there was something wrong with genetically engineered food.

And the rocket scientists over at Monsanto had this to say, "Requiring labeling for ingredients that don’t pose a health issue would undermine both our labeling laws and consumer confidence. Ensuring that such labeling is accurate would also put a huge burden on regulatory agencies."

"This to me raises questions about whose interest the FDA is protecting," said Rep. Dennis J. Kucinich (D-Ohio), who has introduced legislation that would require labeling for genetically engineered food. "They are clearly protecting industry and not the public."

SOURCES:
NaturalNews.com
FoodNavigator-USA.com

Thursday, August 18, 2011

Aspartame The FDA's Dirty Little Secret - Part 1

I get so tired of hearing people say that aspartame/NutraSweet/ Equal must be safe because the FDA approved it! They use it as justification to chug down Coke Zero and feed themselves and their children sugar-free jello, drinks, popsicles, yogurt and 6,000 other products on the market today. I want to try and dispel all the hype about aspartame and educate people as to how EXACTLY it was that aspartame came to be approved and generally recognized as safe (GRAS).
Aspartame was "discovered" in 1965 at the G.D. Searle Company when a chemist, Jim Schlatter, was working on treatment options for gastric ulcers. He accidentally spilled some of the heated chemical on his hand, licked his hand and noticed that it had a sweet taste. He and a friend decided to try the chemical - two amino acids bonded by methanol - in coffee and both agreed that it had a sweet taste. And aspartame was born. Upon this discovery, Searle simply changed the paperwork they were submitting to the FDA from a drug to a food additive, without changing the actual chemical at all. The FDA rejected it.
Fast forward to March 1973, Searle submits it's final research on aspartame along with it's first petition to the FDA that aspartame be approved for use in food. In 1974, aspartame was approved by the FDA for use in carbonated beverages and in dry products. However, in December 1975, the FDA task force concluded that some of Searle's studies were questionable and the FDA withdrew the 1973 approval. But that didn't stop the G.D. Searle company from continuing to push for re-approval of aspartame as a food additive, not a drug.
In October 1980, amidst great controversy and corporate pressure for the re-approval of aspartame, the FDA gathered a Public Board of Inquiry (PBOI) to evaluate aspartame's safety. The PBOI advised against the approval of aspartame finding that it caused an unacceptable level of brain tumors in the animals tested. "The Board has not been presented with proof of a reasonable certainty that aspartame (NutraSweet) is safe for use as a food additive under it's intended conditions of use."

Shockingly, the FDA again approved aspartame for consumer use in 1981. To many medical practitioners and consumer interest groups, the approval was a gross betrayal of public trust; especially as the approval seemed tainted by heavy financial interest. How could all of this really happen? No doubt there were apparently some questionable decisions behind the FDA approval of aspartame and it appears the approval was not for the benefit of you and me. Here's why, according to Jim Turner, Washington consumer attorney and author of The Chemical Feast: The Nadar Report on the Food and Drug Administration. Turner has actively opposed aspartame's approval since the 1970's.
"Searle, a drug company with little experience in food regulations, began studies on aspartame to comply with the FDA approval process, but they failed to do so," states Turner. The early tests of the chemical additive showed it produced microscopic holes and tumors in the brains of mice, epileptic seizures in monkeys and was converted by animals into dangerous substances, including formaldehyde.

In 1974, however, in spite of the information in its files, the FDA approved aspartame as a food additive. But the agency also made public, for the first time, the data supporting the food-additive decision. This data was then reviewed by renowned brain researcher Dr. John Olney from Washington University in St. Louis, as well as other research scientists.

Dr. Olney discovered two studies showing brain tumors in rats and petitioned the FDA for a public hearing. Consumer Action for Improved Foods and Drugs, represented by Mr. Turner, also petitioned for a public hearing based on "the approval process having been founded on 'sloppy' science" and on the reports showing aspartame caused epileptic seizures in monkeys and damage to the human eye.

Dr. Olney had already demonstrated in laboratory studies that aspartic acid (forty percent aspartame) caused microscopic holes to form in the brains of rats after each feeding. Aspartame also includes fifty percent phenylalanine, which is proven to harm children with PKU and methyl (wood) alcohol, which is a carcinogen and extremely neurotoxic in large amounts.

Faced with this array of possible health dangers, the FDA granted the hearing requests. In lieu of withdrawing its aspartame approval, the agency requested that Searle refrain from marketing the sweetener until after completion of the hearing. It then proposed that a Public Board of Inquiry (PBOI) review the matter.

In July of 1975, as the FDA prepared for the PBOI review, an FDA inspector conducted a routine inspection of Searle's Skokie, Illinois testing facility and found many "deviations" from proper procedure protocols. This report led the FDA commissioner, at the time, to create a Special Commissioner's Task Force to review Searle's laboratories.

In December of that year, the Task Force reported serious problems with Searle's research on a wide range of products, including aspartame. It found 11 other pivotal studies conducted in a manner so flawed that it raised more doubts concerning aspartame's safety and created the possibility of serious criminal liability for G.D. Searle. The FDA then delayed aspartame's approval.   It also contracted, over serious internal objection from several FDA representatives, a group of university pathologists (at Searle's expense) to review most of the studies and a task force was eventually set up to review three selected studies. The U.S. Attorney for Chicago requested a grand jury review of a 1960's monkey seizure study.

Not surprisingly, the pathologists paid by Searle only reviewed one part of Searle's laboratory protocols: Searle's failure to properly report data. Not surprisingly, they did not re-open the study's design or conduct protocols. And lo and behold, the Searle-funded pathologists found no serious problems. The FDA task force, on the other hand, found Searle's key tumor safety study unreliable, but their recommendations were ignored.

FDA Chief Counsel Richard Merrill submitted a 33-page letter to U.S. attorney Samuel Skinner recommending a grand jury investigation into G.D. Searle "for concealing material facts and making false statements in reports of animal studies to establish the safety of aspartame." Two specific studies of concern were cited. No action was taken, and Skinner allowed the statue of limitations to run out. Along with two of his aides, Skinner joined Searle's law firm shortly after that.

During the time period these committees met, the FDA organized the PBOI. G.D. Searle and the FDA Bureau of Foods each nominated three members for the board and the FDA commissioner selected one member from each list they submitted. In October 1980, based on its limited review, the board blocked aspartame marketing until the tumor studies could be explained. Unless the FDA commissioner overruled the board, the matter was closed.

The next month, November 1980, Ronald Reagan was elected U.S. President. Donald Rumsfeld (former congressman from Skokie, Illinois, former White House Chief of Staff and twice former Secretary of Defense) had been President of G.D. Searle since January 1977. He left Searle and joined the Reagan transition team. A full court press began against the FDA's board decision to suspend aspartame approval.

In January 1981, Rumsfeld told a corporate sales meeting attendee that he would call in his chips and get aspartame approved by the end of the year. On January 25th, the day President Reagan took office, the previous FDA commissioner's authority was suspended and the next month the appointed commissioner's job went to Dr. Arthur Hull Hayes.

According to Turner, transition records do not show why the administration chose Dr. Hayes, a professor and Defense Department contract researcher. In July of that year, Dr. Hayes, defying the FDA, approved aspartame for dry foods - his first major decision in office. In November 1983, the FDA approved aspartame for soft drinks - Hayes' last decision. Hayes was under fire for accepting corporate gifts and left the agency to work at Searle's public-relations firm as senior medical advisor. Shortly after the FDA soft-drink approval, Searle began test marketing and complaints began to arrive at the FDA's doorstep.

The complaints were more serious than the agency had ever received on any food additive. At the same time, independent research scientists began looking more closely at the dangers of this manufactured chemical sweetener. In 1985, the FDA asked the Centers for Disease Control (CDC) to review the first 650 complaints on aspartame (there were over 10,000 registered complaints as early as 1991).   The CDC realized that the symptoms in approximately twenty-five percent of the complainants stopped and then restarted, either purposely or by accident, when aspartame use was stopped and then restarted. The FDA discounted their report.

Time progressed and aspartame use increased and according to data released in 1995 - human brain tumors, like those in the animal studies, had risen 10% and previously benign tumors grew forcefully. Searle and the FDA deputy commissioner defended that the data posed no problem. Two years later, this FDA deputy commissioner became vice president of clinical research for Searle.

From 1985 to 1995, approximately 400 aspartame research studies were performed both by Searle researchers and independent scientists. Most interestingly, those studies finding no problems with aspartame were one hundred percent funded by G.D. Searle. All studies funded by non-industry sources raised very serious questions and doubts concerning aspartame's safety in the public food supply.

"Given this record, it is little wonder that many health-conscious people believe avoiding NutraSweet improves their quality of life," states Turner, "If and when a scientific consensus concludes that aspartame puts some, if not all , of its consumers at risk, it will be much too late. The point is to eat safely now. Remember: the brain you save may be your own."

SOURCES:
NaturalNews.com
Janet Starr Hull
US Food and Drug Administration

Wednesday, August 17, 2011

The BioTech Industry Thinks We're Stupid

At a time when more Americans then ever before want to know more about their food - where it is grown, what it contains, how it is produced - the FDA's recent decision to approve GMO salmon, which will be available for sale in the U.S. in 2-3 years, seems completely and utterly ridiculous. Coupled with the statisics that show industrialized agriculture is being criticized, farmers markets are popping up everywhere and organic food is one of the fastest growing segments of the food industry, it makes you wonder what the FDA is thinking (and question if they live in a cave completely oblivious to the outside world with the possible exception of Big Ag). This landmark decision approved the first GMO animal to be consumed by humans in the U.S. And it scares me to death!

The FDA flat-out refuses to even consider labeling genetically altered food. In the case of the GMO salmon, the FDA says it cannot require a label on the GM food once it determines that the fish is not "materially" different from other salmon. The FDA defends its approach, saying it is simply following the law, which prohibits misleading labels on food. And the fact that a food, in this case salmon, is produced through a different process, is not sufficient to require a label.

Not only does the FDA refuse to allow labeling of GMO foods, they are also restricting conventional food makers from stating on their labels that their products do not contain any genetically modified ingredients.

The biotechnology industry is opposed to mandatory labeling, saying it will only bewilder a public that is not well informed about genetic engineering. "Extra labeling only confuses the consumer," said David Edwards, director of animal biotechnology at the Biotechnology Industry Organization. "It differentiates products that are not different. As we stick more labels on products that don't really tell us anything more, it makes it harder for consumers to make their choices."

In the European Union and Japan, it is nearly impossible to find genetically modified foods, largely because laws require labeling, said William K. Hallman, director of the Food Policy Institute at Rutgers University. "No one wants to carry products with such a label," he said. "The food companies figure that consumers won't buy it." There is nothing to stop salmon producers or food makers in the United States from voluntarily labeling their products as genetically engineered - except a fear of rejection in the marketplace, Hallman said. And David Edwards thinks consumers are confused.

Ever since the FDA approved the first genetically altered material for use in food in 1992, when Monsanto developed a synthetic hormone injected into cows to increase milk production, the agency has held that it cannot require food producers to label products as genetically engineered. In the intervening years, the use of genetically engineered crops has skyrocketed - 93% of this year's soybean crop is genetically engineered, according to the U.S. Agriculture Department. Byproducts of those crops - soy lecithin, for example - are found in thousands of processed foods from chocolate bars to breakfast cereal. None is labeled as containing genetically modified ingredients.

The recent approval of GM salmon has consumer advocates worried about labeling for genetically engineered beef, pork and other fish which will soon be lined up for federal approval. The AquAdvantage Atlantic salmon has been given a gene from the ocean pout, an eel-like fish, and a growth hormone from a Chinook salmon. This particular salmon grows twice as fast as it's conventionally grown counterpart. Those of you looking to buy salmon will have a tough time picking out the conventional fish from the one created with genes from another species. You could be certain of getting the non-modified version if you bought salmon labeled as "wild," but most salmon consumed in the U.S. is farmed.