Posts Tagged ‘FDA’
Morningland Dairy raided and another family business destroyed 01/25/13
View on YouTube
The FDA is notoriously prejudiced against raw dairy products, and if they personally are opposed to consuming them, fine! But what constitutional authority do they have to tell American citizens what they can and cannot eat and drink? Answer: NONE. With the government takeover of health care, however, you can rest assured that tyrannical attempts to control your diet will increase, not decrease.
The FDA, like so many other federal bureaucracies, has become a tyrannical, unelected, unaccountable apparatus for the Nanny State to rule over Americans instead of representing and serving them. Their goal is not to protect citizens from harming one another, but to protect us from our own choices by restricting them and making them for us. But this abuse of government power is not a victimless crime.
This small, family-armed dairy is the latest casualty in a long line of victims of government abuse and over-regulation. Will your business be next?
MOUNTAIN VIEW, Mo. — After a two and a half year legal battle, 15 tons of cheese made and aged near Mountain View was hauled to a dump. To fans of natural foods, it is monumental waste and over-regulation. To Missouri’s Milk Board, it’s merely protecting public health.
“I see the destruction of what my wife and I and family have worked to build,” said Joseph Dixon, owner ofMorningland Dairy.
Dixon and his family aren’t the only ones outraged by the trashing of about 30,000 pounds of cheese produced on the farm in Howell County.
[...] “They really haven’t found anything, no sicknesses, no illnesses in 30 years. But it’s what-if. And in the United States of America, if what-if now wins, we have no country left,” Dixon said.
Both Howell County Court and the Missouri Court of Appeals sided with the milk board’s decision to destroy all the cheese.
“We asked for trial by jury; we were denied because it was a regulation, not a law. It wasn’t passed by congress,” said Dixon.
A couple of years ago, the Dixons still had hope of someday making cheese again and were milking daily, but now, the milking barn is empty because the dairy herd is gone.
“If I tried to start back up, it would cost so much to get it in the cooler, and then, if they find, quote, one thing they can complain about, one thing, I’m shut down again, and every bit of that has to be destroyed,” said Dixon.
The Milk Board shut down Morningland’s manufacturing operation and ordered all cheese at the facility embargoed on August 26, 2010 after receiving a report from the California Department of Food and Agriculture that Morningland cheese seized in a raid of the Rawesome food club in Venice, California in June 2010 had tested positive for Listeria monocytogenes andStaphyloccocus aureus. Not a single block of cheese in the warehouse had the same batch number as the cheese seized in the Rawesome raid. A Milk Board inspector initially told Joe Dixon that he would only be shut down for a few days—but that changed when FDA stepped up their involvement in the case a short time later and pressured the Milk Board not to let Morningland resume their operations.
On October 1, 2010 the Milk Board sent the Dixons a letter requesting that they destroy the entire inventory of cheese at the facility; when the Dixons refused, the Milk Board filed a petition in the Circuit Court of Howell County to obtain an order for the destruction of the Morningland cheese.
After a two-day trial before Judge David Dunlop, the judge issued a decision on February 23, 2011 ordering the destruction of the cheese. Morningland appealed the decision but on September 27, 2012 the Court of Appeals sided with the Milk Board. A petition to the Missouri Supreme Court to hear the case was rejected onDecember 18, paving the way for the destruction of the cheese to take place.
Neither the Milk Board nor FDA ever tested any of the cheese stored at Morningland. FDA did take 100 environmental swabs at the facility, all of which tested negative for listeria. There was no accusation that any cheese Morningland produced had made anyone sick; there had never been any reported illness from the consumption of Morningland products in the thirty years the farmstead cheese operation had been in business.
The Morningland case was about FDA’s agenda to restrict access to raw dairy products with the eventual goal of banning them. The agency doesn’t hesitate in sacrificing a business like the Dixons’ in order to move its agenda along.
What message does this send to entrepreneurs who are considering starting their own business and creating jobs? Who wants to take the risk of running afoul of busybody bureaucrats with an ax to grind?
Which article of the constitution gives the federal government the right to tell citizens which foods they may or may not consume?
Hundreds of families in the state of Maryland have just seen their source of fresh, raw milk dry up thanks to the U.S. government. The Justice Department, at the urging of the Food and Drug Administration, convinced a federal judge to impose a permanent injunction on Pennsylvania Amish farmer Dan Allgyer prohibiting him from selling his milk to willing customers on the other side of the Mason-Dixon Line.
Although the injunction did not prohibit Allgyer from selling his milk in his home state, the farmer, tired of the stress and strain of fighting the feds, has decided to “shut down his farm altogether,” according to the Washington Times.
As The New American has previously reported, Allgyer was supplying milk to a private food-buying club in Maryland called Grassfed on the Hill. Selling raw milk is legal in Pennsylvania, but not in Maryland, which also prohibits other arrangements, such as cow sharing, whereby individuals may obtain the substance.
The FDA contends that the interstate sale of raw milk, which the agency considers thoroughly unsafe to consume despite the fact that over half the states allow raw milk sales, is illegal simply on the FDA’s own say-so. Thus, though no one had complained about Allgyer’s milk, which Grassfed on the Hill members have obtained for over six years, the FDA took it upon itself to launch a two-year investigation of Allgyer and the club, complete with undercover agents, straw purchases, and early-morning raids on Allgyer’s Rainbow Acres Farm.
On February 2, U.S. District Court Judge Lawrence Stengel, an appointee of President George W. Bush, acceded to the Justice Department’s request for a permanent injunction against Allgyer. Stengel rejected the arguments Allgyer offered in his own defense, including the fact that the arrangement between Allgyer and the club was a private contract. Stengel declared that the club members’ “cow share agreement” — they were actually leasing the cows through another organization — was “merely a subterfuge to create a transaction disguised as a sale of raw milk to consumers.” He even argued in a footnote that “the purchase of raw milk by one who traveled between states to obtain it, or traveled between states before consuming it or sharing it with friends or family members, implicates” interstate commerce and therefore is illegal — going even further than the FDA, which has said it won’t prosecute individuals for crossing state lines with raw milk for their own consumption.
While Stengel did not give the government everything it wanted in the injunction, he did ban Allgyer from selling his milk in Maryland and ordered him to “continuously display” this statement:
Daniel L. Allgyer and Rainbow Acres Farm [and/or any other entity or name by or through which Daniel L. Allgyer operates] will no longer introduce or deliver for introduction, or cause to be introduced and delivered for introduction, into interstate commerce, any unpasteurized milk or unpasteurized milk products. Selling or distributing Rainbow Acres Farm’s unpasteurized milk and unpasteurized milk products outside the state of Pennsylvania is prohibited by federal law.
In addition, the injunction states that if Allgyer is ever again found to be connected in any way with the sale of raw milk across state lines, he will be forced to cover the costs of the government’s investigation and prosecution of him.
It’s not difficult to see why Allgyer decided he was better off giving up dairy farming than trying to carry on with much of his customer base declared off-limits and the sword of Damocles hanging over his head. A statement issued by Karine Bouis-Towe of Grassfed on the Hill said as much:
Dan and Rachel Allgyer have determined that they will discontinue service to our group and close down the farm. Dan has served many of us for more than six years and he is very saddened to have to make this decision but the stress and strain that his family has been under for the past few years due to the case and now the decision has given them no other choice.
Needless to say, the situation has the club’s roughly 500 active members more than a little upset, although the Times notes that they “are wary of talking publicly, fearing the FDA will come after them.”
One who did speak to the paper on condition of anonymity observed: “I can’t believe in 2012 the federal government is raiding Amish farmers at gunpoint all over a basic human right to eat natural food. In Maryland, they force taxpayers to pay for abortions, but God forbid we want the same milk our grandparents drank.” (The FDA, for its part, maintains that individuals “do not have a fundamental right to obtain any food they wish.”)
And the Left wonders why there are so few job creators left in this country?
You’ve heard of “creeping Sharia”? This is “creeping dictatorship”.
President Obama has enlarged and shaped the missions of agencies across the federal government to his own purposes, in pursuit of the “fundamental change” he promised voters. The resulting agency creep is creeping me out.
Totalitarians have a history of recasting representative governments into reflections of their own personal madness. Whether in the case of Communists, Fascists, or modern liberals, day-to-day government is retooled into an incarnation of their dear leader’s obsessions and justified by a vain and unsupportable assertion of higher intelligence.
This time is no different, as is demonstrated by the multiple cases of agency creep we are witnessing in the executive branch. We have recently been treated to internationalist game wardens, eco-warrior accountants, interfaith astronauts, and politicking professors. These contradictions indicate the disjointed fit between the nation and President Obama. Why is the US Wildlife and Fisheries raiding Gibson Guitar, the SEC examining hydraulic fracturing fluids, NASA seeking to build bridges with Muslims, and the Department of Education attacking Rick Perry?
Executive branch agencies are created by Congress and governed by commissions or charters. Agency activities should reflect the purpose enunciated at creation and as explicitly and logically amended from time to time. This representative process, whereby an elected Congress creates an agency with a focus and expertise, appears under attack by an Obama administration bent on molding longstanding agencies into the enforcement bureau for the nutty left and its clichéd causes.
For example, the US Fish and Wildlife Service traces its origins to the U.S. Commission on Fish and Fisheries, which was “created by Congress and charged with studying and recommending solutions to the decline in food fishes and to promote fish culture.” The Service’s strategy was amended and expanded by the Lacey Act, “the first Federal law protecting game, prohibiting the interstate shipment of illegally taken wildlife and importation of species.” Under President Obama, Wildlife and Fisheries is now zealously conducting raids on Gibson Guitar, searching for ebony from Madagascar and misapplying laws from India.
Likewise, the Securities and Exchange Commission was established by Congress in 1934 to “regulate the stock market and prevent corporate abuses relating to the offering and sale of securities.” Basically, widows and orphans gained a regulatory advocate focused on full and accurate disclosure by companies selling stocks and bonds. Under President Obama, the SEC has gained a task far removed from its experience, competency, or reason for existence. SEC examiners are now fully deputized marshals in the war on hydrocarbons. Despite that hydraulic fracturing is safe, represents ahuge advancement in accessing domestic energy sources, and is an obvious font of new jobs, theSEC is targeting oil and gas companies by slowing access to capital through regulatory roadblock.
In a much-reported event, the National Aeronautics and Space Administration revealed that its “foremost” mission is to improve relations with the Muslim world. Note the complete and obvious lack of intersection between the words “aeronautics/space” and “Islam/outreach.” Nonetheless, President Obama decided that such outreach logically followed the space shuttle, Hubble, Rover, and space station successes. In a more recent drift from core competencies, NASA chief Charles Bolden played politics by steering the shuttle museum decision away from Republican-dominated Houston, home of the shuttle program and most of its astronauts.
Finally, we come to Arne Duncan, the secretary of education. He runs the Department of Education, which was established by Congress in 1980 and formed to “promote student achievement and preparation for global competitiveness by fostering educational excellence and ensuring equal access.” Under President Obama, Secretary Duncan has had his focus redirected from the kids to the president’s political opponents. Mr. Duncan recently attacked the Texas school system under governor Rick Perry, claiming it “has really struggled” and “far too few of their high school graduates are actually prepared to go on to college” — this despite facts and test results that contradict the claim. It is unclear how an unsubstantiated smear campaign comports with promoting student achievement, fostering excellence, or ensuring access, but amply clear how such a smear might benefit Mr. Obama in 2012.
These new activities are irrelevant to each agency’s stated goals, mismatched to each agency’s core competencies, and completely disconnected with each agency’s reason to be. The activities are also arguably a breach of the separation of powers, with the president undoing, or at least diluting, the intent of Congress. Wildlife and Fisheries, the SEC, NASA, and the Department of Education are engaged in simultaneous, intentional, and serious cases of strategy creep that can only divert resources and focus away from their legitimate mandates.
These are just a few examples. Others abound. Consider that the EPA has strayed into map-remaking with its new “navigable waters” standard, the IRS is Obamacare’s bouncer, the formerly domestic ATF now has the ability to instigate hostilities on foreign soil through operations like Fast and Furious, and Health and Human Services is funding abortions.
These agencies are operating under the direction of the president. Ashe, Shapiro, Bolden, and Duncan did not just randomly and simultaneously decide to veer off course. Such career-limiting moves are unheard of from lifelong bureaucrats, absent direction. These seemingly random data points clearly represent Obama, the man and the ideology, and are planned. When one considers the forethought and effort required to identify each agency’s available means to execute Obama madness, the president’s ideological intensity and extreme ambition come into frightening focus.
Multipronged ideological assaults of this sort are nothing new. Mussolini’s “Battle of the Grain” subsidized grain program and “Battle for Land” land reclamation program were both seemingly necessary and random, but in hindsight were a deliberate corporative phase targeting control of employment. Il Duce then formed the Industrial Reconstruction Institute to take control of bank holding companies, giving the state the largest industrial sector in Europe.
Germans called this smothering by bureaucracy gleichschaltung, which translates literally as coordination but more precisely means subordinating independent institutions to state authority. The targets of such gleichschaltung can be ranked by value and likely resistance, meaning the totalitarian seeks out cash flow and intransigents.
Like il Duce and der Führer before, the One has embraced gleichschaltung. The president’s version seems to repeatedly affect successful businesses, serious Christians, oil and gas companies, coal companies, and Texas.
The mandates of Wildlife and Fisheries, the SEC, NASA, the Department of Education, the EPA, the IRS, the ATF, and HHS are mandates that elected representatives deemed societally worthy. As such, these agencies’ new Obama-instigated activities represent a trade of the democratically chosen common goal for the Obama personal goal. Such a trade is selfish and characteristic of one who elevates his personal mania above the interests of those he should represent.
The president’s now ample comments already indicate that he represents some of us more than others, and the mere fact that these new initiatives would not survive a legislative hearing is a sufficient indicator of their lack of representative merit. Such hyper-personal backroom governance is the antithesis of democracy. It is installment plan dictatorship by way of bureaucracy, one crazy misdirected program at a time.
The Food and Drug Administration has quietly released a new report about the deaths of and injuries to women from the dangerous RU 486 abortion drug and the Obama administration has done nothing to make the information available to women.
Following its approval during the Clinton administration, the FDA released a report in 2006 that received widespread attention for showing more than 1,100 women had been subjected to “adverse effects” resulting from their taking the abortion drug mifepristone, commonly known a RU 486. Pro-life advocates have waited five years for the FDA to come out with a new report of problems associated with the drug — despite mounting evidence that the abortion drug continues to kill and injure women across the globe.
The FDA, with no fanfare, has released a new report, dated April 30, 2011.The report indicates 14 women in the United States alone have died from using the mifepristone abortion drug and 2,207 women have been injured by it.
Of the women experiencing medical and physical problems resulting from the abortion drug, 612 women required hospitalizations, 339 experienced blood loss significant enough to require a transfusion, 256 experienced infections and 48 women experienced what the FDA labeled as “severe infections.” Given that the RU 486 abortion drug caused sepsis, a potentially lethal infection that resulted in the deaths of women from around the world, the “serious infections” were very likely life-threatening situations.
“Severe infections generally involve death or hospitalization for at least 2-3 days, intravenous antibiotics for at least 24 hours, total antibiotic usage for at least 3 days, and any other physical or clinical findings, laboratory data or surgery that suggest a severe infection,” the FDA report states.
Women developing infections from usage of the RU 486 abortion drug experienced endometritis (involving the lining of the womb), pelvic inflammatory disease (involving the nearby reproductive organs such as the fallopian tubes or ovaries), and pelvic infections with sepsis (a serious systemic infection that has spread beyond the reproductive organs).
The FDA figures also reveal that abortion businesses like Planned Parenthood are still misusing the abortion drug.
Despite the FDA indicating, “Administration of mifepristone and misoprostol is contraindicated in patients with confirmed or suspected ectopic pregnancy (a pregnancy outside the uterus,” the abortion drug was given to women in 58 cases where they had an ectopic pregnancy.
Jeanne Monahan of the Family Research Council commented on the new report.
“The dangerous complications associated with this drug continue include hemorrhaging and infection. In the U.S., at least 612 women have been hospitalized after taking RU-486; and at least 339 women required blood transfusions as a result of serious blood loss after taking the abortion drug,” she said.
“Marketing the abortion drug as simple and painless, such as taking an aspirin, is dangerously misleading to women. RU-486 is in a class of drugs categorized as selective progesterone receptor modulators, which, in addition to blocking progesterone necessary for the developing baby, also suppresses a woman’s immune system. Additionally, it is sometimes the case that the remains of the pregnancy are not entirely expelled from a woman’s uterus, causing infection and other problems,” she said.
Monahan also complained about the usage of the mifepristone abortion drug in cases where an ectopic pregnancy was present.
“Clearly highlighting the need for more stringent medical oversight, the report also indicates that 58 women were prescribed RU-486 despite having ectopic pregnancies,” she said. “To state it more clearly, a woman who has an ectopic pregnancy and takes the RU 486 regimen places her life in danger.”
Monahan says the dangerous status of the abortion drug is not limited to the United States.
“It is not only women in the U.S. who are suffering as a result of chemical abortion, it is a worldwide trend. A recent Australian health department audit of nearly 10,000 abortions performed in 2009 and 2010 compared the safety of RU-486 with surgical abortion, with the outcome being in the words of one major media outlet “The Abortion Pill ‘Less Safe than Surgery,’” Monahan explained. “The Australian report showed that 1 in 18 patients who used RU-486 had to be re-admitted to hospitals (a total of 5.7% of women vs. only .4% of surgical abortions.) The same study revealed that as many as 33% of women who had second trimester RU-486 abortions required some form of surgical intervention.”
The report also indicated approximately 1.52 million women have used the dangerous abortion drug through the end of April 2001.
“Despite the seriousness and intensity of adverse effects related to RU-486, use of this form of abortion is on the rise, and frequently the regimen is dispensed with less medical oversight than surgical abortion,” Monahan said. “Even more troubling, nationally and internationally, “telemed” dissemination of RU-486 is increasing. Telemed abortions involved doctors proscribing RU-486 through Skype or over the Internet rather than during a patient visit.”
“The bottom line is that abortion drugs are not about improving women’s health but are more accurately about advancing a radical pro-abortion agenda regardless of the impact on women’s health, even when it proves deadly,” she concluded.
Reason.tv covered the June 2010 raid in which agents – with guns drawn – stormed the Rawsome food club and confiscated milk, cheese, honey, and other products, terrorizing customers and staff and leaving the fridge open to spoil the remaining inventory:
This time, they arrested three people, charging them with “conspiracy”.
I guess we can all sleep better tonight, knowing the government is protecting us from evil family farms and distribution centers that offer….RAW MILK! Oh, the HORROR!
And we all assumed that we have an unalienable right to make our own food choices without interference from Nanny State bureaucrats who think they know better than customers in a free market. Our mistake.
The owner of a Venice health food market and two other people were arrested on charges related to the allegedly unlawful production and sale of unpasteurized dairy products, a spokesman for the Los Angeles County district attorney’s office said.
The arrests of James Cecil Stewart, Sharon Ann Palmer and Eugenie Bloch on Wednesday marked the latest effort in a government crackdown on the sale of so-called raw dairy products.
Prosecutors in Los Angeles alleged that Stewart, 64, operates a Venice market called Rawesome Foods through which he illegally sold dairy products that did not meet health standards because they were unpasteurized or were produced at unlicensed facilities.
Palmer, 51, has operated Healthy Family Farms in Santa Paula since 2007 without the required licensing for milk production, prosecutors allege. She and her company face nine charges related to the production of unpasteurized milk products.
Bloch, a Healthy Family Farms employee, is charged with three counts of conspiracy.
The arrests followed a one-year investigation during which undercover agents purchased unpasteurized dairy products from Healthy Family Farms stands in Los Angeles, Ventura and Santa Barbara counties, said Matthew Krasnowski, a district attorney spokesman. The products included unpasteurized goat milk, cheese and yogurt.
The arrests came the same week that federal and state health officials warned the public about a food-borne illness outbreak tied to ground turkey contaminated with antibiotic-resistant salmonella, an outbreak in which one Californian has died and 76 others have fallen ill so far.
It also marks the latest salvo in the government’s crackdown on unpasteurized dairy products.
In June 2010 investigators raided the Venice grocery store, seizing stacks of unmarked jugs of raw milk, cartons of raw goat and cow milk, and blocks of unpasteurized goat cheese, among other grocery items. Regulators alleged that Rawesome broke the law by failing to have the proper permits to sell food to the public.
Still, no arrests were made and Rawesome reopened the same week. Stewart said at the time that Rawesome didn’t need such permits because it wasn’t technically a retailer. He contended that the store was a private club whose members paid an annual fee and service charges to obtain products directly from farmers.
While the raid was taking place in Venice, another was occurring at Palmer’s Healthy Family Farms in Ventura County. There, California agriculture officials said, the farm owner’s milk processing plant had not met standards to obtain a license to sell raw milk or raw milk products. Shortly after the raid, Palmer was back in business.
Demand for all manner of raw foods has been growing, spurred by heightened interest in locally produced, unprocessed products.
But government regulators contend such products can be dangerous; there is scientific evidence linking disease outbreaks to raw milk. The milk can transmit bacteria, which can result in diarrhea, dangerously high fevers and in some cases death.
Raw milk, in particular, has drawn regulatory scrutiny, largely because the politically powerful dairy industry has pressed the government to act. It is legal for licensed dairies to sell raw milk at retail outlets in California, according to research by the National Conference of State Legislatures. But the number of such outlets has dwindled amid retailer concerns over potential litigation.
These unaccountable, unconstitutional federal agencies are out of control!
Seen any walnuts in your medicine cabinet lately? According to the Food and Drug Administration, that is precisely where you should find them. Because Diamond Foods made truthful claims about the health benefits of consuming walnuts that the FDA didn’t approve, it sent the company a letter declaring, “Your walnut products are drugs” — and “new drugs” at that — and, therefore, “they may not legally be marketed … in the United States without an approved new drug application.” The agency even threatened Diamond with “seizure” if it failed to comply.
Diamond’s transgression was to make “financial investments to educate the public and supply them with walnuts,” as William Faloon of Life Extension magazine put it. On its website and packaging, the company stated that the omega-3 fatty acids found in walnuts have been shown to have certain health benefits, including reduced risk of heart disease and some types of cancer. These claims, Faloon notes, are well supported by scientific research: “Life Extension has published 57 articles that describe the health benefits of walnuts”; and “The US National Library of Medicine database contains no fewer than 35 peer-reviewed published papers supporting a claim that ingesting walnuts improves vascular health and may reduce heart attack risk.”
This evidence was apparently not good enough for the FDA, which told Diamond that its walnuts were “misbranded” because the “product bears health claims that are not authorized by the FDA.”
The FDA’s letter continues: “We have determined that your walnut products are promoted for conditions that cause them to be drugs because these products are intended for use in the prevention, mitigation, and treatment of disease.” Furthermore, the products are also “misbranded” because they “are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes.” Who knew you had to have directions to eat walnuts?
“The FDA’s language,” Faloon writes, “resembles that of an out-of-control police state where tyranny [reigns] over rationality.” He adds:
This kind of bureaucratic tyranny sends a strong signal to the food industry not to innovate in a way that informs the public about foods that protect against disease. While consumers increasingly reach for healthier dietary choices, the federal government wants to deny food companies the ability to convey findings from scientific studies about their products.
Walnuts aren’t the only food whose health benefits the FDA has tried to suppress. Producers of pomegranate juice and green tea, among others, have felt the bureaucrats’ wrath whenever they have suggested that their products are good for people.
Meanwhile, Faloon points out, foods that have little to no redeeming value are advertised endlessly, often with dubious health claims attached. For example, Frito-Lay is permitted to make all kinds of claims about its fat-laden, fried products, including that Lay’s potato chips are “heart healthy.” Faloon concludes that “the FDA obviously does not want the public to discover that they can reduce their risk of age-related disease by consuming healthy foods. They prefer consumers only learn about mass-marketed garbage foods that shorten life span by increasing degenerative disease risk.”
Faloon thinks he knows why this is the case. First, by stifling competition from makers of more healthful alternatives, junk food manufacturers, who he says “heavily lobb[y]” the federal government for favorable treatment, will rake in ever greater profits. Second, by making it less likely that Americans will consume healthful foods, big pharmaceutical companies and medical device manufacturers stand to gain by selling more “expensive cardiac drugs, stents, and coronary bypass procedures” to those made ill by their diets.
But people are starting to fight back against the FDA’s tactics. “The makers of pomegranate juice, for example, have sued the FTC for censoring their First Amendment right to communicate scientific information to the public,” Faloon reports. Congress is also getting into the act with a bill, the Free Speech About Science Act (H.R. 1364), that, Faloon writes, “protects basic free speech rights, ends censorship of science, and enables the natural health products community to share peer-reviewed scientific findings with the public.”
Of course, if the Constitution were being followed as intended, none of this would be necessary. The FDA would not exist; but if it did, as a creation of Congress it would have no power to censor any speech whatsoever. If companies are making false claims about their products, the market will quickly punish them for it, and genuine fraud can be handled through the courts. In the absence of a government agency supposedly guaranteeing the safety of their food and drugs and the truthfulness of producers’ claims, consumers would become more discerning, as indeed they already are becoming despite the FDA’s attempts to prevent the dissemination of scientific research. Besides, as Faloon observed, “If anyone still thinks that federal agencies like the FDA protect the public, this proclamation that healthy foods are illegal drugs exposes the government’s sordid charade.”
An interagency working group, made up of the Federal Trade Commission (FTC), the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA), just released new regulations on the food industry: “a preliminary proposal for voluntary principles to guide industry self-regulatory efforts to improve the nutritional profile of foods marketed to children.”
Pretty catchy, I know.
According to this “preliminary proposal,” food manufacturers should “encourage children, through advertising and marketing, to choose foods that make a meaningful contribution to a healthful diet (Principle A) and minimize consumption of foods with significant amounts of nutrients that could have a negative impact on health or weight — specifically, sodium, saturated fat, trans fat, and added sugars (Principle B).”
That’s great. As a mother of three very young and seemingly perpetually hungry boys, I’m thrilled that I’ll be able to pass what was previously my job (monitoring and controlling what my kids eat) on to the food manufacturers. My children, inspired by these “new marketing techniques,” will finally fall in line and eat right! No longer will I have to argue with my four-year-old, who seems happy to live on a diet of buttered bread and popsicles, about the need to eat his peas. No longer will I have to tell my two-year-old that he has to “eat two more bites of his turkey sandwich before he can have a cookie.” And my one-year-old can just eat whatever healthy food falls on the floor. Good luck, kid.
What will I do with all this extra time and energy?
The Working Group also recommends that “as industry develops new products and reformulates existing products, it should strive to create foods that meet both of these two basic nutrition principles” (see Principles A and B above) and that “industry focus these efforts on those categories of foods that are most heavily marketed directly to children, such as breakfast cereals, carbonated beverages, restaurant foods and snack foods.”
Oh, that’s wonderful. I’m thrilled that these bureaucrats are working so hard to raise the prices on our groceries. There’s no doubt that these regulations will add to food costs as companies overhaul their products and marketing strategies to satisfy the feds. But, what’s a few more hundred dollars spent each month at the grocery store when, as the Working Group says, the “proposed principles, if fully implemented by industry for these categories, should lead to significant improvements in the overall nutritional profile of foods marketed to children” and will ultimately “improve children’s diets and health and address the epidemic of childhood obesity.”
Moms (and dads) know this is bunk. While these federal agencies join the White House in continuing to ignore the vital role of parents, moms and dads understand that this is just another government power grab to control and dictate what they eat (and more specifically how food companies do business). As usual with the Obama administration, the solution appears always to be with regulation, not trusting parents to make the right decision for their kids.
Helping kids eat well is just one of those things a parent has to do. It’s not always fun but neither is changing diapers. These unpleasant parenting tasks are part of the job. It’s high time the government stopped trying to rescue parents from their basic responsibilities.
Leave us alone and eat your peas!
The Nanny State has found one more area to stick their nose where it doesn’t belong.
I am a veteran of one hospital birth and two water births at home. For my first home water birth, I used a rented birth tub that was 5 feet in circumference. While I loved the buoyancy it provided, I discovered it was a bit too large for a short person like me.
For my second home water birth, I opted for a large feed trough because it was long and narrow and I could use the rails for support. We padded it with blankets and lined it with a huge plastic tarp before filling it with warm water. The weightlessness took the pressure off my back and enabled me to get into comfortable positions more easily.
The fact is, birth tubs are NOT “medical devices”. They are comfort measures to make labor and delivery more comfortable for the mother. During labor, I’ve used other comfort measure such as a hot shower, an exercise ball, hot compresses, and aromatherapy. I’ve known mothers who used a hot rice sock, massage, ice, soothing music, and other comfort measures. Should all these be confiscated and regulated as “medical devices”, as well?
According to Barbara Harper, author of Gentle Birth Choicesand founder of Waterbirth International, the FDA has seized a shipping container of AquaBorn birthing pools at a dock in Portland, Oregon, and have ordered agents to “inspect and destroy.”
“They claim they are unregistered medical equipment, but they are not providing a way or means to get them registered. In other words, if the medical authorities can’t stop waterbirth, then just have the FDA take away the birth pools,” she explains in a lengthy discussion that began yesterday.
While birth pools are imported to Canada under the category “paddling pools” and some are imported here in the U.S. under the category “sitz baths,” they have no legal standing as medical equipment at this time.
But why would they? They are often purchased or rented for personal use in private homes. Barbara’s conversation with an FDA official may shed some light on this as a clash of perspectives. She explains that she was told, “Pregnancy is an illness and birth is a medical event. Therefore, a pool that a woman gives birth in should be classified as medical equipment.” So what about our toilets, our bathtubs, our showers? Kiddie pools, horse troughs, hot tubs? Oh, and what about the fact that pregnancy is *not* an illness?
What the FDA Wants
Martha Blackmore Althouse, owner and manager of Waterbirth Solutions in Beaverton, Oregon, has been interacting with attorneys and the FDA on the issue. She explains:
The FDA is requiring a 510(k) – PreMarket Authorization – to be turned in for each Inflatable Birth Pool. The problem is that there is no Pre-existing Medical Device – “Predicate” – already approved by the FDA. Hence, potential of years of clinical trials and legal fees that can cost up to a million or more. Obviously not feasible.
One potential loop hole is a “PreAmendment Status” product. If there was anyone in the US using birth pools (yes, troughs, tubs of any kind) prior to May 1978, we can get “Birth Pools” grandfathered in to the FDA as an approved Medical Device. Waterbirth would have permanent legitimacy and could not be questioned any further.
So it seems that there could be a solution to this, but not before enduring a long process full of red tape and bureaucracy.
Carpenter maybe a liberal activist, but on this issue we can agree. The government has NO business interfering with women who are exercising their right to a safe, intervention-free home birth!
Don’t worry, America! The Nanny State is here to protect you from the big, bad Amish and their evil raw milk (or from yourself, if you’re a customer who wants the freedom to choose raw milk).
A yearlong sting operation, including aliases, a 5 a.m. surprise inspection and surreptitious purchases from an Amish farm in Pennsylvania, culminated in the federal government announcing this week that it has gone to court to stop Rainbow Acres Farm from selling its contraband to willing customers in the Washington area.
The product in question: unpasteurized milk.
It’s a battle that’s been going on behind the scenes for years, with natural foods advocates arguing that raw milk, as it’s also known, is healthier than the pasteurized product, while the Food and Drug Administration says raw milk can carry harmful bacteria such as salmonella, E. coli and listeria.
“It is the FDA’s position that raw milk should never be consumed,” said Tamara N. Ward, spokeswoman for the FDA, whose investigators have been looking into Rainbow Acres for months, and who finally last week filed a 10-page complaint in federal court in Pennsylvania seeking an order to stop the farm from shipping across state lines any more raw milk or dairy products made from it.
The farm’s owner, Dan Allgyer, didn’t respond to a message seeking comment, but his customers in the District of Columbia and Maryland were furious at what they said was government overreach.
“I look at this as the FDA is in cahoots with the large milk producers,” said Karin Edgett, a D.C. resident who buys directly from Rainbow Acres. “I don’t want the FDA and my tax dollars to go to shut down a farm that hasn’t had any complaints against it. They’re producing good food, and the consumers are extremely happy with it.”
The FDA’s actions stand in contrast to other areas where the Obama administration has said it will take a hands-off approach to violations of the law, including the use of medical marijuana in states that have approved it, and illegal-immigrant students and youths, whom the administration said recently will not be targets of their enforcement efforts.
Raw-milk devotees say pasteurization, the process of heating food to kill harmful organisms, eliminates good bacteria as well, and changes the taste and health benefits of the milk. Many raw-milk drinkers say they feel much healthier after changing over to it, and insist they should have the freedom of choice regarding their food.
Robert Scott Bell speaks at Nullify Now! Phoenix on natural health, healing, big-pharma, the FDA and how big government restricts our health and healing freedom.
Government-sanction medicine and the “Fear and Death Administration” (FDA) is killing us. If we are to move forward and live free, we need to start living healthy with or without federal permission.
Steve Forbes writes about yet another lethal “unintended consquence” of government regulation in his latest editorial:
Governments are notorious for lacking innovation, for being wedded to caution and routine. After all, if you take a risk and it doesn’t pan out, you could be raked over the political coals. A prime example of this stifling bureaucratic approach is the Food & Drug Administration, whose notoriety for making the approval of new drugs ever more expensive–with nothing to show in efficacy and safety–has been increasing over the years. The FDA’s behavior is no surprise to the organization’s watchers: Approve a medication that has an unintended side effect and congressional headline-seekers will be giving officials the third degree. Better to let people die by depriving them of new medicines than to be excoriated by the likes of McCarthyite demagogues such as Representative Henry Waxman (D-Calif.).
But this play-it-safe attitude–even at the expense of human lives–is creating a devastating and potentially far more deadly impact: The pipeline for new antibiotics is drying up. Since the 1940s the miracle of penicillin and its relatives has saved tens of millions of lives. Antibiotics easily conquered such illnesses as pneumonia and tuberculosis, which routinely killed countless numbers of people each year. Bacteria, of course, can become drug-resistant, but for decades pharmaceutical companies, especially in the U.S., routinely came up with new antibiotics to fell new killer germs. Now, however, the flow of new stuff has dried to a trickle.
Authorities are taking note of all this, as is the U.S. Congress. Henry Waxman has declared that the pharmaceutical industry’s failure to develop a reliable new class of antibiotics is an example of “market failure.” No it isn’t, Henry; it’s a failure of government regulation. The FDA has made clinical trials cost-prohibitive.
What does any would-be tyrant need in order to gain control over the lives of citizens? Three things come to mind: martial law, socialized medicine, and food dependency.
In at least two of these categories, President Obama has already succeeded.
By way of executive proclamation, President Obama has secured for himself the power to declare martial law in the event of a national “emergency,” real or contrived, and without the accountability typically required by the Posse Comitatus Act and the Nation Emergencies Act of 1976.
This is the legacy of the “conservative” Bush administration. National emergencies have now been transformed into power-grabbing devices thanks to the virtually unnoticed National Security Presidential Directive (NSPD) 51.
NSPD 51 empowers the president to co-opt all state and local government authority in the event that he declares a national emergency. This is a self-declared power not subjugated to the National Emergencies Act of 1976 as in previous directives.
President Obama quickly went beyond NSPD 51, signing an order creating a “Council of Governors” who would be put in charge of declaring martial law. The directive is in direct violation of Posse Comitatus and the Insurrection Act. This “Council of Governors” answers only to President Obama.
In October of last year, President Obama declared a national emergency in the midst of the much-hyped swine flu crisis. This declaration was largely overlooked. By combining his October declaration with the provisions of NSPD 51, President Obama can now be considered virtually uninhibited by Congress and free to flip the switch at any moment.
Whether or not Republicans achieve repeal, a precedent has been set. It is unlikely that the full damage of ObamaCare can be completely undone without Republican control of the White House. The U.S. government can now dictate the coverage and benefits of most Americans — i.e., those on Medicaid, Medicare, and SCHIP, which together account for thirty percent of the population. In addition, government can punish Americans without insurance with unconstitutional fees and fine employers who refuse to provide every single employee with premium health benefits, making economic recovery unlikely.
In previous articles, I have explained the deadly dimension to ObamaCare as currently construed, demonstrating the serious potential for the mass destruction of human life on the basis of erroneous factors like “hospital readmission.” Who will challenge federal officials with health care at stake? Who would seriously suggest that health care will not be used as a political weapon? When the government has all power and no accountability, it has very little reason to use that power responsibly. Accountability is what makes the American model work. But accountability is removed with ObamaCare.
The one area where elites have been so far reluctant to venture is food. Food is the stuff of life. Control over food would mean direct control over the political decisions of average Americans. The elites have slipped the slope, passing legislation that will give federal bureaucrats jurisdiction over food “production” — i.e., who produces food, what kinds of food are produced, and in what quantities. However, this is not a debate about food regulation or food inspection. What is taking place is in fact a coup d’état, with dinner tables as the strategic weapons.
The greatest tyrants in history have used food as a method of control. To state the obvious, people must eat to live. By controlling the flow of food to people who side with the political intelligentsia, rule is established. People may challenge tyranny when they have meat on the table. But who in their right mind would bite the hands of their benefactors (so called)?
Meet the Food Safety Modernization Act (FSMA), a new legislative proposal designed to centralize control over food stocks to protect Americans from “terror.”
The motive may indeed be to protect the food supply from the actions of terrorists, but what about acts of government terror? Can centralized control by the government protect the people against the whims of human nature? This question is not being asked by those so in favor of surrendering control of food to an entity that cannot even manage a budget, much less an oil spill or other natural disaster. Now we are to believe that this same inefficient, broken entity can guarantee the safety of our food? Something stinks, and it smells like government cheese. Usually when people ask for power, it is because they want power, regardless of the stated motive.
Even if the alleged motive were legitimate, the FDA already inspects food imports, albeit quite poorly. The federal government already possesses the necessary power to thwart terrorist contamination of the food supply. This proposal, then, is not really about protecting food, but instead about controlling food — and by extension, controlling Americans. We must resist while the fruits of the field are still here for the picking.
President Obama is willing to shut off the water in a small town in the heart of America’s agricultural center. Might he be willing to stop shipments of food to politically opposed states?
Last week, the Food and Drug Administration (FDA) revoked its regulatory approval of the drug Avastin to treat late stage, metastatic breast cancer. Each year, the practicing oncologists chosen by 17,500 American women to save them from their life-threatening, heavily progressed cancer prescribe Avastin to treat them.
The FDA explained that it was revoking approval of the drug for that use because it decided that the drug does not provide “a sufficient benefit in slowing disease progression to outweigh the significant risk to patients.” Risk? The drug is prescribed for women who are otherwise going to die from cancer unless the drug saves them at least for a time. The far greater risk to these women is from the FDA, not the drug.
As The Wall Street Journal said last Friday in response to the FDA’s explanation:
Ponder that [word] “sufficient.” The agency is substituting its own judgment about clinical meaningfulness for those of practicing oncologists and terminally ill cancer patients.
That FDA judgment was determined last summer by an internal agency panel of 13 experts, only two of whom were breast cancer oncologists, and none of whom were breast cancer patients.
Death Sentence for Mrs. Turnage?
Contrast the FDA’s elitist, authoritarian, Ruling Class explanation for its bureaucratic dictat with the real world experience of Mrs. Turnage, whose story was told in a New York Post commentary on December 15 entitled “Don’t Kill the Drug That Saved My Mom,” by her son Josh Turnage.
Mrs. Turnage is a “super responder” to Avastin, one of a minority of patients receiving the treatment for whom the drug is powerfully effective. Tumors shrink for about half of patients receiving Avastin. On average, patients taking the drug with chemotherapy experience twice as many days or months with no progression of their tumors as those not taking the drug. That means they live longer, on average a few months longer, with their families and friends. Whether that and the chance for much greater success as for Mrs. Turnage is worth it is for patients to decide, with the advice of their doctors, not government bureaucrats.
As Josh rightly says, “We’re talking about Stage IV cancer; the FDA should let patients and doctors decide if a medicine’s benefits are worth the risks.” That has been the tradition of freedom in America.
As Sally Pipes wrote at Forbes.com last week, “Government drug rationing isn’t going to stop at Avastin.” The FDA decision is a straw in the wind, indicating an ominous turn in American medicine, if doctors, patients, and the American people do not fight back.
The FDA’s decision means that Medicare and Medicaid will likely refuse to pay for the drug for breast cancer. These government programs do not pay for costly medicines where not FDA approved. This in turn provides the legal foundation for private insurance companies to now refuse payment for the treatment as well. They are not legally obligated to pay for costly therapies denied FDA approval and rejected by Medicare and Medicaid. Otherwise, they could be forced to pay for dances by Indian Medicine Men to cure cancer.
Ignorant liberals running your mouths about insurance company rationing, take note of how this works. No insurance company has the power to weigh costs against benefits, and tell you that your health if not your life is not worth the money. But the government has now arrogated to itself the power to do precisely that. That is the meaning of the Avastin decision.
The Senate unexpectedly approved food safety legislation by unanimous consent Sunday evening, rescuing a bill that floated in limbo for weeks because of a clerical error.
The Senate passed the Food Safety and Modernization Act on Nov. 30 by a vote of 73-25. But the bill was later invalidated by a technical objection because it was a revenue-raising measure that did not originate in the House — Senate staff had failed to substitute the food safety language into a House-originated bill.
A coalition of groups supporting the bill sent a letter Sunday to Senate Majority Leader Harry Reid (D-Nev.) and Republican Leader Mitch McConnell (Ky.) calling for action on food safety.
“Our organizations are writing to support attaching S. 510, the FDA Food Safety Modernization Act, to the Senate’s proposed short-term continuing resolution,” the groups wrote. “Strong food-safety legislation will reduce the risk of contamination and provide FDA with the resources and authorities the agency needs to help make prevention the focus of our food safety strategies.”
The American Public Health Association, the Center for Science in the Public Interest, Consumer Federation of America, Consumers Union and other groups signed the letter.
Democrats first attempted to attach the food safety bill to the two-and-a-half-month spending measure but Republicans balked because they wanted to keep that measure clean, according to Senate aides.
Republicans, however, later agreed to pass it by unanimous consent.
How did Americans get to the point where we allow an unelected, unconstitutional group of federal bureaucrats to actually decide who lives and dies by restricting access to potentially life-saving drugs? Our Founding Fathers are turning in their graves!
The Food and Drug Administration’s (FDA) announced yesterday that it would ration the late-stage cancer drug Avastin for breast cancer patients. (Ironically, the same day, the EU announced it would not ration access to Avastin.) The reaction to the FDA’s decision has been fierce:
Rep. Kay Granger: “For the 17,500 women across the country who rely on Avastin to survive, I am extremely disappointed the FDA has chosen to take away one of the very few options for the treatment of late-stage breast cancer. To make matters worse, this announcement comes on the same day that European drug regulators approved the continued use of Avastin for women with late-stage breast cancer. It is troubling that women in Germany and France will soon have access to a life-saving drug, while women in the U.S. will not. I will continue to work in the 112th Congress to ensure doctors and patients continue to have access to every available treatment option.”
Rep. Rodney Alexander: “As expected, the Obama administration has begun its process of rationing health care with its announcement to remove Avastin from the market for women suffering from metastatic breast cancer. Today’s decision to limit women’s access to a lifesaving treatment is amiss, and indicative of the frightful direction our health care system is headed. For the government to deny access to such a viable treatment is a severe intrusion into personal health care decisions that should be left between the patient and the doctor. Given that this drug helps over 17,000 patients manage their disease, it appears this move is merely based on cost cutting and rationing rather than on any real medical grounds. Avastin has extended the lives of thousands of individuals suffering from this devastating disease. Going forward, they will no longer be afforded that opportunity. This decision represents the first major example of things to come if components of the recent health care overhaul are allowed to continue. I will work with others in the incoming majority to restore the fundamentals of the U.S. health care system.”
Susan B. Komen Foundation for a Cure: Komen for the Cure’s president, Elizabeth Thompson said that the organization is concerned about the potential impact on women who are benefitting from Avastin if the FDA ultimately removes its approval for the drug for breast cancer treatment. “We want to be sure that women who are using Avastin, and for whom it is working, can continue to have access to it, that their insurers will continue to pay for it and that the drug’s manufacturer, Genentech/Roche, continues making the drug available to women through its patient support programs and considers an expanded access program.”
Sally Pipes, Pacific Research Institute: “The FDA claims its decision had nothing to do with Avastin’s cost and was based solely on the drug’s medical effectiveness. This isn’t believable. Every year about 40,000 American women die from breast cancer. Avastin is the last hope for many not to meet that fate. While the drug is costly, it often provides immense benefits to patients.”
Sen. David Vitter: “With this disappointing decision, the FDA has chosen to place itself between patients and their doctors by rationing access to a life-extending drug. We can’t allow this government takeover of health care to continue any further. I urge the FDA to consider any forthcoming appeals of this decision and immediately reverse course.”