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FDA Approves Civilian Use of New Medical Device to Treat Gunshot Wounds

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This is from OutDoor Hub.

This would be a great thing for every gun owner, hunter and gun range operator to have in their first aid kits.

outdoorhub-the-fda-just-approved-a-military-device-to-treat-civilian-gunshot-wounds-2015-12-09_20-57-33-880x587

Image from RevMedx

Military technology always spills over into the civilian market. We can thank the Department of Defense for countless innovations from the internet to the GPS you are probably use everyday.

Now a medical device, named the XSTAT 30 and designed to treat soldiers with gunshot wounds, has been approved for civilian use by the Food and Drug Administration (FDA).

The approval comes after being used by the military since 2013. The device works by injecting a number of small sponges into a wound. The sponges quickly absorb blood and then expand, providing hemostatic pressure on the wound to prevent further bleeding. The device is especially useful for wounds in areas that cannot easily be treated with a tourniquet.

According to the United States Army Institute of Surgical Research, 30 to 40 percent of civilian deaths by traumatic injury are the result of hemorrhaging, and 33 to 56 percent occur before the patient reaches a hospital.

This device could help prevent many of those deaths and it has applications for sportsmen as well. The XSTAT 30 would make a range first aid kit much better equipped and it would also be a welcome addition to a hunter’s pack.

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Pizza Industry Vows to Continue Fight Against Obamacare’s Onerous Menu Labeling Regulation

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This is from Town Hall.

I wonder if Moochelle contributed to these moronic food labels?

After all Moochelles dumb assed ideas have screwed up school lunches.

It is time to stop this labeling insanity before small businesses get destroyed.

It’s been a month since the Food and Drug Administration announced its final rule for menu labeling, a regulation that’s already proving to be a nightmare for the major chain restaurants and retail food establishments that must comply by Dec. 1, 2015, or face a stiff penalty.

“It got much worse in the final rule,” Lynn Liddle, chairperson of the American Pizza Community and executive VP of communications and investor relations for Domino’s Pizza, told Townhall. “I was surprised, disappointed, and befuddled because there’s all this new stuff in there where I go, ‘I don’t know how we’re gonna do this.’ … We’re gonna need a lot more time to untangle this mess, which I don’t think is viable or workable.”

While the regulation is bad for all industries, pizza has been hit particularly hard. For one, it’s a food industry unlike any other—90 percent of customers get their food delivered, making the idea of in-store displays of calorie information unnecessary and costly, not to mention extremely difficult since it’s such a customizable food.

Liddle said a concession was made on labeling by the slice rather than the whole pizza, but the rule is still disastrous for small businesses across America.

“[W]hat [FDA] did in these final rules is they expanded their definition of a menu and said ‘we’re gonna look at it and say anything a consumer will think of at that moment as a menu,’ so it’s very squishy right now because nobody really understands this thing because they’re saying if you have a picture or a name of a product, along with a price, were gonna call that a menu, so if you take it to the ridiculous that could include television advertising, because in the restaurant industry you always have a picture of product and a price, that’s how the restaurant industry advertises,” she explained.

“We went to [the FDA] with a proposed solution; we didn’t say ‘we want to get out of it,’ we said, ‘we have a better way’ … and that better way was primarily doing this electronically, which by the way we already do voluntarily, so it was a really workable solution … and basically they’ve ignored it,” she said.

While Domino’s is a major pizza chain across the country, the vast majority of stores are franchises, meaning the burden of implementation falls squarely on the backs of small business owners. And failure to have the appropriate signage or serving food that’s outside of the labeled calorie range can carry civil and criminal penalties, Liddle said, but specificity over how it will be policed and what the penalties are remains unclear.

Meanwhile, studies continue to show that menu labeling has little to no effect on consumers’ purchasing habits. In other words, despite the cost to small business owners across the country, menu labeling will have no significant impact on obesity in America, the purported benefit the FDA used to justify the law as part of the Affordable Care Act to begin with.

Liddle sees the rule as a way for its proponents to feel like they’ve done something that will be good for Americans. “I’ve seen a number of article and commentary from people … saying we need to tell people what to eat,” she said. “I think there’s this belief that … Americans can’t or won’t ever help themselves.”

“I don’t think slapping calorie ranges on a pizza menu board that no one looks at is gonna be any kind of a solution [for reducing obesity],” she continued.

It’s been a long road fighting against the rule since it first came out as part of the Affordable Care Act in 2010, and Liddle says she isn’t done yet.

“I don’t think I have the luxury to stop fighting against this because it’s hurting my small business franchisees … and it’s hurting the [entire] pizza industry with an additional cost their customers haven’t asked for,” she said.

“We’re going to keep pushing for solutions we think are most viable, and we’re encouraged because we have nearly 100 members of Congress that have supported our past legislation, so I think we have a lot of people with a lot of common sense on our side.”

 

Little help needed…

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Hat tip to Old NFO.

 

 

One of our community needs help for a family situation…

Hello my name is Jay (eatgrueldog.wordpress.com) I am trying to get a link to my nieces webpage into the community. She is 28 yrs. old and dying of liver failure. Her sister and husband are raising funds for her post hospital care and funeral expense. I know that you don’t know me but I am doing all that I can to help them out, otherwise I would never ask. I am not soliciting funds, only asking that you share the link to her page ; even a facebook share would help.  http://www.gofundme.com/5vz58w

Jay’s post is HERE.

Cross post if you are so inclined, and/or donate if you can.

This is one of those situations that truly sucks…

 

The Violent Side Effects of Antidepressants that Many Ignore (full)

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This is from JPFO.

This the second part of the medication story.

 

By Dr. Mercola, October 3rd, 2013
Article Source

 

In light of a long list of mass shootings over the past several years, the causative role of psychiatric drugs in violent events will undoubtedly have to be evaluated and addressed at some point. Personally, I’d vote for sooner, rather than later.

Antidepressants in particular have a well-established history of causing violent side effects, including suicide and homicide. In a recent Scientific American1 article, the author states:

“Once again, antidepressants have been linked to an episode of horrific violence. The New York Times2 reports that Aaron Alexis, who allegedly shot 12 people to death at a Navy facility in Washington, DC, earlier this week, received a prescription for the antidepressant trazodone3 in August.”

The drug in question, trazodone, has been associated with:4

“New or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement.”

The naval yard shooting is just the latest event to bring questions about prescription medications to the fore, but it bears noting that in this particular case no evidence has yet been released confirming that the shooter had the drug in his system at the time of the massacre.

Still, questions about the safety, or lack thereof, of antidepressants and other psychiatric drugs really need to be addressed regardless of whether they were instrumental in this particular case. Just last year, a Canadian judge ruled that a teenage boy murdered his friend because of the effects of Prozac.

When will such side effects be taken seriously? Just how many people have to kill themselves or others before a drug is considered too dangerous to be prescribed?

In a paper titled Antidepressants and Violence: Problems at the Interface of Medicine and Law,5 David Healy, a British professor of psychiatry at Cardiff University and an authority on side effects of psychiatric drugs, writes:

Legal systems are likely to continue to be faced with cases of violence associated with the use of psychotropic drugs, and it may fall to the courts to demand access to currently unavailable data. The problem is international and calls for an international response.”

 

Potential Side Effects of Antidepressants = Violence and Worsened Depression

In 2004, the US Food and Drug Administration (FDA) revised6 the labeling requirements for antidepressant medications (SSRI‘s and others), warning that:

“Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders.

Anyone considering the use of [Insert established name] or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need.”

These labeling revisions were in large part driven by lawsuits, in which pharmaceutical companies were forced to reveal previously undisclosed drug data.

For example, a civil lawsuit filed in 20047 charged GlaxoSmithKline (GSK) with fraud, claiming the drug manufacturer hid results from studies on Paxil showing the drug did not work in adolescents and in some cases led to suicidal ideation. Rather than warning doctors of such potential side effects, GSK actually encouraged them to prescribe the drug to teens and children.

According to DrugWatch.com,8 GSK has agreed to pay out more than $1 billion to settle more than 800 different lawsuits related to Paxil—and that’s over and above the $3 billion it agreed to pay to settle the Department of Justice’s investigation into illegal marketing of Paxil and other drugs!

In an effort to gather the necessary data on adverse side effects, Healy and other healthcare experts have formed an organization called RxISK.9 It’s a free, independent website where patients, doctors, and pharmacists can report side effects and research prescription drugs of all kinds. I’d encourage you to bookmark it and refer to it when needed.

 

Antidepressants and ADHD Drugs Top List of Most Violence-Inducing Drug

Please note that antidepressants are not the only type of drugs associated with violent, homicidal behavior, but they are among the most common suspects. A study10 by the Institute of Safe Medication Practices published in 2010 identified no less than 31 commonly-prescribed drugs that are disproportionately associated with cases of violent acts. Topping the list is the quit-smoking drug Chantix, followed by Prozac and Paxil, and drugs used to treat ADHD.

The data was collected from the FDA’s Adverse Event Reporting System (VAERS), and it’s well worth noting here that only an estimated one to 10 percent of all side effects are ever reported to VAERS, so the fact that more than 1,500 violent acts were actually reported as being linked to any given drug is pretty amazing. The vast majority of side effects, regardless of what they are, are typically blamed on something else and connections are brushed aside as “coincidental.”

In all, five of the top 10 most violence-inducing drugs were found to be antidepressants:

  • Fluoxetine (Prozac)
  • Paroxetine (Paxil)
  • Fluvoxamine (Luvox)
  • Venlafaxine (Effexor)
  • Desvenlafaxine (Pristiq)

According to Professor Healy, a study by the Drug Safety Research Unit in Southampton showed that one in every 250 subjects taking Paxil or Prozac were involved in a violent episode. In a study group of 25,000 people, this included 31 assaults and one homicide. In 2011, a whopping 14 million prescriptions for Paxil and more than 25.5 million prescriptions for Prozac were written.11 This could potentially equate to some 158,000 drug-induced incidents of violence annually from these two drugs alone. As reported in the featured article:12

“Another study involving more than 9,000 subjects taking the antidepressant paroxetine (Paxil) for depression and other disorders showed that subjects experienced more than twice as many ‘hostility events’ as subjects taking a placebo.” … Healy suspects that the main causal factor behind suicide and violence toward others is increased mental and/or physical agitation, which leads about five percent of subjects taking antidepressants to drop out of clinical trials, compared to only 0.5 percent of people on placebos.”

Another two in that top 10 list of violence-promoting drugs are commonly-prescribed ADHD medications (including Strattera). When you consider that antidepressants and ADHD drugs are among the most prescribed types of drugs13 in the US, the fact that so many of them are linked to increased rates of violence should be cause for pause. Besides an increased risk of violent episodes, ADHD drugs such as Ritalin, Vyvanse, Strattera, and Adderall (and their generic equivalents) are also responsible for nearly 23,000 emergency room visits annually, as of 2011 statistics. Over a mere six-year span, there’s been a 400 percent increase in ER visits due to side effects of these drugs.

 

Use Antipsychotic Medications with More Care, Psychiatrists Say

In related news,14 the American Psychiatric Association (APA) recently issued a statement urging doctors and patients to reconsider the practice of using anti-psychotic medications as the first line of treatment for:

  • Dementia in the elderly
  • Behavior problems in children, or
  • Insomnia in adults

The drugs in question include Risperdal, Zyprexa, Seroquel, and Abilify. APA’s recommendation with regards to anti-psychotic drug prescriptions is part of a larger campaign called Choosing Wisely,15 which covers a wide array of common medical practices that patients and doctors would do well to question, as they may cause more harm than good. Joel Yager, a psychiatry professor at the University of Colorado-Boulder, told USA Today:

“Doctors who overprescribe the medications are doing what they think might help, often without first trying safer or more effective alternatives.”

 

Key Factors to Overcoming Depression Without Drugs

It’s important to realize that your diet and general lifestyle are foundational factors that must be opitimized if you want to resolve your mental health issues, because your body and mind are so closely interrelated. Depression is indeed a very serious condition; however, it is not a “disease.” Rather, it’s a sign that your body and your life are out of balance.

Mounting and compelling research demonstrates just how interconnected your mental health is with your gastrointestinal health, for example. While many think of their brain as the organ in charge of their mental health, your gut may actually play a far more significant role. The drug treatments available today for depression are no better than they were 50 years ago. Clearly, we need a new approach, and diet is an obvious place to start.

Research tells us that the composition of your gut flora not only affects your physical health, but also has a significant impact on your brain function and mental state. Previous research has also shown that certain probiotics can even help alleviate anxiety16,17. The place to start is to return balance—to your body and your life. Fortunately, research confirms that there are safe and effective ways to address depression that do not involve unsafe drugs. These include:

  • Dramatically decrease your consumption of refined sugar (particularly fructose), grains, and processed foods. (In addition to being high in sugar and grains, processed foods also contain a variety of additives that can affect your brain function and mental state, especially MSG, and artificial sweeteners such as aspartame.) There’s a great book on this subject, The Sugar Blues, written by William Dufty more than 30 years ago, that delves into the topic of sugar and mental health in great detail.
  • Increase consumption of probiotic foods, such as fermented vegetables and kefir, to promote healthy gut flora. Mounting evidence tells us that having a healthy gut is profoundly important for both physical and mental health, and the latter can be severely impacted by an imbalance of intestinal bacteria.
  • Get adequate vitamin B12. Vitamin B12 deficiency can contribute to depression and affects one in four people.
  • Optimize your vitamin D levels, ideally through regular sun exposure. Vitamin D is very important for your mood. In one study, people with the lowest levels of vitamin D were found to be 11 times more prone to be depressed than those who had normal levels.18

    The best way to get vitamin D is through exposure to SUNSHINE, not swallowing a tablet. Remember, SAD (Seasonal Affective Disorder) is a type of depression that we know is related to sunshine deficiency, so it would make sense that the perfect way to optimize your vitamin D is through sun exposure, or a safe tanning bed if you don’t have regular access to the sun.

  • Get plenty of animal-based omega-3 fats. Many people don’t realize that their brain is 60 percent fat, but not just any fat. It is DHA, an animal based omega-3 fat which, along with EPA, is crucial for good brain function and mental health.19Unfortunately, most people don’t get enough from diet alone. Make sure you take a high-quality omega-3 fat, such as krill oil.

    Dr. Stoll, a Harvard psychiatrist, was one of the early leaders in compiling the evidence supporting the use of animal based omega-3 fats for the treatment of depression. He wrote an excellent book that details his experience in this area called The Omega-3 Connection.

  • Evaluate your salt intake. Sodium deficiency actually creates symptoms that are very much like those of depression. Make sure you do NOT use processed salt (regular table salt), however. You’ll want to use an all-natural, unprocessed salt like Himalayan salt, which contains more than 80 different micronutrients.
  • Get adequate daily exercise, which is one of the most effective strategies for preventing and overcoming depression. Studies on exercise as a treatment for depression have shown there is a strong correlation between improved mood and aerobic capacity. So there’s a growing acceptance that the mind-body connection is very real, and that maintaining good physical health can significantly lower your risk of developing depression in the first place.
  • Get adequate amounts of sleep. You can have the best diet and exercise program possible, but if you aren’t sleeping well you can easily become depressed. Sleep and depression are so intimately linked that a sleep disorder is actually part of the definition of the symptom complex that gives the label depression.

 

What the Future May Hold

A recent article in The Guardian20 suggests psychiatric drugs may soon be rendered obsolete, in favor of neurotechnology“No longer focused on developing pills, a huge research effort is now devoted to altering the function of specific neural circuits by physical intervention in the brain,” Vaughan Bell writes, noting that virtually all pharmaceutical companies have closed down or curtailed their research and development of new psychiatric drugs.

The latest “craze” in this field has instead been redirected toward the understanding—and manipulation—of neural networks, with the aim to modify behavior by stimulating specific brain circuits deep within your brain. Some of these procedures include the implanting of electrodes into the brain, for example. According to the article:

“Big money has already been committed. The Obama White House has promised $3 billion to develop technology to help identify brain circuits, while the National Institute of Mental Health has promised to move its seven-figure funding away from research into conditions such as schizophrenia and depression towards a system that looks at how brain networks contribute to difficulties that are shared across diagnoses. This project, given the unspectacular name Research Domain Criteria or the RdoC Project, is being cited as an eventual replacement for the diagnostic system used by current-day psychiatrists.”

One of the latest technologies in this area, called optogenetics, involves “injecting neurons with a benign virus that contains the genetic information for light-sensitive proteins.” As a result of this injection, your brain cells become light-sensitive, allowing them to be remotely controlled via flashes of light sent through fiber optic cables implanted into your brain.

“Let’s make this clear. The scientific revolution in identifying and manipulating brain circuits is already under way,” Vaughan writes. “… Advances in neuroscience are not just discoveries, they also shape, as they always have done, how we view ourselves. As the Prozac nation fades, the empire of the circuit-based human will rise…”

Whether or not this will actually make for happier, healthier, more balanced people is questionable, if you ask me. Yet this is what we may have to contend with in the future.

 

The Benefits of Energy Psychology

The Emotional Freedom Technique (EFT) is a form of psychological acupressure based on the same energy meridians used in traditional acupuncture to treat physical and emotional ailments for over 5,000 years, but without the invasiveness of needles. Instead, simple tapping with the fingertips is used to transfer kinetic energy onto specific meridians on your head and chest while you think about your specific problem — whether it is a traumatic event, an addiction, pain, anxiety, etc. — and voice positive affirmations.

This combination of tapping the energy meridians and voicing positive affirmation works to clear the “short-circuit”—the emotional block—from your body’s bioenergy system, thus restoring your mind and body’s balance, which is essential for optimal health and the healing of physical disease.

Some people are initially wary of these principles that EFT is based on — the electromagnetic energy that flows through the body and regulates our health is only recently becoming recognized in the West. Others are initially taken aback by (and sometimes amused by) the EFT tapping and affirmation methodology. But believe me when I say that, more than any traditional or alternative method I have used or researched, EFT has the most potential to literally work magic.

Clinical trials have shown that EFT is able to rapidly reduce the emotional impact of memories and incidents that trigger emotional distress. Once the distress is reduced or removed, the body can often rebalance itself, and accelerate healing. For example, one study involving 30 moderately to severely depressed college students showed significantly less depression than the control group when evaluated three weeks after receiving a total of four 90-minute EFT sessions.21

A study of 100 veterans with severe PTSD22 who participated in the Iraq Vets Stress Project showed an astounding reduction of symptoms after just six one-hour EFT sessions. After completing six sessions, 90 percent of the veterans had such a reduction in symptoms that they no longer met the clinical criteria for PTSD. Sixty percent no longer met PTSD criteria after only three EFT sessions. At the three-month follow-up, the gains remained stable, suggesting lasting and potentially permanent resolution of the problem.

In the following videos, EFT practitioner Julie Schiffman shows how you can use EFT to relieve your depression, anxiety, and panic attacks. But remember, most of the time one is placed on medication, there are serious emotional health challenges going on. It is imperative to recognize that doing EFT by yourself will likely not work for this problem. You need to be seen by an EFT professional who is experienced and can help guide you through the process Those who suffer from depression really should see a qualified EFT therapist.23

Important Concluding Thoughts

 

I know firsthand that depression is devastating. It takes a toll on the healthiest of families and can destroy lifelong friendships. Few things are harder in life than watching someone you love lose their sense of joy, hope, and purpose in life, and wonder if they will ever find it again. And to not have anything within your power that can change things for them. You wonder if you will ever have your loved one “back” again.

It’s impossible to impart the will to live to somebody who no longer possesses it. No amount of logic, reasoning, or reminders about all they have to live for will put a smile back on the face of a loved one masked by the black cloud of depression. I urge everyone to familiarize yourself with the most common warning signs of severe depression and suicide risk, and don’t hesitate to intervene if you recognize them in someone you know, and/or seek help if you experience them yourself.

There are times when a prescription drug may be helpful. But it’s unclear whether it is the drug providing benefits, or the unbelievable power of your mind that is convinced it is going to work. Studies have found that up to 75 percent of the benefits ofantidepressants can be duplicated by a placebo.

Oftentimes you cannot change your circumstances. You can, however, change your response to them. I encourage you to be balanced in your life. Don’t ignore your body’s warning signs that something needs to change. Sometimes people are so busy taking care of everybody else that they lose sight of themselves. If you have been personally affected by depression, my heart goes out to you. A broken body can be easier to fix than a broken mind. Depression is real. It is my hope that you don’t feel judged here, but that you are encouraged and inspired by those who have been there.

Sources and References:

1 Scientific American September 20, 2013
2 New York Times September 17, 2013
3 MedlinePlus, Trazodone
4 MedlinePlus, Trazodone
5 PLoS Med 3(9): e372
6 FDA.gov, Revisions to Product Labeling (PDF)
7 New York Times June 3, 2004
8 Drugwatch.com Paxil Lawsuits
9 RxISK.org
10 PLoS ONE 5(12): e15337
11 Psychcentral.com, Prescriptions for 2011
12 Scientific American September 20, 2013
13 CDC.gov, Therapeutic Drug Use
14 USAToday.com September 21, 2013
15 Choosingwisely.org
16 Neurogastroenterology and Motility 2011 Dec;23(12):1132-9
17 Proceedings of the National Academy of Sciences 2011 Sep 20;108(38):16050-5.
18 American Journal of Geriatric Psychiatry December 2006; 14(12): 1032-1040
19 Effects of Omega-3 Fatty Acids on Mental Health, Agency for Healthcare Research and Quality, Evidence Report/Technology Assessment: Number 116
20 The Guardian September 21, 2013
21 Brief Group Intervention Using EFT (Emotional Freedom Techniques) for Depression in College Students
22 Veterans Stress Project
23 EFTregister.com

 

FDA TO BAN ARTERY-CLOGGING TRANS FATS

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This is from Breitbarts Big Government.

Here is a prime example of the Obama nanny state

over reach.

How much of a price increase will we see?

How will this change affect the taste and the shelf life of food?

 

WASHINGTON
Heart-clogging trans fats have been slowly disappearing from grocery aisles and restaurant menus in the last decade. Now, the Food and Drug Administration is finishing the job.

The FDA announced Thursday it will require the food industry to gradually phase out artificial trans fats, saying they are a threat to people’s health. Commissioner Margaret Hamburg said the move could prevent 20,000 heart attacks and 7,000 deaths each year.

Hamburg said that while the amount of trans fats in the country’s diet has declined dramatically in the last decade, they “remain an area of significant public health concern.” The trans fats have long been criticized by nutritionists, and New York City and other local governments have banned them.

The agency isn’t yet setting a timeline for the phase-out, but it will collect comments for two months before officials determine how long it will take. Different foods may have different timelines, depending how easy it is to find a substitute.

“We want to do it in a way that doesn’t unduly disrupt markets,” said Michael Taylor, FDA’s deputy commissioner for foods. Still, he says, the food “industry has demonstrated that it is, by and large, feasible to do.”

Though they have been removed from many items, the fats are still found in processed foods, including in some microwave popcorns and frozen pizzas, refrigerated doughs, cookies, biscuits and ready-to-use frostings. They are also sometimes used by restaurants that use the fats for frying. Many larger chains have phased them out, but smaller restaurants may still get food containing trans fats from suppliers.

Trans fats are widely considered the worst kind for your heart, even worse than saturated fats, which also can contribute to heart disease. Trans fats are used both in processed food and in restaurants, often to improve the texture, shelf life or flavor of foods. Diners shouldn’t be able to detect a taste difference if trans fats are replaced by other fats.

To phase them out, the FDA said it had made a preliminary determination that trans fats no longer fall in the agency’s “generally recognized as safe” category, which is reserved for thousands of additives that manufacturers can add to foods without FDA review. Once trans fats are off the list, anyone who wants to use them would have to petition the agency for a regulation allowing it, and that would likely not be approved.

The fats are created when hydrogen is added to vegetable oil to make it more solid, which is why they are often called partially hydrogenated oils. The FDA is not targeting small amounts of trans fats that occur naturally in some meat and dairy products, because they would be too difficult to remove and aren’t considered a major public health threat on their own.

Scientists say there are no health benefits to trans fats and say they can raise levels of so-called “bad” cholesterol, increasing the risk of heart disease _ the leading cause of death in the United States.

Many companies have already phased out trans fats, prompted by new nutrition labels introduced by FDA in 2006 that list trans fats and an by an increasing number of local laws that have banned them. In 2011, Wal Mart pledged to remove all artificial trans fats from the foods the company sells by 2016.

As a result of the local and federal efforts and many companies’ willingness to remove them, consumers have slowly eaten fewer of the fats. According to the FDA, trans fat intake among American consumers declined from 4.6 grams per day in 2003 to around one gram per day in 2012.

Dr. Leon Bruner, chief scientist at the Grocery Manufacturers Association, said in a statement his group estimates that food manufacturers have voluntarily lowered the amount of trans fats in food products by 73 percent.

The group, which represents the country’s largest food companies, did not speculate on a reasonable timeline or speak to how difficult the move may be for some manufacturers. Bruner said in a statement that “consumers can be confident that their food is safe, and we look forward to working with the FDA to better understand their concerns and how our industry can better serve consumers.”

FDA officials say they have been working on trans fat issues for around 15 years _ the first goal was to label them _ and have been collecting data to justify a possible phase-out since just after President Barack Obama came into office in 2009.

The advocacy group Center for Science in the Public Interest first petitioned FDA to ban trans fats nine years ago. The group’s director, Michael Jacobson, says the move is “one of the most important lifesaving actions the FDA could take.”

He says the agency should try to move quickly as it determines a timeline.

“Six months or a year should be more than enough time, especially considering that companies have had a decade to figure out what to do,” Jacobson said.

 

DEA Warns Federal Shutdown Will Lead to Resurgence of Illegal Lemonade Stands

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This is from Girls Just Wanna Have Guns.

THE FOLLOWING ARTICLE IS SATIRE:

Washington DC– In the wake of the shut down of the Federal Government, DEA officials warn the public of the impending resurgence of illegal lemonade stands. Reports of children as young as five years old selling lemonade on street corners all across the country have been pouring in ever since the shut down of the federal government. Officials warn that, if gone unchecked, these stands will engulf every street corner in every suburb across the country.

Using children as underage laborers, these stands make hundreds of dollars every year in non taxable income. Illegal lemonade is, of course, an all cash business, making the flow of the money very difficult to trace. While authorities are unsure, it is estimated that over one thousand dollars of illegal lemonade were purchased in the last week alone, and that anywhere from 300-500 children in any given city are involved in the manufacturing and distribution of illegal lemonade.

FDA Commissioner Margaret Hamburg told reporters today that these illegal stands contribute to one of America’s most dangerous black markets, and that “immediate action must be taken to keep this scourge off the streets”.

“Not only do these illegal lemonade stands violate minimum wage laws, they violate child labor laws, and health codes as well. We don’t know what are in these toxic concoctions. There can be as much as 20 grams of sugar per cup, and this street lemonade is almost always made by children under ten years old in unsanitary conditions. There have even been reports of lemonades being sold in quantities over sixteen ounces.”

In a harrowing study commissioned by the DEA, researchers outline the structure of the underground lemonade market and study the unintended consequences of illegal street lemonade.

“Not only are children forced to make these drinks, but children are the target market as well. These lemonade pushers will set up near suburban areas, parks, and playgrounds where they know they can find kids, and get them hooked. While the first glass may cost only twenty-five cents, lemonade pushers know once they can get a child to try it once, they’ve got a customer for life. Soon these kids will become so dependent on the saccharine drinks that they will go into the illegal manufacturing of lemonade themselves, thereby perpetuating the circle of abuse and addiction.

Street lemonade has become such an epidemic, that the DEA has set up an entire branch just to deal with street corner lemonade stands. When interviewed, an anonymous DEA agent told reporters that before the shut down, the DEA staffed almost three thousand armed agents to investigate and prosecute lemonade related offenses. However, since the federal government shut down, the DEA has had to rely solely on volunteers and vigilantes to help curb street sales of illegal lemonade.

“We’ve been working around the clock to try and keep this garbage off of the streets. Thankfully we’ve had some volunteer support from local busy bodies and control freaks, but it just isn’t enough to stop the organized juggernaut of street lemonade.”

While it is an uphill battle, authorities have made some encouraging progress in stopping the flow of illegal lemonade since the shutdown. In a raid conducted tuesday in a small DC suburb, authorities were able to confiscate over four kilos of uncut South American cane sugar, over 10 bags of Quicktime lemonade mix, and almost forty-five dollars in marked bills. Three area elementary school students have been taken into custody awaiting a trial.

“We need to send a message to people everywhere that if you want to sell lemonade on the streets, the government is watching you, and we will catch you.”
Read more at http://girlsjustwannahaveguns.com/2013/10/dea-warns-federal-shutdown-will-lead-resurgence-illegal-lemonade-stands/#GAHIAc4Sp7tUl7QC.99

My Daughter Died From the Abortion Drug 10 Years Ago Today

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This is from Life News.

These are the stories the Obama Media will not carry.

As it does not promote the pro abortion template.

Obama is worried about the children of Syria being killed.

What about the thousand’s murdered by abortion each day?

The U.S. Supreme Court recently accepted a case Cline v. Oklahoma Coalition for Reproductive Justice, challenging Oklahoma’s regulation of the abortion drug Mifeprex commonly known as mifepristone, RU-486, or The Abortion Pill.​

The case is an appeal by the state of Oklahoma from a ruling by its Supreme Court striking down a 2011 law that requires prescribing physicians to follow the FDA’s protocol for administering the Mifeprex abortion pill regimen using a combination of two drugs; mifepristone and misoprostol.

The Oklahoma law does not ban the use of the Mifeprex regimen, nor does it ban any abortion before or after 49 days gestation. It simply requires that the medical abortion regimen be administered in the way deemed safest by the FDA. The Act imposes no obstacle or undue burden to women seeking access to an abortion.

Monty Patterson’s Participation in the Case

As part of this Supreme Court case, I submitted an “Affidavit of Monty Patterson, father of Holly Patterson” in support of the “Brief of Women and Families Hurt by RU-486.”

My daughter, Holly Patterson, tragically died in 2003, seven days after the initial start of her 7-week-old pregnancy termination from a massive infection known as Clostridium sordellii toxic shock syndrome that was associated with a medically induced abortion.

Planned Parenthood prescribed my teenage daughter an unapproved, off-label RU-486 medical abortion regimen touted to be equally as safe an effective as the FDA protocol. Holly, barely 18-years-old, took advice from her provider and was persuaded to choose their alternative medical abortion regimen.

Holly did not receive accurate and truthful information concerning medical abortion in order to make an informed decision about her safe reproductive healthcare.

Since my daughter’s death, I have researched and studied the risks of mifepristone and misoprostol medical abortion and have built an educational website http://abortionpillrisks.org/ that discusses and details the facts that reveal significant safety concerns for women who consider an early pregnancy termination.

In the past 13 years, since FDA approval of RU-486, there have been an alarming number of serious health complications and injuries to women, including death.

The FDA has evaluated these injuries and deaths and publicly reported the off-label uses of the Mifeprex regimen has resulted in serious or sometimes fatal adverse events.

Personally, I do not believe any medical abortion pill regimen using mifepristone and misprostol to terminate early pregnancy is safe.

My focus is not to be pulled into the larger national abortion debate that has divided the United States into pro-choice and pro-life camps.

The United States Supreme Court has made it landmark decision on the issue of abortion. Women have certain legal rights to access and reproductive health care choices under the law.

With the legalization of abortion, a woman and her family should therefore be entitled to all the facts and risks to properly make informed decisions that are in their best interest, safety, health and welfare. This includes the choice of medical abortion with the drug regimen of mifepristone and misoprostol.

Abortion providers are promoting the use of unapproved off-label medical abortion regimens that may not have received the same degree of scientific scrutiny as the FDA approved mifepristone protocol. This problem needs to be addressed.

I have made it my focus to help educate women, families, researchers, even health care professionals to become informed of the facts and health risks of medical abortion to terminate an early pregnancy.

Significant issues of concern to me are: What are acceptable medical abortion practices? How are medical abortion providers exposing women to unnecessary health risks to already a potentially dangerous procedure?

The issue of legalized medical abortion should not be in question, but the issues of safe medical abortion protocol(s) and practices remain to be answered.

Off-Label Loopholes and Practices

Special interest groups and abortion providers have been taking advantage of huge loopholes in our drug regulatory system. Once medical abortion was approved by the FDA in 2000 and put on the market, there is absolutely nothing to prevent any abortion provider from using an alternative drug regimen in any manner, in any dose, for any patient he or she chooses. The drug’s labeling contains the indications approved by the FDA and these alternative uses are called “off-label” use of drugs.

Medical Abortion advocates contend that “doctors use drugs off-label all the time!” Organizations like Planned Parenthood are taking matters into their own hands when it comes to the use of medical abortion with mifepristone and misoprostol on their women patients. Sometimes these patients are teenage adolescents as young as 14 years old.

Common off-label usage of drugs in general does not prove it is a good idea, especially where safe medical abortion practices are critical to a woman’s health. Should medical abortion providers continue to promote their off-label prescribing as they continue to gain more confidence in what has been a serious mistake resulting in thousands of injuries and at least 14 deaths?

Medical abortion advocates claim off-label uses are not considered experimental to patients because their regimens have been “demonstrated by scientific research to be safer and more effective.”

Who makes the decisions if the medical abortion industry-sponsored research is sound scientific evidence? Who are these scientific bodies? Is it an organization of professionals trying to protect the special interests of their members?

Medical abortion providers using unapproved off-label regimens represents both a cavalier disregard for the safety of women and a total lack of faith in the U.S. Food and Drug Administration’s drug regulatory system.

Isn’t the whole purpose of FDA approved on-label use to provide assurances to the patient there is sound scientific evidence?

Providers Ignore FDA Public Health Advisories

The argument that the approved FDA protocol is an “old guideline” and considered to be “bad medicine” does not appear to be embraced by FDA officials.

The FDA has published Mifeprex “Public Health Advisories” when women have been seriously injured or suffer fatal consequences as a result of Mifeprex off-label medical abortion practice. These advisories state that the safety and effectiveness of other Mifeprex dosing regimens, including use of oral misoprostol tablets intra-vaginally has not been recognized or accepted by the FDA.

The FDA continues to stand by the Mifeprex protocol they evaluated and publicly remind abortion health care professionals of the approved Mifeprex dosing regimen.

Medical abortion practitioners continue to ignore every FDA Public Health Advisory. They continue to use modified regimens, by increasing the gestational age limit, shortening the process, decreasing their costs, changing the dosing regimen, decreasing physician oversight by allowing women to administer misoprostol at home (instead of at the provider’s clinic) and reducing the number of patient’s return visits back to the clinic. Some practitioners advise their patients to repeat misoprostol dosing to try to improve on abortion success rates.

These practitioners have turned their off-label regimens into  the “Do it Yourself” at home procedure where women are shouldering the responsibility for their own health, safety and well-being.

Making The Case For Safety

Medical abortion rights advocates are trying to make the case that off-label regimens are a safety improvement over the current FDA protocol. They oppose any action where providers may be required to prescribe three-times-more Mifeprex, essential for pregnancy termination, than they think is called for. No matter if it violates FDA approved protocol.

What about the off-label prescribing of the second drug misoprostol?

Is it considered a safety improvement for abortion providers to double the dose of buccal or vaginally administered misoprostol to further induce labor and increase contractions to expel the embryo and placental tissues? Further, additional doses of misoprostol may be prescribed for incomplete abortion complications.

Misoprostol carries its own boxed warnings, but they can’t be found in the Mifeprex drug labeling or the Patient Agreement and Medication Guide. Why aren’t providers informing women about uterine rupture that has been reported when misoprostol is administered to induce labor beyond the eighth week of pregnancy?

Providers have increased medical abortion gestation age limits from 7 weeks to 9 weeks to make it available to more women. Is that another safety improvement?

Mifeprex is being prescribed at a 1/3 reduced dose because medical abortion providers understand the cost benefits of misoprostol over Mifeprex. Mifeprex is expensive but misoprostol is a very cheap and readily available. To increase profits, misoprostol is used by providers as the predominant abortifacient agent in the regimen (not mifepristone) to terminate early pregnancy.

Medical evidence points to the fact that off-label uses of Mifeprex have resulted in more serious adverse health events, including death, than the FDA-approved regimen.

Medical abortion rights advocates claim this action is about punishment and discrimination against women who seek Mifeprex to induce medical abortion. Did the FDA have that in mind when they approved the drug sponsor’s application for distribution and prescribing of Mifeprex?

The off-label prescribing of medical abortion drug regimens has resulted in disastrous health consequences for thousands of women. Every recorded U.S. death, as in the case of Holly Patterson, has been a result of off-label Mifeprex and misoprostol use to terminate early pregnancy.

Medical abortion can be an unpredictable and dangerous alternative, especially when abortion providers choose to ignore and circumvent the FDA approved protocol.

Medical Opinion Or Evidence?

FDA’s approval of mifepristone is supposed to be based on controlled studies and independent analysis of data by qualified doctors and scientists designated to review and monitor clinical medical research.

If abortion researchers and providers believe they have regimens that are “safer and more effective” than the one approved by the FDA in 2000, then they should submit them to the U.S. Food and Drug Administration, along with their unbiased and so-called “evidence-based” studies, for rigorous FDA review and evaluation. Obviously, they haven’t, and don’t intend to do so.

After all, shouldn’t women deserve quality information to ensure the medical community has all of the available facts on which to base medical abortion treatment decisions that aren’t biased, industry-sponsored and motivated by profit and market expansion?

If medical abortion advocates, providers, and their researchers were really looking out for the best interest of women’s reproductive health care, this contentious debate requiring a U.S. Supreme Court decision may have been avoided.

 

 

Abortion Drug RU 486 Has Killed Two Million Unborn Children in the U.S.

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This is from Life News.

If it isn’t the Kermit Gosnell‘s of the world murdering babies and killing women.

It is now some pill that is murdering babies and hurting and killing women.

Proverbs 6:16-17

King James Version (KJV)

16 These six things doth the Lord hate: yea, seven are an abomination unto him:

17 A proud look, a lying tongue, and hands that shed innocent blood,

 

The dangerous RU 486 abortion drug has nearly claimed the lives of two million unborn children in the United States since its approval at the end of the Clinton administration.

The Food and Drug Administration, which approved the drug in late 1999, estimated in April 2011 that 1.52 million American women had taken RU-486 to induce an abortion. According to CDC reports, about 16.5 percent of the estimated 1.2 million abortions that take place annually in the United States involve the mifepristone drug, commonly known as RU 486.

In other words, about 198,000 abortions take place each year with the drug, or 16,500 each month, and the RU 486 drug has claimed the lives of approximately 462,000 unborn children in the 28 months since the FDA released its April 2011 estimate — for a total of 1,982,000 abortions. With the Planned Parenthood abortion business pushing increased usage of the mifepristone abortion pill via webcam abortions over the last few years, it’s likely the number of two million abortions involving the RU 486 abortion pill since its approval in the U.S. has already been surpassed.

In addition to the number of unborn children whose lives have been lost to the abortion drug, women have suffered as well, as a Planned Parenthood study admitsat least one woman is seriously injured from the abortion pill daily.

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.

The FDA, with no fanfare, released its April 2011 report showing 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 stated.

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 at that time.

An FDA panel eventually investigated the deaths and found that the vaginal, rather than oral, use of the abortion drug was likely contributing to the deaths. Planned Parenthood had been going against the FDA guidelines on using the abortion drug and changed its protocols to allow for oral use after women died at their facilities.

In 2012, Chris Gacek, who received a Bachelors of Science in economics from the Wharton School, University of Pennsylvania, a Masters and Ph.D. in political science from Stanford University, and a J.D. from the University of Virginia School of Lawauthored a comprehensive report on mifepristone.

On the unsafe effects of RU 486 for women:

Dr. Ralph Miech, emeritus professor at Brown University’s medical school, has published two peer-reviewed articles describing potentially undesirable effects related to RU-486 and its anti-glucocorticoid properties.[8] First, he believes that RU-486′s blockade of cortisol receptors on bacteria-destroying white blood cells may impede the antibacterial defense mechanism of the innate immune system. Such interference, he hypothesizes, played a significant role in the deaths of at least five North Americans in which there was a post abortion, bacterial invasion of the uterus and subsequent septic shock.[9] Second, prompted by an article describing mifepristone-related adverse events with significant and unexpected levels of hemorrhage, Miech’s second article argues that RU-486 appears to interfere with the body’s ability to control uterine hemorrhage.[10] Such interference, if true, would be a dangerous feature of an abortion procedure that is designed to produce a simulated miscarriage. As will be noted below, the number of hemorrhage/transfusion and serious infection cases revealed by FDA support Miech’s concern about RU-486 and hemorrhage.

Looking at specific cases of the abortion drug hurting women:

FDA’s April 2011 RU-486 Adverse Events Summary states that “[t]he estimated number of women who have used mifepristone in the US through the end of April 2011 is approximately 1.52 million women.” As noted above, FDA calculated that by that date there had been 2,207 adverse event reports submitted to FDA.[25] Prior to a 2006 oversight hearing on RU-486 safety, FDA told Rep. Mark Souder (R-Ind.) that it had received 1,070 AERs.[26] Thus, in the second five years of mifepristone marketing in the United States, the FDA received an additional 1,137 AERs-a total which seems consistent with the first five years.

The April 2011 RU-486 Adverse Events Summary states that there were 612 reports of hospitalization received as of April 30, 2011.

FDA’s April 2011 RU-486 Adverse Events Summary indicates that 339 women “experienced blood loss requiring a transfusion” after taking the RU-486 abortion regimen.

By April 2011 FDA had fifty-eight reports of ectopic pregnancy cases – with two resulting in death – in conjunction with mifepristone-misoprostol use.

In the April 2011 RU-486 Adverse Events Summary FDA associated fourteen American deaths to the use of the mifepristone-misoprostol abortion regimen.

And, according to a study on medical abortion’s safety and effectiveness published in Obstetrics & Gynecology and that Gacek noted, the abortion drug is more dangerous for women than surgical abortions:

“Overall, medical abortion had roughly four times the rate of adverse events than surgical abortion did: 20.0% of women in the medical-abortion group and 5.6% of women in the surgical-abortion group had at least one type of adverse event.  Hemorrhage, as an adverse event, was experienced by 15.6% of medical abortion patients compared with 2.1% for surgical patients. Incomplete abortions were experienced by 6.7% of medical abortion patients while only 1.6% of surgical patients had incomplete abortions. The rate for surgical (re)evacuation of the uterus was 5.9% (medical) versus 1.8% (surgical) for all causes (hemorrhage, infection, incomplete abortion).

Supermarkets cry foul as FDA proposes new food labeling rule under ObamaCare

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This is from Fox News Politics.

You thought Obamacare was to make medical treatment free.

Now we know Obamacare will cause higher prices and higher taxes.

Now we know Obamacare will mean higher insurance premiums.

Obamacare will also cause raising food prices due to new labeling rules.

 

 

Supermarket owners argue a pending federal food-labeling rule that stems from the new health care law would overburden thousands of grocers and convenience store owners — to the tune of $1 billion in the first year alone.

Store owner Tom Heinen said the industry’s profit margins already are razor thin. “When you incur a significant cost, there is no way that that doesn’t get passed on to the customer in some form,” he said.

The rule stems from an ObamaCare mandate that restaurants provide nutrition information on menus. Most in the restaurant industry were supportive of the idea, but when the FDA decided to extend the provision to also affect thousands of supermarkets and convenience stores, the backlash was swift.

The proposed regulation would require store owners to label prepared, unpackaged foods found in salad bars and food bars, soups and bakery items. Erik Lieberman, regulatory counsel at the Food Marketing Institute, said testing foods for nutritional data will require either expensive software or even more costly off-site laboratory assessments.

Lieberman said failure to get it right comes with stiff penalties: “If you get it wrong, it’s a federal crime, and you could face jail time and thousands of dollars worth of fines.”

The FDA says much of ObamaCare is aimed at helping Americans live healthier lives, and these proposed labeling requirements would help them do just that. In the text of the proposed regulation, the FDA states: “[The information] should help consumers limit excess calorie intake and understand how the foods that they purchase at these establishments fit within their daily caloric and other nutritional needs.”

An Executive Order issued by President Obama in 2011 says agencies are supposed to calculate a cost-benefit analysis for each new regulation and attempt to use the least burdensome regulatory methods possible. Critics of the FDA’s food labeling proposal say the agency didn’t comply.

“They are required to do it, and they didn’t,” Lieberman said. “They simply said, ‘We can’t quantify a benefit from this rule,’ and that’s because they really can’t.”

The FDA said Wednesday it has received hundreds of public comments on the proposal and will take them into consideration when finalizing the regulation. It is likely to be released later this spring, and the agency says it will “include a final economic analysis.”

Read more: http://www.foxnews.com/politics/2013/02/06/jail-time-for-food-labels/#ixzz2L64MrTs1

 

If the Food and Drug Administration gets its way, your trip to the grocery store could get a tad pricier.

Supermarket owners argue a pending federal food-labeling rule that stems from the new health care law would overburden thousands of grocers and convenience store owners — to the tune of $1 billion in the first year alone.

Store owner Tom Heinen said the industry’s profit margins already are razor thin. “When you incur a significant cost, there is no way that that doesn’t get passed on to the customer in some form,” he said.

The rule stems from an ObamaCare mandate that restaurants provide nutrition information on menus. Most in the restaurant industry were supportive of the idea, but when the FDA decided to extend the provision to also affect thousands of supermarkets and convenience stores, the backlash was swift.

The proposed regulation would require store owners to label prepared, unpackaged foods found in salad bars and food bars, soups and bakery items. Erik Lieberman, regulatory counsel at the Food Marketing Institute, said testing foods for nutritional data will require either expensive software or even more costly off-site laboratory assessments.

Lieberman said failure to get it right comes with stiff penalties: “If you get it wrong, it’s a federal crime, and you could face jail time and thousands of dollars worth of fines.”

The FDA says much of ObamaCare is aimed at helping Americans live healthier lives, and these proposed labeling requirements would help them do just that. In the text of the proposed regulation, the FDA states: “[The information] should help consumers limit excess calorie intake and understand how the foods that they purchase at these establishments fit within their daily caloric and other nutritional needs.”

An Executive Order issued by President Obama in 2011 says agencies are supposed to calculate a cost-benefit analysis for each new regulation and attempt to use the least burdensome regulatory methods possible. Critics of the FDA’s food labeling proposal say the agency didn’t comply.

“They are required to do it, and they didn’t,” Lieberman said. “They simply said, ‘We can’t quantify a benefit from this rule,’ and that’s because they really can’t.”

The FDA said Wednesday it has received hundreds of public comments on the proposal and will take them into consideration when finalizing the regulation. It is likely to be released later this spring, and the agency says it will “include a final economic analysis.”
Read more: http://www.foxnews.com/politics/2013/02/06/jail-time-for-food-labels/#ixzz2L64MrTs1

 

 

Obamacare May Hike Your Pet’s Health Care Bills

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This is from the Heritage Foundation‘s The Foundry.

Obamacare is going to screw us over in ways never imagined.

We are going to see jobs lost and doctor’s offices closing.

Once more time I will say elections have consequences.

 

 

American health care consumers aren’t the only ones who will be hit by slated Obamacare tax hikes. Medical bills for their pets may go up as well.

According to a rule published Friday by the Internal Revenue Service, some medical devices used in veterinary practices will be hit by Obamacare’s 2.3 percent device tax. Many of their manufacturers are expected to hike prices, meaning higher veterinary costs for the nation’s pet owners.

The tax will not hit devices that are used exclusively for veterinary purposes. But a host of such devices are manufactured for use in both human health care and veterinary practices. Those devices’ manufacturers will have to pay the tax.

The IRS rule states:

Section 4191 [of the Internal Revenue Code] limits the definition of a taxable medical device to devices described in section 201(h) of the [Federal Food, Drug, and Cosmetic Act] that are intended for humans, but does not provide that the device must be intended exclusively for humans. Under existing [Food and Drug Administration] regulations, a device intended for use exclusively in veterinary medicine is not required to be listed as a device with the FDA, whereas a device intended for use in human medicine is required to be listed as a device with the FDA even if the device may also be used in veterinary medicine.

According to the FDA, common “dual use” medical devices are “examination gloves, sterile catheters, infusion pumps, etc.”

The device tax is expected to raise costs for consumers. A recent survey of 181 manufacturers found that a 52.5 percent majority plan to “pass along some or all of the increased cost [of the tax] to our consumers.” Among North American manufacturers, the portion who said they would raise prices was an even higher 58 percent.

“Across the board there is bigger inclination among firms to raise prices and pass on costs to customers as a way to deal with the US tax,” the survey found.

Pet owners already spend more than $12 billion on veterinary care annually. Obamacare may make it even more expensive to care for your pet.

 

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