Tag Archive: FDA

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Health Impact News


by Barbara Loe Fisher
National Vaccine Information Center

Following is a public comment made by Barbara Loe Fisher, NVIC Co-founder & President, at the Nov. 13, 2015 meeting of the FDA Vaccines & Related Biological Products Advisory Committee (VRBPAC) on proposed changes to FDA requirements for licensure of vaccines intended for use during pregnancy

Birth defects, chromosomal damage, premature birth, low birth weight, pregnancy complications and sudden infant death syndrome, not infectious diseases, are the leading causes of death for about 23,000 infants dying before their first birthday in the US every year, with half of those deaths occurring on the first day of life. 1   2  Women getting pregnant and delivering babies in America today have more than twice the risk of dying during pregnancy, childbirth or within one year of giving birth than they did three decades ago, with heart failure, high blood pressure and stroke, diabetes, and blood clots being among the leading causes of death. 3   4

In 2006, CDC officials directed doctors to give all pregnant women a flu shot 5  and, in 2011, a Tdap shot during every pregnancy, no matter how little time has elapsed between pregnancies. 6   Prior to FDA licensure, influenza, diphtheria, tetanus and pertussis vaccines were not tested in or proven safe and effective for pregnant women in large clinical trials when given during every pregnancy either singly or simultaneously. 7   8

Categorized by FDA as Pregnancy Category B and C biologicals 9   because it is not known whether the vaccines are genotoxic and can cause fetal harm or can affect maternal fertility and reproduction, administering influenza and Tdap vaccines to pregnant women is an off-label use of these vaccines. 10   11   12   It is a policy that assumes maternal vaccination is necessary, safe and effective without proving it. 13


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AquaBounty has been working on approval for the genetically-modified fish for 20 years

CBC News Posted: Nov 19, 2015 11:27 AM ATLast Updated: Nov 20, 2015 3:25 PM AT

Media placeholder

 AquaBounty’s salmon are genetically modified to grow twice as fast as regular salmon. (AquaBounty Technologies)

Genetically-modified salmon approved by FDA 2:25

A genetically modified salmon that grows at twice the rate of regular salmon has been approved as food by the U.S. Food and Drug Administration.

The eggs for the salmon are raised in a facility in the eastern P.E.I. community of Bay Fortune and exported to Panama, where they’re grown in above-ground tanks.

This is the first genetically modified food animal approved for sale in the world.

“The FDA has thoroughly analyzed and evaluated the data and information submitted by AquaBounty Technologies regarding AquAdvantage Salmon and determined that they have met the regulatory requirements for approval, including that food from the fish is safe to eat,” said Bernadette Dunham, director of the FDA’s Center for Veterinary Medicine, in a news release.

The Massachusetts-based company AquaBounty Technologies first sought approval for its salmon 20 years ago.

In a news release, the company’s CEO Ron Stotish called the product, AquAdvantage Salmon a “game-changer.”



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Say Goodbye to Medical Curcumin!


The FDA continues its war on the compounding of custom medications by eliminating even more dietary ingredients. Action Alert! 

Curcumin is the most important ingredient of the Indian herb turmeric. You probably have it in your kitchen as a yellow spice.

From a health standpoint, this herb is a miracle. It is tremendously anti-inflammatory and has so many health benefits it would take a book to list them all.

Naturally the drug industry wishes it could be patented as a drug. That won’t happen, because natural foods generally cannot be patented. FDA to the rescue! The agency has just ruled that curcumin cannot be used in a compounded medication—that is in a medication prepared just for you by a specialized pharmacy.

That at least knocks out one source of competition for standard anti-inflammatory drugs. And the agency doesn’t seem to care that those same standard anti-inflammatory drugs have been shown to be dangerous.

Unfortunately, it isn’t just curcumin that has been banned.

A few months ago, we noted that the FDA’s Pharmacy Compounding Advisory Committee (PCAC) was a stacked deck, and recent developments unfortunately prove this observation correct.

At its most recent meeting, PCAC voted on whether to include nine substances on the list of bulk drugs that may be compounded under FDA regulations following the passage of the Drug Quality and Security Act. Of these nine substances, only one was approved. We listened in on the meeting and noted that, for a majority of the substances, the committee just adopted the FDA’s recommendation.

Among those that were rejected, curcumin stands out—but so does MSM, another almost magical anti-inflammatory with few if any side effects. There are others as well. Here is a short rundown of the major supplements and drugs that the Committee voted to ban:


Despite robust clinical evidence that curcumin is safe, with superb and well demonstrated anti-inflammatory characteristics, PCAC voted to not allow curcumin onto the FDA’s bulk drug list.

One of the reasons stated for voting not to include curcumin was that it could still be acquired as a dietary supplement. This entirely misses the point of compounded medications and individualized medicine!

Compounded medicine is for segments of the population that have special needs and require nutrients to be delivered in specific ways—for instance, smaller pills, or gluten-free pills, or time-release capsules, or creams that are not offered commercially. Compounding pharmacies are the only way these patients can get access to the nutrients and medications they require. Stating that a substance can still be obtained in supplement form betrays what we suspected all along—that many members of PCAC do not understand what compounding is or why it is important.

Nor is this all. When the FDA grants a monopoly to a drug company to make a drug, it comes in a one-size-fits-all form—which is sometimes completely wrong for the substance. For example, some hormones should never be delivered in pill form: they are destroyed in the intestinal tract or taken out by the liver before they can do you any good. These particular hormones should only be delivered by cream, which compounding pharmacies can create. But drug companies couldn’t care less about the needs of individual patients, because they want to sell pills.

Methylsulfonylmethane (MSM)

MSM is a natural sulfur compound found in fruits and vegetables. Studies have shown that MSM reduces pain related to arthritis with no significant side effects. It also can stop even the most severe allergies in their tracks. If you suffer from seasonal allergies, this substance could be exactly what your body needs to stop it.

Could PCAC and the FDA be trying to clear the market for Big Pharma’s arthritis drugs? Why else would they vote to eliminate this natural substance from compounding?


This substance has exhibited anticancer and antiviral properties, but there is no mystery as to why it was voted down. It is currently being studied by a drug company as a possible drug, so the FDA is no doubt protecting the pharmaceutical company looking into the substance.


Integrative doctors we spoke with use this as an antiviral agent, especially for hepatitis. It does have to be used carefully under medical supervision, but in this case has been banned from prescribed medical use.


This drug has been useful for treating gastroesophageal reflux disease with minimal serious side effects.

This is only the latest assault on compounding. Last month we reported that a number of bioidentical hormones had been nominated to the “Demonstrably Difficult to Compound” list, an attempt to further limit the substances that may be compounded under current law.

By using bogus reasoning to whittle down what ingredients can be used in compounding, the FDA is once again doing the bidding of the very companies the agency is supposed to be regulating—and thereby preventing consumers from getting the medications they need.

Action Alert! Write to the FDA and urge them to reconsider their rejection of these ingredients to the bulk drug list. Please send your message immediately.



Other articles in this week’s Pulse of Natural Health:

New Research BANNED on Medical Food and Supplements?

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Food Poisoning Bulletin

Rhino dietary supplements are being recalled because they contain undeclared drugs and may be a health hazard. FDA analysis found that the products contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase PDE-5 inhibitor, a class of drugs used to treat male erectile dysfunction, making these products unapproved new drugs. Dapoxetine is an active ingredient not approved by the U.S. Food and Drug Administration (FDA). No reports of adverse effects have been received to date.

Desmethyl carbondenafil can interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to life-threatening levels. Dapoxetine has not been approved for use by the FDA. This chemical is an SSRI used to treat depression, which can increase the risk of suicidal thinking and ideation in children, young adults, and adolescents.


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Natural Blaze

Top Dangerous Vaccine Adjuvant Will Be Used for Elderly Flu Vaccinations

Posted on October 12, 2015


By Paul Fassa

The FDA has granted fast track approval for Swiss based Novartis’s flu shot that contains squalene as an adjuvant  to boost what they consider an immune response.

Fast track approval is normally reserved for crucial emergencies during vaccine shortages. You might be aware that there is no shortage of flu vaccines and most hyped flu epidemics are bogus. (Source below, No More Fake News)

But what they call an immune response is mostly a localized cytokine response to toxic adjuvants and preservatives. But the process of creating a cellular memory to defend against future viral attacks is usually bypassed by vaccinating.

That’s why getting a viral disease and recovering or even being exposed to one without falling ill grants lifetime immunity, and that’s how true “herd immunity” can occur.

Squalene was used for troop anthrax vaccinations during the Gulf War and has been associated with Gulf War Syndrome that affected thousands of American soldiers during the Gulf War, many of whom died from that alone, exceeding combat fatalities.


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K-9 Kraving Dog Food is voluntarily recalling their Chicken Patties Dog Food because it may be contaminated with Salmonella and Listeria monocytogenes bacteria. No illnesses have been reported to date, although listeriosis, the illness caused by Listeria bacteria, can take up to 70 days to manifest.

Puppy Eating Dog Food


The recalled product was shipped between July 13 and July 17, 2015 and distributed to retail stores only in Maryland. No other K-9 Kraving Dog Food products are affected by this recall.

Pets can be sickened with Salmonella and Listeria bacteria, and there is a risk to people handling contaminated pet products. Pets with Salmonella infections may be lethargic and have diarrhea that may be bloody, abdominal cramps, and fever. A Listeria monocytogenes infection in dogs can cause lack of appetite, diarrhea, vomiting, high fever, and excessive drooling. If left untreated, a Listeria infection in a dog can lead to paralysis and brain swelling. If your dog has been sick and you have fed him this product, see your veterinarian.


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Explosive: The real reason Holistic Doctors are being killed and vanishing!


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Erin Elizabeth at Health Nut News



15 ambulances and 1 helicopter along with 160 rescue crew were brought in when tragedy struck at the holistic conference.

We wanted to give an update from last week when we broke the story to the health community about the holistic doctors & practitioners being poisoned at the recent holistic conference in Germany.

Holistic doctors & practitioners poisoned at conference

Even though Snopes did yet another piece about us and a few tried to dispute the doctors being  “poisoned” claim: We chose that word in the headline since that’s the exact word the local GERMAN news sources used in their headlines in their article where this horrific scene took place.


The woman who rented the space out to the practitioners also did a video interview where she said (from our translator’s best interpretation) that some were homeopaths and some psychologists. (Other articles have stated some were doctors) Semantics aren’t really important to us so whether they were homeopaths, naturopaths, psychologists or doctors? We know they were holistic and that’s what counts to us in this story.


We were able to obtain a copy of the local German paper with an update.  We had some people saying that those in attendance announced that they took this 2-ce drug (which caused some to be in “life threatening situations” (according to mainstream news) willingly, but actually- this is what the German paper said.

We would still take this with a grain of salt.


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Food Poisoning Bulletin

lifefit-recallLifeFit dietary supplement is being recalled because it contains an undeclared controlled substance that was banned in 2010 for safety reasons. Consumers who have purchased this product should not use it as it poses a serious health threat.

Bacai, LifeFit’s distrbuter, is voluntarily recalling the product sold in plastic bottles of 30 softgels with the lot number 13165. The lot number is located next to the expiration date May 2017. It was distributed worldwide to wholesalers, retailers, and through the internet.

An analysis by the U.S. Food and Drug Administration (FDA) found that the product contains sibutramine, which causes substantial increase in blood pressure and/or pulse rate. This can pose a  in significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. The drug can also cause a life-threatening situation if taken with other medications.



Meridia (sibutramine): Market Withdrawal Due to Risk of Serious Cardiovascular Events

[Posted 10/08/2010]

AUDIENCE: Primary Care, Consumers

ISSUE: Abbott Laboratories and FDA notified healthcare professionals and patients about the voluntary withdrawal of Meridia (sibutramine), an obesity drug, from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke.

BACKGROUND: Meridia was approved November 1997 for weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks for heart disease. The approval was based on clinical data showing that more people receiving sibutramine lost at least 5 percent of their body weight than people on placebo who relied on diet and exercise alone. FDA has now requested market withdrawal after reviewing data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). SCOUT is part of a postmarket requirement to look at cardiovascular safety of sibutramine after the European approval of the drug. The trial demonstrated a 16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped, and death, in a group of patients given sibutramine compared with another given placebo. There was a small difference in weight loss between the placebo group and the group that received sibutramine.

RECOMMENDATION: Physicians are advised to stop prescribing Meridia to their patients, and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs.


[10/08/2010 – Drug Safety Communication – FDA]
[10/08/2010 – Questions and Answers – FDA]
[10/08/2010 – News Release – FDA]

Previous MedWatch Alert:

[01/21/2010 – Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review]



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The Center for Food Safety is warning the public that the EPA is set to approve the direct spraying of the herbicide 2,4-dichlorophenoxyacetic acid (2,4-D) on Dow Chemical’s genetically engineered corn and soybeans. That chemical is one-half of the compound called “Agent Orange” used in Vietnam to destroy foliage; it caused cancer among Vietnam veterans. EPA will render a decision after a 30 day comment period. Dow developed the GE crops, known as “Enlist”, to withstand high doses of 2,4-D (which it also sells) after its disastrous Roundup Ready crops created glyphosate-resistant superweeds.

Crop DustingYou can sign a petition opposing this action at CFS web site called “Dow Watch”. CFS opposes this move by the EPA because they state, “wide scale use of herbicides in tandem with GE crops has led to an epidemic of herbicide resistant weeds, and the next step in the chemical arms race is Dow Chemical’s 2,4-D, a chemical linked to major health problems including cancer, Parkinson’s disease, endocrine disruption, and reproductive problems.”


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​EPA advances approval of powerful weed killer for Dow’s ‘Agent Orange’ GMO crops

Published time: May 02, 2014 00:56
Edited time: May 03, 2014 14:35

Reuters / Doug Wilson / USDA
Photo / Handout

Reuters / Doug Wilson / USDA Photo / Handout

The US Environmental Protection Agency has revealed a proposal for mass use of Dow Chemical’s herbicide 2,4-D on the company’s genetically-engineered corn and soybeans. The GE crops were developed to withstand several herbicides, including 2,4-D.

Dow would be allowed to sell the herbicide if the EPA approves it following a 30-day public comment period.

The 2,4-D chemical, combined with glyphosate, makes up the herbicide Enlist Duo. 2,4-D also makes up half of the toxic mix in the now infamous ‘Agent Orange,’ used by the United States during the Vietnam War, which is thought to have resulted in the deaths of an estimated 400,000 people and birth defects in 500,000 others.

Dow’s genetically-engineered corn and soybeans – known as Enlist – have received preliminary approval from the US Department of Agriculture. Should Enlist crops win ultimate authorization, the USDA said that would increase the annual use of 2,4-D (2,4-dichlorophenoxyacetic acid) in the United States from 26 million pounds per year to possibly 176 million pounds.

The crops are designed to withstand high doses of glyphosate – brought to market by biotech giant Monsanto as their Roundup weed killer – and 2,4-D. Dow’s corn and soybeans thus earned the derogatory name ‘Agent Orange’ crops by opponents of both the highly-toxic chemical mix and the controversial use of genetically-modified organisms (GMOs) in large-scale agriculture.


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Pet treats found contaminated with heavy metals – Health Ranger releases shocking data on lead, mercury and cadmium in dog and cat treats



Monday, April 21, 2014
by Mike Adams, the Health Ranger

(NaturalNews) My food science research in the Natural News Forensic Food Labs has turned up yet another alarming discovery… and this time, it’s about pet treats that may be poisoning your dogs and cats with toxic heavy metals.

Over the last several months, I’ve been testing popular brands of pet treats sold by retailers like Amazon.com, and what I found is downright alarming:

• An astonishing 1.8 ppm of lead in Mundy Rawhide Gourmet Dog Treats made by a company called Cadet. The treats are made in China and labeled “NOT FOR HUMAN CONSUMPTION.”

• A startling 6 ppm of cadmium found in “Red Shrimp” reptile treats made by Zoo Med.

• A shocking level of mercury — over 0.5 ppm found in “Ocean Whitefish” cat treats made by PureBites and labeled “100% natural” and “made in the USA.”

• Over 1.5 ppm lead found in “Natural Rawhide Rings” dog treats from a company called PetSafe. The product package says “Protect. Teach. Love.” and is made in Taiwan.

See the full results right now for over 16 products at the Natural News Forensic Food Labs results page.

All results were achieved via ICP-MS laboratory testing that I conducted myself, using EPA-approved methodology variations. The Natural News Forensic Food Lab is in the process of achieving ISO 17025 accreditation.

Watch out! You may be poisoning your pet

What these results show is that high levels of toxic heavy metals are commonly found in pet treats. Even worse, these heavy metals are invisible to the human eye, and because they aren’t labeled on products, there’s no way to know how much lead, mercury, cadmium or arsenic you may be unintentionally feeding to your pet.

The picture on the right shows chew sticks that contain alarmingly high levels of lead, but you don’t see the lead in the photo, do you?

Shockingly, manufacturers never disclose heavy metals content on product labels, and retailers almost never test for heavy metals. To my knowledge, Natural News Store is the only retailer in the world that tests everything we sell for heavy metals. Amazon.com never tests what it sells, and don’t expect other retailers to, either.

See the PetSafe natural rawhide rings on the left? They’re made in Taiwan from rawhide, sorbitol and potassium sorbate. But they also contain over 1.5 ppm of lead.

Just to give you an idea of what that really means, just one rawhide ring weighing 8 grams would expose your dog to over 24 times the daily lead limit set by California Proposition 65. That’s almost a month’s worth of lead in a single pet treat.

See the full results right now at the Natural News Forensic Food Labs results page, where more than 16 pet treats are detailed.

Contaminated pet treats can kill your favorite dog or cat

Contaminated pet treats can kill your dogs or cats. The FDA openly warns about this on its website(1), saying:

Since 2007, FDA has become aware of an increasing number of illnesses in pets associated with the consumption of jerky pet treats. As of September 24, 2013, FDA has received approximately 3000 reports of pet illnesses which may be related to consumption of the jerky treats. Most of the reports involve jerky products sourced from China. The majority of the complaints involve dogs, but cats also have been affected. The reports involve more than 3600 dogs, 10 cats and include more than 580 deaths.

Over the years, thousands of family pets have been killed by contaminated pet treats, and more deaths will occur until this industry is required to meet stringent quality standards.

Sadly, the FDA still has no limits on heavy metals in pet treats or pet food, so a company can legally manufacture pet treats containing almost any level of heavy metal toxins while legally selling that product at Amazon.com or your favorite pet store.

The USDA, similarly, has no limits on heavy metals in certified organic pet food. So even “organic” pet foods and treats can contain extremely toxic levels of heavy metals while being certified organic by the U.S. government.

And while heavily-contaminated pet treats can kill your pet in a matter of hours or days, pet treats with sub-acute levels of heavy metals can still cause long-term chronic poisoning over time, where the heavy metals build up with each cumulative exposure.

Are there any pet treats with low heavy metals?

Yes! In fact, my laboratory research was able to verify that the “Real Meat Healthy Gourmet Dog & Puppy Treats” product made by the Real Meat Company(2) was remarkably low in heavy metals, registering zero cadmium, mercury and arsenic while showing only a tiny trace of lead.


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