2017: Let’s Win Some More

Looking ahead, here’s what we hope to accomplish by all working together.

Stop FDA’s Current Attempt to Eliminate New and Better Supplements

You can read our full coverage of the issue here. Simply put, the FDA has mangled Congress’s original intent when it enacted in the Dietary Supplement Health and Education Act of 1994 (DSHEA), imposing what is in reality a pre-approval process on all supplements developed or modified since 1994. If the FDA’s NDI (New Dietary Ingredient, i.e., new supplement) “guidance” stands, thousands of supplements will be eliminated from the market. We must not allow this.

(As our readers know, supplements are not drugs. Being natural foods, they cannot be patented. No company can spend billions for FDA approval as drugs. They are already regulated, are the safest thing we consume, and the FDA has the power to remove any one of them from the market. Who will be helped if supplements cost $100 a bottle or require a prescription? Only drug companies, of course.)

Break Up the FDA

Winning the NDI battle isn’t enough. The FDA, as currently structured, is not fit to regulate either food or supplements. It dances to the tune of the drug companies, which directly pay its bills.

The FDA controls over a quarter of the American economy, but it is deeply corrupt and incompetent. The first step is to break it up into a food and supplements agency and a drug agency. This is the only way to ensure that the sale of healthy food and supplement products are promoted by the regulators rather than censored and blocked at every turn.

The people in charge of regulating drugs should not call the shots for food and supplements. This is the tail wagging the dog. But it is exactly what we have today.

Make the FDA a Safety Watchdog Once Again

We took a wrong turn with the Kefauver-Harris Amendment to the Food, Drug, and Cosmetic Act and its later add-ons. Prior to that legislation in 1962, the FDA was charged with ensuring safety. Afterward, it had to approve effectiveness as well. This was well intended, but completely unrealistic.

Congressional auditors agree that the agency is not competent to decide on effectiveness. It never will be. It relies on outside experts, but these experts are too often bought and paid for by industry—or else they want to preserve their own lucrative medical practices by preventing new drugs, technologies, or procedures. Let the FDA concentrate on safety. Then let the medical profession work out effectiveness.

Just Say No to (Prescription) Drugs

Building a healthier America also requires breaking the stranglehold that Big Pharma has on healthcare in this country. In earlier articles, we suggested that Americans have become addicted to legal drugs that often offer more harm than benefit. We will continue to report on the dangers of pharmaceutical drugs, including opioids, antidepressants, statins, acid blockers, and so many more.

Just read the inserts of most drugs today: most have alarming side effects; most have never been tested on the young or the old; and many are simply not effective. We will continue to arm consumers with the information that will allow them, in consultation with their doctor, to “just say no” to legal as well as illegal drugs.

We will also work to prevent healthy substances such as hemp extract, which can provide real pain relief, from being turned into illegal drugs for no reason other than to protect Big Pharma profits.

Preserve Customized Natural Medicines

Many of us know that individualized medicine—in which treatments and cures are tailored to an individual’s biology and genetics—is the wave of the future. High-tech, innovative testing, followed by customized, natural medicines made at a compounding pharmacy, are key components of this approach to health.

A multitude of FDA actions in the past three years threatens to wipe traditional compounding pharmacies off the map—it’s “death by a thousand cuts.” And it’s quite deliberate—just another effort to clear the field for Big Pharma’s standardized, one-size-fits-all products.

Different FDA “guidance” documents—which are very difficult to challenge—are aimed at the elimination of the traditional compounding industry. Two key areas of concern are the immediate threats to compounded bioidentical hormones and dietary supplements, because millions of consumer who rely on these products could lose them:

• Save bioidentical hormones. Several critical hormones (progesterone, progesterone with estradiol, testosterone, and estriol) have been nominated to the FDA’s “Demonstrably Difficult to Compound” list. When completed, it will be illegal to compound items on this list. This would be a tremendous blow to everyone who relies on natural hormones to stay healthy—particularly in cases where no adequate substitute exists.
• Save compounded dietary supplements. The FDA has said that, for supplements to be eligible to be compounded, they must appear on a pre-approved list. Yet the agency’s Pharmacy Compounding Advisory Committee (another stacked deck against natural medicine) has voted to reject important supplements—curcumin, boswellia, and aloe vera, to name just a few—from this list. More and more supplements will be banned from use. Intravenous vitamins and minerals are also at risk of being banned, either directly or by steps that could drive the price out of reach, which is an indirect ban.

A more comprehensive list of the various threats to the compounding industry can be found here.

We must fight to preserve the compounding industry as we know it, which means fighting the agency on each and every one of these policies through petitions, legislative action, and legal action.

Protect Vaccine Choice

It’s long been our position that reasonable questions can be asked about the safety of the current vaccination schedule. Some vaccines have dangerous adjuvants that have not been tested for safety; others do not. We believe that parents have the right to make informed decisions about the healthcare of their children. We reject laws like California’s SB 277 that take away this freedom. Children cannot be parented by the state. We will continue to fight mandatory vaccination in other states in 2017, as well as continue our legal challenge to SB 277.

Fight Crony Medical Monopolies

The Academy of Nutrition and Dietetics (AND), the American Medical Association (AMA), and the Federation of State Medical Boards (FSMB), among others, all try to exert influence on state and national policy, often to exclude practitioners whom they regard as competitors. We will continue to fight for a level playing field and oppose state-level monopolies on the practice of medicine and nutrition. We will oppose the FSMB’s efforts to control the practice of medicine in as many states as possible.

This is just a glimpse of the year ahead. We won many battles in 2016 (the subject of another article) and with your help will win even more in 2017.

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

Are GMOs the Same as Conventional Crops?

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Are GMOs the Same as Conventional Crops?

Of course not. But that is what the US government has been pretending. Action Alert!

A new study states authoritatively, in scientific terms, that GMOs (genetically modified organisms) and conventional crops are different and explains why. This is a critical first step toward making it easier for you to have a choice about whether GM (genetically modified) plants and animals will end up on your dinner table.

For years we’ve been told with a straight face by regulators that GM food is the same as natural food. But using in-depth genetic analysis, a team of researchers has revealed significant differences in plant metabolism—differences that also translate into nutrient imbalances and loss. For instance, the researchers found that GM corn had less vitamin E than its conventional counterpart.

It’s not as if the government has been entirely denying what should be obvious to anyone. There have been a few admissions from the FDA (not the USDA) over the years that genetic modification can significantly alter levels of important nutrients. The agency has also admitted that when the wrong genes are forced into plants, the plant’s ability to make normal proteins can be impeded or stopped altogether, and that this can set off a chain reaction elsewhere in the plant that can be toxic to the person who eventually eats it. But despite these admissions, we are supposed to accept that there is no fundamental difference between GMOs and traditional food!

The FDA, of course, has done (and still does) no testing of its own. It relies on manufacturer’s data. This is built on the completely faulty premise that artificially corrupting the code by putting genes in backwards or putting in genes from animals is the essentially the same as natural plant breeding. Moreover, if you go back to the inception of GMO foods, there is evidence that many or most FDA scientists disagreed with this (or at least questioned it) and sought more testing. They were simply overruled by their bosses.

“Substantial equivalence” is the crucial legal basis for the FDA’s regulatory scheme. The agency asserts that GM plants do not need any special safety assessments if the GM plant is similar enough in its nutritional composition. Note that the bar for demonstrating substantial equivalence is quite low: there is only a cursory review of industry data. Once substantial equivalence of a GM crop is demonstrated, that crop becomes for all intents and purposes GRAS (“Generally Recognized as Safe”) and no further scrutiny or safety assessment is required.

If scientists can continue to produce data showing that GM plants are NOT substantially equivalent to conventional plants, then this crony capitalist regulatory scheme run by industry may be overturned.

Action Alert! Write to the FDA and tell them to use these findings to analyze more closely whether GE crops are truly “substantially equivalent” to conventional crops. Please send your message today.

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

2017: Let’s Win Some More

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Action Alert: Tell the FDA GMOs Are Not the Same As Conventional Crops

Related article: Are GMOs the Same as Conventional Crops?

Trouble Taking Action? Click here.

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2017: Let’s Win Some More

Looking ahead, here’s what we hope to accomplish by all working together.

Stop FDA’s Current Attempt to Eliminate New and Better Supplements

You can read our full coverage of the issue here. Simply put, the FDA has mangled Congress’s original intent when it enacted in the Dietary Supplement Health and Education Act of 1994 (DSHEA), imposing what is in reality a pre-approval process on all supplements developed or modified since 1994. If the FDA’s NDI (New Dietary Ingredient, i.e., new supplement) “guidance” stands, thousands of supplements will be eliminated from the market. We must not allow this.

(As our readers know, supplements are not drugs. Being natural foods, they cannot be patented. No company can spend billions for FDA approval as drugs. They are already regulated, are the safest thing we consume, and the FDA has the power to remove any one of them from the market. Who will be helped if supplements cost $100 a bottle or require a prescription? Only drug companies, of course.)

Break Up the FDA

Winning the NDI battle isn’t enough. The FDA, as currently structured, is not fit to regulate either food or supplements. It dances to the tune of the drug companies, which directly pay its bills.

The FDA controls over a quarter of the American economy, but it is deeply corrupt and incompetent. The first step is to break it up into a food and supplements agency and a drug agency. This is the only way to ensure that the sale of healthy food and supplement products are promoted by the regulators rather than censored and blocked at every turn.

The people in charge of regulating drugs should not call the shots for food and supplements. This is the tail wagging the dog. But it is exactly what we have today.

Make the FDA a Safety Watchdog Once Again

We took a wrong turn with the Kefauver-Harris Amendment to the Food, Drug, and Cosmetic Act and its later add-ons. Prior to that legislation in 1962, the FDA was charged with ensuring safety. Afterward, it had to approve effectiveness as well. This was well intended, but completely unrealistic.

Congressional auditors agree that the agency is not competent to decide on effectiveness. It never will be. It relies on outside experts, but these experts are too often bought and paid for by industry—or else they want to preserve their own lucrative medical practices by preventing new drugs, technologies, or procedures. Let the FDA concentrate on safety. Then let the medical profession work out effectiveness.

Just Say No to (Prescription) Drugs

Building a healthier America also requires breaking the stranglehold that Big Pharma has on healthcare in this country. In earlier articles, we suggested that Americans have become addicted to legal drugs that often offer more harm than benefit. We will continue to report on the dangers of pharmaceutical drugs, including opioids, antidepressants, statins, acid blockers, and so many more.

Just read the inserts of most drugs today: most have alarming side effects; most have never been tested on the young or the old; and many are simply not effective. We will continue to arm consumers with the information that will allow them, in consultation with their doctor, to “just say no” to legal as well as illegal drugs.

We will also work to prevent healthy substances such as hemp extract, which can provide real pain relief, from being turned into illegal drugs for no reason other than to protect Big Pharma profits.

Preserve Customized Natural Medicines

Many of us know that individualized medicine—in which treatments and cures are tailored to an individual’s biology and genetics—is the wave of the future. High-tech, innovative testing, followed by customized, natural medicines made at a compounding pharmacy, are key components of this approach to health.

A multitude of FDA actions in the past three years threatens to wipe traditional compounding pharmacies off the map—it’s “death by a thousand cuts.” And it’s quite deliberate—just another effort to clear the field for Big Pharma’s standardized, one-size-fits-all products.

Different FDA “guidance” documents—which are very difficult to challenge—are aimed at the elimination of the traditional compounding industry. Two key areas of concern are the immediate threats to compounded bioidentical hormones and dietary supplements, because millions of consumer who rely on these products could lose them:

• Save bioidentical hormones. Several critical hormones (progesterone, progesterone with estradiol, testosterone, and estriol) have been nominated to the FDA’s “Demonstrably Difficult to Compound” list. When completed, it will be illegal to compound items on this list. This would be a tremendous blow to everyone who relies on natural hormones to stay healthy—particularly in cases where no adequate substitute exists.
• Save compounded dietary supplements. The FDA has said that, for supplements to be eligible to be compounded, they must appear on a pre-approved list. Yet the agency’s Pharmacy Compounding Advisory Committee (another stacked deck against natural medicine) has voted to reject important supplements—curcumin, boswellia, and aloe vera, to name just a few—from this list. More and more supplements will be banned from use. Intravenous vitamins and minerals are also at risk of being banned, either directly or by steps that could drive the price out of reach, which is an indirect ban.

A more comprehensive list of the various threats to the compounding industry can be found here.

We must fight to preserve the compounding industry as we know it, which means fighting the agency on each and every one of these policies through petitions, legislative action, and legal action.

Protect Vaccine Choice

It’s long been our position that reasonable questions can be asked about the safety of the current vaccination schedule. Some vaccines have dangerous adjuvants that have not been tested for safety; others do not. We believe that parents have the right to make informed decisions about the healthcare of their children. We reject laws like California’s SB 277 that take away this freedom. Children cannot be parented by the state. We will continue to fight mandatory vaccination in other states in 2017, as well as continue our legal challenge to SB 277.

Fight Crony Medical Monopolies

The Academy of Nutrition and Dietetics (AND), the American Medical Association (AMA), and the Federation of State Medical Boards (FSMB), among others, all try to exert influence on state and national policy, often to exclude practitioners whom they regard as competitors. We will continue to fight for a level playing field and oppose state-level monopolies on the practice of medicine and nutrition. We will oppose the FSMB’s efforts to control the practice of medicine in as many states as possible.

This is just a glimpse of the year ahead. We won many battles in 2016 (the subject of another article) and with your help will win even more in 2017.

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

Are GMOs the Same as Conventional Crops?

from The Alliance for Natural Health http://ift.tt/2hPd5ws via Aloe for Health
from Tumblr http://ift.tt/2iAlYZq

Are GMOs the Same as Conventional Crops?

Of course not. But that is what the US government has been pretending. Action Alert!

A new study states authoritatively, in scientific terms, that GMOs (genetically modified organisms) and conventional crops are different and explains why. This is a critical first step toward making it easier for you to have a choice about whether GM (genetically modified) plants and animals will end up on your dinner table.

For years we’ve been told with a straight face by regulators that GM food is the same as natural food. But using in-depth genetic analysis, a team of researchers has revealed significant differences in plant metabolism—differences that also translate into nutrient imbalances and loss. For instance, the researchers found that GM corn had less vitamin E than its conventional counterpart.

It’s not as if the government has been entirely denying what should be obvious to anyone. There have been a few admissions from the FDA (not the USDA) over the years that genetic modification can significantly alter levels of important nutrients. The agency has also admitted that when the wrong genes are forced into plants, the plant’s ability to make normal proteins can be impeded or stopped altogether, and that this can set off a chain reaction elsewhere in the plant that can be toxic to the person who eventually eats it. But despite these admissions, we are supposed to accept that there is no fundamental difference between GMOs and traditional food!

The FDA, of course, has done (and still does) no testing of its own. It relies on manufacturer’s data. This is built on the completely faulty premise that artificially corrupting the code by putting genes in backwards or putting in genes from animals is the essentially the same as natural plant breeding. Moreover, if you go back to the inception of GMO foods, there is evidence that many or most FDA scientists disagreed with this (or at least questioned it) and sought more testing. They were simply overruled by their bosses.

“Substantial equivalence” is the crucial legal basis for the FDA’s regulatory scheme. The agency asserts that GM plants do not need any special safety assessments if the GM plant is similar enough in its nutritional composition. Note that the bar for demonstrating substantial equivalence is quite low: there is only a cursory review of industry data. Once substantial equivalence of a GM crop is demonstrated, that crop becomes for all intents and purposes GRAS (“Generally Recognized as Safe”) and no further scrutiny or safety assessment is required.

If scientists can continue to produce data showing that GM plants are NOT substantially equivalent to conventional plants, then this crony capitalist regulatory scheme run by industry may be overturned.

Action Alert! Write to the FDA and tell them to use these findings to analyze more closely whether GE crops are truly “substantially equivalent” to conventional crops. Please send your message today.

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

2017: Let’s Win Some More

from The Alliance for Natural Health http://ift.tt/2iAirKz via Aloe for Health
from Tumblr http://ift.tt/2hP4TfB

Action Alert: Tell the FDA GMOs Are Not the Same As Conventional Crops

Related article: Are GMOs the Same as Conventional Crops?

Trouble Taking Action? Click here.

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from Tumblr http://ift.tt/2iAlYIU

Top Medical Crony to Be Retained by Trump Administration?

Keeping Francis Collins as director of the National Institutes for Health (NIH) would send exactly the wrong message. Action Alert!

Right now, the federal government subsidizes the pharmaceutical industry, then grants it legally enforced monopolies which allow it to charge insane prices on those subsidized drugs, then buys the drugs in huge quantities at those same inflated prices. No wonder the industry is so profitable and has so much money to lobby Congress and contribute to political campaigns!

Powerful GOP legislators seem to like these arrangements just fine. And they have now asked President-elect Trump to retain the Obama administration’s director of the National Institutes for Health (NIH)—who, based on his history, will keep the good times rolling for Big Pharma.

In a letter to the president-elect, outgoing House and Energy Commerce chair Fred Upton (R-MI), Senate health committee chair Lamar Alexander (R-TN), and the two chairs of the appropriations committees that oversee NIH—Sen. Roy Blunt (R-MO) and Rep. Tom Cole (R-OK)—urged Trump to keep Francis Collins as director of NIH.

Rep. Upton and Sen. Alexander were instrumental in passing the 21st Century Cures Act (which was signed into law last week). It is, in effect, another big gift to Big Pharma to subsidize the development of new drugs. As we discuss elsewhere in this week’s Pulse, one of the major functions of NIH is to funnel taxpayer dollars into drug research that is then handed over to pharmaceutical companies. Since the 1930s, NIH has invested $900 billion in the basic and applied research that formed both the pharmaceutical industry and the biotech industry; 75% of the most innovative drugs originated from NIH funding.

Under Collins, NIH launched an “unprecedented” partnership with ten pharmaceutical companies. One of the director’s main areas of focus at the agency has been “translational science”—essentially, turning theoretical research into profitable products for the drug industry. In a paper he wrote, Collins bemoans the “triple frustrations of long timelines, steep costs, and high failure rate” blocking more new drugs coming to market. To further assist Big Pharma, he started the National Center for Advancing Translational Science (NCATS). Among NCATS’ priorities is “de-risking” drug development. In plain English, this means that taxpayer dollars are going into research that drug companies don’t want to pay for, because research is risky and often fails.

What else is NCATS using taxpayer money for? One of their most recent news releases concerns research into identifying what combination of drugs can treat antibiotic-resistant infections. As we’ve reported before, this defies logic: bacteria will become resistant to those drugs, and the cycle will continue. Natural remedies are not discussed, presumably because they can’t be patented and therefore lack profit potential for the drug industry.

Another initiative championed by Collins’s NCATS institute? Space medicine! This isn’t a joke. Apparently Collins thinks it’s a research priority to study “the effects of a microgravity environment on the human body.”

We don’t think Collins is a bad person. But he is caught up in—and now exemplifies—a thoroughly rotten system. We need a new and different director at NIH.

Action Alert! Urge the Trump transition team to appoint a new director of NIH. Please send your message immediately.

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

Should Big Pharma Be on Your Holiday Gift List?

EPA Changes Its Tune on Fracking

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